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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001548-36 | EudraCT Number |
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This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipatasertib + Paclitaxel | Experimental |
| |
| Placebo + Paclitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipatasertib | Drug | Ipatasertib, 400 milligrams (mg), administered orally once a day (QD) on Days 1-21 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A: Progression-Free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined locally by the investigator through the use of Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), or death from any cause, whichever occurred first, assessed up to 27 months for this outcome measure. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. | From randomization up to 27 months |
| Cohort B: PFS | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurred first, assessed up to 24.4 months for this outcome measure. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Abbreviation used in statistical analysis: PI3K=phosphoinositide 3-kinase and mTOR=mammalian target of rapamycin inhibitor. | From randomization up to 24.4 months |
| Cohort C: PFS | PFS for Cohort C was defined as the time from enrollment to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurred first, assessed up to 31 months for this outcome measure. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A and B: Objective Response Rate (ORR) | ORR was defined as percentage of participants with partial response (PR) or complete response (CR) on 2 consecutive occasions ≥4 weeks apart as determined by the investigator using RECIST v.1.1, assessed up to 27 months for Cohort A and up to 24.4 months for Cohort B, for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Percentages are rounded off to the nearest decimal point. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Moores Cancer Center | La Jolla | California | 92093 | United States | ||
| USC Norris Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34860318 | Derived | Turner N, Dent RA, O'Shaughnessy J, Kim SB, Isakoff SJ, Barrios C, Saji S, Bondarenko I, Nowecki Z, Lian Q, Reilly SJ, Hinton H, Wongchenko MJ, Kovic B, Mani A, Oliveira M. Ipatasertib plus paclitaxel for PIK3CA/AKT1/PTEN-altered hormone receptor-positive HER2-negative advanced breast cancer: primary results from cohort B of the IPATunity130 randomized phase 3 trial. Breast Cancer Res Treat. 2022 Feb;191(3):565-576. doi: 10.1007/s10549-021-06450-x. Epub 2021 Dec 3. |
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Participants with TNBC or hormone receptor positive(HR+)/human epidermal growth factor receptor 2 negative(HER2-) breast adenocarcinoma with phosphatidylinositol-4,5-bisphosphate3-kinase,catalytic subunit, alpha(PIK3CA)/serine-threonine kinase(AKT1)/phosphatase & tensin homolog (PTEN)-altered tumor were randomized to ipatasertib 400 mg+paclitaxel or placebo+paclitaxel (Cohorts A,B) & those with TNBC without PIK3CA/ AKT1/PTEN-altered tumor received ipatasertib+atezolizumab+paclitaxel (Cohort C).
Participants with protocol specified triple-negative breast cancer (TNBC) or HR+/HER- took part in the study in the following countries: Argentina, Australia, Belgium, Brazil, Canada, Chile, Costa Rica, Czech Republic, France, Greece, Germany, Hungary, Italy, India, Japan, Macedonia, Mexico, Poland, Peru, Republic of Korea, Russian Federation, Slovenia, Spain, Singapore, South Africa, Taiwan, Turkey, Ukraine, United Kingdom, and United States from 6 January 2018 to 4 January 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A: Placebo + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 milligram per square meter (mg/m^2), intravenously (IV), on Days 1, 8, and 15 of each 28-day cycle and placebo, orally once a day (QD), on Days 1 to 21 of each 28-day cycle up to 58.9 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2022 | Jan 2, 2024 |
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| Paclitaxel | Drug | Paclitaxel, 80 mg/square meter (m^2), administered intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
|
| Placebo | Drug | Matching placebo, administered orally QD on Days 1-21 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination. |
|
| From enrollment up to 31 months |
| From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B |
| Cohort C: ORR | ORR was defined as percentage of participants with PR or CR on 2 consecutive occasions ≥4 weeks apart as determined by the investigator using RECIST v.1.1, assessed up to 31 months for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Percentages are rounded off to the nearest decimal point. | From enrollment up to 31 months |
| Cohort A and B: Duration of Response (DOR) | DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD, as determined locally by the investigator through the use of RECIST v1.1, or death from any cause, whichever occurred first assessed up to 27 months for Cohort A and up to 24.4 months for Cohort B, for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B |
| Cohort C: DOR | DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD, as determined locally by the investigator through the use of RECIST v1.1, or death from any cause, whichever occurred first, assessed up to 31 months for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | From enrollment up to 31 months |
| Cohort A and B: Clinical Benefit Rate (CBR) | CBR was defined as percentage of participants with an objective response (CR or PR), or stable disease (SD) for at least 24 weeks, as determined by the investigator through the use of RECIST v.1.1. assessed up to From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages are rounded off to the nearest decimal point. | From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B |
| Cohort C: CBR | CBR was defined as percentage of participants with an objective response (CR or PR), or SD for at least 24 weeks, as determined by the investigator through the use of RECIST v.1.1 assessed up to 31 months for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages are rounded off to the nearest decimal point. | From enrollment up to 31 months |
| Overall Survival (OS) | OS was defined as the time from randomization to death from any cause. | From randomization/ enrollment (Cohort C) up to death from any cause, up to 45 months for Cohort A, up to 46 months for Cohort B and up to 31 months for Cohort C |
| Cohort A and B: Change From Baseline in Global Health Status (GHS)/Health-Related Quality of Life (HRQoL) Score Measured by GHS/HRQoL Scale (Questions 29 and 30) of the EORTC QLQ-C30 | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is a cancer-specific instrument with 30 questions covering symptoms, functioning, and health-related quality of life (HRQoL). The participant's assessment of overall HRQoL is assessed by using the last 2 questions (29 and 30) of the instrument, with each of these items based on a 7-point scale (1=very poor to 7=excellent), which are then combined into the GHS/QoL multi-item scale. The scores obtained for each question were averaged into a raw score for the scale, and this raw score for the scale was then subsequently linearly transformed to a scale score of 0 to 100, with a high score indicating better GHS/QoL. Negative change from Baseline values in the GHS/QoL change from baseline analysis indicated deterioration in HRQoL and positive values indicated improvement. | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 (cycle length=28 days) |
| Cohort C: Change From Baseline in GHS/HRQoL Score Measured by GHS/HRQoL Scale (Questions 29 and 30) of the EORTC QLQ-C30 | EORTC QLQ-C30 is a cancer-specific instrument with 30 questions covering symptoms, functioning, and health-related quality of life (HRQoL). The participant's assessment of overall HRQoL is assessed by using the last 2 questions (29 and 30) of the instrument, with each of these items based on a 7-point scale (1=very poor to 7=excellent), which are then combined into the GHS/QoL multi-item scale. The scores obtained for each question were averaged into a raw score for the scale, and this raw score for the scale was then subsequently linearly transformed to a scale score of 0 to 100, with a high score indicating better GHS/QoL. Negative change from Baseline values in the GHS/QoL change from baseline analysis indicated deterioration in HRQoL and positive values indicated improvement. | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, and 44 (cycle length=28 days) |
| Cohort B: Time to Deterioration (TTD) in Pain | Time to deterioration in GHS/HRQoL was defined as the time from randomization to first observed ≥ 11-point increase from Baseline in pain scale score (Question 9 and 19) in EORTC QLQ-C30 linearly transformed GHS/HRQoL scale score, assessed up 24.4 months for this outcome measure. TTD was planned to be assessed only in cohort with HR+/HER2 - breast cancer participants (Cohort B). Questions 9 and 19 that assessed pain, used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). The scores were linearly transformed on a scale of 0 to 100, with higher scores indicating increased severity in symptoms. | Baseline up to 24.4 months |
| Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. | Up to 58.9 months for Cohort A, up to 59.9 months for Cohort B and up to 45.5 months for Cohort C |
| Number of Participants With at Least One Adverse Events of Special Interest (AESI) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the NCI CTCAE, Version 4.0. AESI include cases of potential drug-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law. Suspected transmission of an infectious agent by the study drug, Grade >= 3 fasting hyperglycemia, hepatotoxicity, diarrhea, rash, ALT/AST elevations. Grade >= 2 colitis/enterocolitis. | Up to 58.9 months for Cohort A, up to 59.9 months for Cohort B and up to 45.5 months for Cohort C |
| Cohorts A and B:Plasma Concentration of Ipatasertib | Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days) |
| Cohort C: Plasma Concentration of Ipatasertib | Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days) |
| Cohorts A and B: Plasma Concentration of G-037720 | G-037720 was a metabolite of ipatasertib. | Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days ) |
| Cohort C: Plasma Concentration of G-037720 | G-037720 was a metabolite of ipatasertib. | Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days ) |
| Cohort C: 1-year Event-free PFS Rate | PFS was defined as the time from enrollment to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurred first. Event-free PFS rate was defined as percentage of participants who did not experience any event and survived at 1 year after enrollment. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Percentages are rounded off to the nearest decimal point. As prespecified in the protocol, this outcome measure was applicable only to Cohort C. | From enrollment until the occurrence of disease progression or death from any cause, whichever occurred earlier, up to 1 year |
| Cohort C: 1-year Event-free OS Rate | OS was defined as the time from enrollment to death from any cause. Event-free OS rate was defined as percentage of participants who did not experience any event and survived at 1 year after enrollment. As prespecified in the protocol, this outcome measure was applicable only to Cohort C. Percentages were rounded off to the nearest decimal. | From enrollment up to death from any cause, up to 1 year |
| Cohort C: Serum Concentration of Atezolizumab | As prespecified in the protocol, this outcome measure was applicable only to Cohort C. | Day 1 of Cycle 1: 30 minutes post dose, predose on Day 15 of Cycle 1 and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length=28 days) |
| Cohort C: Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | The numbers of ADA-positive participants after drug administration were summarized for participants exposed to atezolizumab. As prespecified in the protocol, this outcome measure was applicable only to Cohort C. | Up to 45.5 months |
| Los Angeles |
| California |
| 90033 |
| United States |
| USC Norris Cancer Center; USC Oncology Hematology Newport Beach | Newport Beach | California | 92663 | United States |
| Kaiser Permanente - Oakland | Oakland | California | 94611 | United States |
| Kaiser Permanente - Roseville | Roseville | California | 95661 | United States |
| UC Davis; Comprehensive Cancer Center | Sacramento | California | 95817 | United States |
| Kaiser Permanente Sacramento Medical Center | Sacramento | California | 95825 | United States |
| Kaiser Permanente - San Francisco (2238 Geary) | San Francisco | California | 94115 | United States |
| UCSF Comprehensive Cancer Ctr | San Francisco | California | 94158 | United States |
| K. Permanente - San Jose | San Jose | California | 95119 | United States |
| Kaiser Permanente - San Leandro | San Leandro | California | 94577 | United States |
| K. Permanente - Santa Clara | Santa Clara | California | 95051 | United States |
| Kaiser Permanente - South San Francisco | South San Francisco | California | 94080 | United States |
| Kaiser Permanente - Vallejo | Vallejo | California | 94589 | United States |
| K. Permanente - Walnut Creek | Walnut Creek | California | 94596 | United States |
| Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | United States |
| UF Health Cancer Center at Orlando Health | Orlando | Florida | 32824 | United States |
| Memorial Hospital West | Pembroke Pines | Florida | 33028 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21287 | United States |
| Memorial Sloan Kettering Cancer Center at Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering | New York | New York | 10065 | United States |
| West Clinic | Germantown | Tennessee | 38138 | United States |
| Texas Oncology, P.A. | Dallas | Texas | 75246 | United States |
| UT Southwestern Medical Center; Simmons Comprehensive Cancer Center, Simmons Pharmacy | Dallas | Texas | 75390 | United States |
| Oncology Consultants PA | Houston | Texas | 77030 | United States |
| Fundación CENIT para la Investigación en Neurociencias | Buenos Aires | C1125ABD | Argentina |
| Hosp Provincial D. Centenarios; Oncology Dept | Rosario | S2002KDS | Argentina |
| Chris O'Brien Lifehouse | Camperdown | New South Wales | 2050 | Australia |
| Calvary Mater Newcastle; Medical Oncology | Waratah | New South Wales | 2298 | Australia |
| Westmead Hospital; Medical Oncology | Wentworthville | New South Wales | 2145 | Australia |
| Mater Hospital; Cancer Services | South Brisbane | Queensland | 4101 | Australia |
| Cabrini Medical Centre; Oncology | Malvern | Victoria | 3144 | Australia |
| Fiona Stanley Hospital; FSH Cancer Centre Clinical Trials Unit | Bull Creek | Western Australia | 6149 | Australia |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| GHdC Site Notre Dame | Charleroi | 6000 | Belgium |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Santa Casa de Misericordia de Salvador | Salvador | Estado de Bahia | 40050-410 | Brazil |
| Hospital Araujo Jorge; Departamento de Ginecologia E Mama | Goiânia | Goiás | 74605-070 | Brazil |
| Hospital do Câncer de Londrina | Londrina | Paraná | 86015-520 | Brazil |
| Instituto Nacional de Cancer - INCa; Oncologia | Rio de Janeiro | Rio de Janeiro | 20560-120 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Faculdade de Medicina do ABC - FMABC | Santo André | São Paulo | 09060-650 | Brazil |
| Hospital Perola Byington | São Paulo | São Paulo | 01317-000 | Brazil |
| British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Sociedad de Investigaciones Medicas Ltda (SIM) | Temuco | 4800827 | Chile |
| Clinica CIMCA | San José | 10103 | Costa Rica |
| ICIMED Instituto de Investigación en Ciencias Médicas | San José | 10108 | Costa Rica |
| Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e | Brno | 656 53 | Czechia |
| Fakultni nemocnice Olomouc; Onkologicka klinika | Olomouc | 779 00 | Czechia |
| CHU Besançon - Hôpital Jean Minjoz | Besançon | 25030 | France |
| Polyclinique Bordeaux Nord Aquitaine | Bordeaux | 33300 | France |
| Centre Georges Francois Leclerc; Oncologie 3 | Dijon | 21079 | France |
| ICM; Medecine B3 | Montpellier | 34298 | France |
| Centre Catherine De Sienne | Nantes | 44202 | France |
| APHP - Hospital Saint Louis | Paris | 75475 | France |
| Institut Jean Godinot; Oncologie Medicale | Reims | 51056 | France |
| Onkologische Schwerpunktpraxis Kurfürstendamm | Berlin | 10707 | Germany |
| Praxis Dr.med. Katja Ziegler-Löhr | Cologne | 50679 | Germany |
| Praxis für Interdisziplinäre Onkologie und Hämatologie GbR | Freiburg im Breisgau | 79110 | Germany |
| Universitätsklinikum Hamburg-Eppendorf; Frauenklinik | Hamburg | 20246 | Germany |
| Universitätsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe | Homburg/Saar | 66424 | Germany |
| Dres. Andreas Köhler und Roswitha Fuchs | Langen | 63225 | Germany |
| Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe | Minden | 32429 | Germany |
| Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie | Recklinghausen | 45659 | Germany |
| Universitätsfrauen- und Poliklinik am Klinikum Suedstadt | Rostock | 18059 | Germany |
| Universitätsklinikum Würzburg; Frauenklinik | Würzburg | 97080 | Germany |
| Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine | Athens | 115 22 | Greece |
| Agioi Anargyroi; 3Rd Dept. of Medical Oncology | Athens | 145 64 | Greece |
| Euromedical General Clinic of Thessaloniki; Oncology Department | Thessaloniki | 546 45 | Greece |
| Orszagos Onkologial Intezet; Onkologiai Osztaly X | Budapest | 1122 | Hungary |
| Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly | Miskolc | 3501 | Hungary |
| Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika | Szeged | 6720 | Hungary |
| Hetenyi Geza County Hospital; Onkologiai Kozpont | Szolnok | 5004 | Hungary |
| Zala County Hospital ICU | Zalaegerszeg | 8900 | Hungary |
| Indraprastha Apollo Hospitals | New Delhi | National Capital Territory of Delhi | 110076 | India |
| Rajiv Gandhi Cancer Inst.&Research Center; Medical Oncology | New Delhi | National Capital Territory of Delhi | 110085 | India |
| Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica | Naples | Campania | 80131 | Italy |
| Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica | Bologna | Emilia-Romagna | 40138 | Italy |
| Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| Ospedale Santa Maria Annunziata; Oncologia | Bagno a Ripoli | Tuscany | 50012 | Italy |
| IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II | Padova | Veneto | 35128 | Italy |
| Aichi Cancer Center Hospital | Aichi | 464-8681 | Japan |
| National Cancer Center Hospital East | Chiba | 277-8577 | Japan |
| National Hospital Organization Kyushu Cancer Center;Breast Oncology | Fukuoka | 811-1395 | Japan |
| Fukushima Medical University Hospital | Fukushima | 960-1295 | Japan |
| Hyogo Medical University Hospital | Hyōgo | 663-8501 | Japan |
| St. Marianna University Hospital | Kanagawa | 216-8511 | Japan |
| Kanagawa Cancer Center | Kanagawa | 241-8515 | Japan |
| Tokai University Hospital | Kanagawa | 259-1193 | Japan |
| Kumamoto Shinto General Hospital | Kumamoto | 862-8655 | Japan |
| Niigata Cancer Center Hospital | Niigata | 951-8566 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| National Hospital Organization Osaka National Hospital | Osaka | 540-0006 | Japan |
| Kinki University Hospital, Faculty of Medicine; Surgery | Osaka | 589-8511 | Japan |
| Saitama Cancer Center, Breast Oncology | Saitama | 362-0806 | Japan |
| Shizuoka Cancer Center | Shizuoka | 411-8777 | Japan |
| National Cancer Center Hospital | Tokyo | 104-0045 | Japan |
| St. Luke's International Hospital | Tokyo | 104-8560 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135-8550 | Japan |
| Showa University Hospital; Breast Surgery | Tokyo | 142-8666 | Japan |
| Centro Medico Dalinde | Mexico City | Mexico CITY (federal District) | 06760 | Mexico |
| Centro Médico Zambrano Hellion | Monterrey | Nuevo León | 66278 | Mexico |
| Merida | Investigacion Clinica | Mérida | Yucatán | 97125 | Mexico |
| CENEIT Oncologicos; DENTRO DE CONDOMINIO SAN FRANCISCO | Mexico City | 03100 | Mexico |
| Clinical Hospital; Oncology Department | Bitola | 7000 | North Macedonia |
| PHI University Clinic of Radiotherapy and Oncology; Breast malignancy | Skopje | 1000 | North Macedonia |
| PHI University Clinic of Radiotherapy and Oncology; Malignant diseases of thorax | Skopje | 1000 | North Macedonia |
| Centro Medico Monte Carmelo | Arequipa | 04001 | Peru |
| Hospital Daniel Alcides Carrion | Callao | 07021 | Peru |
| Clínica San Gabriel; Unidad de Investigación Oncológica de la Clínica San Gabriel | Lima | 15088 | Peru |
| Hospital Nacional Cayetano Heredia; Ocología; Servicio de Hematología Oncología Médica | Lima | 15102 | Peru |
| Oncosalud Sac; Oncología | Lima | 41 | Peru |
| Instituto Nacional de Enfermedades Neoplasicas | Lima | Lima 34 | Peru |
| Clinica Ricardo Palma | San Isidro | Lima 27 | Peru |
| Instituto Regional de Enfermedades Neoplasicas - IREN Norte | Trujillo | 13014 | Peru |
| Instyt. Centrum Zdrowia Matki Polki; Klinika Chirurgii Onk. Chorób Piersi z Podod. Onko Klinicznej | ?ód? | 93-338 | Poland |
| Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; III Klin. Radioter. i Chemioter. | Gliwice | 44-101 | Poland |
| Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie; Klinika Nowotworow Piersi i Chirurgii Rekonstr | Warsaw | 02-781 | Poland |
| Arkhangelsk Regional Clinical Oncology Dispensary | Arkhangelsk | Arhangelsk | 163045 | Russia |
| Moscow City Oncology Hospital #62 | Moscovskaya Oblast | Moscow Oblast | 143423 | Russia |
| Federal State Institution, Moscow Research Oncology Institute n.a. P.A. Hertzen; Oncourology | Moscow | Moscow Oblast | 125284 | Russia |
| Blokhin Cancer Research Center; Combined Treatment | Moskva | Moscow Oblast | 115478 | Russia |
| FSI Rostov research oncological institute of MoH and SD of RF; PAD | Rostov-on-Don | Rostov Oblast | 344037 | Russia |
| S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Clinical Oncology Dispensary of Ministry of Health of Tatarstan | Kazan' | Tatarstan Republic | 420029 | Russia |
| Ivanovo Regional Oncology Dispensary | Ivanovo | 153040 | Russia |
| SBIH Kaluga Region Clinical Oncology Dispensary | Kaluga | 248007 | Russia |
| National University Hospital; National University Cancer Institute, Singapore (NCIS) | Singapore | 119228 | Singapore |
| National Cancer Centre; Medical Oncology | Singapore | 168583 | Singapore |
| Institute of Oncology Ljubljana | Ljubljana | 1000 | Slovenia |
| Medical Oncology Centre of Rosebank; Oncology | Johannesburg | 2196 | South Africa |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Inha University Hospital | Incheon | 22332 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 463-707 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Provincial de Castellon; Servicio de Oncologia | Castellon | Castellon | 12002 | Spain |
| Hospital Universitario Reina Sofia; Servicio de Oncologia | Córdoba | Cordoba | 14004 | Spain |
| Hospital de Donostia; Servicio de Oncologia | Guipuzcoa | Guipuzcoa | 20014 | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia | Santiago de Compostela | LA Coruña | 15706 | Spain |
| Hospital Universitario Puerta de Hierro; Servicio de Oncologia | Majadahonda | Madrid | 28222 | Spain |
| Hospital del Mar; Servicio de Oncologia | Barcelona | 08003 | Spain |
| Vall d?Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | 08035 | Spain |
| Hospital Clinic Barcelona; Servicio de oncologia | Barcelona | 08036 | Spain |
| Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | 28034 | Spain |
| HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia | Madrid | 28050 | Spain |
| Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Seville | 41013 | Spain |
| Hospital Clinico Universitario; Oncologia | Valencia | 46010 | Spain |
| Chi Mei Medical Center Liou Ying Campus | Liuying Township | 736 | Taiwan |
| VETERANS GENERAL HOSPITAL; Department of General Surgery | Taipei | 00112 | Taiwan |
| National Taiwan Uni Hospital; General Surgery | Taipei | 100 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology | Taipei | 11259 | Taiwan |
| Ankara Bilkent City Hospital | Ankara | 06490 | Turkey (Türkiye) |
| Dicle Uni Medical Faculty; Internal Medicine | Diyarbakır | 10000 | Turkey (Türkiye) |
| Medipol University Medical Faculty; Oncology Department | Istanbul | 34214 | Turkey (Türkiye) |
| Prof. Dr. Cemil Tascioglu City Hospital; Med Onc | Istanbul | 34384 | Turkey (Türkiye) |
| Katip Celebi University Ataturk Training and Research Hospital; Oncology | Izmir | 35360 | Turkey (Türkiye) |
| Sakarya University Medical School; Medical Oncology | Sakarya | 54100 | Turkey (Türkiye) |
| Chemotherapy SI Dnipropetrovsk MA of MOHU | Dnipropetrovsk | 49102 | Ukraine |
| Kyiv City Clinical Oncological Center, Day Hospital Department for Oncological patients | Kiev | 03115 | Ukraine |
| National Cancer Institute MOH of Ukraine | Kiev | 36022 | Ukraine |
| Lviv State Oncological Regional Treatment and Diagnostic Center | Lviv | 79031 | Ukraine |
| Velindre Cancer Centre | Cardiff | CF14 2TL | United Kingdom |
| University Hospital coventry; Oncology Department | Coventry | CV2 2DX | United Kingdom |
| The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit | Glasgow | G12 0YN | United Kingdom |
| Royal Marsden Hospital - London | London | SW3 6JJ | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8BT | United Kingdom |
| Royal Stoke University Hospital | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Royal Marsden Hospital; Dept of Medical Oncology | Sutton | SM2 5PT | United Kingdom |
| FG001 | Cohort A: Ipatasertib + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 58.9 months. |
| FG002 | Cohort B: Placebo + Paclitaxel | Participants with histologically confirmed HR+ /HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and placebo, orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
| FG003 | Cohort B: Ipatasertib + Paclitaxel | Participants with histologically confirmed HR+/HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
| FG004 | Cohort C: Ipatasertib + Atezolizumab + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC without PIK3CA/AKT1/PTEN-altered tumors and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle, ipatasertib at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle, and atezolizumab 840 mg, IV, on Days 1 and 15 of each 28-day cycle up to 45.5 months. |
| Safety Evaluable Population | Safety Evaluable Population included all participants who received any amount of study treatment. Participants who were randomized (Cohorts A and B) or enrolled (Cohort C) into the study but who did not receive any study drug were not included in the Safety Evaluable Population. |
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| NOT COMPLETED |
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Intention-to-treat (ITT) Population included all randomized participants in Cohorts A and B regardless of whether the participants received the assigned treatment. For Cohort C, the ITT population consisted of all enrolled participants in Cohort C.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A: Placebo + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and placebo, orally QD, on Days 1 to 21 of each 28-day cycle up to 58.9 months. |
| BG001 | Cohort A: Ipatasertib + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 58.9 months. |
| BG002 | Cohort B: Placebo + Paclitaxel | Participants with histologically confirmed HR+ /HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and placebo, orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
| BG003 | Cohort B: Ipatasertib + Paclitaxel | Participants with histologically confirmed HR+/HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
| BG004 | Cohort C: Ipatasertib + Atezolizumab + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC without PIK3CA/AKT1/PTEN-altered tumors and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle, ipatasertib at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle, and atezolizumab 840 mg, IV, on Days 1 and 15 of each 28-day cycle up to 45.5 months. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Cohort A: Progression-Free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined locally by the investigator through the use of Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1), or death from any cause, whichever occurred first, assessed up to 27 months for this outcome measure. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. | ITT Population included all randomized participants in Cohorts A regardless of whether the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | From randomization up to 27 months |
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| Primary | Cohort B: PFS | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurred first, assessed up to 24.4 months for this outcome measure. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Abbreviation used in statistical analysis: PI3K=phosphoinositide 3-kinase and mTOR=mammalian target of rapamycin inhibitor. | ITT Population included all randomized participants in Cohort B regardless of whether the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | From randomization up to 24.4 months |
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| Primary | Cohort C: PFS | PFS for Cohort C was defined as the time from enrollment to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurred first, assessed up to 31 months for this outcome measure. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | ITT population included of all enrolled participants in Cohort C. | Posted | Median | 95% Confidence Interval | months | From enrollment up to 31 months |
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| Secondary | Cohort A and B: Objective Response Rate (ORR) | ORR was defined as percentage of participants with partial response (PR) or complete response (CR) on 2 consecutive occasions ≥4 weeks apart as determined by the investigator using RECIST v.1.1, assessed up to 27 months for Cohort A and up to 24.4 months for Cohort B, for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Percentages are rounded off to the nearest decimal point. | ITT Population included all randomized participants in Cohorts A and B regardless of whether the participants received the assigned treatment. Overall number analyzed is the number of participants with measurable disease at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B |
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| Secondary | Cohort C: ORR | ORR was defined as percentage of participants with PR or CR on 2 consecutive occasions ≥4 weeks apart as determined by the investigator using RECIST v.1.1, assessed up to 31 months for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Percentages are rounded off to the nearest decimal point. | ITT population consisted of all enrolled participants in Cohort C. | Posted | Number | 95% Confidence Interval | percentage of participants | From enrollment up to 31 months |
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| Secondary | Cohort A and B: Duration of Response (DOR) | DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD, as determined locally by the investigator through the use of RECIST v1.1, or death from any cause, whichever occurred first assessed up to 27 months for Cohort A and up to 24.4 months for Cohort B, for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | ITT Population included all randomized participants in Cohorts A and B regardless of whether the participants received the assigned treatment. Overall number analyzed is the number of participants with objective response i.e., responders. | Posted | Median | 95% Confidence Interval | months | From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B |
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| Secondary | Cohort C: DOR | DOR was defined as the time from the first occurrence of a documented OR (CR or PR) to PD, as determined locally by the investigator through the use of RECIST v1.1, or death from any cause, whichever occurred first, assessed up to 31 months for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. | ITT population consisted of all enrolled participants in Cohort C. Overall number analyzed is the number of participants with objective response i.e., responders. | Posted | Median | 95% Confidence Interval | months | From enrollment up to 31 months |
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| Secondary | Cohort A and B: Clinical Benefit Rate (CBR) | CBR was defined as percentage of participants with an objective response (CR or PR), or stable disease (SD) for at least 24 weeks, as determined by the investigator through the use of RECIST v.1.1. assessed up to From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages are rounded off to the nearest decimal point. | ITT Population included all randomized participants in Cohorts A and B regardless of whether the participants received the assigned treatment. Overall number analyzed is the number of participants with measurable disease at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to 27 months for Cohort A and up to 24.4 months for Cohort B |
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| Secondary | Cohort C: CBR | CBR was defined as percentage of participants with an objective response (CR or PR), or SD for at least 24 weeks, as determined by the investigator through the use of RECIST v.1.1 assessed up to 31 months for this outcome measure. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Percentages are rounded off to the nearest decimal point. | ITT population consisted of all enrolled participants in Cohort C. | Posted | Number | 95% Confidence Interval | percentage of participants | From enrollment up to 31 months |
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| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to death from any cause. | ITT Population included all randomized participants in Cohorts A and B regardless of whether the participants received the assigned treatment. For Cohort C, the ITT population consisted of all enrolled participants in Cohort C. | Posted | Median | 95% Confidence Interval | months | From randomization/ enrollment (Cohort C) up to death from any cause, up to 45 months for Cohort A, up to 46 months for Cohort B and up to 31 months for Cohort C |
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| Secondary | Cohort A and B: Change From Baseline in Global Health Status (GHS)/Health-Related Quality of Life (HRQoL) Score Measured by GHS/HRQoL Scale (Questions 29 and 30) of the EORTC QLQ-C30 | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is a cancer-specific instrument with 30 questions covering symptoms, functioning, and health-related quality of life (HRQoL). The participant's assessment of overall HRQoL is assessed by using the last 2 questions (29 and 30) of the instrument, with each of these items based on a 7-point scale (1=very poor to 7=excellent), which are then combined into the GHS/QoL multi-item scale. The scores obtained for each question were averaged into a raw score for the scale, and this raw score for the scale was then subsequently linearly transformed to a scale score of 0 to 100, with a high score indicating better GHS/QoL. Negative change from Baseline values in the GHS/QoL change from baseline analysis indicated deterioration in HRQoL and positive values indicated improvement. | Patient-reported outcome (PRO)-evaluable Population included all randomized (Cohorts A and B) participants who had a baseline and at least 1 postbaseline PRO assessment.Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Mean | Standard Deviation | score on scale | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24 (cycle length=28 days) |
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| Secondary | Cohort C: Change From Baseline in GHS/HRQoL Score Measured by GHS/HRQoL Scale (Questions 29 and 30) of the EORTC QLQ-C30 | EORTC QLQ-C30 is a cancer-specific instrument with 30 questions covering symptoms, functioning, and health-related quality of life (HRQoL). The participant's assessment of overall HRQoL is assessed by using the last 2 questions (29 and 30) of the instrument, with each of these items based on a 7-point scale (1=very poor to 7=excellent), which are then combined into the GHS/QoL multi-item scale. The scores obtained for each question were averaged into a raw score for the scale, and this raw score for the scale was then subsequently linearly transformed to a scale score of 0 to 100, with a high score indicating better GHS/QoL. Negative change from Baseline values in the GHS/QoL change from baseline analysis indicated deterioration in HRQoL and positive values indicated improvement. | PRO-evaluable Population for Cohort C included all enrolled participants who had a baseline and at least 1 postbaseline PRO assessment.Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Mean | Standard Deviation | score on scale | Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, and 44 (cycle length=28 days) |
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| Secondary | Cohort B: Time to Deterioration (TTD) in Pain | Time to deterioration in GHS/HRQoL was defined as the time from randomization to first observed ≥ 11-point increase from Baseline in pain scale score (Question 9 and 19) in EORTC QLQ-C30 linearly transformed GHS/HRQoL scale score, assessed up 24.4 months for this outcome measure. TTD was planned to be assessed only in cohort with HR+/HER2 - breast cancer participants (Cohort B). Questions 9 and 19 that assessed pain, used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). The scores were linearly transformed on a scale of 0 to 100, with higher scores indicating increased severity in symptoms. | ITT Population for Cohort B included as all randomized participants regardless of whether the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Baseline up to 24.4 months |
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| Secondary | Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0. | Safety Evaluable Population included all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | Up to 58.9 months for Cohort A, up to 59.9 months for Cohort B and up to 45.5 months for Cohort C |
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| Secondary | Number of Participants With at Least One Adverse Events of Special Interest (AESI) | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the NCI CTCAE, Version 4.0. AESI include cases of potential drug-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law. Suspected transmission of an infectious agent by the study drug, Grade >= 3 fasting hyperglycemia, hepatotoxicity, diarrhea, rash, ALT/AST elevations. Grade >= 2 colitis/enterocolitis. | Safety Evaluable Population included all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | Up to 58.9 months for Cohort A, up to 59.9 months for Cohort B and up to 45.5 months for Cohort C |
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| Secondary | Cohorts A and B:Plasma Concentration of Ipatasertib | PK Evaluable Population included all participants who had at least one evaluable plasma sample. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days) |
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| Secondary | Cohort C: Plasma Concentration of Ipatasertib | PK Evaluable Population included all participants who had at least one evaluable plasma sample. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days) |
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| Secondary | Cohorts A and B: Plasma Concentration of G-037720 | G-037720 was a metabolite of ipatasertib. | PK Evaluable Population included all participants who had at least one evaluable plasma sample. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days ) |
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| Secondary | Cohort C: Plasma Concentration of G-037720 | G-037720 was a metabolite of ipatasertib. | PK Evaluable Population included all participants who had at least one evaluable plasma sample. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Days 1 and 15 of Cycle 1: 1 to 3 hours post dose, and on Day 15 of Cycle 3: 2 to 4 hours post dose (cycle length= 28 days ) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cohort C: 1-year Event-free PFS Rate | PFS was defined as the time from enrollment to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurred first. Event-free PFS rate was defined as percentage of participants who did not experience any event and survived at 1 year after enrollment. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Percentages are rounded off to the nearest decimal point. As prespecified in the protocol, this outcome measure was applicable only to Cohort C. | ITT Population for Cohort C included all enrolled participants in Cohort C. | Posted | Number | 95% Confidence Interval | percentage of participants | From enrollment until the occurrence of disease progression or death from any cause, whichever occurred earlier, up to 1 year |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cohort C: 1-year Event-free OS Rate | OS was defined as the time from enrollment to death from any cause. Event-free OS rate was defined as percentage of participants who did not experience any event and survived at 1 year after enrollment. As prespecified in the protocol, this outcome measure was applicable only to Cohort C. Percentages were rounded off to the nearest decimal. | ITT Population for Cohort C included all enrolled participants in Cohort C. | Posted | Number | 95% Confidence Interval | percentage of participants | From enrollment up to death from any cause, up to 1 year |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cohort C: Serum Concentration of Atezolizumab | As prespecified in the protocol, this outcome measure was applicable only to Cohort C. | For Cohort C, PK Evaluable Population included all participants who had at least one evaluable plasma sample in Cohort C. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified time point. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | Day 1 of Cycle 1: 30 minutes post dose, predose on Day 15 of Cycle 1 and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 (cycle length=28 days) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cohort C: Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | The numbers of ADA-positive participants after drug administration were summarized for participants exposed to atezolizumab. As prespecified in the protocol, this outcome measure was applicable only to Cohort C. | For Cohort C, Safety Evaluable Population included all participants who received any amount of study treatment in cohort C. Overall number analyzed is the number of participants with an ADA assay result from at least one post-baseline sample. | Posted | Count of Participants | Participants | Up to 45.5 months |
|
|
Up to 58.9 months for Cohort A, up to 59.9 months for Cohort B and up to 45.5 months for Cohort C
All-cause Mortality: ITT Population included all randomized participants in Cohorts A and B regardless of whether the participants received the assigned treatment. For Cohort C, the ITT population consisted of all enrolled participants in Cohort C. Serious and Other Adverse Events: Safety Evaluable Population included all participants who received any amount of study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | COHORT A Placebo + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and placebo, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 58.9 months. | 41 | 87 | 20 | 87 | 82 | 87 |
| EG001 | COHORT A Ipatasertib + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 58.9 months. | 91 | 168 | 34 | 166 | 161 | 166 |
| EG002 | COHORT B Placebo + Paclitaxel | Participants with histologically confirmed HR+ /HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and placebo, orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. | 44 | 76 | 11 | 75 | 72 | 75 |
| EG003 | COHORT B Ipatasertib + Paclitaxel | Participants with histologically confirmed HR+/HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. | 78 | 146 | 30 | 145 | 141 | 145 |
| EG004 | COHORT C Ipatasertib + Atezolizumab + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC without PIK3CA/AKT1/PTEN-altered tumors and no prior systemic chemotherapy in the advanced disease setting received paclitaxel chemotherapy 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle, ipatasertib at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle, and atezolizumab 840 mg, IV, on Days 1 and 15 of each 28-day cycle up to 45.5 months. | 50 | 102 | 29 | 102 | 101 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Epiretinal membrane | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperthermia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Abscess jaw | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Emphysematous cystitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Intervertebral disc compression | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Schwannoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Tumour fistulisation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 12, 2020 | Jan 2, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C583616 | ipatasertib |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants with histologically confirmed HR+/HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months.
|
|
|
| Participants |
|
|
| Cohort A: Ipatasertib + Paclitaxel |
Participants with histologically confirmed locally advanced unresectable or metastatic TNBC with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 58.9 months. |
| OG002 | Cohort B: Placebo + Paclitaxel | Participants with histologically confirmed HR+ /HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and placebo, orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
| OG003 | Cohort B: Ipatasertib + Paclitaxel | Participants with histologically confirmed HR+/HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
|
|
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| OG001 | Cohort A: Ipatasertib + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 58.9 months. |
| OG002 | Cohort B: Placebo + Paclitaxel | Participants with histologically confirmed HR+ /HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and placebo, orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
| OG003 | Cohort B: Ipatasertib + Paclitaxel | Participants with histologically confirmed HR+/HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
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| OG001 | Cohort A: Ipatasertib + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 58.9 months. |
| OG002 | Cohort B: Placebo + Paclitaxel | Participants with histologically confirmed HR+ /HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and placebo, orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
| OG003 | Cohort B: Ipatasertib + Paclitaxel | Participants with histologically confirmed HR+/HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
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| OG002 | Cohort B: Placebo + Paclitaxel | Participants with histologically confirmed HR+ /HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and placebo, orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
| OG003 | Cohort B: Ipatasertib + Paclitaxel | Participants with histologically confirmed HR+/HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
| OG004 | Cohort C: Ipatasertib + Atezolizumab + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC without PIK3CA/AKT1/PTEN-altered tumors and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle, ipatasertib at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle, and atezolizumab 840 mg, IV, on Days 1 and 15 of each 28-day cycle up to 45.5 months. |
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| OG001 | Cohort A: Ipatasertib + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 58.9 months. |
| OG002 | Cohort B: Placebo + Paclitaxel | Participants with histologically confirmed HR+ /HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and placebo, orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
| OG003 | Cohort B: Ipatasertib + Paclitaxel | Participants with histologically confirmed HR+/HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
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| OG002 | Cohort B: Placebo + Paclitaxel | Participants with histologically confirmed HR+ /HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and placebo, orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
| OG003 | Cohort B: Ipatasertib + Paclitaxel | Participants with histologically confirmed HR+/HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
| OG004 | Cohort C: Ipatasertib + Atezolizumab + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC without PIK3CA/AKT1/PTEN-altered tumors and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle, ipatasertib at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle, and atezolizumab 840 mg, IV, on Days 1 and 15 of each 28-day cycle up to 45.5 months. |
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| OG001 | Cohort A: Ipatasertib + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 58.9 months. |
| OG002 | Cohort B: Placebo + Paclitaxel | Participants with histologically confirmed HR+ /HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and placebo, orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
| OG003 | Cohort B: Ipatasertib + Paclitaxel | Participants with histologically confirmed HR+/HER2- adenocarcinoma of the breast with PIK3CA/AKT1/PTEN alteration and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy, 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle up to 59.9 months. |
| OG004 | Cohort C: Ipatasertib + Atezolizumab + Paclitaxel | Participants with histologically confirmed locally advanced unresectable or metastatic TNBC without PIK3CA/AKT1/PTEN-altered tumors and no prior systemic chemotherapy in the advanced disease setting and who were candidates for taxane monotherapy received paclitaxel chemotherapy 80 mg/m^2, IV, on Days 1, 8, and 15 of each 28-day cycle, ipatasertib at a dose of 400 mg, administered orally QD, on Days 1 to 21 of each 28-day cycle, and atezolizumab 840 mg, IV, on Days 1 and 15 of each 28-day cycle up to 45.5 months. |
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