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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-002455-42 | EudraCT Number | ||
| 2023-505812-39-00 | EU Trial (CTIS) Number |
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This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inavolisib + Palbociclib + Fulvestrant | Experimental | Participants will receive inavolisib, palbociclib, and fulvestrant. |
|
| Placebo + Palbociclib + Fulvestrant | Placebo Comparator | Participants will receive placebo, palbociclib, and fulvestrant. Participants randomized to the placebo arm who are still deriving benefit from the study treatment will be given an optional opportunity to crossover to the inavolisib arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inavolisib | Drug | Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 or death from any cause (whichever occurs first). 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 in the 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. Data for participants without the occurrence of PD or death as of the clinical cutoff date (CCOD) were censored at the time of the last tumor assessment prior to the CCOD. Median PFS was calculated using the Kaplan-Meier methodology. | Up to 3.7 years |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response Rate (ORR) | ORR is defined as the percentage of participants with a complete response (CR) and/or partial response (PR) on at least two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is 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 is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline. |
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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 |
|---|---|---|---|---|---|---|
| Beverly Hills Cancer Center | Beverly Hills | California | 90211 | United States | ||
| Massachusetts General Hospital. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40454641 | Derived | Jhaveri KL, Im SA, Saura C, Loibl S, Kalinsky K, Schmid P, Loi S, Thanopoulou E, Shankar N, Jin Y, Stout TJ, Clark TD, Song C, Juric D, Turner NC. Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2025 Jul 10;393(2):151-161. doi: 10.1056/NEJMoa2501796. Epub 2025 May 31. | |
| 39476340 | Derived |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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A total of 325 participants with phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit, alpha isoform (PIK3CA) mutation, hormone receptor-positive, human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer were randomized in 1:1 ratio to Inavolisib+ Palbociclib + Fulvestrant (Inavo+Palbo+Fulv) arm or Placebo + Palbociclib + Fulvestrant (Pbo+Palbo+Fulv) arm in this study.
Participants took part in the study across 123 investigative centers in 28 countries. This study is still ongoing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inavo+Palbo+Fulv | Participants received inavolisib, 9 milligrams (mg), orally, once daily (QD) on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, intramuscular (IM) injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination. |
| 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 | Mar 8, 2023 | Sep 16, 2024 |
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| Placebo | Drug | Participants will receive oral placebo on Days 1-28 of each 28-day cycle. |
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| Palbociclib | Drug | Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle. |
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| Fulvestrant | Drug | Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks. |
|
| Up to approximately 6 years |
| Percentage of Participants With Best Overall Response Rate (BOR) | BOR is defined as the percentage of participants with a CR or PR, as determined by the investigator according to RECIST v1.1. CR is 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 is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline. | Up to approximately 6 years |
| Duration of Response (DOR) | DOR is defined as the time from the first occurrence of a CR or PR to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first). CR is 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 is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the 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 is also considered progression. | Up to approximately 6 years |
| Percentage of Participants With Clinical Benefit Rate (CBR) | CBR is defined as the percentage of participants with a CR, PR, and/or stable disease (SD) for at least 24 weeks, as determined by the investigator according to RECIST v1.1. CR= 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=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline. PD=at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), 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 is also considered progression. SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum in the study. | Up to approximately 6 years |
| Overall Survival (OS) | OS is defined as the time from randomization to death from any cause. | Up to approximately 6 years |
| Time to Deterioration (TTD) in Pain | TTD in pain is defined as the time from randomization to the first documentation of a ≥ 2-point increase from baseline on the "worst pain" item from the Brief Pain Inventory-Short Form (BPI-SF). BPI-SF is a self-administered questionnaire in which the participant was asked to rate severity on a 10-point scale where 0 represents 'No pain/No interference' and 10 represents 'Pain/Interference as bad as you can imagine'. A ≥2-point change is defined as clinically meaningful difference. | From randomization to first documentation of a ≥ 2-point increase (Up to approximately 6 years) |
| TTD in Physical Function (PF) | TTD in physical function is defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive cycles or initial decrease followed by death or treatment discontinuation within three weeks of last assessment in the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) PF scale (items 1-5). A ≥10-point change is defined as a clinically meaningful difference. EORTC QLQ-C30 is a cancer-specific health-related quality-of life (QoL) questionnaire with 30 questions. For the PF scale, participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest & needing help with eating, dressing, washing themselves, or using the toilet) is scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning. | Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)] |
| TTD in Role Function (RF) | TTD in Role Function is defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive cycles, or initial decrease followed by death or treatment discontinuation within three weeks of last assessment in the EORTC QLQ-C30 RF scale (items 6 and 7). A ≥10-point change is defined as clinically meaningful difference. EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. For the role functioning scale, participant responses to the 2 questions "Q6: Were you limited in doing either your work or daily activities" and "Q7: Were you limited in pursuing your hobbies or other leisure time activities" were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a low score indicating better functioning. | Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)] |
| TTD in Global Health Status (GHS) | TTD in (GHS)/health-related quality of life (HRQoL) is defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive cycles, or initial decrease followed by death or treatment discontinuation within three weeks of last assessment in the EORTC QLQ-30 GHS/HRQoL scale. A ≥10-point change is defined as clinically meaningful difference. EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to the questions regarding Global Health Status (Q29: GHS; "How would you rate your overall health during the past week?") and Quality of Life (Q30: QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better outcome. | Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)] |
| Number of Participants With Adverse Events (AEs) | An AE is an untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. | Up to approximately 6 years |
| Plasma Concentration of Inavolisib | Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days) |
| Plasma Concentration of Palbociclib | Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days) |
| Plasma Concentration of Fulvestrant | Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days) |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Sarah Cannon Research Institute / Tennessee Oncology | Chattanooga | Tennessee | 37403 | United States |
| Sarah Cannon Research Institute / Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Texas Oncology - Central South | Austin | Texas | 78731 | United States |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | United States |
| Texas Oncology - Northeast Texas | Tyler | Texas | 75702 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| Centro de Investigaciones Médicas y Desarrollo LC S.R.L | Buenos Aires | Ciudad Autónoma de BuenosAires | C1113AAE | Argentina |
| Centro Oncologico Korben | Ciudad Autonoma Buenos Aires | C1426AGE | Argentina |
| Hosp Provincial D. Centenarios | Rosario | S2002KDS | Argentina |
| Macquarie University Hospital | Macquarie Park | New South Wales | 2109 | Australia |
| Southern Medical Day Care Centre | Wollongong | New South Wales | 2500 | Australia |
| Mater Adult Hospital | South Brisbane | Queensland | 4101 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Western Health | Fitzroy | Victoria | 3065 | Australia |
| UZ Leuven Gasthuisberg | Leuven | 3000 | Belgium |
| Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil |
| Arthur J.E. Child Comprehensive Cancer Center-Calgary | Calgary | Alberta | T2N 5G2 | Canada |
| London Regional Cancer Program, London Health Sciences Centre, Baines Centre | London | Ontario | N6A 4L6 | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 1Z5 | Canada |
| Hopital du Saint Sacrement | Québec | Quebec | G1S 4L8 | Canada |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| The First Hospital of Jilin University | Changchun | 130021 | China |
| The First Affiliated Hospital, Chongqing Medical University | Chongqing | 400016 | China |
| Fujian Medical University Union Hospital | Fujian | 350001 | China |
| Sun Yet-sen University Cancer Center | Guangzhou | 510060 | China |
| Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 201315 | China |
| Hebei Medical University Fourth Hospital | Shijiazhuang | 050035 | China |
| Tianjin Cancer Hospital | Tianjin | 300060 | China |
| Hubei Cancer Hospital | Wuhan | 430079 | China |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Xi'an | 710061 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| Vejle Sygehus | Vejle | 7100 | Denmark |
| Centre Jean Perrin Centre Regional de Lutte Contre Le Cancer D auvergne | Clermont-Ferrand | 63003 | France |
| Centre Georges Francois Leclerc | Dijon | 21079 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Hopital Prive Jean Mermoz | Lyon | 69373 | France |
| Institut régional du Cancer Montpellier | Montpellier | 34298 | France |
| Institut Universitaire du Cancer de Toulouse-Oncopole | Toulouse | 31059 | France |
| Israel-Georgian Medical Research Clinic Healthycore | Tbilisi | 0112 | Georgia |
| Tbilisi Oncology Dispensary | Tbilisi | 0159 | Georgia |
| Ambulantes Tumorzentrum Spandau | Berlin | 13581 | Germany |
| Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH | Essen | 45136 | Germany |
| Nationales Centrum für Tumorerkrankungen (NCT) | Heidelberg | 69120 | Germany |
| Universitätsklinikum Mannheim | Mannheim | 68167 | Germany |
| Klinikum Mutterhaus der Borromaeerinnen gGmbH | Trier | 54290 | Germany |
| Universitätsfrauenklinik Ulm | Ulm | 89075 | Germany |
| Anticancer Hospital Ag. Savas | Athens | 115 22 | Greece |
| Univ General Hosp Heraklion | Heraklion | 711 10 | Greece |
| Euromedical General Clinic of Thessaloniki | Thessaloniki | 546 45 | Greece |
| European Interbalkan Medical Center | Thessaloniki | 570 01 | Greece |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Orszagos Onkologiai Intezet | Budapest | 1122 | Hungary |
| Uzsoki Utcai Korhaz | Budapest | 1145 | Hungary |
| Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet | Szolnok | 5004 | Hungary |
| A.O. Universitaria Di Parma | Parma | Emilia-Romagna | 43100 | Italy |
| Az. Osp. Spedali Civili | Brescia | Lombardy | 25123 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardy | 20133 | Italy |
| Ospedale Santa Maria Annunziata | Bagno a Ripoli | Tuscany | 50012 | Italy |
| IOV - Istituto Oncologico Veneto - IRCCS | Padova | Veneto | 35128 | Italy |
| National Cancer Institute IKN | Putrajaya | Federal Territory of Putrajaya | 62250 | Malaysia |
| Hospital Sultan Ismail | Johor Bahru | Johor | 81100 | Malaysia |
| Sarawak General Hospital | Sarawak | Sarawak | 93586 | Malaysia |
| Palmerston North Hospital | Palmerston North | 4442 | New Zealand |
| Narodowy Instytut Onkologii Odzia? w Gliwicach | Gliwice | 44-102 | Poland |
| Przychodnia Lekarska KOMED, Roman Karaszewski | Konin | 625000 | Poland |
| Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad | Warsaw | 02-781 | Poland |
| Centro Clinico Champalimaud | Lisbon | 1400-038 | Portugal |
| IPO do Porto | Porto | 4200-072 | Portugal |
| Moscow Clinical Scientific Center | Moscow | Moscow Oblast | 111123 | Russia |
| Blokhin Cancer Research Center | Moscow | Moscow Oblast | 115552 | Russia |
| MEDSI Clinical Hospital on Pyatnitsky Highway | Moscow | Moscow Oblast | 143422 | Russia |
| LLC Medscan | Moskva | Moscow Oblast | 119421 | Russia |
| Clinical Hospital Lapino (LLC Haven) | Yudino | Moscow Oblast | 143081 | Russia |
| Medical Clinic "AB Medical group" | Saint Petersburg | Sankt-Peterburg | 197082 | Russia |
| Volgograd Regional Clinical Oncology Dispensary | Volgograd | 400138 | Russia |
| Regional Clinical Oncology Hospital | Yaroslavl | 150040 | Russia |
| National University Hospital | Singapore | 119228 | Singapore |
| National Cancer Centre | Singapore | 168583 | Singapore |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Kyungpook National University Medical Center | Daegu | 41404 | South Korea |
| National Cancer Center | Gyeonggi-do | 10408 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | 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 |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
| Samsung Medical Center | Seoul | 6351 | South Korea |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Vall d?Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | 08035 | Spain |
| Insituto Catalán de Oncologia (ICO) | Barcelona | 08907 | Spain |
| Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico | Jaén | 23007 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Clinica Universidad de Navarra-Madrid | Madrid | 28027 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Puerta de Hierro | Madrid | 28222 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Instituto Valenciano Oncologia | Valencia | 46009 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Kaohsiung Medical Uni Chung-Ho Hospital | Kaohsiung City | 807 | Taiwan |
| Veterans General Hospital | Taipei | 00112 | Taiwan |
| National Taiwan Uni Hospital | Taipei | 100 | Taiwan |
| Koo Foundation Sun Yat-Sen Cancer Center | Taipei | 112 | Taiwan |
| Tri-Service General Hospital, Division of General Surgery | Taipei | 114 | Taiwan |
| Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | 50200 | Thailand |
| Chulabhorn Hospital | Lak Si | 10210 | Thailand |
| Songklanagarind Hospital | Songkhla | 90110 | Thailand |
| Adana Baskent University Hospital | Adana | 01120 | Turkey (Türkiye) |
| Gulhane Training and Research Hospital | Ankara | 06010 | Turkey (Türkiye) |
| Ege University Medical Faculty | Bornova, ?zm?r | 35100 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Faculty of Medicine | Istanbul | 34098 | Turkey (Türkiye) |
| Prof. Dr. Cemil Tascioglu City Hospital | Istanbul | 34384 | Turkey (Türkiye) |
| SI Institute of general&urgent surgery n/a Zaytseva V.T NAMSU | Kharkiv | Kharkiv Governorate | 61018 | Ukraine |
| Municipal Institution SubCarpathian Clinical Oncological Centre | Ivano-Frankivsk | KIEV Governorate | 76018 | Ukraine |
| Uzhhorod Central City Clinical Hospital | Uzhhorod | KIEV Governorate | 88000 | Ukraine |
| City Clinical Hospital #4 | Dnipropetrovsk | 49102 | Ukraine |
| ME Kryviy Rih Oncology Dispensary of Dnipropetrovs?k Regional Council | Kryvyi Rih | 50048 | Ukraine |
| Kyiv City Clinical Oncological Center | Kyiv | 03115 | Ukraine |
| Royal Marsden Hospital - Fulham | London | SW3 6JJ | United Kingdom |
| Mount Vernon Hospital | Northwood | HA6 2RN | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LJ | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Turner NC, Im SA, Saura C, Juric D, Loibl S, Kalinsky K, Schmid P, Loi S, Sunpaweravong P, Musolino A, Li H, Zhang Q, Nowecki Z, Leung R, Thanopoulou E, Shankar N, Lei G, Stout TJ, Hutchinson KE, Schutzman JL, Song C, Jhaveri KL. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. N Engl J Med. 2024 Oct 31;391(17):1584-1596. doi: 10.1056/NEJMoa2404625. |
| FG001 | Pbo+Palbo+Fulv | Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination. |
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS) included all participants who were randomized to receive the treatment they were assigned.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Inavo+Palbo+Fulv | Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination. |
| BG001 | Pbo+Palbo+Fulv | Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Progression-Free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 or death from any cause (whichever occurs first). 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 in the 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. Data for participants without the occurrence of PD or death as of the clinical cutoff date (CCOD) were censored at the time of the last tumor assessment prior to the CCOD. Median PFS was calculated using the Kaplan-Meier methodology. | FAS included all participants who were randomized to receive the treatment they were assigned. | Posted | Median | 95% Confidence Interval | months | Up to 3.7 years |
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| Secondary | Percentage of Participants With Objective Response Rate (ORR) | ORR is defined as the percentage of participants with a complete response (CR) and/or partial response (PR) on at least two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR is 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 is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline. | Not Posted | Sep 2031 | Up to approximately 6 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Best Overall Response Rate (BOR) | BOR is defined as the percentage of participants with a CR or PR, as determined by the investigator according to RECIST v1.1. CR is 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 is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline. | Not Posted | Sep 2031 | Up to approximately 6 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR is defined as the time from the first occurrence of a CR or PR to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first). CR is 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 is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the 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 is also considered progression. | Not Posted | Sep 2031 | Up to approximately 6 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Benefit Rate (CBR) | CBR is defined as the percentage of participants with a CR, PR, and/or stable disease (SD) for at least 24 weeks, as determined by the investigator according to RECIST v1.1. CR= 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=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), including baseline. PD=at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study (nadir), 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 is also considered progression. SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum in the study. | Not Posted | Sep 2031 | Up to approximately 6 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the time from randomization to death from any cause. | Not Posted | Sep 2031 | Up to approximately 6 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Deterioration (TTD) in Pain | TTD in pain is defined as the time from randomization to the first documentation of a ≥ 2-point increase from baseline on the "worst pain" item from the Brief Pain Inventory-Short Form (BPI-SF). BPI-SF is a self-administered questionnaire in which the participant was asked to rate severity on a 10-point scale where 0 represents 'No pain/No interference' and 10 represents 'Pain/Interference as bad as you can imagine'. A ≥2-point change is defined as clinically meaningful difference. | Not Posted | Sep 2031 | From randomization to first documentation of a ≥ 2-point increase (Up to approximately 6 years) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Physical Function (PF) | TTD in physical function is defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive cycles or initial decrease followed by death or treatment discontinuation within three weeks of last assessment in the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) PF scale (items 1-5). A ≥10-point change is defined as a clinically meaningful difference. EORTC QLQ-C30 is a cancer-specific health-related quality-of life (QoL) questionnaire with 30 questions. For the PF scale, participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest & needing help with eating, dressing, washing themselves, or using the toilet) is scored on a 4-point scale (1=Not at All to 4=Very Much). Scores are linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning. | Not Posted | Sep 2031 | Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)] | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Role Function (RF) | TTD in Role Function is defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive cycles, or initial decrease followed by death or treatment discontinuation within three weeks of last assessment in the EORTC QLQ-C30 RF scale (items 6 and 7). A ≥10-point change is defined as clinically meaningful difference. EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. For the role functioning scale, participant responses to the 2 questions "Q6: Were you limited in doing either your work or daily activities" and "Q7: Were you limited in pursuing your hobbies or other leisure time activities" were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a low score indicating better functioning. | Not Posted | Sep 2031 | Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)] | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD in Global Health Status (GHS) | TTD in (GHS)/health-related quality of life (HRQoL) is defined as the time from randomization to the first documentation of a ≥ 10-point decrease from baseline held for two consecutive cycles, or initial decrease followed by death or treatment discontinuation within three weeks of last assessment in the EORTC QLQ-30 GHS/HRQoL scale. A ≥10-point change is defined as clinically meaningful difference. EORTC QLQ-C30 is a cancer specific health-related QoL questionnaire. Participant responses to the questions regarding Global Health Status (Q29: GHS; "How would you rate your overall health during the past week?") and Quality of Life (Q30: QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better outcome. | Not Posted | Sep 2031 | Treatment: Day 1 of Cycles 1-3, then Day 1 of every other cycle until treatment discontinuation. Post-treatment: Every 8 weeks for 2 years, then every 12 weeks thereafter, to end of study (up to 6 years) (Cycle length = 28 days)] | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | An AE is an untoward medical occurrence in participant administered a pharmaceutical product & regardless of causal relationship with this treatment. An AE can therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. | Not Posted | Sep 2031 | Up to approximately 6 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Inavolisib | Pharmacokinetic (PK) evaluable population included all participants who received at least one dose of study drug, had at least one post-baseline sample, and was based on the treatment participants actually received. 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 timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram/milliliter (ng/ml) | Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Palbociclib | PK evaluable population included all participants who received at least one dose of study drug, had at least one post-baseline sample, and was based on the treatment participants actually received. 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 timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/ml | Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentration of Fulvestrant | PK evaluable population included all participants who received at least one dose of study drug, had at least one post-baseline sample, and was based on the treatment participants actually received. 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 timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/ml | Predose on Cycle 1 Days 1, 8 and 15 and Cycle 2 Day 15; 3 hours post-dose on Cycle 1 Days 1 and 15 (Cycle length = 28 days) |
|
Up to 3.7 years
Safety analysis set (SAS) included all participants who were exposed to study treatment. 2 participants randomized to the Pbo+Palbo+Fulv arm received at least one dose of inavolisib in error and were included in the Inavo+Palbo+Fulv arm in SAS population for the purposes of safety analyses. This study is ongoing, and data collected up to the primary completion date are reported here.
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 | Inavo+Palbo+Fulv | Participants received inavolisib, 9 mg, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then on Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination. | 43 | 162 | 39 | 162 | 157 | 162 |
| EG001 | Pbo+Palbo+Fulv | Participants received placebo, orally, QD on Days 1-28 of each 28 day cycle along with palbociclib 125 mg, orally, QD on Days 1-21 and fulvestrant, 500 mg, IM injections on Days 1 and 15 of Cycle 1 and then of Day 1 of each subsequent 28 day cycle until unequivocal disease progression, unacceptable toxicity, participant withdrawal of consent, or study termination. | 54 | 162 | 17 | 162 | 158 | 162 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Post procedural fistula | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Procedural headache | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Snake bite | Injury, poisoning and procedural complications | MedDRA version 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Tetany | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA version 26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA version 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Blood insulin increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 26.1 | 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 | Sep 18, 2023 | Sep 16, 2024 | SAP_001.pdf |
| 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 |
|---|---|
| C000723546 | inavolisib |
| C500026 | palbociclib |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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 |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|