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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003029-16 | EudraCT Number |
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| Name | Class |
|---|---|
| SOLTI Breast Cancer Research Group | OTHER |
This is a randomized, double-blind, placebo-controlled, multicenter, pre-operative Phase II study designed to estimate the efficacy of ipatasertib combined with paclitaxel chemotherapy versus placebo combined with paclitaxel chemotherapy in women with Stage Ia - IIIa triple-negative breast adenocarcinoma. The anticipated time on study treatment is 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipatasertib + Paclitaxel | Experimental | Participants will receive ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses). |
|
| Placebo + Paclitaxel | Placebo Comparator | Participants will receive placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipatasertib | Drug | Ipatasertib will be administered at a dose of 400 milligrams (mg) orally daily on Days 1-21 of each 28-day cycle for 3 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pathological Complete Response (pCR) in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in All Participants) | pCR was defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer (AJCC) Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes. | Surgery visit (at approximately Weeks 14 to 19) |
| Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Have Phosphatase and Tensin Homolog [PTEN]-Low Tumors) | pCR was defined by ypT0/Tis ypN0 in the AJCC Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes. | Surgery visit (at approximately Weeks 14 to 19) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in All Participants) | pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue. | Surgery visit (at approximately Weeks 14 to 19) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates, PC-CASA | Tucson | Arizona | 85704 | United States | ||
| Sansum Medical Clinic, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31147675 | Derived | Oliveira M, Saura C, Nuciforo P, Calvo I, Andersen J, Passos-Coelho JL, Gil Gil M, Bermejo B, Patt DA, Ciruelos E, de la Pena L, Xu N, Wongchenko M, Shi Z, Singel SM, Isakoff SJ. FAIRLANE, a double-blind placebo-controlled randomized phase II trial of neoadjuvant ipatasertib plus paclitaxel for early triple-negative breast cancer. Ann Oncol. 2019 Aug 1;30(8):1289-1297. doi: 10.1093/annonc/mdz177. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ipatasertib + Paclitaxel | Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses). |
| FG001 | Placebo + Paclitaxel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 19, 2016 |
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|
| Paclitaxel | Drug | Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m^2) as IV infusion QW for 3 cycles. |
|
| Placebo | Drug | Participants will receive placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles. |
|
| Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in Participants Who Have PTEN-low Tumors) | pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue. | Surgery visit (at approximately Weeks 14 to 19) |
| Percentage of Participants With Objective Tumor Response by Magnetic Resonance Imaging (MRI), As Assessed by Investigator Per the Modified Response Evaluation Criteria in Solid Tumors (RECIST) (in All Participants) | Objective tumor response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR). CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | Screening up to disease progression or death (assessed at screening, pre-surgical visit [approximately Weeks 10-12], early termination visit [up to Week 16]) |
| Percentage of Participants With Objective Tumor Response by MRI, As Assessed by Investigator Per Modified RECIST (in Participants Who Have PTEN-low Tumors) | ORR was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. ORR was the sum of complete response (CR) and partial response (PR). CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | Screening up to disease progression or death (assessed at screening, pre-surgical visit [approximately Weeks 10-12], early termination visit [up to Week 16]) |
| Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Are Akt Diagnostic Positive [Dx+]) | pCR was defined by ypT0/Tis ypN0 in the AJCC Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes. | Surgery visit (at approximately Weeks 14 to 19) |
| Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in Participants Who Are Akt Dx+) | pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue. | Surgery visit (at approximately Weeks 14 to 19) |
| Percentage of Participants With pCR According to American Joint Committee on Cancer Staging System, by Breast Cancer Subtype | pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast subtypes by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue. The intrinsic molecular subtypes of breast cancer included here are luminal A (LumA), Her-2, basal-like, normal and unknown. | Surgery visit (at approximately Weeks 14 to 19) |
| Percentage of Participants With Response to Undergoing Breast Conserving Surgery (BCS) Among Participants With T2 or T3 Tumors | After neoadjuvant treatment, the number of patients who is appropriate for breast conserving surgery is reported as a measure of efficacy of the treatment to shrink the tumor enough for patients to benefit from less aggressive surgical management. Breast-conserving surgery was defined as removal of part of the breast tissue during surgery. T2 or T3 in the AJCC Staging System were defined as follows: T2: tumor was more than 2 centimeter (cm) but no more than 5 cm across; T3: tumor was larger than 5 cm across. | Surgery visit (at approximately Weeks 14 to 19) |
| Percentage of Participants With Response to Conversion to BCS Among Participants With T2 or T3 Tumors | After neoadjuvant treatment, the number of patients who is appropriate for breast conserving surgery is reported as a measure of efficacy of the treatment to shrink the tumor enough for patients to benefit from less aggressive surgical management. Breast-conserving surgery was defined as removal of part of the breast tissue during surgery. T2 or T3 in the AJCC Staging System were defined as follows: T2: tumor was more than 2 centimeter (cm) but no more than 5 cm across; T3: tumor was larger than 5 cm across. | From screening to surgery visit (at approximately Weeks 14 to 19) |
| Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event 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. | Screening up to Week 24 |
| Plasma Concentrations of Ipatasertib on Day 1 and Day 8 | Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants. | 0.5 and 4 hours post dose on Day 1 of Cycle 1, 166 and 170 hours post dose from Day 1 of Cycle 1 (Cycle length = 28 days) |
| Minimum Observed Plasma Concentration (Cmin) of Ipatasertib | Plasma samples for pharmacokinetic characterization was collected on Day 1 and Day 8 in all participants. | 0.5 and 4 hours post dose on Day 1 of Cycle 1, 166 and 170 hours post dose from Day 1 of Cycle 1 (Cycle length = 28 days) |
| Santa Barbara |
| California |
| 93105 |
| United States |
| Rocky Mountain Cancer Center - Lakewood (West) | Lakewood | Colorado | 80228 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Mass General/North Shore Cancer | Danvers | Massachusetts | 01923 | United States |
| Nebraska Cancer Specialists; Oncology Hematology West, PC | Omaha | Nebraska | 68130 | United States |
| Carolinas Healthcare System | Charlotte | North Carolina | 28208 | United States |
| Northwest Cancer Specialists - Portland (NE Hoyt St) | Portland | Oregon | 97213 | United States |
| Roper Bon Secours St. Francis Cancer Center | Charleston | South Carolina | 29414 | United States |
| Texas Oncology | Austin | Texas | 78705 | United States |
| Texas Oncology Cancer Center | Austin | Texas | 78731 | United States |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Texas Oncology - Houston (Gessner) | Houston | Texas | 77024 | United States |
| Texas Oncology-Tyler | Irving | Texas | 75063 | United States |
| South Texas Cancer Center - McAllen | McAllen | Texas | 78503 | United States |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | United States |
| IPO de Lisboa; Servico de Oncologia Medica | Lisbon | 1099-023 | Portugal |
| Hospital Beatriz Angelo; Departamento de Oncologia | Loures | 2674-514 | Portugal |
| IPO do Porto; Servico de Oncologia Medica | Porto | 4200-072 | Portugal |
| Hospital Universitario Son Espases | Palma de Mallorca | Balearic Islands | 07014 | Spain |
| Hospital Son Llatzer; Servicio de Oncologia | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Hospital Provincial de Castellon; Servicio de Oncologia | Castellon | Castellon | 12002 | Spain |
| Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia | Santiago de Compostela | LA Coruña | 15706 | Spain |
| Hospital Universitari de Lleida Arnau de Vilanova | Lleida | Lerida | 25198 | Spain |
| Hospital Universitario Fundación Alcorcón | Alcorcón (Madrid) | Madrid | 28922 | Spain |
| Hospital Rey Juan Carlos; Pharmacy | Móstoles | Madrid | 28933 | Spain |
| Hospital Regional Universitario Carlos Haya; hospital Materno Infantil, servicio de Farmacia | Málaga | Malaga | 29011 | Spain |
| Hospital Universitario Virgen Macarena | Seville | Sevilla | 41071 | Spain |
| Hospital Universitari Sant Joan de Reus; Servicio de Oncologia | Reus | Tarragona | 43204 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| Institut Catala d Oncologia Hospital Duran i Reynals | Barcelona | 08908 | Spain |
| Hospital San Pedro De Alcantara; Servicio de Oncologia | Cáceres | 10003 | Spain |
| Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia | Girona | 17007 | Spain |
| Centro Oncologico MD Anderson International Espana | Madrid | 28033 | Spain |
| Fundacion Jimenez Diaz; Servicio de Oncologia | Madrid | 28040 | Spain |
| Hospital Universitario Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica | Madrid | 28050 | Spain |
| Hospital Quiron de Madrid; Servicio de Oncologia | Madrid | 28223 | Spain |
| Hospital Universitario de Fuenlabrada; Servicio de Oncologia | Madrid | 28943 | Spain |
| Hospital Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Clinico Universitario; Oncologia | Valencia | 46010 | Spain |
Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The intent-to-treat (ITT) population included all randomized participants, with participants allocated to the treatment arms to which they were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ipatasertib + Paclitaxel | Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses). |
| BG001 | Placebo + Paclitaxel | Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Pathological Complete Response (pCR) in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in All Participants) | pCR was defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer (AJCC) Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes. | The ITT population included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Surgery visit (at approximately Weeks 14 to 19) |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Have Phosphatase and Tensin Homolog [PTEN]-Low Tumors) | pCR was defined by ypT0/Tis ypN0 in the AJCC Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes. | The ITT population included all randomized participants who have PTEN-low tumors. | Posted | Number | 95% Confidence Interval | percentage of participants | Surgery visit (at approximately Weeks 14 to 19) |
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| Secondary | Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in All Participants) | pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue. | The ITT population included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Surgery visit (at approximately Weeks 14 to 19) |
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| Secondary | Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in Participants Who Have PTEN-low Tumors) | pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue. | The ITT population included all randomized participants who have PTEN-low tumors. | Posted | Number | 95% Confidence Interval | percentage of participants | Surgery visit (at approximately Weeks 14 to 19) |
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| Secondary | Percentage of Participants With Objective Tumor Response by Magnetic Resonance Imaging (MRI), As Assessed by Investigator Per the Modified Response Evaluation Criteria in Solid Tumors (RECIST) (in All Participants) | Objective tumor response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR). CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | The ITT population included all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Screening up to disease progression or death (assessed at screening, pre-surgical visit [approximately Weeks 10-12], early termination visit [up to Week 16]) |
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| Secondary | Percentage of Participants With Objective Tumor Response by MRI, As Assessed by Investigator Per Modified RECIST (in Participants Who Have PTEN-low Tumors) | ORR was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. ORR was the sum of complete response (CR) and partial response (PR). CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. | The ITT population included all randomized participants who have PTEN-low tumors. | Posted | Number | 95% Confidence Interval | percentage of participants | Screening up to disease progression or death (assessed at screening, pre-surgical visit [approximately Weeks 10-12], early termination visit [up to Week 16]) |
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| Secondary | Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Are Akt Diagnostic Positive [Dx+]) | pCR was defined by ypT0/Tis ypN0 in the AJCC Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes. | The ITT population included all randomized participants who are Akt Dx+. | Posted | Number | 95% Confidence Interval | percentage of participants | Surgery visit (at approximately Weeks 14 to 19) |
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| Secondary | Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in Participants Who Are Akt Dx+) | pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue. | The ITT population included all randomized participants who are Akt Dx+. | Posted | Number | 95% Confidence Interval | percentage of participants | Surgery visit (at approximately Weeks 14 to 19) |
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| Secondary | Percentage of Participants With pCR According to American Joint Committee on Cancer Staging System, by Breast Cancer Subtype | pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast subtypes by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue. The intrinsic molecular subtypes of breast cancer included here are luminal A (LumA), Her-2, basal-like, normal and unknown. | The ITT population included all randomized participants. | Posted | Number | percentage of participants | Surgery visit (at approximately Weeks 14 to 19) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Response to Undergoing Breast Conserving Surgery (BCS) Among Participants With T2 or T3 Tumors | After neoadjuvant treatment, the number of patients who is appropriate for breast conserving surgery is reported as a measure of efficacy of the treatment to shrink the tumor enough for patients to benefit from less aggressive surgical management. Breast-conserving surgery was defined as removal of part of the breast tissue during surgery. T2 or T3 in the AJCC Staging System were defined as follows: T2: tumor was more than 2 centimeter (cm) but no more than 5 cm across; T3: tumor was larger than 5 cm across. | The ITT population included all randomized participants with T2 or T3 Tumors. | Posted | Number | 95% Confidence Interval | percentage of participants | Surgery visit (at approximately Weeks 14 to 19) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Response to Conversion to BCS Among Participants With T2 or T3 Tumors | After neoadjuvant treatment, the number of patients who is appropriate for breast conserving surgery is reported as a measure of efficacy of the treatment to shrink the tumor enough for patients to benefit from less aggressive surgical management. Breast-conserving surgery was defined as removal of part of the breast tissue during surgery. T2 or T3 in the AJCC Staging System were defined as follows: T2: tumor was more than 2 centimeter (cm) but no more than 5 cm across; T3: tumor was larger than 5 cm across. | The ITT population included all randomized participants with T2 or T3 Tumors with response to conversion to BCS. | Posted | Number | 95% Confidence Interval | percentage of participants | From screening to surgery visit (at approximately Weeks 14 to 19) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event 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. | The safety population was identical to the ITT population and included all randomized participants. | Posted | Number | percentage of participants | Screening up to Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Concentrations of Ipatasertib on Day 1 and Day 8 | Plasma samples for pharmacokinetic characterization was collected at various timepoints in all participants. | The ITT population included all randomized participants. Reported here are data for participants with data available. | Posted | Mean | Standard Deviation | ng/mL | 0.5 and 4 hours post dose on Day 1 of Cycle 1, 166 and 170 hours post dose from Day 1 of Cycle 1 (Cycle length = 28 days) |
|
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| Secondary | Minimum Observed Plasma Concentration (Cmin) of Ipatasertib | Plasma samples for pharmacokinetic characterization was collected on Day 1 and Day 8 in all participants. | The ITT population included all participants. | Posted | Mean | Standard Deviation | ng/mL | 0.5 and 4 hours post dose on Day 1 of Cycle 1, 166 and 170 hours post dose from Day 1 of Cycle 1 (Cycle length = 28 days) |
|
|
2 years and 6 months
The safety population was identical to the ITT population. The ITT population comprised all 151 randomized patients.
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 | Ipatasertib + Paclitaxel | Participants received ipatasertib orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel intravenous (IV) infusion every week (QW) for 3 cycles (12 total doses). | 1 | 76 | 10 | 76 | 76 | 76 |
| EG001 | Placebo + Paclitaxel | Participants received placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles and paclitaxel IV infusion QW for 3 cycles (12 total doses). | 0 | 75 | 3 | 75 | 73 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device related infection | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Sickle cell anaemia with crisis | Blood and lymphatic system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA, version 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Mucosal dryness | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA, version 20.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA, version 20.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Onycholysis | Skin and subcutaneous tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA, version 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA, version 20.0 | 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 |
| Jul 26, 2018 |
| Prot_SAP_000.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 |
|---|---|
| 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 |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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