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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511931-87-00 | Registry Identifier | EU CT Number | |
| 2019-002637-11 | EudraCT Number |
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The study was terminated following a strategic decision to halt recruitment due to persistently slow enrollment. This decision was not driven by any new or unexpected safety concerns.
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The purpose of this study was to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)
The recruitment of Part A was halted on 11-Nov-2022 due to slow recruitment. Since Part B1 did not meet its primary objective for confirmed overall response rate, the Part B2 was not initiated, and the recruitment was halted for the entire study.
Upon confirming either PIK3CA mutation and/or PTEN loss status, advanced TNBC participants meeting all other eligibility criteria were assigned to either Part A (PIK3CA mutation regardless of PTEN loss) or Part B1 (PTEN loss with PIK3CA unknown or non-mutant).
In Part A, participants were randomized a 1:1 to receive either:
In Part B1, participants received alpelisib 300 mg daily orally + nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 of each 28-day cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: alpelisib + nab-paclitaxel | Experimental | Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle |
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| Part A: placebo + nab-paclitaxel | Placebo Comparator | Participants received placebo + nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 of each 28-day cycle. |
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| Part B1: alpelisib + nab-paclitaxel | Experimental | Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 of each 28-day cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alpelisib | Drug | 300 mg orally, once per day (QD), tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Per Investigator Assessment in Study Part A | PFS was defined as time from the date of randomization to the date of the first documented progressive disease (PD) or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date. | Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months |
| Overall Response Rate (ORR) Based on Local Radiology Assessments in Participants With Measurable Disease at Baseline in Study Part B1 | ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until progressive disease (PD)/recurrence. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival in Study Part A | Overall survival is defined as the time from date of randomization to date of death due to any cause. | Up to 66 months |
| Overall Response Rate (ORR) With Confirmed Response in Study Part A |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California LA | Los Angeles | California | 90095 | United States | ||
| Hematology and Oncology Clinic |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Alpelisib + Nab-paclitaxel | Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle. |
| FG001 | Part A: Placebo + Nab-paclitaxel |
| 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 14, 2023 | May 28, 2024 |
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| placebo | Drug | 300 mg orally, once per day (QD), tablets |
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| nab-paclitaxel | Drug | 100 mg/m^2 IV infusion, once per day (QD) |
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ORR with confirmed response was the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until progressive disease (PD)/recurrence. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm.
| Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months |
| Clinical Benefit Rate (CBR) With Confirmed Response in Study Part A | Clinical benefit rate (CBR) was defined as the percentage of participants with a best overall response of complete response (CR), or partial response (PR) or an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1 based on investigator's assessment. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. | Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months |
| Clinical Benefit Rate (CBR) With Confirmed Response in Study Part B1 | Clinical benefit rate (CBR) was defined as the percentage of participants with a best overall response of complete response (CR), or partial response (PR) or an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1 based on investigator's assessment. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. | Up to 6 months |
| Time to Response (TTR) in Study Part A | Time to response (TTR) was defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR were based on tumor response data as per local review and according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. | Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months |
| Time to Response (TTR) in Study Part B1 | Time to response (TTR) was defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response was used, not date of confirmation). CR and PR were based on tumor response data as per local review and according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. | Up to 6 months |
| Duration of Response (DOR) With Confirmed Response in Study Part A | Duration of response (DOR) with confirmed response only applied to participants whose best overall response (BOR) was confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date was the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date was defined as the date of the first documented progressive disease (PD) or death due to underlying cancer. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. | Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months |
| Duration of Response (DOR) With Confirmed Response in Study Part B1 | Duration of response (DOR) with confirmed response only applied to participants whose best overall response (BOR) was confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date was the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date was defined as the date of the first documented progressive disease (PD) or death due to underlying cancer. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. | Up to approximately 20 months |
| Overall Survival in Study Part B1 | Overall survival for Part B1 was defined as the number of participants who were alive at the end of the post-treatment period. | Up to approximately 26 months. |
| Progression-free Survival (PFS) Per Investigator Assessment in Study Part B1 | PFS was defined as time from the date of enrolment to the date of the first documented progressive disease (PD) or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date. | Up to 6 months |
| PFS Based on Local Radiology Assessments Using RECIST 1.1 Criteria for Participants by PIK3CA Mutation Status Measured in Baseline Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Study Part A | PFS in participants with PIK3CA mutation as measured in ctDNA. PFS was defined as time from the date of randomization to the date of the first documented progression or death due to any cause. | Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months |
| Post-Hoc: All Collected Deaths | On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from Day 31 after last dose of study medication to the data cut-off date. | On-treatment deaths: Up to approximately 28 months (Part A) or approximately 17 months (Part B1). Post-treatment survival follow-up deaths: Up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). |
| Baton Rouge |
| Louisiana |
| 70809 |
| United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Park Nicollet Institute | Saint Louis Park | Minnesota | 55416 | United States |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | United States |
| Novartis Investigative Site | Rosario | Santa Fe Province | S2000KZE | Argentina |
| Novartis Investigative Site | CABA | C1113AAE | Argentina |
| Novartis Investigative Site | Melbourne | Victoria | 3000 | Australia |
| Novartis Investigative Site | Nedlands | Western Australia | 6009 | Australia |
| Novartis Investigative Site | Innsbruck | Tyrol | 6020 | Austria |
| Novartis Investigative Site | Leoben | A 8700 | Austria |
| Novartis Investigative Site | Barretos | São Paulo | 14784 400 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 01317-002 | Brazil |
| Novartis Investigative Site | São Paulo | São Paulo | 04014-002 | Brazil |
| Novartis Investigative Site | Plovdiv | 4004 | Bulgaria |
| Novartis Investigative Site | Hefei | Anhui | 230001 | China |
| Novartis Investigative Site | Shijiazhuang | Hebei | 050011 | China |
| Novartis Investigative Site | Changsha | Hunan | 410013 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210029 | China |
| Novartis Investigative Site | Nanchang | Jiangxi | 330009 | China |
| Novartis Investigative Site | Changchun | Jilin | 130021 | China |
| Novartis Investigative Site | Shengyang | Liaoning | 110042 | China |
| Novartis Investigative Site | Shenyang | Liaoning | 110011 | China |
| Novartis Investigative Site | Chengdu | Sichuan | 610041 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310016 | China |
| Novartis Investigative Site | Dalian | 116000 | China |
| Novartis Investigative Site | Shanghai | 200025 | China |
| Novartis Investigative Site | Tianjin | 300480 | China |
| Novartis Investigative Site | Bogotá | 110221 | Colombia |
| Novartis Investigative Site | Zagreb | 10000 | Croatia |
| Novartis Investigative Site | Saint-Cloud | Hauts De Seine | 92210 | France |
| Novartis Investigative Site | Angers | 49055 | France |
| Novartis Investigative Site | Saint-Herblain | 44805 | France |
| Novartis Investigative Site | Villejuif | 94800 | France |
| Novartis Investigative Site | Dresden | Saxony | 01307 | Germany |
| Novartis Investigative Site | Leipzig | Saxony | 04103 | Germany |
| Novartis Investigative Site | Essen | 45136 | Germany |
| Novartis Investigative Site | Budapest | 1134 | Hungary |
| Novartis Investigative Site | Faridabad | Haryana | 121 001 | India |
| Novartis Investigative Site | Mumbai | Maharashtra | 400056 | India |
| Novartis Investigative Site | Vellore | Tamil Nadu | 632 004 | India |
| Novartis Investigative Site | Hyderabad | Telangana | 500034 | India |
| Novartis Investigative Site | Tel Aviv | 6423906 | Israel |
| Novartis Investigative Site | Meldola | FC | 47014 | Italy |
| Novartis Investigative Site | Roma | RM | 00128 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Petaling Jaya | Selangor | 46050 | Malaysia |
| Novartis Investigative Site | Kuala Lumpur | 59100 | Malaysia |
| Novartis Investigative Site | Monterrey | Nuevo León | 64460 | Mexico |
| Novartis Investigative Site | Oslo | NO-0407 | Norway |
| Novartis Investigative Site | Trujillo | La Libertad | 13011 | Peru |
| Novartis Investigative Site | Gdynia | 81 519 | Poland |
| Novartis Investigative Site | Opole | 45-061 | Poland |
| Novartis Investigative Site | Poznan | 61 485 | Poland |
| Novartis Investigative Site | Arkhangelsk | 163045 | Russia |
| Novartis Investigative Site | Chelyabinsk | 454048 | Russia |
| Novartis Investigative Site | Moscow | 117997 | Russia |
| Novartis Investigative Site | Moscow | 123056 | Russia |
| Novartis Investigative Site | Saint Petersburg | 196603 | Russia |
| Novartis Investigative Site | Bratislava | 812 50 | Slovakia |
| Novartis Investigative Site | Bratislava | 83310 | Slovakia |
| Novartis Investigative Site | Košice | 041 91 | Slovakia |
| Novartis Investigative Site | Ljubljana | 1000 | Slovenia |
| Novartis Investigative Site | Port Elizabeth | Western Cape | 6045 | South Africa |
| Novartis Investigative Site | Johannesburg | 2196 | South Africa |
| Novartis Investigative Site | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Seoul | 05505 | South Korea |
| Novartis Investigative Site | Seoul | 06351 | South Korea |
| Novartis Investigative Site | Palma | Balearic Islands | 07120 | Spain |
| Novartis Investigative Site | Badajoz | Extremadura | 06080 | Spain |
| Novartis Investigative Site | Alicante | 03010 | Spain |
| Novartis Investigative Site | Lausanne | 1011 | Switzerland |
| Novartis Investigative Site | Taipei | 10002 | Taiwan |
| Novartis Investigative Site | Taipei | 10449 | Taiwan |
| Novartis Investigative Site | Istanbul | Fatih | 34098 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | Kadikoy | 34722 | Turkey (Türkiye) |
| Novartis Investigative Site | Nottingham | NG5 1PB | United Kingdom |
| Novartis Investigative Site | Oxford | OX3 7LE | United Kingdom |
Participants received placebo + nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 of each 28-day cycle.
| FG002 | Part B1: Alpelisib + Nab-paclitaxel | Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 of each 28-day cycle. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Alpelisib + Nab-paclitaxel | Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle. |
| BG001 | Part A: Placebo + Nab-paclitaxel | Participants received placebo + nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 of each 28-day cycle. |
| BG002 | Part B1: Alpelisib + Nab-paclitaxel | Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 of each 28-day cycle. |
| BG003 | 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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| Race/Ethnicity, Customized | 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) Per Investigator Assessment in Study Part A | PFS was defined as time from the date of randomization to the date of the first documented progressive disease (PD) or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date. | Part A: The full analysis set included all participants to whom study treatment was assigned by randomization. | Posted | Median | 95% Confidence Interval | months | Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months |
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| Primary | Overall Response Rate (ORR) Based on Local Radiology Assessments in Participants With Measurable Disease at Baseline in Study Part B1 | ORR was defined as the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until progressive disease (PD)/recurrence. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. | Part B1: The full analysis set included all participants to whom study treatment was assigned. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 6 months |
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| Secondary | Overall Survival in Study Part A | Overall survival is defined as the time from date of randomization to date of death due to any cause. | Not Posted | May 2026 | Up to 66 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) With Confirmed Response in Study Part A | ORR with confirmed response was the percentage of participants with best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), as per local review and according to RECIST 1.1. BOR was defined as the best response recorded from the start of the study treatment until progressive disease (PD)/recurrence. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters; PD= At least a 20% increase in the sum of diameters of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. | Part A: The full analysis set included all participants to whom study treatment was assigned by randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months |
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| Secondary | Clinical Benefit Rate (CBR) With Confirmed Response in Study Part A | Clinical benefit rate (CBR) was defined as the percentage of participants with a best overall response of complete response (CR), or partial response (PR) or an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1 based on investigator's assessment. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. | Part A: The full analysis set included all participants to whom study treatment was assigned by randomization. | Posted | Number | 95% Confidence Interval | percentage of participants | Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months |
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| Secondary | Clinical Benefit Rate (CBR) With Confirmed Response in Study Part B1 | Clinical benefit rate (CBR) was defined as the percentage of participants with a best overall response of complete response (CR), or partial response (PR) or an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1 based on investigator's assessment. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease. | Part B1: The full analysis set included all participants to whom study treatment was assigned. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 6 months |
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| Secondary | Time to Response (TTR) in Study Part A | Time to response (TTR) was defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response is used, not date of confirmation). CR and PR were based on tumor response data as per local review and according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. | Part A: The full analysis set included all participants to whom study treatment was assigned by randomization. | Posted | Median | 95% Confidence Interval | months | Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months |
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| Secondary | Time to Response (TTR) in Study Part B1 | Time to response (TTR) was defined as the time from the date of randomization/enrolment to the first documented response of either complete response (CR) or partial response (PR), which must be subsequently confirmed (although date of initial response was used, not date of confirmation). CR and PR were based on tumor response data as per local review and according to RECIST 1.1. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. | Part B1: The full analysis set included all participants to whom study treatment was assigned. | Posted | Median | 95% Confidence Interval | months | Up to 6 months |
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| Secondary | Duration of Response (DOR) With Confirmed Response in Study Part A | Duration of response (DOR) with confirmed response only applied to participants whose best overall response (BOR) was confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date was the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date was defined as the date of the first documented progressive disease (PD) or death due to underlying cancer. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. | Part A: The full analysis set included all participants to whom study treatment was assigned by randomization. Results are reported for participants whose best overall response was confirmed complete response (CR) or confirmed partial response (PR). | Posted | Median | 95% Confidence Interval | months | Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months |
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| Secondary | Duration of Response (DOR) With Confirmed Response in Study Part B1 | Duration of response (DOR) with confirmed response only applied to participants whose best overall response (BOR) was confirmed complete response (CR) or confirmed partial response (PR) according to RECIST 1.1 based on tumor response data per local review. The start date was the date of first documented response of CR or PR (i.e. the start date of response, not the date when response was confirmed), and the end date was defined as the date of the first documented progressive disease (PD) or death due to underlying cancer. CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. | Part B1: The full analysis set included all participants to whom study treatment was assigned. Results are reported for participants whose best overall response was confirmed complete response (CR) or confirmed partial response (PR). | Posted | Median | 95% Confidence Interval | months | Up to approximately 20 months |
|
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| Secondary | Overall Survival in Study Part B1 | Overall survival for Part B1 was defined as the number of participants who were alive at the end of the post-treatment period. | Part B1: All participants to whom study treatment was assigned. | Posted | Count of Participants | Participants | Up to approximately 26 months. |
|
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| Secondary | Progression-free Survival (PFS) Per Investigator Assessment in Study Part B1 | PFS was defined as time from the date of enrolment to the date of the first documented progressive disease (PD) or death due to any cause. PFS was assessed via a local radiology assessment according to RECIST 1.1. PD=At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm^2. PFS was censored at the date of the last adequate tumor assessment, if no PFS event was observed prior to the analysis cut-off date. | Part B1: The full analysis set included all participants to whom study treatment was assigned. | Posted | Median | 95% Confidence Interval | months | Up to 6 months |
|
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| Secondary | PFS Based on Local Radiology Assessments Using RECIST 1.1 Criteria for Participants by PIK3CA Mutation Status Measured in Baseline Circulating Tumor Deoxyribonucleic Acid (ctDNA) in Study Part A | PFS in participants with PIK3CA mutation as measured in ctDNA. PFS was defined as time from the date of randomization to the date of the first documented progression or death due to any cause. | Part A: The full analysis set included all participants to whom study treatment was assigned by randomization. Results are reported for participants with available data. | Posted | Median | 95% Confidence Interval | months | Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months |
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| Secondary | Post-Hoc: All Collected Deaths | On-treatment deaths due to any cause were collected from first dose of study medication to 30 days after the last dose of study treatment. Post-treatment survival follow-up deaths were collected from Day 31 after last dose of study medication to the data cut-off date. | Parts A and B: All participants to whom study treatment was assigned. | Posted | Count of Participants | Participants | On-treatment deaths: Up to approximately 28 months (Part A) or approximately 17 months (Part B1). Post-treatment survival follow-up deaths: Up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). |
|
Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.
Any sign or symptom that occurred during the conduct of the trial and safety follow-up. Deaths in the post-treatment survival follow-up were not considered adverse events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.
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 | Part A: Alpelisib + Nab-paclitaxelEdit | Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m^2 intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle. | 6 | 52 | 22 | 52 | 51 | 52 |
| EG001 | Part A: Placebo + Nab-paclitaxelEdit | Participants received placebo + nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 of each 28-day cycle. | 6 | 50 | 15 | 50 | 47 | 50 |
| EG002 | Part B1: Alpelisib + Nab-paclitaxelEdit | Participants received alpelisib 300 mg orally + nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 of each 28-day cycle. | 3 | 35 | 14 | 35 | 34 | 35 |
| EG003 | Part A: Alpelisib + Nab-paclitaxel (Post-treatment Survival Follow-up) | Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period. | 19 | 46 | 0 | 0 | 0 | 0 |
| EG004 | Part A: Placebo + Nab-paclitaxel (Post-treatment Survival Follow-up) | Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period. | 14 | 44 | 0 | 0 | 0 | 0 |
| EG005 | Part B1: Alpelisib + Nab-paclitaxel (Post-treatment Survival Follow-up) | Deaths collected in the post-treatment survival follow-up period (starting from Day 31 post-treatment). No AEs were collected during this period. | 11 | 32 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abscess soft tissue | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Bronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Alpha hydroxybutyrate dehydrogenase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood insulin increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA (26.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 3, 2023 | May 28, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C585539 | Alpelisib |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Multiple |
|
| Black Or African American |
|
| American Indian or Alaska Native |
|
| Unknown |
|
| Participants |
|
|
Participants received placebo + nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 of each 28-day cycle. |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants received placebo + nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 of each 28-day cycle. |
|
|
| Participants |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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