Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss
Phase 3
Terminated
NCT04251533
| Condition | Triple Negative Breast Neoplasms |
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| Phase | Phase 3 |
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| Sponsor | Novartis Pharmaceuticals |
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| Status | Terminated |
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| Enrollment | 137 participants |
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| Interventions | alpelisib, nab-paclitaxel |
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| Start date | Jun 8, 2020 |
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| Completion date | May 31, 2023 |
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| Results posted | Jul 31, 2024 |
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Summary
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)
Progression-free Survival (PFS) Per Investigator Assessment in Study Part A
Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months · months
| Part A: Alpelisib + Nab-paclitaxel | 7.2 months |
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| Part A: Placebo + Nab-paclitaxel | 5.6 months |
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| Hazard Ratio (HR) | 1.49 (95% CI 0.92–2.41) |
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Overall Response Rate (ORR) Based on Local Radiology Assessments in Participants With Measurable Disease at Baseline in Study Part B1
Up to 6 months · percentage of participants
| Part B1: Alpelisib + Nab-paclitaxel | 14.3 percentage of participants |
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Open in BENITIONS
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