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Alpelisib / Triple Negative Breast Neoplasms · Phase 3 Trial
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registry record for a Phase 3 study of alpelisib plus nab-paclitaxel in advanced triple-negative breast cancer that was terminated before completion. No efficacy or safety results are posted on the registry; the study design, population, and planned endpoints are documented but the trial yields no evidence on treatment effect.
Phase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Triple Negative Breast Neoplasms; age from 18 Years; to 100 Years. Intervention: Part A: alpelisib + nab-paclitaxel; Part B1: alpelisib + nab-paclitaxel. Compared with: Part A: placebo + nab-paclitaxel — Placebo Comparator. n = 137. 78 sites across 30 countries.
This is a clinical trial registry record for a Phase 3 study of alpelisib plus nab-paclitaxel in advanced triple-negative breast cancer that was terminated before completion. No efficacy or safety results are posted on the registry; the study design, population, and planned endpoints are documented but the trial yields no evidence on treatment effect.
Results are not posted on this registry record; no efficacy, safety, or outcome data are available.
No clinical guidance can be drawn from this record. Clinicians should await peer-reviewed publications of any interim or final data from this terminated trial before considering alpelisib plus nab-paclitaxel in this population.
This is a terminated Phase 3 trial registry record with no results posted; the study design and population are defined but no efficacy or safety data are available for assessment.
As stated by the source record.
Quoted from the source exactly as published.
No clinical guidance can be drawn from this record. Clinicians should await peer-reviewed publications of any interim or final data from this terminated trial before considering alpelisib plus nab-paclitaxel in this population.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04251533). This is a study registration, not published results. Lead sponsor: Novartis Pharmaceuticals. Recruitment status: TERMINATED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 137 participants (ACTUAL). Conditions: Triple Negative Breast Neoplasms. Interventions: DRUG: alpelisib; DRUG: placebo; DRUG: nab-paclitaxel. Primary outcome measures: 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; Overall Response Rate (ORR) Based on Local Radiology Assessments in Participants With Measurable Disease at Baseline in Study Part B1 , Up to 6 months. Brief 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)
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.