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
NCT04251533 · EPIK-B3 Phase 3Terminated
- Lead sponsor
- Novartis Pharmaceuticals (Industry)
- Enrollment
- 137 (actual)
- Start date
- 8 Jun 2020
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 5 Feb 2026
- Last update posted
- 10 Sep 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Double
- Arms
- 3
Interventions
- alpelisib Drug
- placebo Drug
- nab-paclitaxel Drug
Conditions and primary outcome
- Triple Negative Breast Neoplasms
Primary outcome
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)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT04251533 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
Progression-free Survival (PFS) Per Investigator Assessment in Study Part A
- Time frame
- Once all participants have completed at least 6 months of study treatment or have discontinued from study treatment, up to 35 months
- Measure
- Median
- Unit
- months
Part A: Alpelisib + Nab-paclitaxel vs Part A: Placebo + Nab-paclitaxelSuperiority
- Estimate
- 1.49Hazard Ratio (HR)
- 95% CI, two-sided
- 0.92 to 2.41
- p-value
- Not given
- Method
- Regression, Cox
Serious adverse events
Time frame: 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.
| Group | Affected | At risk |
|---|---|---|
| Part A: Alpelisib + Nab-paclitaxelEdit | 22 | 52 |
| Part A: Placebo + Nab-paclitaxelEdit | 15 | 50 |
| Part B1: Alpelisib + Nab-paclitaxelEdit | 14 | 35 |
| Part A: Alpelisib + Nab-paclitaxel (Post-treatment Survival Follow-up) | 0 | 0 |
| Part A: Placebo + Nab-paclitaxel (Post-treatment Survival Follow-up) | 0 | 0 |
| Part B1: Alpelisib + Nab-paclitaxel (Post-treatment Survival Follow-up) | 0 | 0 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT04251533.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04251533 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.