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NCT04251533 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Triple Negative Breast Neoplasms, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 137
- Enrollment target
- 20
- Study locations
NCT04251533: Active Phase 3 study of Triple Negative Breast Neoplasms, sponsored by Novartis Pharmaceuticals.
NCT04251533 is a Phase 3 study of Triple Negative Breast Neoplasms that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 137 participants, below the 649-participant average among 10 other Triple Negative Breast Neoplasms trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04251533, a Phase 3 study of Triple Negative Breast Neoplasms, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 137 participants
- Enrollment target
- 20
- Study locations
Study 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)
Primary Outcome
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
Conditions Studied
Interventions
- DRUG placebo
- DRUG nab-paclitaxel
- DRUG alpelisib
Study Locations (20)
Other
- Novartis Investigative Site - CABA
- Novartis Investigative Site - Leoben
- Novartis Investigative Site - Plovdiv
São Paulo
- Novartis Investigative Site - Barretos
- Novartis Investigative Site - São Paulo
- Novartis Investigative Site - São Paulo
Minnesota
- Mayo Clinic Rochester - Rochester
- Park Nicollet Institute - Saint Louis Park
California
- University of California LA - Los Angeles
Louisiana
- Hematology and Oncology Clinic - Baton Rouge
Tennessee
- SCRI Oncology Partners - Nashville
Santa Fe Province
- Novartis Investigative Site - Rosario
Victoria
- Novartis Investigative Site - Melbourne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2020-06-08 |
| Est. Completion | 2027-01-28 |
| Phase | Phase 3 |
What the registry record for NCT04251533 still lists
NCT04251533 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 649-participant average among 10 other Triple Negative Breast Neoplasms trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Triple Negative Breast Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT04251533 names 20 study sites across 15 states, led by Other, São Paulo, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04251533 about?
NCT04251533 is a clinical study titled "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". 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 withou...
What is the current status of trial NCT04251533?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 137 participants. The study started on 2020-06-08. Estimated completion is 2027-01-28.
What conditions does trial NCT04251533 study?
This clinical trial studies the following conditions: Triple Negative Breast Neoplasms.
What interventions are being tested in trial NCT04251533?
The interventions under investigation include: placebo (DRUG), nab-paclitaxel (DRUG), alpelisib (DRUG).
Who is sponsoring clinical trial NCT04251533?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04251533 being conducted?
This trial has 20 study locations across California, Louisiana, Minnesota, Tennessee, Santa Fe Province. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Triple Negative Breast Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04251533's enrollment target sits among peer trials
137 10th of 10 higher than 1 of 10 other Triple Negative Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative Breast Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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