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NCT03056755 · ClinicalTrials.gov registry record · Phase 2
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 383
- Enrollment target
NCT03056755: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT03056755 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 383 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (188% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03056755, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 383 participants
- Enrollment target
Study Summary
This was a Phase II, multicenter, open-label, three-cohort, non-comparative study of alpelisib plus endocrine therapy (either fulvestrant or letrozole) in subjects (pre- and post-menopausal women and men) with HR-positive, HER2-negative aBC harboring PIK3CA mutation(s) in the tumor, whose disease had progressed on or after prior treatments.
Primary Outcome
Percentage of participants who were alive without disease progression at 6-month follow-up based on local investigator assessment per RECIST v1.1 in Cohort A, Cohort B and Cohort C. Participants who progressed, died, or discontinued study before 6 months were counted as a failure.
Interventions
- DRUG Letrozole
- DRUG Fulvestrant
- DRUG Goserelin
- DRUG Alpelisib
- DRUG Leuprolide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 383 participants |
| Start Date | 2017-08-29 |
| Est. Completion | 2024-11-12 |
| Phase | Phase 2 |
What the finished NCT03056755 record still lists
NCT03056755 is an interventional study that assigns participants to a tested intervention. The registered 383 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (188% higher).
The record links to 0 conditions, and to 5 interventions - of which Letrozole is the first listed.
NCT03056755 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03056755 about?
NCT03056755 is a clinical study titled "Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments". This was a Phase II, multicenter, open-label, three-cohort, non-comparative study of alpelisib plus endocrine therapy (either fulvestrant or letrozole) in subjects (pre- and post-menopausal women and men) with HR-positive, HER2-negative aBC harboring PIK3CA mutation(s) in the tumor, whose disease ha...
What is the current status of trial NCT03056755?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 383 participants. The study started on 2017-08-29. Estimated completion is 2024-11-12.
What interventions are being tested in trial NCT03056755?
The interventions under investigation include: Letrozole (DRUG), Fulvestrant (DRUG), Goserelin (DRUG), Alpelisib (DRUG), Leuprolide (DRUG).
Who is sponsoring clinical trial NCT03056755?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03056755's enrollment target sits among peer trials
383 111th of 2000 higher than 1,890 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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