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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 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 383 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03056755
The ClinicalTrials.gov registry entry for NCT03056755 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 383 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Letrozole is the first listed.
NCT03056755 reports 0 study locations.
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.
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