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
Completed · Phase 2
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT03056755
- Run by
- Novartis Pharmaceuticals
- People needed
- 383
- Starts
- 2017-08-29
- Expected to finish
- 2024-11-12
- Last updated by the study team
- 2026-01-13
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic Arizona — Phoenix, Arizona, United States
- Kaiser Permanente Medical Group — Anaheim, California, United States
- Beverly Hills Cancer Center — Beverly Hills, California, United States
- University of Calif Irvine Med Cntr — Irvine, California, United States
- Kaiser Permanent Southern Californi — San Diego, California, United States
- UCSF — San Francisco, California, United States
- Yale University Yale Cancer Center — New Haven, Connecticut, United States
- Advent Health Cancer Institute — Orlando, Florida, United States
- University of Kansas Cancer Center — Kansas City, Kansas, United States
- University of Louisville James Graham Brown Cancer Center — Louisville, Kentucky, United States
- Mercy Medical Center — Baltimore, Maryland, United States
- Greater Baltimore Med Center Cancer Center — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Lahey Clinic — Burlington, Massachusetts, United States
- Josephine Ford Cancer Center — Detroit, Michigan, United States
- St Vincent Frontier Cancer Center — Billings, Montana, United States
- New Mexico Cancer Care Alliance — Albuquerque, New Mexico, United States
- Memorial Sloane Ketterin Cancer Ctr — New York, New York, United States
- Uni Hosp of Cleveland Cancer Center — Cleveland, Ohio, United States
- Texas Oncology — Dallas, Texas, United States
- Cancer Care Centers of South Texas HOAST — San Antonio, Texas, United States
- UT Health San Antonio — San Antonio, Texas, United States
- Virginia Oncology Associates — Norfolk, Virginia, United States
- Northwest Medical Specialists — Tacoma, Washington, United States
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
Full record on ClinicalTrials.gov
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