Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor
Completed · Phase 3 · Has a placebo group
Conditions studied: Breast Cancer
In brief
This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer (MBC) whose disease has progressed on or after aromatase inhibitor (AI) treatment.
Key facts
- Study ID
- NCT01610284
- Run by
- Novartis Pharmaceuticals
- People needed
- 1147
- Starts
- 2012-08-07
- Expected to finish
- 2019-04-19
- Last updated by the study team
- 2020-08-25
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Arizona Oncology Associates Dept of Oncology — Phoenix, Arizona, United States
- Highlands Oncology Group — Fayetteville, Arkansas, United States
- Shapiro and Stafford and Yee and Polanski Study Coordinator — Arcadia, California, United States
- Cancer Care Associates Dept.ofCancerCareAssoc. — Fresno, California, United States
- St. Jude Heritage Medical Group Virginia Crosson Cancer Center — Fullerton, California, United States
- University of California San Diego - Moores Cancer Center UCSD 3 — La Jolla, California, United States
- Los Angeles Hematology/Oncology Medical Group LA Cancer Network — Los Angeles, California, United States
- USC Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3) — Los Angeles, California, United States
- University of California at Los Angeles Dept. of UCLA — Los Angeles, California, United States
- Ventura County Hematology and Oncology PMK Medical Group — Oxnard, California, United States
- Coastal Integrative Cancer Care — San Luis Obispo, California, United States
- Santa Barbara Hematolgy Oncology Medical Group — Santa Barbara, California, United States
- Central Coast Medical Oncology Corporation — Santa Maria, California, United States
- St Joseph Heritage Healthcare Dept. of RRMG (4) — Santa Rosa, California, United States
- Granada Hills Cancer Center — Valencia, California, United States
- Kaiser Permanente Northwest Kaiser — Denver, Colorado, United States
- Rocky Mountain Cancer Centers RMCC — Greenwood Village, Colorado, United States
- Memorial Regional Cancer Center MRCC — Hollywood, Florida, United States
- Cancer Specialists of North Florida SC - F2302 — Jacksonville, Florida, United States
- University of Miami Univ Miami 2 — Miami, Florida, United States
- MD Anderson Cancer Center - Orlando MD Orlando — Orlando, Florida, United States
- Georgia Cancer Specialists SC — Decatur, Georgia, United States
- North Shore University Health System — Evanston, Illinois, United States
- Cadence Health — Geneva, Illinois, United States
- University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2) — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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