A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Metastatic Breast Cancer
In brief
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment. Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).
Key facts
- Study ID
- NCT01633060
- Run by
- Novartis Pharmaceuticals
- People needed
- 432
- Starts
- 2012-10-03
- Expected to finish
- 2017-09-21
- Last updated by the study team
- 2019-01-30
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Ironwood Cancer and Research Centers SC — Chandler, Arizona, United States
- Highlands Oncology Group — Fayetteville, Arkansas, United States
- Compassionate Cancer Care Medical Group CCCMG — Fountain Valley, California, United States
- Los Angeles Hematology/Oncology Medical Group Onc Dept. — Los Angeles, California, United States
- Cedars Sinai Medical Center SC-5 — Los Angeles, California, United States
- University of California at Los Angeles UCLA SC — Los Angeles, California, United States
- Pacific Cancer Care — Monterey, California, United States
- Rocky Mountain Cancer Centers SC — Denver, Colorado, United States
- University Cancer & Blood Center, LLC — Athens, Georgia, United States
- Emory University School of Medicine/Winship Cancer Institute Emory — Atlanta, Georgia, United States
- Moanalua Medical Center. Attn: Oncology Dept — Honolulu, Hawaii, United States
- Edward Hospital Edward Hospital — Naperville, Illinois, United States
- Crescent City Research Consortium, LLC SC — Metairie, Louisiana, United States
- Lsu Health Sciences Center/ Lsu School of Medicine Lsu — New Orleans, Louisiana, United States
- John Ochsner Heart and Vascular Institute Clinical Trials Ochsner 2 — New Orleans, Louisiana, United States
- LSU Health Sciences Center Feist-Weiller Cancer Center — New Orleans, Louisiana, United States
- University of Maryland Medical Center Univ Maryland — Baltimore, Maryland, United States
- Mercy Medical Research Institute SC — Manchester, Missouri, United States
- Morristown Memorial Hospital Morristown Mem — Morristown, New Jersey, United States
- CINJ at Cooper University Hospital Dept of Onc — Voorhees Township, New Jersey, United States
- Clinical Research Alliance BKM120F2303 — Lake Success, New York, United States
- Clinical Research Alliance — Lake Success, New York, United States
- Montefiore Medical Center Montefiore — The Bronx, New York, United States
- Northwest Cancer Specialists Compass Oncology -BKM — Portland, Oregon, United States
- University of South Alabama / Mitchell Cancer Institute Univ South AL — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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