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
NCT ID: NCT01633060
Last Updated: 2019-01-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
432 participants
INTERVENTIONAL
2012-10-03
2017-09-21
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BKM120 100mg + Fulvestrant
BKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.
Fulvestrant
Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter)
BKM120
BKM120 100 mg once daily
Placebo + Fulvestrant
BKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
Fulvestrant
Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter)
BKM120 matching placebo
BKM120 matching placebo, once daily
Interventions
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Fulvestrant
Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter)
BKM120
BKM120 100 mg once daily
BKM120 matching placebo
BKM120 matching placebo, once daily
Eligibility Criteria
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Inclusion Criteria
* Histologically and/or cytologically confirmed diagnosis of breast cancer
* Radiologic evidence of inoperable locally advanced or metastatic breast cancer
* Adequate tumor tissue for the analysis of PI3K-related biomarkers
* Human epidermal growth factor receptor-2 (HER2) negative disease, and a known positive hormone receptor status
* Postmenopausal women
* Prior treatment with aromatase inhibitors
* Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry
* Adequate bone marrow and organ function
* ECOG performance status ≤ 2
Exclusion Criteria
* More than one chemotherapy line for metastatic disease
* Hypersensitivity to any of the excipients of buparlisib or fulvestrant
* Symptomatic central nervous system metastases
* Concurrent malignancy or malignancy within 3 years of study enrollment
* Certain drugs or radiation within 2-4 weeks of enrollment
* Increasing or chronic treatment (\>5 days) with corticosteroids or another immunosuppressive agent
* Certain scores on an anxiety and depression mood questionnaire given at screening
* Acute viral hepatitis or a history of chronic or active hepatitis B virus or hepatitis C virus
* Active cardiac disease or a history of cardiac dysfunction
18 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of South Alabama / Mitchell Cancer Institute Univ South AL
Mobile, Alabama, United States
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
Oregon Health and Science University SC-5
Portland, Oregon, United States
University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital
Pittsburgh, Pennsylvania, United States
The West Clinic Dept. of the West Clinic
Memphis, Tennessee, United States
Texas Oncology PA Dallas Presbyterian Hospital SC
Dallas, Texas, United States
Texas Oncology Texas Oncology - Sammons
Dallas, Texas, United States
Texas Oncology P A SC-Austin
Dallas, Texas, United States
Texas Oncology P A Texas Oncology - Fort Worth (3
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Tech University Health Science Center Dept of Texas Tech
El Paso, Texas, United States
The Methodist Hospital Cancer Center
Houston, Texas, United States
US Oncology, P.A.
Tyler, Texas, United States
Northwest Medical Specialties
Tacoma, Washington, United States
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Countries
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References
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Di Leo A, Johnston S, Lee KS, Ciruelos E, Lonning PE, Janni W, O'Regan R, Mouret-Reynier MA, Kalev D, Egle D, Csoszi T, Bordonaro R, Decker T, Tjan-Heijnen VCG, Blau S, Schirone A, Weber D, El-Hashimy M, Dharan B, Sellami D, Bachelot T. Buparlisib plus fulvestrant in postmenopausal women with hormone-receptor-positive, HER2-negative, advanced breast cancer progressing on or after mTOR inhibition (BELLE-3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):87-100. doi: 10.1016/S1470-2045(17)30688-5. Epub 2017 Dec 7.
Other Identifiers
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2012-002571-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBKM120F2303
Identifier Type: -
Identifier Source: org_study_id
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