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
BELLE-2
A Phase III Randomized, Double Blind Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative Locally Advanced or Metastatic Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment
2 other identifiers
interventional
1,147
28 countries
265
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Aug 2012
Typical duration for phase_3 breast-cancer
265 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2012
CompletedFirst Posted
Study publicly available on registry
June 4, 2012
CompletedStudy Start
First participant enrolled
August 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2019
CompletedResults Posted
Study results publicly available
June 18, 2020
CompletedAugust 25, 2020
August 1, 2020
2.7 years
May 11, 2012
April 15, 2020
August 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) Based on Local Investigator Assessment - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort
Progression Free Survival (PFS) is defined as the time from date of randomization to the date of first radiologically documented progression or death due to any cause. If a patient did not progress or die at the time of the analysis data cut-off or start of new antineoplastic therapy, PFS was censored at the date of the last adequate tumor assessment before the earliest of the cut-off date or the start date of additional anti-neoplastic therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria RECIST v1.1, as 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline and/or unequivocal progression of the non-target lesions and/or appearance of a new lesion. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm.
Date of randomization to the date of first documented tumor progression or death from any cause, whichever occurs first, reported between day of first patient randomized up to approximately 4 years
Secondary Outcomes (8)
Overall Survival (OS) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort
Every 3 months following end of treatment visit, assessed for approximately 5 years
Overall Response Rate (ORR) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort
From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 5 years
Clinical Benefit Rate (CBR) - Full Analysis Set (FAS) in Full Population, Main Study Cohort and PI3K Unknown Cohort
From the date of randomization until the date of the first documented disease progression or date of death from any cause whichever came first, assessed for approximately 5 years
Number of Participants With On-Treatments Adverse Events, Serious Adverse Events and Deaths
From first dose of study treatment to 30 days after last dose of study treatment, assessed for approximately 5 years
Plasma Concentration-time Profiles of BKM120 in Combination With Fulvestrant at Cycle 2 Day 1
Cycle2 Day1 (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 24 hours post-dose). Each cycle is 28 days.
- +3 more secondary outcomes
Study Arms (2)
BKM120 100mg + Fulvestrant
EXPERIMENTALBKM120 100 mg per day and fulvestrant given until progression or as described in the protocol.
Placebo + Fulvestrant
PLACEBO COMPARATORBKM120 matching placebo daily and fulvestrant given until progression or as described in the protocol.
Interventions
Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter)
Eligibility Criteria
You may qualify if:
- Locally advanced or metastatic breast cancer
- HER2-negative and hormone receptor-positive status (common breast cancer classification tests)
- Postmenopausal woman
- A tumor sample must be shipped to a Novartis designated laboratory for identification of biomarkers (PI3K activation status)
- Progression or recurrence of breast cancer while on or after aromatase inhibitor treatment
- Measurable disease or non measurable disease bone lesions in the absence of measurable disease as per RECIST 1.1
- Adequate bone marrow and organ function defined by laboratory values
You may not qualify if:
- Previous treatment with PI3K inhibitors, AKT inhibitors, mTOR inhibitor or fulvestrant
- More than one prior chemotherapy line for metastatic disease
- Symptomatic brain metastases
- Increasing or chronic treatment (\> 5 days) with corticosteroids or another immunosuppressive agent
- Active heart (cardiac) disease as defined in the protocol
- Certain scores on an anxiety and depression mood questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (268)
University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)
Mobile, Alabama, 36688, United States
Arizona Oncology Associates Dept of Oncology
Phoenix, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Shapiro and Stafford and Yee and Polanski Study Coordinator
Arcadia, California, 91007, United States
Cancer Care Associates Dept.ofCancerCareAssoc.
Fresno, California, 93720, United States
St. Jude Heritage Medical Group Virginia Crosson Cancer Center
Fullerton, California, 92835, United States
University of California San Diego - Moores Cancer Center UCSD 3
La Jolla, California, 92093-0658, United States
Los Angeles Hematology/Oncology Medical Group LA Cancer Network
Los Angeles, California, 90017, United States
USC Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3)
Los Angeles, California, 90053, United States
University of California at Los Angeles Dept. of UCLA
Los Angeles, California, 90095, United States
Ventura County Hematology and Oncology PMK Medical Group
Oxnard, California, 93030, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, 93401, United States
Santa Barbara Hematolgy Oncology Medical Group
Santa Barbara, California, 93105, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454, United States
St Joseph Heritage Healthcare Dept. of RRMG (4)
Santa Rosa, California, 94503, United States
Granada Hills Cancer Center
Valencia, California, 91355, 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, 33021, United States
Cancer Specialists of North Florida SC - F2302
Jacksonville, Florida, 32258, United States
University of Miami Univ Miami 2
Miami, Florida, 33136, United States
MD Anderson Cancer Center - Orlando MD Orlando
Orlando, Florida, 32806, United States
Georgia Cancer Specialists SC
Decatur, Georgia, 30033, United States
North Shore University Health System
Evanston, Illinois, 60201, United States
Cadence Health
Geneva, Illinois, 60134, United States
Cancer Care and Hematology Specialists of Chicagoland Niles
Multiple Locations, Illinois, United States
Cancer Center of Kansas CCK
Wichita, Kansas, 67214-3728, United States
Mercy Medical Center Mercy Medical SC
Baltimore, Maryland, 21202, United States
Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Sidney/John Hopkins
Baltimore, Maryland, 21231, United States
Frederick Memorial Hospital Fred. Mem. Hosp.
Frederick, Maryland, 21701, United States
Maryland Oncology Hematology, P.A. SC
Rockville, Maryland, 20850, United States
Massachusetts General Hospital SC
Boston, Massachusetts, 02114, United States
West Michigan Cancer Center Dept of Oncology
Kalamazoo, Michigan, 49007, United States
Hematology and Oncology Association at Bridgepoint Hem Onc Bridgepoint
Tupelo, Mississippi, 38801, United States
Washington University School of Medicine Regulatory
St Louis, Missouri, 63110, United States
Hackensack Meridian Health
Brick, New Jersey, 08724, United States
The Valley Hospital / Luckow Pavillion
Paramus, New Jersey, 07652, United States
Clinical Research Alliance SC-2
Lake Success, New York, 11042, United States
Memorial Sloan Kettering Dept Onc
New York, New York, 10017, United States
University of Rochester Medical Center Univ Rochester
Rochester, New York, 14642, United States
Levine Cancer Institute Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Case Western Reserve SC
Cleveland, Ohio, 44106-5000, United States
Northwest Cancer Specialists Portland Loc
Portland, Oregon, 97210, United States
St. Luke's Hospital and Health Network St Luke's (2)
Bethlehem, Pennsylvania, 18015, United States
Charleston Hematology Oncology Association PA
Charleston, South Carolina, 29414, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909, United States
Vanderbilt University Medical Center Vanderbilt - Thompson Ln
Nashville, Tennessee, 37232, United States
Texas Oncology P A Midtown
Dallas, Texas, 75251, United States
Texas Oncology P A TX Onc - Bedford
Dallas, Texas, 75251, United States
Texas Oncology P A TX Onc - Med City Dallas
Dallas, Texas, 75251, United States
Texas Oncology P A TX Onc - Southwest
Dallas, Texas, 75251, United States
Oncology Consultants Oncology Consultants, P.A.
Houston, Texas, 77024, United States
Cancer Therapy and Research Center UT Health Science Center Institute for Drug Development
San Antonio, Texas, 78229, United States
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)
Salt Lake City, Utah, 84106, United States
Oncology Hematology Associates of Southeast Virginia Salem VA Branch
Roanoke, Virginia, 24014, United States
Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc
Kennewick, Washington, 99336, United States
West Virginia University/ Mary Babb Randolph Cancer Center Dept of Oncology
Morgantown, West Virginia, 26506, United States
Cancer TEAM Bellin Health Belin Health
Green Bay, Wisconsin, 54313, United States
Dean Health System Dean Hematology Oncology
Madison, Wisconsin, 53717, United States
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3
Madison, Wisconsin, 53792-6164, United States
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Related Publications (2)
Campone M, Im SA, Iwata H, Clemons M, Ito Y, Awada A, Chia S, Jagiello-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Cortes J, De Laurentiis M, Arteaga CL, Jiang Z, Jonat W, Le Mouhaer S, Sankaran B, Bourdeau L, El-Hashimy M, Sellami D, Baselga J. Buparlisib plus fulvestrant versus placebo plus fulvestrant for postmenopausal, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer: Overall survival results from BELLE-2. Eur J Cancer. 2018 Nov;103:147-154. doi: 10.1016/j.ejca.2018.08.002. Epub 2018 Sep 18.
PMID: 30241001DERIVEDBaselga J, Im SA, Iwata H, Cortes J, De Laurentiis M, Jiang Z, Arteaga CL, Jonat W, Clemons M, Ito Y, Awada A, Chia S, Jagiello-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Takahashi M, Vuylsteke P, Hachemi S, Dharan B, Di Tomaso E, Urban P, Massacesi C, Campone M. Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Jul;18(7):904-916. doi: 10.1016/S1470-2045(17)30376-5. Epub 2017 May 30.
PMID: 28576675DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Novartis made the decision not to pursue further development of buparlisib and to terminate the ongoing studies in Breast Cancer. The CBKM120F2302 study was terminated on 19-Apr-2019 (last subject last visit).
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2012
First Posted
June 4, 2012
Study Start
August 7, 2012
Primary Completion
April 29, 2015
Study Completion
April 19, 2019
Last Updated
August 25, 2020
Results First Posted
June 18, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com