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
NCT ID: NCT01610284
Last Updated: 2020-08-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1147 participants
INTERVENTIONAL
2012-08-07
2019-04-19
Brief Summary
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Detailed Description
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Novartis made the decision not to pursue further development of buparlisib and to terminate the ongoing studies in the program. Accordingly, on 19-Dec-2016, Novartis notified all the Investigators about the decision not to pursue further development of buparlisib in Breast Cancer. As a result, the CBKM120F2302 study was terminated on 19-Apr-2019 (last subject last visit).
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
* 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
Exclusion Criteria
* 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
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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Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Valencia, Valencia, Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)
Mobile, Alabama, United States
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
Cancer Care and Hematology Specialists of Chicagoland Niles
Multiple Locations, Illinois, United States
Cancer Center of Kansas CCK
Wichita, Kansas, United States
Mercy Medical Center Mercy Medical SC
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Sidney/John Hopkins
Baltimore, Maryland, United States
Frederick Memorial Hospital Fred. Mem. Hosp.
Frederick, Maryland, United States
Maryland Oncology Hematology, P.A. SC
Rockville, Maryland, United States
Massachusetts General Hospital SC
Boston, Massachusetts, United States
West Michigan Cancer Center Dept of Oncology
Kalamazoo, Michigan, United States
Hematology and Oncology Association at Bridgepoint Hem Onc Bridgepoint
Tupelo, Mississippi, United States
Washington University School of Medicine Regulatory
St Louis, Missouri, United States
Hackensack Meridian Health
Brick, New Jersey, United States
The Valley Hospital / Luckow Pavillion
Paramus, New Jersey, United States
Clinical Research Alliance SC-2
Lake Success, New York, United States
Memorial Sloan Kettering Dept Onc
New York, New York, United States
University of Rochester Medical Center Univ Rochester
Rochester, New York, United States
Levine Cancer Institute Levine Cancer Institute
Charlotte, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Case Western Reserve SC
Cleveland, Ohio, United States
Northwest Cancer Specialists Portland Loc
Portland, Oregon, United States
St. Luke's Hospital and Health Network St Luke's (2)
Bethlehem, Pennsylvania, United States
Charleston Hematology Oncology Association PA
Charleston, South Carolina, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Vanderbilt University Medical Center Vanderbilt - Thompson Ln
Nashville, Tennessee, United States
Texas Oncology P A Midtown
Dallas, Texas, United States
Texas Oncology P A TX Onc - Bedford
Dallas, Texas, United States
Texas Oncology P A TX Onc - Med City Dallas
Dallas, Texas, United States
Texas Oncology P A TX Onc - Southwest
Dallas, Texas, United States
Oncology Consultants Oncology Consultants, P.A.
Houston, Texas, United States
Cancer Therapy and Research Center UT Health Science Center Institute for Drug Development
San Antonio, Texas, United States
Utah Cancer Specialists Dept.of Utah Cancer Spec. (3)
Salt Lake City, Utah, United States
Oncology Hematology Associates of Southeast Virginia Salem VA Branch
Roanoke, Virginia, United States
Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc
Kennewick, Washington, United States
West Virginia University/ Mary Babb Randolph Cancer Center Dept of Oncology
Morgantown, West Virginia, United States
Cancer TEAM Bellin Health Belin Health
Green Bay, Wisconsin, United States
Dean Health System Dean Hematology Oncology
Madison, Wisconsin, United States
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3
Madison, Wisconsin, United States
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CABA, Buenos Aires, Argentina
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Rio Negro, Viedma, Argentina
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Heraklion Crete, Greece, Greece
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Nagoya, Aichi-ken, Japan
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Yokohama, Kanagawa, Japan
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Kumamoto, Kumamoto, Japan
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Sakyo Ku, Kyoto, Japan
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Osaka, Osaka, Japan
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Osaka, Osaka, Japan
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Suita, Osaka, Japan
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Koto Ku, Tokyo, Japan
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Nijmegen, , Netherlands
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Surquillo, Lima region, Peru
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Krakow, , Poland
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Olsztyn, , Poland
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Warsaw, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Saint Petersburg, , Russia
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Singapore, , Singapore
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Bratislava, Slovak Republic, Slovakia
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Košice, , Slovakia
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Johannesburg, , South Africa
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Parktown, , South Africa
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Suwon, Gyeonggi-do, South Korea
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Seoul, Seocho Gu, South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Elche, Alicante, Spain
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Córdoba, Andalusia, Spain
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Jaén, Andalusia, Spain
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Málaga, Andalusia, Spain
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Seville, Andalusia, Spain
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Seville, Andalusia, Spain
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Toledo, Castille-La Mancha, Spain
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Barcelona, Catalonia, Spain
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Las Palmas de Gran Canarias, Las Palmas de Gran Canaria, Spain
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San Sebastián de los Reyes, Madrid, Spain
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El Palmar, Murcia, Spain
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Oviedo, Principality of Asturias, Spain
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Madrid, , Spain
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Madrid, , Spain
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Zaragoza, , Spain
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Bellinzona, , Switzerland
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Geneva, , Switzerland
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Zurich, , Switzerland
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Truro, Cornwall, United Kingdom
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Bournemouth, , United Kingdom
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Derby, , United Kingdom
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Leicester, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Oxford, , United Kingdom
Countries
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References
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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.
Baselga 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.
Other Identifiers
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2011-005524-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CBKM120F2302
Identifier Type: -
Identifier Source: org_study_id
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