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
Description
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.
Detailed Description
Patients were randomized (1:1) to receive buparlisib (100 mg/day) or placebo with fulvestrant
(500 mg); randomization was stratified by PI3K pathway activation status (activated,
non-activated, unknown determined in archival tumor tissue) and visceral disease status
(present or absent). Tumor evaluation was performed 6 weeks after the randomization date and
then every 8 weeks until radiological progression (based on Response Evaluation Criteria In
Solid Tumors [RECIST] version 1.1).
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).
Phase
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.Inclusion and Exclusion Criteria
- 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 Key
- 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
Sites
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California
- Los Angeles Hematology/Oncology Medical Group LA Cancer Network, Los Angeles, California, 90017
- Los Angeles Hematology/Oncology Medical Group LA Cancer Network, Los Angeles, California, 90017
- Shapiro & Stafford & Yee & Polanski Study Coordinator, Arcadia, California, 91007
- Shapiro & Stafford & Yee & Polanski Study Coordinator, Arcadia, California, 91007
- Coast Hematology Oncology Associates, Long Beach, California, 90806
- USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3), Los Angeles, California, 90053
- USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3), Los Angeles, California, 90053
- University of California at Los Angeles Dept. of UCLA, Los Angeles, California, 90095
- University of California at Los Angeles Dept. of UCLA, Los Angeles, California, 90095
- St. Jude Heritage Medical Group Virginia Crosson Cancer Center, Fullerton, California, 92835
- St. Jude Heritage Medical Group Virginia Crosson Cancer Center, Fullerton, California, 92835
- Compassionate Cancer Care Medical Group CCCMG, Fountain Valley, California, 92708
- Granada Hills Cancer Center, Valencia, California, 91355
- Granada Hills Cancer Center, Valencia, California, 91355
- Ventura County Hematology and Oncology PMK Medical Group, Oxnard, California, 93030
- Ventura County Hematology and Oncology PMK Medical Group, Oxnard, California, 93030
- Santa Barbara Hematolgy Oncology Medical Group, Santa Barbara, California, 93105
- Santa Barbara Hematolgy Oncology Medical Group, Santa Barbara, California, 93105
- Central Coast Medical Oncology Corporation, Santa Maria, California, 93454
- Central Coast Medical Oncology Corporation, Santa Maria, California, 93454
- Coastal Integrative Cancer Care, San Luis Obispo, California, 93401
- Cancer Care Associates Dept.ofCancerCareAssoc., Fresno, California, 93720
- St Joseph Heritage Healthcare Dept. of RRMG (4), Santa Rosa, California, 94503
- Redwood Regional Medical Group - Santa Rosa Dept. of RRMG (4), Santa Rosa, California, 94503
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Utah
- Utah Cancer Specialists Dept.of Utah Cancer Spec. (3), Salt Lake City, Utah, 84106
- Utah Cancer Specialists Dept.of Utah Cancer Spec. (3), Salt Lake City, Utah, 84106
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Colorado
- St. Mary's Cancer Center St Mary's, Grand Junction, Colorado, 81502
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Oregon
- Cancer Care of the Cascades St. Charles Medical Center, Bend, Oregon, 97701
- Northwest Cancer Specialists Portland Loc, Portland, Oregon, 97210
- Northwest Cancer Specialists Portland Loc, Portland, Oregon, 97210
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Washington
- Columbia Basin Hematology & Oncology Columbia Basin, Kennewick, Washington, 99336
- Columbia Basin Hematology Columbia Basin, Kennewick, Washington, 99336
- Cancer Care Northwest CC Northwest- Spokane South, Spokane, Washington, 99202
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Texas
- Cancer Therapy & Research Center / UT Health Science Center Institute for Drug Development, San Antonio, Texas, 78229
- Cancer Therapy & Research Center / UT Health Science Center Institute for Drug Development, San Antonio, Texas, 78229
- Texas Oncology Midtown, Dallas, Texas, 75251
- Texas Oncology, P.A. Midtown, Dallas, Texas, 75251
- Texas Oncology TX Onc - Bedford, Dallas, Texas, 75251
- Texas Oncology TX Onc - Med City Dallas, Dallas, Texas, 75251
- Texas Oncology TX Onc - Southwest, Dallas, Texas, 75251
- Texas Oncology, P.A. TX Onc - Southwest, Dallas, Texas, 75251
- Texas Oncology, P.A. TX Onc - Med City Dallas, Dallas, Texas, 75251
- Texas Oncology, P.A. TX Onc - Bedford, Dallas, Texas, 75251
- Texas Oncology P.A. - Plano East, Plano, Texas, 75075
- US Oncology Central Monitoring US Oncology Central Pharmacy, Dallas, Texas, 75246
- Oncology Consultants Oncology Consultants, P.A., Houston, Texas, 77024
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Nebraska
- Southeast Nebraska Oncology Cancer Center, Lincoln, Nebraska, 68510
- Southeast Nebraska Oncology, Lincoln, Nebraska, 68510
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North Dakota
- Mid Dakota Clinic, P.C. Dept of Oncology, Bismark, North Dakota, 58501
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Missouri
- Research Medical Center Reseach Med Center (6), Kansas City, Missouri, 64132
- Missouri Cancer Associates Dept.ofMissouriCancerAssoc., Columbia, Missouri, 65201
- Washington University School of Medicine Wash Univ School of Med, St. Louis, Missouri, 63110
- Washington University School of Medicine Regulatory, St. Louis, Missouri, 63110
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Arkansas
- Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville, Arkansas, 72703
- Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville, Arkansas, 72703
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Minnesota
- Fairview Southdale Medical Oncology Clinic, Edina, Minnesota, 55435
- Park Nicollet Institute Dept Onc, St. Louis Park, Minnesota, 55416
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Wisconsin
- Dean Health System Dean Hematology Oncology, Madison, Wisconsin, 53717
- Dean Health System Dean Hematology Oncology, Madison, Wisconsin, 53717
- Cancer TEAM Bellin Health Belin Health, Green Bay, Wisconsin, 54313
- Cancer TEAM Bellin Health Belin Health, Green Bay, Wisconsin, 54313
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Mississippi
- Hematology and Oncology Association at Bridgepoint Hem Onc Bridgepoint, Tupelo, Mississippi, 38801
- Hematology and Oncology Association at Bridgepoint Hem Onc Bridgepoint, Tupelo, Mississippi, 38801
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Illinois
- Cadence Health, Geneva, Illinois, 60134
- Cadence Health, Geneva, Illinois, 60134
- Rush University Medical Center Rush2, Chicago, Illinois, 60612
- North Shore University Health System, Evanston, Illinois, 60201
- Vanguard Health Chicago, Chicago, Illinois, 60640
- Advocate Illinois MasonicMedical Cent/Creticos Cancer Center Dept. of Creticos Cancer Cente, Chicago, Illinois, 60657
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Alabama
- University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2), Mobile, Alabama, 36688
- University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2), Mobile, Alabama, 36688
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Tennessee
- Vanderbilt University Medical Center Vanderbilt - Thompson Ln, Nashville, Tennessee, 37232
- Vanderbilt University Medical Center Vanderbilt - Thompson Ln, Nashville, Tennessee, 37232
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Indiana
- Central Indiana Cancer Centers CICC - East (2), Indianapolis, Indiana, 46227
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Kentucky
- University of Louisville / James Graham Brown Cancer Center SC, Louisville, Kentucky, 40202
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Michigan
- West Michigan Cancer Center Dept of Oncology, Kalamazoo, Michigan, 49007
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Georgia
- Georgia Cancer Specialists. SC, Decatur, Georgia, 30033
- Georgia Cancer Specialists. SC, Decatur, Georgia, 30033
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France
- Novartis Investigative Site, Villejuif Cedex, 94805
- Novartis Investigative Site, Villejuif Cedex, 94805
- Novartis Investigative Site, La Roche sur Yon cedex 9, 85925
- Novartis Investigative Site, Avignon Cedex, 84082
- Novartis Investigative Site, Avignon Cedex, 84082
- Novartis Investigative Site, Lille Cedex, 59020
- Novartis Investigative Site, Lille Cedex, 59020
- Novartis Investigative Site, Paris, 75010
- Novartis Investigative Site, Paris, 75010
- Novartis Investigative Site, Paris, 75231
- Novartis Investigative Site, Paris, 75231
- Novartis Investigative Site, Le Mans Cedex, 72015
- Novartis Investigative Site, Le Mans Cedex, 72015
- Novartis Investigative Site, Clermont-Ferrand, 63011
- Novartis Investigative Site, Clermont-Ferrand, 63011
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Italy
- Novartis Investigative Site, Napoli, 80131
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Germany
- Novartis Investigative Site, Würzburg, 97080
- Novartis Investigative Site, Würzburg, 97080
- Novartis Investigative Site, München, 80638
- Novartis Investigative Site, München, 80638
- Novartis Investigative Site, Heidelberg, 69120
- Novartis Investigative Site, Heidelberg, 69120
- Novartis Investigative Site, Saarbrücken, 66113
- Novartis Investigative Site, Saarbrücken, 66113
- Novartis Investigative Site, Koblenz, 56068
- Novartis Investigative Site, Rodgau, 63110
- Novartis Investigative Site, Magdeburg, 39108
- Novartis Investigative Site, Magdeburg, 39108
- Novartis Investigative Site, Essen, 45147
- Novartis Investigative Site, Essen, 45147
- Novartis Investigative Site, Hannover, 30177
- Novartis Investigative Site, Hannover, 30177
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CZ
- Novartis Investigative Site, Catanzaro, CZ, 88100
- Novartis Investigative Site, Catanzaro, CZ, 88100
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PI
- Novartis Investigative Site, Pisa, PI, 56126
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Czech Republic
- Novartis Investigative Site, Brno, 65653
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FI
- Novartis Investigative Site, Firenze, FI, 50134
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Spain
- Novartis Investigative Site, Zaragoza, 50009
- Novartis Investigative Site, Zaragoza, 50009
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LU
- Novartis Investigative Site, Lido di Camaiore, LU, 55041
- Novartis Investigative Site, Lido di Camaiore, LU, 55041
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Las Palmas de Gran Canaria
- Novartis Investigative Site, Las Palmas de Gran Canarias, Las Palmas de Gran Canaria, 35016
- Novartis Investigative Site, Las Palmas de Gran Canarias, Las Palmas de Gran Canaria, 35016
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Comunidad Valenciana
- Novartis Investigative Site, Valencia, Comunidad Valenciana, 46017
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Las Palmas de G.C
- Novartis Investigative Site, Las Palmas de Gran Canaria, Las Palmas de G.C, 35010
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Castilla la Mancha
- Novartis Investigative Site, Toledo, Castilla la Mancha, 45004
- Novartis Investigative Site, Toledo, Castilla la Mancha, 45004
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Andalucia
- Novartis Investigative Site, Sevilla, Andalucia, 41014
- Novartis Investigative Site, Sevilla, Andalucia, 41014
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Murcia
- Novartis Investigative Site, El Palmar, Murcia, 30120
- Novartis Investigative Site, El Palmar, Murcia, 30120
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VE
- Novartis Investigative Site, Mirano, VE, 30035
- Novartis Investigative Site, Mirano, VE, 30035