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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

  • 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
  • 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
  • Colorado

    • St. Mary's Cancer Center St Mary's, Grand Junction, Colorado, 81502
  • 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
  • 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
  • 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
  • Nebraska

    • Southeast Nebraska Oncology Cancer Center, Lincoln, Nebraska, 68510
    • Southeast Nebraska Oncology, Lincoln, Nebraska, 68510
  • North Dakota

    • Mid Dakota Clinic, P.C. Dept of Oncology, Bismark, North Dakota, 58501
  • 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
  • Arkansas

    • Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville, Arkansas, 72703
    • Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville, Arkansas, 72703
  • Minnesota

    • Fairview Southdale Medical Oncology Clinic, Edina, Minnesota, 55435
    • Park Nicollet Institute Dept Onc, St. Louis Park, Minnesota, 55416
  • 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
  • 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
  • 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
  • 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
  • Tennessee

    • Vanderbilt University Medical Center Vanderbilt - Thompson Ln, Nashville, Tennessee, 37232
    • Vanderbilt University Medical Center Vanderbilt - Thompson Ln, Nashville, Tennessee, 37232
  • Indiana

    • Central Indiana Cancer Centers CICC - East (2), Indianapolis, Indiana, 46227
  • Kentucky

    • University of Louisville / James Graham Brown Cancer Center SC, Louisville, Kentucky, 40202
  • Michigan

    • West Michigan Cancer Center Dept of Oncology, Kalamazoo, Michigan, 49007
  • Georgia

    • Georgia Cancer Specialists. SC, Decatur, Georgia, 30033
    • Georgia Cancer Specialists. SC, Decatur, Georgia, 30033
  • 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
  • Italy

    • Novartis Investigative Site, Napoli, 80131
  • 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
  • CZ

    • Novartis Investigative Site, Catanzaro, CZ, 88100
    • Novartis Investigative Site, Catanzaro, CZ, 88100
  • PI

    • Novartis Investigative Site, Pisa, PI, 56126
  • Czech Republic

    • Novartis Investigative Site, Brno, 65653
  • FI

    • Novartis Investigative Site, Firenze, FI, 50134
  • Spain

    • Novartis Investigative Site, Zaragoza, 50009
    • Novartis Investigative Site, Zaragoza, 50009
  • LU

    • Novartis Investigative Site, Lido di Camaiore, LU, 55041
    • Novartis Investigative Site, Lido di Camaiore, LU, 55041
  • 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
  • Comunidad Valenciana

    • Novartis Investigative Site, Valencia, Comunidad Valenciana, 46017
  • Las Palmas de G.C

    • Novartis Investigative Site, Las Palmas de Gran Canaria, Las Palmas de G.C, 35010
  • Castilla la Mancha

    • Novartis Investigative Site, Toledo, Castilla la Mancha, 45004
    • Novartis Investigative Site, Toledo, Castilla la Mancha, 45004
  • Andalucia

    • Novartis Investigative Site, Sevilla, Andalucia, 41014
    • Novartis Investigative Site, Sevilla, Andalucia, 41014
  • Murcia

    • Novartis Investigative Site, El Palmar, Murcia, 30120
    • Novartis Investigative Site, El Palmar, Murcia, 30120
  • VE

    • Novartis Investigative Site, Mirano, VE, 30035
    • Novartis Investigative Site, Mirano, VE, 30035
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