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1B-12-11: 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

The purpose of this study is to determine wether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer refractory to aromatase inhibitor.

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

  • 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
  • Other protocol-defined inclusion/exclusion criteria may apply

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
    • University of California at Los Angeles Dept. of UCLA, Los Angeles, California, 90095
    • 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
    • USC/Kenneth Norris Comprehensive Cancer Center Dept.ofNorrisCompCancerCtr (3), Los Angeles, California, 90053
    • 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 Columbia Basin, Kennewick, Washington, 99336
    • Columbia Basin Hematology & Oncology 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 TX Onc - Med City Dallas, Dallas, Texas, 75251
    • Texas Oncology, P.A. Midtown, 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. TX Onc - Southwest, Dallas, Texas, 75251
    • Texas Oncology TX Onc - Southwest, Dallas, Texas, 75251
    • Texas Oncology Midtown, Dallas, Texas, 75251
    • Texas Oncology 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, Lincoln, Nebraska, 68510
    • Southeast Nebraska Oncology Cancer Center, 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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