A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi

Description

A Phase III Randomized, Double Blind, Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment. This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with HR+, HER2-, AI treated locally advanced or metastatic breast cancer who progressed on or after mTor inhibitor based treatment.

Study Start Date

October 2012

Estimated Completion Date

March 2017

Interventions

  • Drug: BKM120 matching placebo
  • Drug: Fulvestrant
  • Drug: BKM120

Specialties

  • Obstetrics & Gynecology: Breast
  • Oncology: Breast,Pharmacology/Therapy
  • Pharmacy: Chemotherapy/Oncology,Drug Trials
  • Physician Assistant: Clinical Pharmacology,Hematology/Oncology

MeSH Terms

  • Breast Neoplasms

Study ID

Novartis -- CBKM120F2303

Status

Unknown

Trial ID

NCT01633060

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

420

Sponsor

Novartis

Inclusion Criteria

  • Postmenopausal women
  • Breast cancer that is locally advanced or metastatic
  • HER2 negative disease, and a known positive hormone receptor status (common breast cancer classification tests)
  • A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization
  • Prior treatment with AIs
  • Evidence of progression to the combination of mTORi and endocrine therapy given as the last therapy prior to study entry
  • Adequate bone marrow and organ function

Exclusion Criteria

  • More than 1 prior chemotherapy given for locally advanced or metastatic disease
  • Previous treatment with PI3K inhibitors, AKT inhibitors or fulvestrant
  • Symptomatic CNS metastases
  • Concurrent malignancy or malignancy within 3 years prior to start of study treatment
  • Certain drugs or radiation within 2-4 weeks of enrollment
  • Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
  • Active heart (cardiac) disease or a history of cardiac dysfunction as defined in the protocol
  • HyperSsensitivity to fulvestrant treatment excipients
  • Certain scores on an anxiety and depression mood questionnaire given at screening
  • Other protocol defined criteria may apply

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (52)

Study Location Distance Name Phone Email
Clinical Research Alliance - Lake Success, New York 39.6 miles Victoria Travers 855-737-2873 vtravers@researchcra.com
Clinical Research Alliance - Lake Success, New York 39.6 miles None None None
Montefiore Medical Center Montefiore - Bronx, New York 40.3 miles None None None
Montefiore Medical Center Montefiore - Bronx, New York 40.3 miles Christina GarciaMiller 718-405-8545 crgarcia@montefiore.org
Morristown Memorial Hospital Morristown Mem - Morristown, New Jersey 71.1 miles None None None
New York Oncology Hematology PC Dept of NYOH Albany - Troy, New York 107.3 miles None None None
New York Oncology Hematology PC Dept of NYOH Albany - Troy, New York 107.3 miles None None None
CINJ at Cooper University Hospital Dept of Onc - Voorhees, New Jersey 131.2 miles None None None
University of Maryland Medical Center Univ Maryland - Baltimore, Maryland 222.5 miles None None None
Holy Cross Hospital Holy Cross - Silver Spring, Maryland 252.5 miles None None None
University of Pittsburgh Cancer Institute Dept of Magee Womens Hospital - Pittsburgh, Pennsylvania 354.1 miles Rometa Pollard 412-641-2261 pollardrr@upmc.edu
University of Pittsburgh Cancer Institute Dept of Magee Womens Hospital - Pittsburgh, Pennsylvania 354.1 miles None None None
University Cancer Blood Center LLC - Athens, Georgia 748.7 miles None None None
Edward Hospital Edward Hospital - Naperville, Illinois 772.9 miles Erin Vidra 630-646-6072 Evidra@edward.org
Edward Hospital Edward Hospital - Naperville, Illinois 772.9 miles None None None
Emory University School of MedicineWinship Cancer Institute Emory - Atlanta, Georgia 795.6 miles Nwaugo L Ogbonnaya 404-778-4824 nwaugo.ogbonnaya@emoryhealthcare.org
Emory University School of MedicineWinship Cancer Institute Emory - Atlanta, Georgia 795.6 miles None None None
University of Wisconsin BKM120F2303 - Madison, Wisconsin 839.6 miles None None None
Washington University School of Medicine SC - St. Louis, Missouri 919.8 miles None None None
Washington University School of Medicine SC - St. Louis, Missouri 919.8 miles None None None
Mercy Medical Research Institute SC - Manchester, Missouri 934.6 miles None None None
The West Clinic Dept of the West Clinic - Memphis, Tennessee 996.2 miles None None None
University of South Alabama Mitchell Cancer Institute Univ South AL - Mobile, Alabama 1,107.7 miles None None None
Highlands Oncology Group Dept of Highlands Oncology Grp - Fayetteville, Arkansas 1,181.6 miles None None None
Highlands Oncology Group Dept of Highlands Oncology Grp - Fayetteville, Arkansas 1,181.6 miles Lori Drummond +1 479 872 8130 ldrummond@hogonc.com
Avera Cancer Avera SC - Sioux Falls, South Dakota 1,208.2 miles None None None
Crescent City Research Consortium LLC SC - Metairie, Louisiana 1,226.0 miles None None None
Lsu Health Sciences Center Lsu School of Medicine Lsu - New Orleans, Louisiana 1,226.2 miles None None None
Ochsner Clinic Foundation Ochsner 2 - New Orleans, Louisiana 1,227.0 miles None None None
Texas Oncology PA - Tyler, Texas 1,363.6 miles None None None
Texas Oncology Texas Oncology Fort Worth 3 - Dallas, Texas 1,415.7 miles None None None
Texas Oncology SCAustin - Dallas, Texas 1,415.7 miles None None None
Texas Oncology PA SC - Dallas, Texas 1,416.1 miles None None None
Texas Oncology Texas Oncology Sammons - Dallas, Texas 1,420.1 miles None None None
US Oncology Central Monitoring - Dallas, Texas 1,420.1 miles None None None
The Methodist Hospital Cancer Center - Houston, Texas 1,475.7 miles Aranzazu Calzado 713-441-0685 rxids@tmhs.org
The Methodist Hospital Cancer Center - Houston, Texas 1,475.7 miles None None None
Rocky Mountain Cancer Centers SC - Denver, Colorado 1,665.3 miles Susan Catherine Hall +1 303 430 2700 Susan.Hall@USOncology.com
Rocky Mountain Cancer Centers SC - Denver, Colorado 1,665.3 miles None None None
Texas Tech University Health Science Center Dept of Texas Tech - El Paso, Texas 1,946.0 miles None None None
Ironwood Cancer and Research Centers SC - Chandler, Arizona 2,179.2 miles None None None
Northwest Medical Specialties - Tacoma, Washington 2,436.7 miles None None None
Oregon Health Science University SC5 - Portland, Oregon 2,468.2 miles None None None
Northwest Cancer Specialists Compass Oncology BKM - Portland, Oregon 2,468.8 miles None None None
Compassionate Cancer Care Medical Group CCCMG - Fountain Valley, California 2,483.5 miles None None None
Compassionate Cancer Care Medical Group CCCMG - Fountain Valley, California 2,483.5 miles Chi Nguyen 714-698-0300 cnguyen@compcareresearch.com
Los Angeles HematologyOncology Medical Group Onc Dept - Los Angeles, California 2,490.2 miles None None None
Los Angeles HematologyOncology Medical Group Onc Dept - Los Angeles, California 2,490.2 miles Krystal Griffith 310-989-7757 kgriffith@scoranet.org
Cedars Sinai Medical Center SC5 - Los Angeles, California 2,495.4 miles None None None
University of California at Los Angeles UCLA SC - Los Angeles, California 2,499.3 miles None None None
Pacific Cancer Care - Monterey, California 2,605.3 miles None None None
Moanalua Medical Center Attn Oncology Dept - Honolulu, Hawaii 5,002.1 miles None None None

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