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



Status:Terminated
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/1/2019
Start Date:October 3, 2012
End Date:September 21, 2017

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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 AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment

This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to
determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo
plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human
epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor
(AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or
after mammalian target of rapamycin inhibitor (mTORi)-based treatment.

Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in
combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg.
Randomization was stratified according to visceral disease status (present or absent).

Novartis decided not to pursue further development of buparlisib program. On 19 Dec 2016,
Novartis notified the Investigators about this decision; accordingly the CBKM120F2303 study
was terminated.

Key inclusion criteria

- Female patients age 18 years or older

- Histologically and/or cytologically confirmed diagnosis of breast cancer

- Radiologic evidence of inoperable locally advanced or metastatic breast cancer

- Adequate tumor tissue for the analysis of PI3K-related biomarkers

- Human epidermal growth factor receptor-2 (HER2) negative disease, and a known positive
hormone receptor status

- Postmenopausal women

- Prior treatment with aromatase inhibitors

- 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

- ECOG performance status ≤ 2

Key exclusion criteria

- Previous treatment with PI3K inhibitors, protein kinase B inhibitors or fulvestrant

- More than one chemotherapy line for metastatic disease

- Hypersensitivity to any of the excipients of buparlisib or fulvestrant

- Symptomatic central nervous system metastases

- Concurrent malignancy or malignancy within 3 years of study enrollment

- Certain drugs or radiation within 2-4 weeks of enrollment

- Increasing or chronic treatment (>5 days) with corticosteroids or another
immunosuppressive agent

- Certain scores on an anxiety and depression mood questionnaire given at screening

- Acute viral hepatitis or a history of chronic or active hepatitis B virus or hepatitis
C virus

- Active cardiac disease or a history of cardiac dysfunction
We found this trial at
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New Orleans, Louisiana 70122
Principal Investigator: Gary Von Burton
Phone: 318-813-1403
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Athens, Georgia 30607
Principal Investigator: Petros Nikolinakos
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Atlanta, Georgia 30322
Principal Investigator: Elisavet M. Paplomata
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Baltimore, Maryland 21201
Principal Investigator: Katherine Tkaczuk
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Bronx, New York 10467
Principal Investigator: Jesus D Anampa
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Caba, Buenos Aires
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Chandler, Arizona 85224
Principal Investigator: Mikhail I. Shtivelband
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Dallas, Texas 75246
Principal Investigator: Cynthia Osborne
Phone: 214-370-1916
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8196 Walnut Hill Lane
Dallas, Texas 75231
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Dallas, Texas 75251
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Denver, Colorado 80218
Principal Investigator: Ling Ma
Phone: +1 303 430 2700
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El Paso, Texas 79905
Principal Investigator: Zeina Nahleh
Phone: 915-545-6510
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Fayetteville, Arkansas 72703
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Fountain Valley, California 92708
Principal Investigator: Haresh Jhangiani
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Honolulu, Hawaii 96817
Principal Investigator: Jennifer Carney
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Houston, Texas 77030
Principal Investigator: Angel Rodriguez
Phone: 713-441-0685
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Lake Success, New York 11042
Principal Investigator: Morton Coleman
Phone: 855-737-2873
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Lake Success, New York 11042
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Los Angeles, California 90017
Principal Investigator: Lasika Seneviratne
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Los Angeles, California 90048
Principal Investigator: William Audeh
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Los Angeles, California 90095
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Manchester, Missouri 63021
Principal Investigator: Mohan K. Tummala
Phone: 417-820-8099
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Memphis, Tennessee 38120
Principal Investigator: Jason C. Chandler
Phone: 901-683-0055
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Metairie, Louisiana 70006
Principal Investigator: Thomas Cosgriff
Phone: 504-885-2960
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Mobile, Alabama 36688
Principal Investigator: Carol Wiseman Norden
Phone: +1 251 445 9870
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Monterey, California 93940
Principal Investigator: Laura Stampleman
Phone: 831-755-1701
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Morristown, New Jersey 07962
Principal Investigator: Naveed Jan
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Naperville, Illinois 60540
Principal Investigator: Joseph Kash
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New Orleans, Louisiana 70115
Principal Investigator: Michelle Loch
Phone: 504-568-2428
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1514 Jefferson Highway
New Orleans, Louisiana 70121
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Shannon Puhalla
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Portland, Oregon 97210
Principal Investigator: John W. Smith
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Portland, Oregon 97239
Principal Investigator: Kathleen Kemmer
Phone: 503-418-9736
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Tacoma, Washington 98405
Principal Investigator: Sibel Blau
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Tyler, Texas 75702
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Voorhees, New Jersey 08043
Principal Investigator: Robert A. Somer
Phone: 856-673-4908
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