Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/7/2019 |
Start Date: | August 7, 2012 |
End Date: | March 25, 2019 |
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
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.
is effective and safe in treating patients with hormone receptor-positive, HER2-negative
locally advanced or metastatic breast cancer refractory to aromatase inhibitor.
Inclusion 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
Exclusion Criteria:
- 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
We found this trial at
61
sites
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Baltimore, Maryland 21231
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Los Angeles, California 90053
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Mobile, Alabama 36688
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Morgantown, West Virginia 26506
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8915 West Golf Road
Multiple Locations, Illinois 60714
Multiple Locations, Illinois 60714
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Saint Louis, Missouri 63110
Principal Investigator: Cynthia X. Ma
Phone: 314-362-7249
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San Antonio, Texas 78229
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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