Clinical Trial VICCBRE1280
Title
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
Principal Investigator(s)
Details
- Protocol No. VICCBRE1280
- Open Date: 02/07/2013
- Staging: Phase III
- Age Group: Adults
- Scope: National
- Objective: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (full population) and for PI3K pathway activated sub-population.
- Disease Sites: Breast
- Therapies: None Specified
- Drugs: Blinded Drug; Fulvestrant
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01610284
- Secondary Protocol No: CBKM120F2302
Description
The purpose of this study is to determine the treatment benefit and the safety profile of BKM120 or placebo (an inactive substance) taken with fulvestrant in patients whose breast cancer is inoperable or has spread to other organs in the body. As we do not know if combining BKM120 and fulvestrant is better than fulvestrant alone, we need to make comparisons to find out which of these two treatments (fulvestrant plus BKM120 and fulvestrant plus placebo) give better results.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
|---|---|
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
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