BKM120 For Triple Negative Breast Cancer

Status: Recruiting
Phase: Phase 2
Diagnosis: Breast: Metastatic
NCT ID: NCT01790932 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-438


This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not yet approved BKM120 for use in patients, including people with your type of cancer. BKM120 is a drug that works by blocking a protein called PI3K which may contribute to cancer growth. This drug has been used in experiments in the laboratory and information from these research studies suggests that BKM120 may help to prevent cancer cells from growing. In this research study, the investigators are looking to see if BKM120 works to stop breast cancer cells from growing.


Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Dana Farber Cancer Institute at Faulkner Hospital

Overall PI:
Erica Mayer, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Gerburg Wulf, MD, Beth Israel Deaconess Medical Center
Nancy Lin, MD, Dana-Farber Cancer Institute

Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478

Eligibility Criteria

Inclusion Criteria: - Pathologically and radiologically confirmed metastatic triple negative breast cancer - At least two prior chemotherapy regimens in the neoadjuvant, adjuvant or metastatic setting - Availability of a representative tumor specimen - At least one measurable lesion Exclusion Criteria: - Have received previous treatment with PI3K inhibitors - Symptomatic CNS metastases (controlled and asymptomatic CNS metastases are acceptable) - Concurrent malignancy or has a malignancy within 3 years of study enrollment - Any of the following mood disorders: active major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, history of suicidal attempt or ideation, homicidal ideation, greater than or equal to CTCAE grade 3 anxiety - Concurrently using other approved or investigational antineoplastic agent and/or chemotherapy within 21 days prior to enrollment in this study - Has received radiation therapy within 28 days prior to enrollment in this study or has not recovered from side effects of such therapy - Major surgery within 28 days of starting therapy or has not recovered from major side effects of a previous surgery - Poorly controlled diabetes mellitus - History of cardiac dysfunction - Currently receiving treatment with QT prolonging medication and the treatment cannot be discontinued or switched to a different medication - Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120 - Receiving chronic treatment with steroids or another immunosuppressive agent - Other concurrent severe and/or uncontrolled medical condition that would contraindicate participation in this study - History of non-compliance to a medical regimen - Currently being treated with drugs known to be moderate or strong inhibitors or inducers of isoenzyme CYP3A - Known history of HIV - Pregnant or breastfeeding - Unwilling to observe total abstinence or to use double barrier method for birth control throughout trial
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