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Brief Title: A Trial of BKM120 (a PI3K Inhibitor) in Patients With Triple Negative Metastatic Breast Cancer
Official Title: A Phase II Trial of BKM120 (a PI3K Inhibitor) in Patients With Triple Negative Metastatic Breast Cancer
Study ID: NCT01629615
Brief Summary: The purpose of this study is to evaluate the clinical activity of BKM120 in patients with metastatic triple-negative breast cancer.
Detailed Description: This is a prospective, non-randomized, open-label, multicenter, single-arm exploratory study of single agent BKM120 in the treatment of metastatic triple negative breast cancer patients. Patients will first undergo screening, tumor measurement and collection of available tumor block from the primary tumor and/or a metastatic site. Available tumor block is required in all patients per inclusion criteria. Analysis of this tumor block will be used for correlation of predictive markers and clinical response in order to define potential subpopulation that benefit from BKM120. Following confirmation of eligibility criteria, subjects will be enrolled. BKM120 will then be administered in a 100mg dose, orally, once daily, in a continuous schedule. A treatment cycle is defined as 28 days for the purposes of scheduling procedures and evaluations. Treatment with BKM120 will continue until disease progression, unacceptable toxicity that precludes any further treatment, and/or discontinuation of the treatment by investigator or patient decision.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Dana-Farber at Faulkner Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Hospital Universitario Vall d´Hebron, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Instituto Valenciano de Oncología, Valencia, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain
Name: Jose Baselga, MD
Affiliation: Massachusetts General Hospital
Role: STUDY_CHAIR
Name: Eric Winer, MD
Affiliation: Dana-Farber Cancer Institute
Role: STUDY_CHAIR
Name: Jordi Rodon, MD
Affiliation: Hospital Universitario Vall d´Hebron
Role: PRINCIPAL_INVESTIGATOR