Spots Global Cancer Trial Database for Cabozantinib for Metastatic Triple Negative BrCa

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Cabozantinib for Metastatic Triple Negative BrCa

Official Title: A Phase II Study of XL184 (Cabozantinib) for Metastatic Triple-Negative Breast Cancer

Study ID: NCT01738438

Conditions

Breast Cancer

Interventions

Cabozantinib

Study Description

Brief Summary: In this research study, we are looking at the anti-tumor effects of Cabozantinib (XL184) in metastatic breast cancer. Data suggest that MET expression and activation are important for initiation and progression of triple-negative breast cancer (TNBC). We evaluated the efficacy of cabozantinib (XL184), a novel inhibitor of multiple receptor tyrosine kinases, including MET and VEGFR2, in patients with metastatic TNBC.

Detailed Description: OBJECTIVES: Primary \* To evaluate the activity of cabozantinib, as defined by objective response rate in patients with triple-negative metastatic breast cancer Secondary * To evaluate progression free survival * To evaluate c-Met and phospho c-Met expression in archival tumor tissue * To evaluate the incidence of c-Met amplified circulating tumor cells at baseline * To evaluate potential plasma biomarkers of cabozantinib DESIGN: This study uses a two-stage design enrolling 35 patients to evaluate efficacy of cabozantinib based on overall response defined as complete or partial response per RECIST1.1 criteria. The null and alternative overall response rates were 5% and 20%. If one or more patients enrolled in the stage one cohort (n=13 patients) achieve PR or better then accrual proceeds to stage two (n=22 patients).