NCT01738438

Cabozantinib for Metastatic Triple Negative BrCa

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Cabozantinib

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2012-11-30
• Last updated: 2016-12-06
• Results posted: 2016-07-07

Locations

3 sites across 1 country: United States