Background:

In RIBBON-1, the combination of Bev with Cap as 1st-line therapy for MBC significantly improved progression-free survival (PFS) compared with Cap alone, with limited impact on tolerability. Vin and Cap are active agents with few overlapping toxicities. The combination of both cytotoxic drugs in phase I/II trials showed good tolerability and promising clinical activity. The CARIN trial aims to further improve efficacy by adding Vin to Cap/Bev to establish a less toxic alternative to taxane-based 1st line therapy.

Patients and Methods:

CARIN is a multicenter randomized study comparing the efficacy of Cap plus Bev versus the same regimen combined with Vin. From 04/2009 until 10/2012 598 pts in 61 participating centers were randomized (1:1) to receive Cap 1000 mg/m2 bid days 1–14 + Bev 15 mg/kg q3w (Arm A) or Cap/Bev combined with Vin 25 mg/m2 days 1+8 (Arm B). Randomization was stratified by prior therapy with anthracycline and/or taxane (yes/no) and hormone receptor status (ER/PR +/-). Treatment was continued until progression or unacceptable toxicity. Key eligibility criteria included Her-2 negative metastatic or locally recurrent disease, no prior palliative chemotherapy for MBC, ECOG ≤2, and absence of brain metastases. Primary endpoint was progression-free survival (PFS); secondary endpoints included objective response rate, overall survival, and safety & tolerability. Baseline demographics, prior therapy and disease characteristics were well balanced. 21.5% of pts had triple negative BC, 10.6% had bone metastases only. Progression free survival data for the two treatment arms will be compared using a log-rank test. The influence of pretreatment, hormone receptor status and predictive variables on progression free survival will be analyzed within a cox regression model.

Results:

Data Cleaning and analysis will be complete by October 2013 and results for the primary endpoint PFS and secondary endpoints will be presented at the meeting.

Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-13-01.