Capecitabine In Combination With Bendamustine In Pretreated Women With Her2-Negative Metastatic Breast Cancer: Efficacy Results Of A Phase Ii Trial (Agmt Mbc-6).

1032Background: Capecitabine is a well-established treatment option in HER2-negative advanced breast cancer (ABC) patients. Bendamustine is a generally well tolerated cytotoxic drug. Since bendamustine has already shown anticancer activity in ABC we evaluated the efficacy and tolerability of bendamustine in combination with capecitabine in pretreated patients with ABC. Methods: MBC-6 is a non-randomized, multicenter, open-label, single-arm phase II study in patients with HER2-negative ABC (ClinicalTrials.gov: NCT01891227). All patients were pretreated with anthracyclines and/or taxans and had measurable disease according to RECIST 1.1. Patients received 1000 mg/m2 capecitabine twice daily on days 1 to 14 in combination with 80 mg/m2 bendamustine on day 1 and 8 of a 3-week cycle. The primary endpoint was overall response rate (ORR). Secondary endpoints were progression-free survival (PFS), clinical benefit rate (CBR), safety and quality of life. Results: From September 2013 to May 2015, 40 patients were re...