A phase II study of gemcitabine combined with vinorelbine as first-line chemotherapy for metastatic breast cancer.

Background And Objectives: There is an unmet need for new combination treatments, especially for aggressive, visceral, and high tumor burden metastatic breast cancer. Gemcitabine (GEM) has shown synergy with vinorelbine (VRL) in preclinical models, and has a toxicity profile that is different from VRL, another recently approved cytotoxic drug that seems to be effective in the treatment of breast cancer.

Methods: We studied the efficacy and side effects of the GEM-VRL combination as first-line chemotherapy in patients in an open-label, single arm, phase II study in patients with locally advanced or metastatic breast cancer who had been previously treated with an anthracycline-based regimen in the adjuvant/neoadjuvant setting.