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Sorafenib in combination with docetaxel as first-line therapy for HER2-negative metastatic breast cancer: Final results of the randomized, double-blind, placebo-controlled phase II MADONNA study

The Breast Apr 30, 2019

Mavratzas A, et al. - Among patients with metastatic or locally advanced HER2-negative breast cancer, researchers evaluated the antitumor activity and toxicity profile of docetaxel with the antiangiogenic multikinase inhibitor sorafenib or matching placebo as a first-line treatment. For this multicenter, double-blind phase II study, participants were randomized 1:1 to obtain docetaxel 100 mg/m2 on day 1 every 3 weeks in combination with sorafenib 400 mg bid or placebo on days 2–18 of each cycle until tumor progression, or unacceptable toxicity. No statistically significant differences were found between sorafenib dosing schedules. In patients with metastatic breast cancer, the addition of sorafenib to taxane-based first-line chemotherapy did not improve progression-free survival and resulted in increased toxicity.
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