Randomized phase II study evaluating weekly oral vinorelbine versus weekly paclitaxel in estrogen receptor-positive, HER2-negative patients with advanced breast cancer (NorBreast-231 trial).

•We evaluated oral vinorelbine vs weekly paclitaxel in ER + advanced breast cancer.•The disease control rate (primary endpoint) was ∼75% in both arms.•Progression-free and overall survival and QoL were similar in the 2 arms.•Differences in safety profiles were consistent with previous experience.•Oral vinorelbine is a reasonable first-line option to discuss with patients.