Dose reductions or discontinuations of taxane were allowed according to investigators' usual practice. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent. In this treatment group, premenopausal patients had to be treated with a GnRH analog. Patients who had been treated with a taxane (either paclitaxel 80–90 mg/m 2 for 3 weeks of a 4-week cycle, or docetaxel 75 mg/m 2 every 3 weeks) plus bevacizumab were randomized 1:1 to continue on the same regimen with the same taxane plus bevacizumab (15 mg/kg every 3 weeks or 10 mg/kg every 2 weeks) (T + BEV arm), or to receive exemestane (25 mg daily, p.o.) in combination with bevacizumab (15 mg/kg every 3 weeks) (E + BEV arm). Enrollment was initiated at 40 French sites. This was a multicenter, randomized, open-label phase III trial. All patients were required to provide written informed consent before entering the study. Additional eligibility requirements included an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 life expectancy ≥3 months no grade 3/4 peripheral neuropathy no proteinuria (urine dipstick for proteinuria >2+, unless 24-h urine collection showed ≤1 g protein) and adequate bone marrow, kidney, and liver function. ![]() complete or partial response or stable disease) 16–24 weeks after starting first-line taxane plus bevacizumab. Patients had to have nonprogressive disease (i.e. Prior endocrine therapy with nonsteroidal AIs (but not exemestane) was allowed in the adjuvant or metastatic setting. Previous neoadjuvant or adjuvant anthracycline- and taxane-based chemotherapy was permitted. At least one evaluable target lesion by RECIST criteria was required for tumor response. Tumors had to be ER-positive (progesterone positive or negative) and HER2-negative. Eligible patients had histologically or cytologically confirmed locally advanced non-resectable breast cancer and/or MBC.
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