[Translation] A randomized, open-label, multicenter, phase III bridging clinical study comparing the efficacy and safety of elacestrant with standard treatment (fulvestrant or aromatase inhibitor) in Chinese postmenopausal women or men with advanced breast cancer who have ER-positive, HER2-negative, and ESR1 mutations and have disease progression during or after 1 or 2 lines of endocrine therapy
本研究目的是在既往接受过1或2线内分泌治疗的雌激素受体(ER)阳性(ER+)、人表皮生长因子受体-2(HER2)阴性(HER2-)、存在雌激素受体1(ESR1)突变的中国绝经后女性或男性晚期乳腺癌患者中,与标准治疗(SoC)[氟维司群或芳香化酶抑制剂(AI)]相比较,通过设盲的独立评审委员会(BIRC)评估的无进展生存期(BIRC-PFS),评价elacestrant治疗在中国人群的有效性。
[Translation] The purpose of this study was to evaluate the effectiveness of elacestrant therapy in the Chinese population, as measured by blinded independent review committee (BIRC)-assessed progression-free survival (BIRC-PFS), compared with standard of care (SoC) [fulvestrant or aromatase inhibitor (AI)] in postmenopausal Chinese women or men with advanced breast cancer who were estrogen receptor (ER)-positive (ER+), human epidermal growth factor receptor-2 (HER2)-negative (HER2-), or had estrogen receptor 1 (ESR1) mutations and had received 1 or 2 lines of endocrine therapy.