This is a prospective, single arm phase II study to evaluate the efficacy and safety of fulvestrant as a maintenance hormone therapy after first-line chemotherapy for postmenopausal HR positive advanced breast cancer.~Approximately 58 women who have stable disease or responded to first line chemotherapy with at least 4 and less than 8 weeks of treatment for metastatic breast cancer will be enrolled to this study and receive fulvestrant 500mg as a maintenance therapy. The treatment will continue until the objective disease progression or intolerable AE.~Efficacy will be determined based on tumor assessments performed by each investigator according to RECIST (Response Evaluation Criteria in Solid Tumors ) 1.1. Safety will be monitored based on the frequency and severity of adverse events (AEs), as assessed by Common Terminology Criteria (CTC) grade version 4.0.~Tumor assessments will be assessed by computed tomography (CT) or magnetic resonance imaging (MRI) every 12 weeks for all patients until documented evidence of objective disease progression.~Reporting of SAEs (serious adverse events) to regulatory authorities will be done by the investigator in accordance with local regulations.
This is a prospective, single arm phase II study to evaluate the efficacy and safety of fulvestrant as a maintenance hormone therapy after first-line chemotherapy for postmenopausal HR positive advanced breast cancer.