A Multicenter, Open-label, Randomized Controlled Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer With Disease Progression After Previous Endocrine Therapy

What this Trial Is About

Researchers are evaluating the effects of HRS-8080 compared to treatments chosen by physicians in women with locally advanced or metastatic breast cancer who have experienced disease progression after previous endocrine therapy. This Phase 3 clinical trial plans to enroll 240 female patients aged 18 to 75 years with confirmed breast cancer. The study aims to better understand treatment outcomes following prior endocrine therapy in this patient group. Participants will be randomly assigned to receive one of several treatments: HRS-8080 tablets taken orally, Fulvestrant injections, or oral tablets of Exemestane, Everolimus combined with Exemestane, Anastrozole, or Letrozole. The study is open-label, meaning both doctors and patients know which treatment is being given. The treatments will be administered according to the study protocol, and patients will be followed over approximately two to three years for outcome measurements. During the trial, participants will be regularly assessed through clinical evaluations to monitor progression-free survival, overall response rate, clinical benefit, duration of response, overall survival, and safety outcomes including adverse events. Progression-free survival will be evaluated both by independent central review and investigators over about two years, with overall survival followed for around three years. Patients’ health status and organ function will be monitored throughout, and their involvement will last as long as the study duration.

A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer