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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

This study is a multicenter, open-label, randomized controlled Phase 3 clinical trial. It is planned to enroll 240 female patients with locally advanced or metastatic breast cancer followed by disease progression after previous endocrine therapy.

Eligibility criteria

Qualifiers

Women aged 18 to 75 years old (including both values).

ECOG Physical Strength Status (PS) : 0 to 1 point.

Patients with locally advanced or metastatic breast cancer confirmed by histology.

Patients previously received 1-2 lines of endocrine therapy.

Disqualifiers

Patients with rapid disease progress and investigators determine that endocrine therapy is not suitable or tolerant.

A history of severe clinical cardiovascular diseases.

Patients with uncontrollable tumor-related pain as judged by investigators.

Severe infection exists within 4 weeks before the first study administration.

Trial design

Treatments tested in this trial

  • HRS-8080 Tablet
  • Fulvestrant injection
  • Exemestane tablets
  • Everolimus Tablets
  • Anastrozole Tablets
  • Letrozole Tablets

Treatment groups

240 Participants
are divided into 4 treatment groups