A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HRS-8080 Combined With Dalpiciclib Versus Fulvestrant Combined With Dalpiciclib in Patients With Locally Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced/metastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Women aged 18 - 75 years old;
• Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1;
• Patients with histologically confirmed locally advanced or metastatic breast cancer;
• Patients with prior adjuvant endocrine resistance following curative-intent surgery;
• Menstrual status: postmenopausal, perimenopausal, or premenopausal;
• Presence of evaluable lesions;
• Organ function must meet required criteria.
Locations
Other Locations
China
Chinese PLA General Hospital Fifth Medical Center
RECRUITING
Beijing
Contact Information
Primary
Zhan Zhang
Zhan.zhang@hengrui.com
+86 17721286165
Time Frame
Start Date: 2026-03-04
Estimated Completion Date: 2031-12
Participants
Target number of participants: 912
Treatments
Experimental: HRS-8080 combined with Dalpiciclib
Active_comparator: Fulvestrant combined with Dalpiciclib
Related Therapeutic Areas
Sponsors
Leads: Shandong Suncadia Medicine Co., Ltd.