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A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.
Sponsor: Shandong Suncadia Medicine Co., Ltd.
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.
Official title: 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.
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
912
Start Date
2026-03-04
Completion Date
2031-12
Last Updated
2026-03-27
Healthy Volunteers
No
Interventions
HRS-8080 Tablet ; Dalpiciclib Isethionate
* HRS-8080 Tablet * Dalpiciclib Isethionate
Fulvestrant injection ;Dalpiciclib Isethionate
* Fulvestrant injection * Dalpiciclib Isethionate
Locations (1)
Chinese PLA General Hospital Fifth Medical Center
Beijing, Beijing Municipality, China