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RECRUITING
NCT07354022
PHASE3

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.

View on ClinicalTrials.gov

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

DRUG

HRS-8080 Tablet ; Dalpiciclib Isethionate

* HRS-8080 Tablet * Dalpiciclib Isethionate

DRUG

Fulvestrant injection ;Dalpiciclib Isethionate

* Fulvestrant injection * Dalpiciclib Isethionate

Locations (1)

Chinese PLA General Hospital Fifth Medical Center

Beijing, Beijing Municipality, China