Clinical Trial

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.

Recruiting Phase 3
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-01-20; most recent amendment 2026-06-01.
Status change: Not Yet Recruiting → Recruiting 2026-03-26
Trial Details
NCT Number NCT07354022
Lead Sponsor Shandong Suncadia Medicine Co., Ltd.
Conditions Locally Advanced or Metastatic Breast Cancer
Enrollment 912 participants
Start Date 2026-05-05
Primary Completion 2028-12 (estimated)
Study Completion 2031-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-02