drugset / Trial / NCT07354022

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.

NCT07354022

Phase 3 Recruiting 912 enrolled Shandong Suncadia Medicine Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-05-05
Primary completion
2028-12
Completion
2031-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fulvestrant Small molecule
Subject HRS-8080 Unknown
Background Dalpiciclib Small molecule

Indications