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.

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 912 (estimated)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced or Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	HRS-8080 Tablet ; Dalpiciclib Isethionate	* HRS-8080 Tablet * Dalpiciclib Isethionate
DRUG	Fulvestrant injection ;Dalpiciclib Isethionate	* Fulvestrant injection * Dalpiciclib Isethionate

Timeline

• Start date: 2026-03-04
• Primary completion: 2028-12-01
• Completion: 2031-12-01
• First posted: 2026-01-21
• Last updated: 2026-03-27

Locations

1 site across 1 country: China