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RECRUITING
NCT07389733
PHASE1/PHASE2

A Study of HRS-6208 in Combination With HRS-8080, or Fulvestrant, or Letrozole, With or Without HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer

Sponsor: Shandong Suncadia Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

This study aims to evaluate the safety, tolerability, efficacy and pharmacokinetics of HRS-6208 in combination with HRS-8080 ± HRS-6209, or in combination with fulvestrant ± HRS-6209, or in combination with letrozole ± HRS-6209 in patients with advanced unresectable or metastatic breast cancer.

Official title: Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HRS-6208 in Combination With HRS-8080 ± HRS-6209, or in Combination With Fulvestrant ± HRS-6209, or in Combination With Letrozole ± HRS-6209 in Patients With Advanced Unresectable or Metastatic Breast Cancer: an Open Label, Multicenter, Phase Ib/II Study

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-03-27

Completion Date

2028-12

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

HRS-6208 Capsule

HRS-6208 capsule.

DRUG

HRS-6209 Capsule

HRS-6209 capsule.

DRUG

HRS-8080 Tablet

HRS-8080 tablet.

DRUG

Fulvestrant injection

Fulvestrant injection.

DRUG

Letrozole tablets

Letrozole tablets.

Locations (2)

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China