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NOT YET RECRUITING
NCT07894328
PHASE3

A Phase III Clinical Study of HRS-6209 Plus Letrozole as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the efficacy and safety of HRS-6209 in combination with letrozole compared with dalpciclib or palbociclib in combination with aromatase inhibitor in patients with advanced or metastatic breast cancer who have not received prior systemic treatment for advanced or metastatic disease. Approximately half of the participants will receive HRS-6209 plus letrozole while the other half of participants will receive dalpciclib or palbociclib in combination with aromatase inhibitor. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

Official title: A Multi-Center, Open-Label, Randomized Phase III Clinical Study of HRS-6209 Plus Letrozole as First-line Therapy in Patients With Advanced or Metastatic Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1050

Start Date

2026-11-20

Completion Date

2031-09-30

Last Updated

2026-10-26

Healthy Volunteers

No

Conditions

Interventions

DRUG

HRS-6209 + Letrozole

HRS-6209 + Letrozole

DRUG

Dalpciclib/Palbociclib + Letrozole/Anastrozole

Dalpciclib/Palbociclib + Letrozole/Anastrozole

Locations (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China