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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.
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
HRS-6209 + Letrozole
HRS-6209 + Letrozole
Dalpciclib/Palbociclib + Letrozole/Anastrozole
Dalpciclib/Palbociclib + Letrozole/Anastrozole
Locations (1)
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China