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Phase III Study :SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Summary
The study is to evaluate the efficacy and safety of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative. To observe the PK characteristics of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.
Official title: A Multicenter, Randomized, Double-blind Phase III Study:SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage,Female Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
5274
Start Date
2021-04-30
Completion Date
2031-10-31
Last Updated
2024-08-01
Healthy Volunteers
No
Interventions
SHR6390
SHR6390 combined with endocrine therapy
placebo
placebo combined with endocrine therapy
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China