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ACTIVE NOT RECRUITING
NCT04842617
PHASE3

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.

View on ClinicalTrials.gov

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

DRUG

SHR6390

SHR6390 combined with endocrine therapy

DRUG

placebo

placebo combined with endocrine therapy

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China