Clinical Trial

Phase III Study ：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative

Active, Not Recruiting Phase 3
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2021-04-12; most recent amendment 2024-07-30.
Status change: Enrolling by Invitation → Active, Not Recruiting 2024-07-30
Status change: Not Yet Recruiting → Enrolling by Invitation 2021-05-20
Trial Details
NCT Number NCT04842617
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer
Enrollment 5,274 participants
Start Date 2021-04-30
Primary Completion 2026-10-31 (estimated)
Study Completion 2031-10-31 (estimated)
Updated on ClinicalTrials.gov 2024-08-01