drugset / Trial / NCT04842617

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

NCT04842617

Phase 3 Active not recruiting 5274 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-04-30
Primary completion
2026-10-31
Completion
2031-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalpiciclib Small molecule