drugset
drugset / Trial / NCT05780567

Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer

NCT05780567 ↗

Phase 3 Active not recruiting 1946 enrolled Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a Phase III, randomized, double-blind, parallel, multi-center trail to evaluate the efficacy and safety of TQB3616 capsule combined with endocrine compared to placebo compared with endocrine in HR-positive and HER2-negative breast cancer adjuvant therapy. Approximately 1946 female subjects will be randomized to either TQB3616 combined with endocrine group or TQB3616-matching placebo combined endocrine group. Randomization will follow a 2:1 ratio, 1297 subjects in experimental group and 649 in the the Placebo Comparator group.

Timeline

Start
2023-03-30
Primary completion
2026-12
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Subject TQB3616 Small molecule 180 mg Oral
Background Anastrozole Other / unclassified 1 mg Oral
Background Letrozole Other / unclassified 2.5 mg Oral
Background Tamoxifen Small molecule 10 mg Oral

Indications

breast cancer