Overview

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

Status:
Not yet recruiting

Trial end date:
2027-01-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Treatments:

Anastrozole
Letrozole
Tamoxifen