NCT04796623

A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer

A Open-label, Multicenter Phase II Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative Advanced Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open-label, multi-cohort phase II clinical trials to evaluate the efficacy and safety of TQB3616 capsules combined with Fulvestrant injection in subjects with HR-positive and HER2-negative advanced and/or metastatic breast cancer, including Cohort 1 and Cohort 2. Each cohort will enroll 30-60 cases.

Conditions

• HR-positive, HER2-negative Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	TQB3616 capsules	TQB3616 capsules 180 mg given orally, once daily in 28-day cycle.
DRUG	Fulvestrant injection	Fulvestrant injection was given at a fixed dose of 500mg on day 1, day 15 of the first cycle and day 1 of each subsequent cycle, and each cycle is 28 days.

Timeline

• Start date: 2021-02-04
• Primary completion: 2024-05-24
• Completion: 2024-05-24
• First posted: 2021-03-15
• Last updated: 2026-04-08

Locations

17 sites across 1 country: China