NCT05365178

To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer

A Randomized, Double-blind, Parallel-controlled Phase III Trial Evaluating the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated HR-positive, HER2-negative Advanced Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 432 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, parallel-controlled, multicenter trial design was used in this study. Subjects who meet the criteria will be randomly divided into 2:1 groups to receive TBQ3616 capsule combined with Fulvestrant injection (experimental group) or placebo capsule combined with fulvestrant (control group). A total of 428 subjects were required.

Conditions

• HR-positive, HER2-negative Breast Neoplasms

Interventions

Type	Name	Description
DRUG	TQB3616 capsule	TQB3616 capsule is a CDK (cyclin-dependent kinases) 2/4/6 kinase inhibitor, which can selectively inhibit THE activity of CDK2/4/6 kinase, make it form a complex with Cyclin D, reduce the phosphorylation level of retinoblastoma protein (Rb) in cancer cells, and prevent cells from entering S phase from G1 phase
DRUG	Placebo	It is a placebo
DRUG	Fulvestrant injection	Fulvestrant is a competitive estrogen receptor antagonist, and its mechanism is related to the down-regulation of estrogen receptor (ER) protein level

Timeline

• Start date: 2022-07-01
• Primary completion: 2025-07-02
• Completion: 2026-06-01
• First posted: 2022-05-09
• Last updated: 2026-01-07

Locations

88 sites across 1 country: China