NCT04355520

A Study of TQ-B3525 Tablets Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer

A Phase Ib, Single-arm, Open-label Study of TQ-B3525 Tablets Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a open-label, multicenter phase Ib study to evaluate safety and efficacy of TQ-B3525 tablets combined with fulvestrant injection in subjects with HR-positive, HER2-negative and PIK3CA mutation advanced breast cancer.

Conditions

• HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	TQ-B3525	TQ-B3525 tablets were taken orally, once daily in 28-day cycle; The doses were 20 mg and 30 mg.
DRUG	Fulvestrant injection	Fulvestrant injection 500mg administered intravenously (IV) on day 1, day 15 of first cycle and on day 1 of follow-up treatment cycle. Each cycle is 28 days.

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-06-01
• Completion: 2021-09-01
• First posted: 2020-04-21
• Last updated: 2020-04-21

Locations

4 sites across 1 country: China