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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

July 31, 2020

Primary Completion Date

June 30, 2021

Study Completion Date

September 30, 2021

Conditions
HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer
Interventions
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.

Trial Locations (4)

100021

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing

110042

Liaoning Cancer Hospital, Shenyang

130021

The First Hospital of Jilin university, Changchun

410600

Hunan Cancer Hospital, Changsha

All Listed Sponsors
lead

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY