A Study to Evaluate the Efficacy and Safety of TSL-1502 Capsules in Breast Cancer Patients With Germline BRCA Mutations

PHASE2RecruitingINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

June 30, 2022

Primary Completion Date

December 31, 2024

Study Completion Date

June 30, 2026

Conditions
Breast Cancer Metastatic
Interventions
DRUG

TSL-1502 capsules(low dose)

350 mg each time, orally administered QD, every 3 weeks as a treatment cycle.

DRUG

TSL-1502 capsules(high dose)

500 mg each time, orally administered QD, every 3 weeks as a treatment cycle.

DRUG

Investigator's choice of chemotherapy

Capecitabine tablets, 1250 mg/m2 each time, BID oral administration; Vinorelbine tartrate injection, 25 \~ 30 mg/m2 each time, intravenous drip (15 \~ 20 min); Eribulin mesylate injection, 1.4 mg/m2 each time, intravenous injection (2 \~ 5 min)

Trial Locations (1)

Unknown

RECRUITING

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing

All Listed Sponsors
lead

Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.

INDUSTRY