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

NCT05420779 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2024-05-08

No results posted yet for this study

Summary

This research study is evaluating the efficacy and safety of TSL-1502 capsules in patients with breast cancer, will be included HER2-negative locally advanced or metastatic breast cancer patients with germline BRCA mutations.

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)

Sponsors & Collaborators

  • Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Rui Liu · Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2024-12-31
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05420779 on ClinicalTrials.gov