drugset / Trial / NCT05420779

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

NCT05420779

Phase 2 Unknown 125 enrolled Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Capecitabine Small molecule 1250 mg/m2 Oral
Comparator Eribulin Small molecule 1.4 mg/m2 Intravenous
Subject TSL-1502 Unknown 350 mg Oral
Subject TSL-1502 Unknown 500 mg Oral
Comparator Vinorelbine Small molecule 25 mg/m2 Intravenous
Comparator Vinorelbine Small molecule 30 mg/m2 Intravenous

Indications