RecruitingPhase 2NCT05420779

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

A Randomized, Parallel, Open-label, Positive Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of TSL-1502 Capsules in HER2-negative Locally Advanced or Metastatic Breast Cancer Patients With Germline BRCA Mutations

Sponsor

Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.

Enrollment

125 participants

Start Date

Jun 30, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Metastatic

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new PARP inhibitor drug (TSL-1502) in women with advanced breast cancer who have a BRCA gene mutation — a hereditary change that impairs the body's ability to repair DNA. PARP inhibitors exploit this weakness in cancer cells to stop them from repairing themselves and growing. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have locally advanced or metastatic HER2-negative breast cancer - You have a confirmed germline BRCA1 or BRCA2 mutation - You have received prior chemotherapy that has not worked - Your organs and blood counts are functioning adequately **You may NOT be eligible if...** - You have HER2-positive breast cancer - You have had a prior PARP inhibitor treatment - You have significant bone marrow suppression or organ dysfunction - You have uncontrolled brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTSL-1502 capsules(low dose)

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

DRUGTSL-1502 capsules(high dose)

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

DRUGInvestigator'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)