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

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.

Trial Details

NCT ID
NCT05420779
Phase
PHASE2
Sponsor
Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • TSL-1502 capsules(low dose)
  • TSL-1502 capsules(high dose)
  • Investigator's choice of chemotherapy
Locations (sample)
  • Beijing, China|39.9075,116.39723

Key Eligibility Criteria

  • 1\) Agree to follow the clinical trial protocol, volunteer, and sign the informed consent form (ICF).
  • 2\) Women aged ≥ 18 years and ≤ 75 years at the date of signing the ICF. 3) HER2-locally advanced breast cancer diagnosed by histopathology and/or …
  • 4\) Prior platinum therapy is allowed, but the best response to platinum therapy is required to be CR, PR, or persistent ≥ 12 weeks SD. If given as…
  • 5\) Hormone receptor-positive patients need to have received at least first-line of endocrine therapy for locally advanced or metastatic breast can…

For full eligibility, visit ClinicalTrials.gov.

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