Organoid-based Functional Precision Therapy for Advanced Breast Cancer

This is a phase II, multicenter, open-label, randomized controlled trial to compare the efficacy of organoid-guided treatment (OGT) to treatment of physician's choice (TPC) in previously treated, HER2-negative locally advanced or metastatic breast cancer. The study will seek to provide evidence for utilizing patient-derived organoid (PDO) model to personalize treatment strategies and inform clinical care for advanced breast cancer. Subjects randomized to the OGT group will undergo PDO generation and receive treatment dictated by subsequent PDO drug sensitivity screening. Subjects randomized to

Trial Details

NCT ID
NCT06102824
Phase
PHASE2
Sponsor
Guangdong Provincial People's Hospital
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Organoid-guided treatment
  • Taxane
  • Capecitabine
  • Gemcitabine
  • Vinorelbine
  • Eribulin
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Must be competent and able to comprehend, sign, and date a written informed consent form (ICF) before performance of any study-specific procedures …
  • Men or women ≥18 years old.
  • Pathologically documented unresectable locally advanced or metastatic breast cancer that:
  • 1 Confirmed as HER2-negative status, defined as IHC 0, IHC 1+, or IHC 2+/ISH- according to American Society of Clinical Oncology College of America…

For full eligibility, visit ClinicalTrials.gov.

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