An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy

This is a prospective, open-label, Bayesian adaptive Phase 2 clinical trial evaluating the efficacy and safety of a novel triple-combination therapy (CDK4/6 inhibitors + Fulvestrant + L-Ornithine L-Aspartate) in patients with HR-positive/HER2-negative advanced breast cancer (ABC) who have progressed on prior standard therapy including CDK4/6 inhibitors and endocrine therapy.

Trial Details

NCT ID
NCT07117630
Phase
PHASE2
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • L-Ornithine L-Aspartate
  • CDK4/6 inhibitor
  • Fulvestrant
Locations (sample)
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • Women aged ≥ 18 years old.
  • Patients with histologically confirmed HR+/HER2- invasive breast cancer (specific definition: ER \> 10% tumor cell positivity by immunohistochemist…
  • Patients with HR+/HER2- advanced breast cancer who have experienced disease progression after receiving systemic therapy including CDK4/6 inhibitor…
  • Patients whom the investigator judges to be suitable for continued endocrine therapy

For full eligibility, visit ClinicalTrials.gov.

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