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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.
Details
| Lead sponsor | Fudan University |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 20 |
| Start date | 2025-09-25 |
| Completion | 2027-08 |
Conditions
- Breast Cancer
Interventions
- L-Ornithine L-Aspartate
- CDK4/6 inhibitor
- Fulvestrant
Primary outcomes
- Objective Response Rate (ORR) — Baseline until disease progression or loss of clinical benefit, assessed up to 6 months
Countries
China