drugset / Trial / NCT07117630
An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, Phase II, open-label, two-arm parallel study evaluating the efficacy and safety of combined treatment (L-Ornithine L-Aspartate, N-Acetylcysteine) with CDK4/6 inhibitors and Fulvestrant 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.
Timeline
- Start
- 2025-09-25
- Primary completion
- 2027-06
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | L-ornithine L-aspartate | Other / unclassified | 3 g | Oral |
| Subject | N-acetylcysteine | Small molecule | 600 mg | Oral |
| Subject | Pioglitazone | Small molecule | 30 mg | Oral |
| Background | Fulvestrant | Small molecule | 500 mg | Intramuscular |