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

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.

NCT Number	NCT07117630
Lead Sponsor	Fudan University
Conditions	Breast Cancer
Enrollment	60 participants
Start Date	2025-09-25
Primary Completion	2027-06 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2026-07-13