NCT07117630

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	L-Ornithine L-Aspartate	3g orally three times daily
DRUG	CDK4/6 inhibitor	at the physician's choice
DRUG	Fulvestrant	500mg IM on Days 1 \& 15 of Cycle 1, then Day 1 of subsequent cycles

Timeline

• Start date: 2025-09-25
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2025-08-12
• Last updated: 2025-12-05

Locations

1 site across 1 country: China