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RECRUITING
NCT07117630
PHASE2

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-09-25

Completion Date

2027-08

Last Updated

2026-05-19

Healthy Volunteers

No

Conditions

Interventions

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

DRUG

N-Acetylcysteine (NAC) Treatment

600mg orally twice daily

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China