RecruitingPhase 2NCT07117630

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

Sponsor

Fudan University

Enrollment

40 participants

Start Date

Sep 25, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment approach for women with advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative — a common subtype. The cancer has continued to grow despite prior treatment including CDK4/6 inhibitors and hormone therapy. The trial uses a Bayesian adaptive design, which means the study can adjust as it collects data. **You may be eligible if...** - You are a woman aged 18 or older - Your breast cancer is confirmed HR+/HER2- by biopsy - Your cancer has progressed after receiving CDK4/6 inhibitors and hormone therapy - You have measurable disease **You may NOT be eligible if...** - You have not received prior standard treatments for advanced breast cancer - You have uncontrolled or serious other medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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