An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Women aged ≥ 18 years old. * Patients with histologically confirmed HR+/HER2- invasive breast cancer (specific definition: ER \> 10% tumor cell positivity by immunohistochemistry is defined as ER positive, PR positive, PR \> 10% tumor cell positivity is defined as PR positive; HER2 0 - 1+ or HER2 ++ but negative by FISH without amplification is defined as HER2 negative). * Patients with HR+/HER2- advanced breast cancer who have experienced disease progression after receiving systemic therapy including CDK4/6 inhibitors and endocrine therapy. * Patients whom the investigator judges to be suitable for continued endocrine therapy * Patients with at least one measurable lesion per RECIST version 1.1 criteria (≥ 20 mm on conventional CT scan, ≥ 10 mm on spiral CT scan, and without prior radiotherapy for measurable lesion). * Patients whose main organs function normally by meeting the following requirements: * Hematology criteria: HB ≥ 90 g/L (no blood transfusion withi