Actively Recruiting
An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy
Led by Fudan University · Updated on 2025-12-05
20
Participants Needed
1
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 63; 18 years old
- Histologically confirmed HR+/HER2- invasive breast cancer defined by ER �3E 10% or PR �3E 10% tumor cell positivity and HER2 negative status
- Advanced breast cancer with progression after systemic therapy including CDK4/6 inhibitors and endocrine therapy
- Investigator assessment supports continued endocrine therapy
- At least one measurable lesion by RECIST version 1.1 criteria without prior radiotherapy
- Normal main organ function meeting defined hematology and blood chemistry criteria
- No radiotherapy, molecular targeted therapy, or surgery within 3 weeks prior to study start and recovery from prior therapy toxicities
- ECOG performance status 64; 2 and life expectancy 63; 3 months
- Female subjects of childbearing potential using medically acceptable contraception during treatment and for 3 months after last dose
- Voluntary enrollment with signed informed consent, good compliance, and willingness to follow-up
You will not qualify if you...
- Radiotherapy (except palliative), chemotherapy, immunotherapy, or bisphosphonates (except for bone metastases) within 3 weeks prior to treatment
- Uncontrolled central nervous system metastases requiring corticosteroids or mannitol
- History of uncontrolled heart disease including recent myocardial infarction or ventricular arrhythmia
- Ongoing adverse reactions 63; Grade 1 from prior therapy except alopecia or investigator-approved cases
- Major surgery within 3 weeks prior to study treatment except minor outpatient procedures
- Pregnant or lactating patients
- History of malignancy within past 5 years except cured basal cell carcinoma or carcinoma in situ of cervix
- Inability to swallow or conditions affecting drug absorption
- Presence of uncontrolled third space effusions such as large pleural fluid or ascites
- Long-term unhealed wounds or fractures
- Active hepatitis B or C infection or abnormal liver function
- Known allergy or history of allergy to study drug components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
Z
Zhiming Shao, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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