Actively Recruiting
Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer
Led by Fudan University · Updated on 2024-02-06
145
Participants Needed
1
Research Sites
225 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
P
Peking University Cancer Hospital & Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
CONDITIONS
Official Title
Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years
- Histologically confirmed HR+ / HER2- invasive breast cancer (ER > 10% or PR > 10%)
- SNF4 subtype confirmed by pathology at Fudan University Affiliated Cancer Hospital
- Locally advanced breast cancer not suitable for radical treatment or recurrent metastatic breast cancer
- Measurable disease by RECIST v1.1 or unmeasurable lytic or mixed bone lesions without measurable lesions
- Adequate bone marrow function: absolute neutrophil count > 1.5 x10⁹/L; platelet count > 75 x10⁹/L; hemoglobin > 9 g/dL
- No prior chemotherapy or targeted therapy for metastatic disease
- Adequate liver and kidney function
- ECOG performance status ≤ 2 and life expectancy ≥ 3 months
- Voluntary participation with signed informed consent and agreement to follow-up
You will not qualify if you...
- Received chemotherapy, radiotherapy, immunotherapy, or surgery (except outpatient surgery) for metastatic disease
- Symptomatic, untreated, or actively progressing central nervous system metastases requiring steroids or mannitol
- Significant cardiovascular disease within the last 6 months (including heart failure, angina, myocardial infarction, or ventricular arrhythmia)
- Pregnant or breastfeeding
- History of malignant tumors within the past 5 years except cured basal cell skin carcinoma or cervical carcinoma in situ
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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