Actively Recruiting
Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
Led by Fudan University · Updated on 2024-06-07
184
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF4 subtype of advanced breast cancer. The study was used to explore the efficacy of Apatinib in combination with standard endocrine therapy.
CONDITIONS
Official Title
Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Pathologically confirmed HR+/HER2- breast cancer (ER >10% or PR >10%, HER0 or +, and if HER2++, FISH negative)
- SNF4 subtype confirmed by digital pathology of H&E sections
- Locally advanced breast cancer not eligible for radical local therapy or metastatic breast cancer without prior adjuvant CDK4/6 inhibitor use or at least one year after ending adjuvant CDK4/6 inhibitor therapy
- No prior chemotherapy, targeted therapy, or other treatments for advanced or metastatic breast cancer
- At least one measurable lesion not previously treated with radiation and evaluable by RECIST 1.1
- Normal main organ functions meeting specified blood and biochemical standards
- ECOG performance status 0 or 1 and expected survival over 3 months
- Fertile females must use medically approved contraception during treatment and for at least 3 months after last study drug use
- Voluntary participation with signed informed consent and ability to comply with follow-up
You will not qualify if you...
- Uncontrolled central nervous system metastasis requiring glucocorticoids or mannitol
- History of significant or uncontrolled heart disease including recent heart failure, angina, heart attack within 6 months, or ventricular arrhythmia
- Radiotherapy, chemotherapy, surgery, targeted therapy, or immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks before starting study drugs
- Pregnant or breastfeeding women
- Other malignancies within last 3 years except cured basal cell skin cancer or cervical carcinoma in situ
- Significant comorbid conditions including mental illness that may affect participation
- Known allergy to study drug components or other monoclonal antibodies
- Investigator judgment deeming patient unsuitable for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao, MD, PhD
CONTACT
P
Peng Ji, MD
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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