Actively Recruiting
A Prospective, Open, Multicenter Single-arm Clinical Studie of Docetaxel, Carboplatin Combined With Inetetamab and Pyrotinib in the Treatment of Local-advanced HER2-positive Breast Cancer
Led by Wang Ouchen · Updated on 2024-01-31
154
Participants Needed
1
Research Sites
504 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, open, multi-center, single arm trial. The treatment group will receive six cycles of docetaxel, carboplatin combined with Inetetamab and Pyrotinib before surgery. By focusing on tpCR (ypT0/is, ypN0) evaluated by pathology, the efficacy of docetaxel, carboplatin combined with Inetetamab and Pyrotinib in the preoperative treatment of locally advanced HER2-positive breast cancer will be evaluated. During long-term follow-up, event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival (DDFS), overall survival (OS), central nervous system disease-free survival (CNSDFS) under this treatment regimen will be evaluated, and the efficacy-related biomarkers will be explored. The cardiotoxicity of Inetetamab and Pyrotinib in the treatment of breast cancer is also be evaluated.
CONDITIONS
Official Title
A Prospective, Open, Multicenter Single-arm Clinical Studie of Docetaxel, Carboplatin Combined With Inetetamab and Pyrotinib in the Treatment of Local-advanced HER2-positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years old
- ECOG performance status of 0 or 1
- Histologically confirmed invasive breast cancer with primary tumor diameter greater than 2 cm
- Locally advanced breast cancer stage
- HER2-positive breast cancer confirmed by pathology
- Known hormone receptor status (ER and PR)
- Adequate organ function with specific blood counts, liver and kidney function within defined limits
- Left ventricular ejection fraction (LVEF) of 60% or higher
- 12-lead ECG with QTcF less than 470 milliseconds
- Female patients who are not menopausal or surgically sterilized agree to abstain from sex or use effective contraception during and for at least 7 months after treatment
- Willingness to provide informed consent, comply with study requirements, and cooperate with follow-up
You will not qualify if you...
- Metastatic (stage IV) breast cancer
- Prior anti-tumor therapy or radiotherapy for any malignant tumor except certain cured cancers
- Participation in other anti-tumor therapy clinical trials concurrently
- Major surgery unrelated to breast cancer within 4 weeks before enrollment or incomplete recovery from such surgery
- Severe cardiac conditions including heart failure, systolic dysfunction (LVEF lower than 60%), high-risk arrhythmias, significant valve disease, recent myocardial infarction, or poorly controlled hypertension
- Inability to swallow or any condition affecting drug absorption
- Known allergy to study drugs or history of immunodeficiency, including HIV positive or organ transplantation
- Pregnancy, lactation, positive pregnancy test, or unwillingness to use contraception throughout and for 7 months after study treatment
- Serious comorbidities or other conditions that may interfere with treatment or study participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
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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