Actively Recruiting
Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in ABC
Led by Zhejiang Cancer Hospital · Updated on 2023-05-12
100
Participants Needed
1
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, no interventional, single arm cohort study, which aims to study the efficacy and safety of inetetamab combined with pyrotinib and vinorelbine in the Treatment of HER2 positive advanced breast cancer in the real world. The study will be conducted by signing an informed consent form for study enrollment, collecting patient case information, and conducting observation and follow-up.
CONDITIONS
Official Title
Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in ABC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed HER2-positive advanced breast cancer by cytology or histology
- HER2 positive defined as more than 10% immunoreactive cells with IHC score 3 or positive HER2 gene amplification by ISH
- Locally advanced or metastatic breast cancer not removable by surgery
- Good organ function to tolerate chemotherapy, anti-HER2 monoclonal antibodies, and anti-HER2 TKI drugs
- Left ventricular ejection fraction (LVEF) and QT intervals within acceptable safety range by echocardiography or MUGA
- ECOG performance status score between 0 and 2
- Willing to sign informed consent
- Agree to use contraception during the study and for 6 months after treatment
- Not breastfeeding
You will not qualify if you...
- Pregnant or lactating women
- History of other metastatic or potentially metastatic malignant tumors in past 5 years except cured cervical carcinoma in situ, thyroid cancer, or skin basal or squamous cell carcinoma
- Known allergy to study drug components
- History of immunodeficiency including HIV positive or other acquired or congenital immunodeficiency
- Considered unsuitable for inclusion by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
C
Chen zhanhong
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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