Actively Recruiting
Led by Zhejiang Cancer Hospital · Updated on 2023-05-12
100
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the safety and effectiveness of combining inetetamab with pyrotinib and vinorelbine for treating HER2-positive advanced breast cancer in a real-world setting. This prospective, observational study involves a single group of participants and aims to gather information through patient consent, case collection, and ongoing observation and follow-up. The study is sponsored by Zhejiang Cancer Hospital and focuses on a specific patient population with advanced disease. Participants will receive the combination treatment of inetetamab, pyrotinib, and vinorelbine during the treatment period. The study includes several periods: screening, treatment, and survival and follow-up phases. There are no comparison groups or interventions beyond this single treatment approach, and the study does not involve randomization or placebo controls. During participation, individuals will undergo evaluations including tumor progression monitoring and adverse event assessments for up to 48 months. Researchers will measure outcomes such as progression-free survival, overall survival, objective response rate, and disease control rate. The study involves collecting clinical data and following up regularly to assess treatment effects and safety over time.
CONDITIONS
Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in ABC
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to about 48 months or until disease progression or discontinuation
Participants receive inetetamab combined with pyrotinib and vinorelbine for advanced breast cancer.
Visits occur as part of routine care with assessments for treatment response and safety
Duration - Up to about 48 months
Participants are monitored for overall survival and long-term safety after treatment ends.
Follow-up visits according to clinical practice for survival assessment
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
C
Chen zhanhong
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Fei Ma, Quchang Ouyang, Wei Li...
https://pubmed.ncbi.nlm.nih.gov/31430226Binghe Xu, Min Yan, Fei Ma...
https://pubmed.ncbi.nlm.nih.gov/33581774