NCT05856383|Recruiting
Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in ABC
HER2-VIP
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HER2-VIP
Sponsor study identifier
observational
100
1 country
1
Study Start
March 16, 2022
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 16, 2022
Actual (reported)April 2, 2023
Actual (reported)May 12, 2023
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Progressive free survival(PFS)
The time between the date of treatment of inetetamab combined with pyrotinib and vinorelbine and the progression of the tumor or death from any cause.
From date of treatment of inetetamab combined with pyrotinib and vinorelbine until the date of the progression of the tumor or death from any cause, whichever came first, assessed up to about 48 months
Adverse events
The duration of adverse reaction data collection should be from the date the patient started medication to 30 days after the end of the last medication
assessed up to 48 months
Overall Survival(OS)
From date of the patient starts treatment of inetetamab combined with pyrotinib and vinorelbine and vinorelbine and death from any cause，assessed up to about 48 months.
Objective response rate(ORR)
up to 48 months.
Disease Control Rate (DCR)
up to 48 months.
Group of ues of inetetamab combined with pyrotinib and vinorelbine
Inetetamab Combined With Pyrotinib and Vinorelbine
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Inetetamab Combined With Pyrotinib and Vinorelbine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordpatients with HER2 positive dvanced breast cancer.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Ma F, Ouyang Q, Li W, Jiang Z, Tong Z, Liu Y, Li H, Yu S, Feng J, Wang S, Hu X, Zou J, Zhu X, Xu B. Pyrotinib or Lapatinib Combined With Capecitabine in HER2-Positive Metastatic Breast Cancer With Prior Taxanes, Anthracyclines, and/or Trastuzumab: A Randomized, Phase II Study. J Clin Oncol. 2019 Oct 10;37(29):2610-2619. doi: 10.1200/JCO.19.00108. Epub 2019 Aug 20.
Xu B, Yan M, Ma F, Hu X, Feng J, Ouyang Q, Tong Z, Li H, Zhang Q, Sun T, Wang X, Yin Y, Cheng Y, Li W, Gu Y, Chen Q, Liu J, Cheng J, Geng C, Qin S, Wang S, Lu J, Shen K, Liu Q, Wang X, Wang H, Luo T, Yang J, Wu Y, Yu Z, Zhu X, Chen C, Zou J; PHOEBE Investigators. Pyrotinib plus capecitabine versus lapatinib plus capecitabine for the treatment of HER2-positive metastatic breast cancer (PHOEBE): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2021 Mar;22(3):351-360. doi: 10.1016/S1470-2045(20)30702-6. Epub 2021 Feb 11.
Chen zhanhong
Zhejiang Cancer Hospital
First Submitted
April 2, 2023
First Posted
May 12, 2023
Study Start
March 16, 2022
Actual (reported)Primary Completion
December 31, 2027
EstimatedThe Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 12, 2023
Record last verified: 2023-05
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Source: ClinicalTrials.gov.
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