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Trial Title:
Inetetamab Combined With Pyrotinib and Vinorelbine as First-line to Third-line Treatment for HER2-positive Metastatic Breast Cancer
NCT ID:
NCT05764941
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Vinorelbine
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Inetetamab
Description:
8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle.
Arm group label:
Observational Group
Intervention type:
Drug
Intervention name:
Pyrotinib
Description:
400mg, oral, every day.
Arm group label:
Observational Group
Intervention type:
Drug
Intervention name:
Vinorelbine
Description:
25 mg/m2, D1, D8, every 3 weeks for one cycle.
Arm group label:
Observational Group
Summary:
This is a real world study to evaluate the efficacy and safety of inetetamb combined with
pyrotinib and vinorelbine as first-line to third-line treatment after trastuzumab
progression in HER2-positive metastatic breast cancer.
Detailed description:
HER2-positive breast cancers account for 15%-20% of all breast cancers. Despite
trastuzumab has significantly improved the survival of patients with HER2-positivie
metastatic breast cancer as the first-line standard treatment, the selection of drugs
after trastuzumab treatment failure remains difficulty and challenge. Inetetamab, a new
antibody to optimize the ADCC effect, has shown great effectiveness in treating
HER2-positive metastatic breast cancer, but therapies subsequent to trastuzumab
progression are still controversial. Pyrotinib, another second-line HER2 targeted drug,
is a typical representative of TKI drugs, which not only has a strong HER2 antagonistic
effect but also can synergize with monoclonal antibodies to amplify the ADCC effect.
Here, investigators studied the efficacy and safety of inetetamb combined with pyrotinib
and vinorelbine as first-line to third-line treatment after trastuzumab progression, so
as to provide new ideas for the treatment of patients with HER2-positive metastatic
breast cancer.
Criteria for eligibility:
Study pop:
HER2-positive metastatic breast cancer patients received inetetamab combined with
pyrotinib and vinorelbine after trastuzumab failure
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Female and 18-80 years old;
2. The patient was diagnosed as HER2-positive breast cancer by histopathology (HER2
positive (IHC +++ or IHC++ but FISH/CISH+ ));
3. All patients have previously received ≤ 2 lines chemotherapy for metastatic breast
cancer;
4. Patients received inetetamab combined with pyrotinib and vinorelbine after
trastuzumab failure;
5. According to RECIST 1.1, patients with at least one target lesion or simple bone
metastasis can be evaluated;
6. ECOG score of physical status was less than 2, and the expected survival time was
not less than 3 months;
7. Complete and traceable medical data.
Exclusion Criteria:
1. Incomplete medical data;
2. The investigator believes that the patient is not suitable to enter this study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jiangsu Provincial People's Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinhai Tang
Investigator:
Last name:
Yongmei Yin
Email:
Principal Investigator
Investigator:
Last name:
Wei Li
Email:
Sub-Investigator
Start date:
January 1, 2020
Completion date:
March 31, 2024
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05764941
