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Trial Title:
Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in ABC
NCT ID:
NCT05856383
Condition:
HER2-positive Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Vinorelbine
Conditions: Keywords:
Advanced breast cancer，HER2-positive
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Inetetamab Combined With Pyrotinib and Vinorelbine
Description:
Inetetamab Combined With Pyrotinib and Vinorelbine
Arm group label:
Group of ues of inetetamab combined with pyrotinib and vinorelbine
Summary:
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.
Detailed description:
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.The research process is
divided into screening period, treatment period, and survival and follow-up periods.
Criteria for eligibility:
Study pop:
patients with HER2 positive dvanced breast cancer.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years;
2. The HER2 positive advanced breast cancer confirmed by cytology or histology must
meet the following conditions at the same time:
(1) HER2 positive is defined as>10% of immunoreactive cells with an immunohistochemical
(IHC) score of 3 or an in situ hybridization (ISH) result of HER2 gene amplification (2)
Advanced breast cancer is defined as locally advanced breast cancer or metastatic breast
cancer that cannot be removed by radical surgery confirmed by researchers; 3. The
functional level of the main organs has been evaluated by the researchers to withstand
chemotherapy, anti HER2 monoclonal antibodies, and anti HER2 TKI drugs. The LVEF and QT
intervals measured by echocardiography or MUGA are within a clinically acceptable safety
range. If the survival benefits of the treatment value are assessed by the researcher to
be greater than the risks faced, the admission conditions for the specific organ function
level can be appropriately relaxed by the researcher, but the reasons need to be
explained in the medical record; 4. ECOG score: 0-2 points; 5. Voluntarily sign the
informed consent form for this study. 6. Contraception during the study period and within
6 months after treatment, non lactation.
Exclusion Criteria:
1. Pregnant or lactating women;
2. At the same time or in the past five years, patients with one or more malignant
tumors with metastatic capacity or potential other than HER2 positive breast cancer,
but not including cured cervical carcinoma in situ, thyroid cancer, skin basal cell
carcinoma or squamous cell carcinoma. For other malignant tumors occurring within a
period of more than 5 years from this treatment, if only cured by surgery, they are
allowed to be included.
3. Persons with a known history of allergy to the drug components of this protocol;
4. Have a history of immunodeficiency, including HIV testing positive, or have other
acquired or congenital immunodeficiency diseases;
5. The researcher believes that it is not suitable for inclusion.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Chen zhanhong
Phone:
13606505124
Email:
czred@sina.com
Start date:
March 16, 2022
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Zhejiang Cancer Hospital
Agency class:
Other
Source:
Zhejiang Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05856383
