Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in ABC

Recruiting

• Conditions: HER2-positive Advanced Breast Cancer
• Interventions: Drug: Inetetamab Combined With Pyrotinib and Vinorelbine

• Registration Number: NCT05856383
• Lead Sponsor: Zhejiang Cancer Hospital

Brief 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.

Study Timeline

• Study Start: 2022-03-16
• Study First Submitted: 2023-04-02
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-03
• Last Update Submitted: 2023-05-03
• Study First Posted: 2023-05-12
• Last Update Posted: 2023-05-12
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group of ues of inetetamab combined with pyrotinib and vinorelbine	Inetetamab Combined With Pyrotinib and Vinorelbine	Group of ues of inetetamab combined with pyrotinib and vinorelbine

Primary Outcome Measures

Name	Time	Method
Adverse events	assessed up to 48 months	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
Progressive free survival(PFS)	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	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.

Secondary Outcome Measures

Name	Time	Method
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.	Refers to the time between the date when the patient starts treatment of inetetamab combined with pyrotinib and vinorelbine and vinorelbine and death from any cause.
Objective response rate(ORR)	up to 48 months.	Refers to the proportion of patients whose tumors have shrunk to a certain amount and remained for a certain period of time. The percentage of cases that include CR and PR in the number of evaluable cases.
Disease Control Rate (DCR)	up to 48 months.	Refers to the percentage of confirmed cases of complete remission (CR), partial remission (PR), and disease stabilization (SD) (≥ 4 weeks) among patients with evaluable efficacy.

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China