Inetetamab Combined With Pyrotinib and Vinorelbine as First-line to Third-line Treatment for HER2-positive Metastatic Breast Cancer

NCT ID: NCT05764941

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2024-03-31

Brief 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.

Conditions

Breast Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Observational Group

Patients receive initetamab combined with pyrotinib and vinorelbine after trastuzumab progression.

Inetetamab

Intervention Type: DRUG

8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle.

Pyrotinib

Intervention Type: DRUG

400mg, oral, every day.

Vinorelbine

Intervention Type: DRUG

25 mg/m2, D1, D8, every 3 weeks for one cycle.

Interventions

Inetetamab

8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle.

Intervention Type: DRUG

Pyrotinib

400mg, oral, every day.

Intervention Type: DRUG

Vinorelbine

25 mg/m2, D1, D8, every 3 weeks for one cycle.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongmei Yin

Role: CONTACT

ymyin@njmu.edu.cn

02568307102

Wei Li

Role: CONTACT

real.lw@163.com

02568307102

Facility Contacts

Jinhai Tang

Role: primary

Other Identifiers

ILLUMINE

Identifier Type: -

Identifier Source: org_study_id