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

Recruiting

• Conditions: Breast Neoplasms
• Interventions: Drug: Inetetamab; Drug: Pyrotinib; Drug: Vinorelbine

• Registration Number: NCT05764941
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Study First Posted: 2023-03-13
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-27
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-31

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational Group	Pyrotinib	Patients receive initetamab combined with pyrotinib and vinorelbine after trastuzumab progression.
Observational Group	Vinorelbine	Patients receive initetamab combined with pyrotinib and vinorelbine after trastuzumab progression.
Observational Group	Inetetamab	Patients receive initetamab combined with pyrotinib and vinorelbine after trastuzumab progression.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	2 years	Progression-free survival estimated using Kaplan-Meier methods is defined as the time from the date of informed consent to the earlier of death or disease progression. Patients alive without disease progression are censored at the date of last disease evaluation. Progressive disease (PD) based on RECIST 1.1 is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Equivocal progression of non-target lesions also qualifies as PD.
Objective Response Rate (ORR)	2 years	The overall response rate is defined as the percentage of patients with a best overall response of CR or PR relative to the appropriate analysis set

Secondary Outcome Measures

Name	Time	Method
The Number of Participants Who Experienced Adverse Events (AE)	2 years	Safety will be assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events).

Trial Locations

Locations (1)

Jiangsu Provincial People's Hospital; 🇨🇳 Nanjing, Jiangsu, China