NCT05764941

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

Real World Study of Inetetamab Combined With Pyrotinib and Vinorelbine as First-line to Third-line Treatment for Trastuzumab Resistant HER2-positive Metastatic Breast Cancer: a Multicenter, Retrospective Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Inetetamab	8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle.
DRUG	Pyrotinib	400mg, oral, every day.
DRUG	Vinorelbine	25 mg/m2, D1, D8, every 3 weeks for one cycle.

Timeline

• Start date: 2020-01-01
• Primary completion: 2024-03-01
• Completion: 2024-03-31
• First posted: 2023-03-13
• Last updated: 2023-03-27

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study