NCT06015100

Efficacy and Safety of Inetetamab Plus Pyrotiniband and Capecitabine in HER2-positive Metastatic Breast Cancer Patients With or Without Brain Metastasis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Yan Xue · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study intends to include HER2-positive metastatic breast cancer patients (with or without brain metastasis) who have become resistant to previous treatment with trastuzumab. It will use pertuzumab in combination with pyrotinib and capecitabine to observe efficacy and safety. The choice of capecitabine as the chemotherapy drug is mainly based on the following reasons: ① it has been less commonly used as neoadjuvant treatment, making it less prone to cross-resistance; ② its oral formulation is convenient for administration, making it more acceptable to patients; ③ previous studies have shown good efficacy when combined with pyrotinib; ④ previous research in breast cancer patients with brain metastasis has also demonstrated certain effectiveness. It is hoped that through this study, preliminary evidence can be provided for the dual-target treatment of original Chinese drugs, as well as the treatment of HER2+ MBC after resistance to trastuzumab, and the addition of new data for patients with brain metastasis.

Detailed description

Research Title A single-center, open-label, single-arm clinical study on the efficacy and safety of pertuzumab in combination with pyrotinib and capecitabine in the treatment of HER2-positive metastatic breast cancer patients who have developed resistance to previous trastuzumab treatment (with or without brain metastasis). Study Drugs - Injectable pertuzumab: 50mg/vial - Pyrotinib: 80mg/tablet Research Objective To evaluate the effectiveness and safety of pertuzumab in combination with pyrotinib and capecitabine in the treatment of HER2-positive metastatic breast cancer patients who have developed resistance to previous trastuzumab treatment (with or without brain metastasis). This study aims to provide preliminary evidence for the dual-target treatment of original Chinese drugs, and to add new data to the treatment model for trastuzumab-resistant HER2+ MBC and patients with brain metastasis. Study Design A single-center, open-label, single-arm clinical study with a planned enrollment of 40 patients.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Inetetamab plus pyrotiniband and capecitabine	Inetetamab plus pyrotiniband and capecitabine

Timeline

• Start date: 2021-02-20
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2023-08-29
• Last updated: 2023-08-29

Locations

1 site across 1 country: China