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Clinical Trial Summary

This is an exploratory, single-arm, multi-center study to assess the efficacy and safety of T-DXd combined with pyrotinib as the first-line treatment of HER2-positive metastatic breast cancer. This study is planned to recruit 3 to 12 patients in safety run-in (Part A) and 39 to 42 patients in dose expansion (Part B) in several investigational sites in China. The total number of patients enrolled in the study will be 45 to 51. Among them, 45 patients will start at the recommended dose. Patients who fulfill all the inclusion criteria and none of the exclusion criteria will receive T-DXd combined with pyrotinib until confirmed progressive disease. Patients will attend a safety follow up visit 40 days after last dose of T-DXd with pyrotinib. There are two main parts to this study; Part A, Combination dose finding and Parts B, Dose expansion. Tumor assessments will be performed at Screening as baseline with follow-up every 9 weeks(±7 days) from the date of first dosing date of T-DXd with pyrotinib for 54 weeks, and then every 12 weeks (±7 days) until confirmed objective disease progression. Primary Objective for Part A: To define the recommended dose of pyrotinib combined with T-DXd Recommended dose Secondary Objective for Part A: To investigate the safety and tolerability of T-DXd + pyrotinib as first-line treatment of HER2-positive metastatic breast cancer. Primary Objective for Part B : To determine the efficacy of T-DXd + pyrotinib as first-line treatment of HER2-positive metastatic breast cancer. Secondary Objective for Part B : To further determine the efficacy of T-DXd + pyrotinib as first-line treatment of HER2-positive metastatic breast cancer and To further evaluate the safety and tolerability profile of T-DXd + pyrotinib as first-line treatment of HER2-positive metastatic breast cancer.


Clinical Trial Description

Combination of HER2-antibody-drug conjugate and tyrosine kinase inhibitors demonstrated additive or synergistic anti-tumour effects in HER2-positive cell lines or metastatic breast cancer in in vitro or in vivo studies .It is expected that the efficacy will be further improved in early-line patients with the combination of HER2-antibody-drug conjugate and tyrosine kinase inhibitors. Given the efficacy of T-DXd monotherapy and the widely used of pyrotinib in second-line metastatic HER2-positive breast cancer, and no major overlapping toxicities between T-DXd and pyrotinib, it may be a promising combination regimen to explore in first-line HER2+ metastatic breast cancer in China. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06245824
Study type Interventional
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact Binghe Xu, Doctor
Phone +86 13501028690
Email xubh@cicams.ac.cn
Status Not yet recruiting
Phase Phase 4
Start date January 30, 2024
Completion date December 1, 2026

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