drugset
drugset / Trial / NCT05020964

Screening Plasma HER2 Amplication by Digital PCR in Advanced Breast Cancer Patients Treated With Trastuzumab and Pyrotinib

NCT05020964 ↗

Phase 2 Unknown 68 enrolled Chinese Academy of Medical Sciences
NaSingle-groupOpen-labelTreatment

Summary

The hypothesis of this study is to discover the efficacy and safety of trastuzumab combined with pyrotinib in treating advanced breast cancer with HER2 positive, which is detected by digital PCR. It is a single-arm, multicenter phase II clinical study. The purpose of this study is: 1. To explore the Response rate (RR) and progression-free survival(PFS) and safety of patients with recurrent metastatic breast cancer who received trastuzumab combined with pyrotinib in positive plasma HER2 amplification detected by digital PCR. 2. To explore the potential using of digital PCR in recurrent and metastatic breast cancer.

Timeline

Start
2021-08-20
Primary completion
2022-09-01
Completion
2023-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Pyrotinib Small molecule 400 mg Oral
Subject Trastuzumab Monoclonal antibody 8 mg/kg —

Indications

breast cancer