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Brief Title: Screening Plasma HER2 Amplication by Digital PCR in Advanced Breast Cancer Patients Treated With Trastuzumab and Pyrotinib
Official Title: Screening Plasma HER2 Amplication by Digital PCR in Advanced Breast Cancer Patients Treated With Trastuzumab and Pyrotinib
Study ID: NCT05020964
Brief 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Name: Yuan Peng
Affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Role: STUDY_CHAIR