NCT05020964

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab and Pyrotinib	Trastuzumab: 3-week dosing regimen, The initial load dose was 8 mg/kg. Pyrotinib: 400 mg orally once daily, take it continuously, every 21 days as a cycle. Use until intolerable toxicity or disease progression occurs.

Timeline

• Start date: 2021-08-20
• Primary completion: 2022-09-01
• Completion: 2023-09-01
• First posted: 2021-08-25
• Last updated: 2021-08-25