drugset / Trial / NCT03412643

Study of Neoadjuvant Chemotherapy Plus Trastuzumab and Pertuzumab in HER2-Negative Breast Cancer Patients With Abnormal HER2 Signaling

NCT03412643 ↗

NaSingle-groupOpen-labelTreatment

Summary

This is a prospective, single arm, open label, multicenter interventional study designed to evaluate the efficacy of neoadjuvant chemotherapy with anti-HER2 antibodies in patients with HER2-negative invasive breast cancer who have abnormal HER2 signaling activity determined by the Celcuity CELx HER2 Signaling Function (HSF) testing.

Timeline

Start
2018-05-14
Primary completion
2023-10-30
Completion
2023-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous
Subject Pertuzumab Monoclonal antibody 420 mg Intravenous
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous