At a glance
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An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab in Early Stage HER2-Negative Breast Cancer Patients Selected With a Test Measuring Live Cell HER2 Signaling Transduction (FACT 1)
In Brief
A Phase 2 clinical trial evaluating Doxorubicin, Cyclophosphamide, and 4 other interventions for HER2-negative Breast Cancer. Targeting 64 participants across 43 sites.
Detailed 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.
Study Details
Timeline
Interventions
60 mg/m2 IV Day 1 every 2 weeks or 3 weeks at investigator's discretion for a total of 4 cycles
600 mg/m2 IV Day 1 every 2 weeks or 3 weeks at investigator's discretion for a total of 4 cycles
80 mg/m2 IV weekly for 12 doses
loading dose of 8 mg/kg IV; then 6 mg/kg IV every 3 weeks for Cycles 2-4
loading dose of 840 mg IV; then 420 mg IV every 3 weeks for Cycles 2-4
Prior to drug interventions 3, 4,and 5, the Celcuity CELx HSF diagnostic test will be conducted to assess HER2 signaling activity