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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)

Protocol Chair: Eleftherios Mamounas, MD, MPH

Protocol Officer: Priya Rastogi, MD

Primary Objective: To evaluate whether patients with HER2-negative breast cancers based on standard ASCO/CAP testing criteria, but with abnormal HER2-driven signaling pathways determined by the Celcuity HSF assay and receive HER2-targeted therapy with neoadjuvant chemotherapy, will have a higher rate of pathological complete response in the breast and lymph nodes (pCR breast and lymph nodes) than has been found historically in patients with HER2-negative breast cancer who has received neoadjuvant chemotherapy alone.

Patient Population: Early Stage HER2-Negative Breast Cancer

Target Accrual: 64 patients

Status: Recruiting participants

ClinicalTrials.gov Identifier: NCT03412643