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
The Mission of NSABP Foundation, Inc. is to design and conduct practice changing cancer research, including clinical trials and laboratory studies in the medical, surgical and prevention settings in order to improve the survival outcome and quality of life of patients with breast and colorectal cancer, and to disseminate the results of NSABP collaborative research to benefit the world-wide community.
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