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.
Patients will be required to have a prescreening research core needle biopsy to procure a
fresh tumor specimen that will be sent to Celcuity for CELx HSF testing, in order to assess
the status of their HER2 signaling activity (abnormally or normally active).
Patients who have abnormal HER2 signaling activity will receive weekly paclitaxel plus the
anti-HER2 therapy regimen of trastuzumab and pertuzumab following completion of initial
doxorubicin/cyclophosphamide.The primary endpoint of the study is to evaluate whether
patients with HER2-negative breast cancers based on standard American Society of Clinical
Oncology (ASCO)/College of American Pathologists (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 have received neoadjuvant
chemotherapy alone. Secondary endpoints include pathologic complete response (breast),
clinical complete response (cCR), residual cancer burden (RCB) 0-1 index, and relationship
between quantitative CELx score and pCR rate.
It is expected that approximately 270 patients will need to be prescreened in order to enroll
54 patients (26 ER-positive/HER2-negative and 28 ER-negative/HER2-negative) who have abnormal
HER2 signaling activity.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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