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Celcuity CELx HSF Test on tumor material obtained from research core biopsy to select patients with abnormal HER2 signaling tumors

Doxorubicin + cyclophosphamide followed by Weekly Paclitaxel +Trastuzumab+Pertuzumab

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

Weekly Paclitaxel

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

Celcuity CELx HSF

Director, Department of Site and Study Management

Contact Person

Norman Wolmark, MD

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.

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

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)

Percentage of patients with absence of residual invasive cancer in H\&E slides of resected breast specimens and all sampled regional lymph nodes following the completion of neoadjuvant systemic therapy

Percentage of patients with absence of residual invasive cancer in H\&E slides of resected breast specimens following the completion of neoadjuvant systemic therapy

Percentage of patients with clinical complete response (cCR) measured by physical examination of the breast and axilla

Combined index of pathologic measurements of residual tumor size and cellularity and number and size of regional lymph nodes

Regression of quantitative CELx scores by pCR outcome

Frequency of adverse events categorized using the NCI Common Terminology Criteria for Adverse Events version 4.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Neoadjuvant Chemotherapy Plus Trastuzumab and Pertuzumab in HER2-Negative Breast Cancer Patients With Abnormal HER2 Signaling	NCT03412643	HER2-negative B...	Doxorubicin Cyclophosphamid... Weekly Paclitax... Trastuzumab Pertuzumab Celcuity CELx H...	18 Years -	NSABP Foundation Inc
Study of Neoadjuvant Chemotherapy Plus Trastuzumab and Pertuzumab in HER2-Negative Breast Cancer Patients With Abnormal HER2 Signaling	NCT03412643	HER2-negative B...	Doxorubicin Cyclophosphamid... Weekly Paclitax... Trastuzumab Pertuzumab Celcuity CELx H...	18 Years -	NSABP Foundation Inc

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