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Phase 2 Study to Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer Using ctDNA and HARPS Biomarker Assay.

Primary Objective:
1. To evaluate the rate of pathologic complete response (pCR) using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) as assessed by the local pathologist at the time of definitive surgery in subjects with HARPS-positive and HARPS-negative HER2-positive breast cancer treated using an adaptive neoadjuvant trial design.

Secondary Objectives:
1. To assess 3-year invasive disease-free survival (iDFS) in patients with HARPS-positive and HARPS-negative HER2-positive breast cancer.
2. To correlate changes in ctDNA with treatment outcomes in patients with HARPS-positive and HARPS-negative HER2-positive breast cancer.
3. To understand the changes in quality of life (QOL) measure in patients with HARPS-positive HER2-positive breast cancer treated using an adaptive neoadjuvant trial design.

Protocol Number: 042507
Phase: Phase II
Applicable Disease Sites: Breast
Drugs Involved: Pertuzumab
Principal Investigator: Mridula A George
Scope: Local
Therapies Involved: Chemotherapy multiple agents systemic
Surgery
Participating Institutions:
  • RWJBarnabas Health
    • Community Medical Center
    • Cooperman Barnabas, Livingston
    • Jersey City Medical Center, Jersey City
    • Monmouth Medical Center
    • Newark Beth Israel Medical Center
    • Robert Wood Johnson University Hospital, Hamilton
    • Robert Wood Johnson University Hospital, Somerset
    • Trinitas Hospital and Comprehensive Cancer Center
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.