Neoadjuvant therapy for abnormal HER2- Signaling

September 18, 2018

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)

  • Clinical Trial Information

    Trial Contact: Jobson, Gillian S; Pelley, Jennifer; Morales, Leticia

  • IRB No: 18.057.04

    Protocol Abbrev: NSABP-FB12

    Principal Investigator: Nikita Chandrakant Shah, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: FB-12

    Treatment: Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab

    Therapies Involved: Chemotherapy

    ClinicalTrials.gov ID: NCT03412643

  • Objective

    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 HSF testing.

  • Key Eligibility

    •   Medical oncologist has indicated the intention to administer doxorubicin/cyclophosphamide followed by paclitaxel.
    •   All patients will be required to have a research core biopsy procedure to procure fresh tumor tissue for pre-entry central HER2 signaling testing by Celcuity
    •   Patients must be female, ≥ 18 years old. The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy.