HER2+ Metastatic Breast Cancer with Prior Anti-HER2 Therapies

A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients With HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment

January 17, 2018

  • Clinical Trial Information

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

    Trial Phone: 321.841.6696 ; 321.841.4348 ; 321.841.2285

  • IRB No: 17.039.04

    Protocol Abbrev: SOPHIA

    Principal Investigator: Nikita Chandrakant Shah, MD

    Sub Investigators: Baidas, Said MD; Cuesta, Ana MD; Rostorfer, Regan MD; Moroose, Rebecca MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: CP-MGAH22-04 SOPHIA

    Treatment: Medication

    Applicable Disease Sites: Breast Cancer

    Therapies Involved: Margetuximab plus chemotherapy or Trastuzumab plus chemotherapy

    ClinicalTrials.gov ID: NCT02492711

  • Objective

    The purpose of this study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab plus chemotherapy

  • Key Eligibility

    Inclusion Criteria:
    •   Metastatic or locally-advanced relapsed/refractory HER2+ breast cancer.Tumors may be estrogen receptor (ER)/progesterone receptor (PgR) positive or negative.
    •   Have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-HER2 directed therapy in the metastatic setting. In either case, patients must have received prior treatment with pertuzumab, in the (neo)adjuvant or metastatic setting. Prior radiotherapy, hormonal therapies, and other anti-HER2 therapies are allowed.
    •   Prior treatment with at least one, and no more than three, lines of therapy overall in the metastatic setting. Patients must have progressed on or following, the most recent line of therapy.
    •   Resolution of all chemotherapy or radiation-related toxicities to ≤ Grade 1
    •   Life expectancy ≥ 12 weeks
    •   Acceptable laboratory parameters