Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

  • Clinical Trial Information

    Trial Contact: Manchola-Orozco, Carolina

    Trial Phone: 321.841.7293

  • IRB No: CCTG MA.39

    Protocol Abbrev: MA.39

    Principal Investigator: Patrick Kelly, MD, PhD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: CCTG MA.39

    Treatment: Whole Breast Irradiation (WBI) Radiotherapy (RT)

    Therapies Involved: Radiation

    ClinicalTrials.gov ID: NCT03488693

  • Objective

    To compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not, defined as time from randomization to time of invasive recurrent disease in the
    ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC

  • Key Eligibility

    •   Patients must have newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases.
    •   Patients must have been treated by BCS or mastectomy.
    •   Patients must be ER ≥ 1% and HER2 negative on local testing
    •   Patients must have an Oncotype DX recurrence score <18
    •   Patients must have had endocrine therapy initiated or planned for ≥ 5 years. Endocrine therapy can be given concurrently or following RT.
    •   Patient's ECOG performance status must be 0, 1 or 2.
    •   Patient's age must be ≥ 40 years.
    •   Patient's life expectancy is ≥10 years