Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer

This Phase III trial compares the recurrence-free interval (RFI) among patients with early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, and are randomized to not receive adjuvant breast radiotherapy versus those who are randomized to receive adjuvant radiotherapy per the standard of care.

Trial Details

NCT ID
NCT05705401
Phase
PHASE3
Sponsor
NRG Oncology
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Standard of Care Adjuvant Breast Radiation
  • Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Jonesboro, Arkansas, United States|35.8423,-90.70428
  • Antioch, California, United States|38.00492,-121.80579
  • Roseville, California, United States|38.75212,-121.28801
  • Aurora, Colorado, United States|39.72943,-104.83192

Key Eligibility Criteria

  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in t…
  • female and male patients who have undergone breast conserving surgery and completed a minimum of 4 cycles (12 weeks) of neoadjuvant or adjuvant che…
  • ≥ 40 years of age
  • ECOG performance status of 0 ,1, or 2/Karnofsky performance status above 60

For full eligibility, visit ClinicalTrials.gov.

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