Clinical Trial Title A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO)
Trial Status Open to Enrollment
Start Date 05/19/2023
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Breast Cancer
Description 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.
Eligibility Criteria

Eligibility Criteria

  • The trial is open to female and male patients who have undergone breast conserving surgery and completed a minimum of 4 cycles (12 weeks) of neoadjuvant or adjuvant chemotherapy in combination with HER2-targeted therapy.
  • The patient must be ≥ 40 years of age.
  • The patient must have an ECOG performance status of 0 ,1, or 2/Karnofsky performance status above 60.
  • Histologically or cytologically confirmed invasive breast carcinoma.
  • The tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results.
  • The tumor must have ER and PgR status assessed locally using current ASCO/CAP Guidelines.
  • Patient must have undergone axillary staging, either sentinel node biopsy (SNB) or axillary lymph nodal dissection (ALND). In neoadjuvant patients, SNB following neoadjuvant therapy is strongly recommended. SNB prior to neoadjuvant therapy is discouraged, but patients are permitted if node negative (pN0).

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number Central IRB
Notes Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer - Full Text View -
Principal Investigator Andrew Kee, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail