PhIII Randomized Trial Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer" (HERO*)

Cancer
Erin Heather Healy
A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer" (HERO*)
Breast

Study 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

-Patient must be at least 40 years of age

-Patient must have undergone breast conserving surgery and complete a minimum of 4 cycles (12 weeks) of neoadjuvant or adjuvant chemotherapy in combination with HER2-targeted therapy.

-Patient must have confirmed invasive breast carcinoma

-Patients with evidence of metastatic disease

-Patients planning for or status-post mastectomy

-Patients with use of any investigational product within 30 days prior to randomization

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