Active — Not RecruitingPhase 3

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

United States1,300 participantsStarted 2023-05-19

Plain-language summary

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.

Who can participate

Age range40 Years

SexALL

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Inclusion criteria

✓≥ 40 years of age

What they're measuring

recurrence-free interval (RFI)

Timeframe: From randomization to first recurrence event or censoring for the duration of the trial, at 10.5 years

Trial details

NCT IDNCT05705401

SponsorNRG Oncology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2034-02-01

View on ClinicalTrials.gov More HER2-positive Breast Cancer trials