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

NCT05705401 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2026-04-27

No results posted yet for this study

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.

Conditions

Interventions

RADIATION

Standard of Care Adjuvant Breast Radiation

adjuvant breast radiotherapy per the current standard of care

DRUG

Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation

participants are randomized to continue their standard of care systemic HER2-targeted therapy without adjuvant breast radiotherapy

Sponsors & Collaborators

Principal Investigators

  • Norman Wolmark, MD · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-19
Primary Completion
2034-02-01
Completion
2037-02-01

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05705401 on ClinicalTrials.gov