Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis

This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic dr

Trial Details

NCT ID
NCT07578116
Phase
PHASE3
Sponsor
SWOG Cancer Research Network
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Biopsy Procedure
  • Biospecimen Collection
  • Breast Conservation Treatment
  • Computed Tomography
  • Cyclin-Dependent Kinase 4 Inhibitor
  • Cyclin-Dependent Kinase 6 Inhibitor
Locations (sample)
  • Jonesboro, Arkansas, United States|35.8423,-90.70428
  • Derby, Connecticut, United States|41.32065,-73.089
  • Fairfield, Connecticut, United States|41.14121,-73.26373
  • Greenwich, Connecticut, United States|41.02649,-73.62846
  • Guilford, Connecticut, United States|41.28899,-72.68176

Key Eligibility Criteria

  • REGISTRATION STEP 1 - SCREENING \& INITIAL TREATMENT:
  • Participants must have histologically confirmed de novo metastatic (i.e. American Joint Committee on Cancer \[AJCC\] stage IV, no prior history of …
  • NOTE: If HER2 positivity at metastatic site is equivocal due to limitations in HER2 analysis in bone, or it is not feasible or safe to biopsy the m…
  • Participants with brain metastases are eligible if they meet all of the following criteria at baseline:

For full eligibility, visit ClinicalTrials.gov.

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