Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy

This clinical trial studies eliminating surgery and/or radiation therapy in treating breast cancer patients. In HER2 positive and triple negative breast cancers, after systemic therapy, when image-guided biopsy shows no residual cancer, patients then receive standard breast radiotherapy with no surgery. In ER positive/HER2 negative breast cancers, after endocrine therapy and ablative radiotherapy, when image-guided biopsy shows no residual cancer, patients then receive standard endocrine therapy with no surgery. For patients who have HER2 positive and triple negative breast cancers and standar

Trial Details

NCT ID
NCT02945579
Phase
NA
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Undergo EBRT
  • Laboratory Biomarker Analysis
  • Quality-of-Life Assessment
  • Questionnaire Administration
  • Partial Breast Irradiation
Locations (sample)
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Honolulu, Hawaii, United States|21.30694,-157.85833
  • Rochester, Minnesota, United States|44.02163,-92.4699
  • Voorhees Township, New Jersey, United States|40.4795,-74.49062

Key Eligibility Criteria

  • Cohort A1 and A2
  • Conditions for patient eligibility: Patients on this portion of the study can receive radiation treatment at any MD Anderson Cancer Center or any o…
  • Pathologically confirmed unicentric invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0 or N1 (≤ 4 abnormal axillary …
  • HER2 positive (IHC 3+ and or FISH amplified) or triple receptor negative (TN, ER/PR\< 10% HER2 negative …

For full eligibility, visit ClinicalTrials.gov.

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