Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy
M.D. Anderson Cancer Center
Summary
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 standard surgery, after systemic therapy, breast radiotherapy is being eliminated when the pathology from surgery shows no residual cancer.
Description
PRIMARY OBJECTIVES: I. Cohort A1 and A2: To determine the 6 mo, 1, 2, 3, 5, 7, and 10 year biopsy confirmed ipsilateral breast tumor recurrence rate (IBTR, invasive and/or in situ) among patients who do not undergo surgery. II. Cohort B: To determine the pCR rate 6 or 12 months after radiation therapy based on image-guided biopsy. III. Cohort C: To determine the 6 mo, 1, 2, 3, 5, 7 and 10-year ipsilateral breast tumor recurrence rate among patients who undergo surgery alone without radiation. SECONDARY OBJECTIVES: I. Cohort B: To determine the 6 mo, 1, 2, 3, 5, 7 and 10--year biopsy confi…
Eligibility
- Age range
- 30+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion 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 outside hospital and may be enrolled prior to, during, or following neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below: 1. Pathologically confirmed unicentric invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0 or N1 (≤ 4 abnormal axillary nodes on initial ultrasound), clinical stage M0. 2. HER2 positive (IH…
Interventions
- RadiationUndergo EBRT
Undergo EBRT
- OtherLaboratory Biomarker Analysis
Correlative studies
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
- RadiationPartial Breast Irradiation
Undergo partial breast irradiation
Locations (8)
- MD Anderson Cancer Center - BannerGilbert, Arizona
- Baptist MD Anderson Cancer CenterJacksonville, Florida
- Queen's Medical CenterHonolulu, Hawaii
- Mayo ClinicRochester, Minnesota
- Cooper Hospital Univ Med Ctr, MD Anderson at Cooper VoorheesVoorhees Township, New Jersey
- Carolinas Medical Center/Levine Cancer InstituteCharlotte, North Carolina