Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy
Eligible age
30+ yrs
Accepts
Women
Locations
8 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: M.D. Anderson Cancer Center
You may qualify if…
- ✓ 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 (IHC 3+ and or FISH amplified) or triple receptor negative (TN, ER/PR\< 10% HER2 negative (IHC 1+ or 2+ FISH non-amplified) receiving any standard routine clinical NST regimen.
- ✓ 3. Patient desires breast conserving therapy.
- ✓ 4. Age 40 years or older. This age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences \[124, 125\].
- ✓ 5. Female sex.
- ✓ 6. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer.
You may not qualify if…
- ✕ 1. Radiologic evidence for a stage T3 or clinical stage T4 breast cancer in Cohort A1/A2/C; radiologic evidence for a stage T2-T3 or clinical stage T4 breast cancer in Cohort B1/B2.
- ✕ 2. Clinical or pathologic evidence for distant metastases.
- ✕ 3. Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breast.
- ✕ 4. Clinical evidence of progression of disease \>20% in the breast or new evidence of nodal metastases.
- ✕ 5. Patient is known to be pregnant.
- ✕ 6. Patient is participating in a NST protocol in which surgical excision of the breast and or lymph nodes are required in Cohort A1/A2/B1/B2.
Where it's recruiting
Gilbert
Jacksonville
Honolulu
Rochester
Voorhees Township
Charlotte
Pittsburgh
Houston
Source: ClinicalTrials.gov · NCT02945579 · last updated 2026-03-09