Actively Recruiting
Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy
Led by M.D. Anderson Cancer Center · Updated on 2026-03-09
120
Participants Needed
8
Research Sites
575 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female sex
- Age 30 years or older (40 years or older for some cohorts)
- Pathologically confirmed unicentric invasive breast cancer stage T1 or T2 (up to 5 cm), N0 or N1 (up to 4 abnormal lymph nodes), M0
- HER2 positive (IHC 3+ or FISH amplified) or triple negative breast cancer (ER/PR < 10%, HER2 negative)
- Patients desiring breast conserving therapy
- For ER/PR positive HER2 negative cancer: clinical stage T1N0M0, non-lobular, no lymphovascular invasion
- Oncotype score ≤ 25 if age ≥ 50; Oncotype 0-20 and tumor size ≤1.5 cm if age 40-49 for ER/PR positive patients
- Agree to take anti-estrogen therapy if applicable
- No evidence of residual invasive tumor or DCIS if undergoing surgery
- No evidence of metastatic disease or isolated tumor cells in lymph nodes
- Ability to undergo biopsy or surgery for tumor site when required
- No history of prior radiation to the breast area requiring study treatment
- For patients with prior non-breast cancer, all treatment must be completed and no evidence of disease
You will not qualify if you...
- Radiologic evidence of stage T3 or clinical stage T4 breast cancer (varies by cohort)
- Evidence of distant metastases
- Prior diagnosis of invasive or ductal carcinoma in situ in the same breast
- Disease progression > 20% in the breast or new nodal metastases
- Known pregnancy
- Participation in a neoadjuvant systemic therapy protocol requiring surgical excision of breast or lymph nodes for certain cohorts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
MD Anderson Cancer Center - Banner
Gilbert, Arizona, United States, 85234
Completed
2
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Actively Recruiting
3
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Completed
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
Cooper Hospital Univ Med Ctr, MD Anderson at Cooper Voorhees
Voorhees Township, New Jersey, United States, 08103
Actively Recruiting
6
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
7
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
8
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
H
Henry Kuerer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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