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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

Cohort A1 and A2

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.

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.

Patient desires breast conserving therapy.

Disqualifiers

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.

Clinical or pathologic evidence for distant metastases.

Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breast.

Clinical evidence of progression of disease >20% in the breast or new evidence of nodal metastases.

Trial design

Treatments tested in this trial

  • Undergo EBRT
  • Laboratory Biomarker Analysis
  • Quality-of-Life Assessment
  • Questionnaire Administration
  • Partial Breast Irradiation

Treatment groups

120 Participants
are divided into 4 treatment groups

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator