Eliminating Surgery or Radiotherapy after Neoadjuvant Systemic Therapy in Treating Patients with Breast Cancer

Inclusion Criteria

• COHORT A1/A2: 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
• COHORT A1/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
• COHORT A1/A2: HER2 positive (immunohistochemistry [IHC] 3+ and or fluorescence in situ hybridization [FISH] amplified) or triple receptor negative (triple negative [TN], estrogen receptor [ER]/progesterone receptor [PR] < 10% HER2 negative [IHC 1+ or 2+ FISH non-amplified]) receiving any standard routine clinical NST regimen
• COHORT A1/A2: Patient desires breast conserving therapy
• COHORT A1/A2: 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
• COHORT A1/A2: Female sex
• COHORT A1/A2: 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
• COHORT A1/A2: Patient must have an initial nodal ultrasound that does not demonstrate more than four suspicious lymph nodes, any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present
• COHORT A1/A2: Patient understands that the breast lesion size on final breast imaging must be less than or equal to 2 cm prior to the biopsy procedure being performed on study and if the biopsy shows residual carcinoma the patient will be taken off study
• COHORT B1/B2: Patients on this portion of the study will be limited to receive radiation treatment at MD Anderson Cancer Center or other approved locations and must be enrolled prior to any neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below
• COHORT B1/B2: ER and/or PR positive, HER2 negative
• COHORT B1/B2: Clinical stage T1N0M0, unicentric non-lobular breast cancer, no lymphovascular space invasion
• COHORT B1/B2: At least 40 years of age
• COHORT B1/B2: Oncotype =< 25 if age >= 50 years
• COHORT B1/B2: Oncotype 0-20 and tumor size =< 1.5 cm if age 40-49 years
• COHORT B1/B2: Patient agrees to take anti-estrogen therapy and is interested in breast conservation
• COHORT B1/B2: Female sex
• COHORT B1/B2: 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
• COHORT B1/B2: No history of prior radiation to the area of the breast that would require protocol-mandated treatment
• COHORT C: Patients on this portion of the study can receive surgical 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
• COHORT C: Pathologically confirmed invasive breast cancer defined as radiologic clinical stage T1 or T2 (=< 5 cm), N0, clinical stage M0
• COHORT C: HER2 positive (IHC 3+ and or FISH amplified) receiving any standard routine clinical NST regimen containing her-2 directed therapy
• COHORT C: Pathologically confirmed invasive breast cancer defined as radiologic clinical stage T1 (=< 2 cm), N0, clinical stage M0 and triple negative, receiving any standard routine clinical NST regimen
• COHORT C: Patients participating in the optional pretreatment biopsy, the patient should be able undergo biopsy or surgery of the primary tumor site of suspected or proven invasive breast cancer and should be planned to receive neoadjuvant systemic therapy
• COHORT C: Patient desires breast conserving therapy
• COHORT C: Age 30 years or older if HER2 positive. Age 50 or older if HER2 negative (triple negative)
• COHORT C: Female sex
• COHORT C: 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
• COHORT C: Patient must have an initial nodal ultrasound that does not demonstrate suspicious lymph nodes; any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present
• COHORT C: Patient must have no evidence of residual invasive tumor or ductal carcinoma in situ (DCIS) on pathologic review of the lumpectomy surgical specimen
• COHORT C: Patient must have no evidence of metastatic disease involving the lymph nodes on pathologic review of the lymph node surgical specimen. If treatment effect in the nodes is noted on the pathology report, the investigators would generally discourage enrollment on this protocol
• COHORT C: Unifocal disease or limited multifocal disease that can be excised in a single lumpectomy specimen
• COHORT D: Patients on this portion of the study meet all eligibility requirements for cohort C, but have not enrolled onto the study to omit radiation. Patients in Cohort D can be identified at the time of diagnosis or prior to lumpectomy. They are not required to participate in one of the treatment arms of the study, but can ultimately choose to move to an omission Cohort at a later time point
• COHORT D: Patients with triple negative or her-2 positive tumor who are amenable to breast conserving treatment and have received or are planned for neoadjuvant systemic therapy prior to surgery are eligible for Cohort D
• COHORT D: Eligible patients in cohort D who have undergone optional ARTIDIS biopsies of the primary breast tumor at the time of diagnosis, prior to starting neoadjuvant therapy, or following completion of systemic therapy, at the time of surgery, may later move to Cohort A or C if they meet all eligibility requirements and ultimately desire surgery or radiation omission

Exclusion Criteria

• Radiologic evidence for a stage T3 or clinical stage T4 breast cancer in Cohort A1/A2C; 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
• Patient is known to be pregnant
• 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