Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery
Condition: Ductal Breast Carcinoma In Situ; Estrogen Receptor Negative; Estrogen Receptor Positive; HER2/Neu Negative; Invasive Cribriform Breast Carcinoma; Invasive Ductal Carcinoma, Not Otherwise Specified; Lobular Breast Carcinoma In Situ; Mucinous Breast Carcinoma; Papillary Breast Carcinoma; Progesterone Receptor Positive; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIC Breast Cancer; Tubular Breast Carcinoma
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Ductal, Breast; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular
Intervention: Therapeutic Conventional Surgery; Radiation Therapy; Laboratory Biomarker Analysis; Quality-of-Life Assessment
Intervention description: Undergo wide local excision breast surgery; Undergo SFRT; Correlative studies; Ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well radiation therapy works in treating post-menopausal
      women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x
      rays to kill tumor cells. This may be an effective treatment for breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Core needle biopsy (e.g. Mammotome, core, stereotactic, ultrasound guided) showing
             invasive mammary cancer (with or without concomitant ductal carcinoma or lobular
             carcinoma in situ) or ductal carcinoma in situ; acceptable histologic types of
             invasive mammary cancer include ductal, tubular, mucinous, papillary, cribriform and
             "NOS" (not otherwise specified); invasive lobular cancer is excluded

          -  Age >= 50 years and postmenopausal with no menses for at least one year prior to study
             enrollment

          -  Age > 70 years with invasive breast cancer clinical size =< 3 cm OR Age 50 - 70 years
             with invasive breast cancer clinical size =< 1.5 cm OR Age >= 50 years and
             postmenopausal with any grade ductal carcinoma in situ (DCIS) clinical extent =< 1.5
             cm (clinical tumor size will be determined by pre-operative breast
             imaging-mammography, ultrasound and/or magnetic resonance imaging; in cases of
             multiple measurements, the largest recorded single dimension will be used to determine
             eligibility)

          -  Hormone receptor status

               -  Estrogen or progesterone receptor positive or

               -  Estrogen and progesterone receptor negative and clinical tumor size =< 1.0 cm

          -  Human epidermal growth factor receptor 2 (HER2)/neu negative on the core biopsy
             analysis defined as 0 or 1+ by immunohistochemistry or not amplified by fluorescent in
             situ hybridization analysis

          -  Tumor >= 0.5 cm from skin as defined by breast ultrasound

          -  Unicentric tumor

          -  Axillary lymph nodes negative by pre-operative physical examination in all cases and
             pathologic examination from surgery for invasive disease

          -  Negative surgical margins, defined as no margin-labeling ink on tumor cells from
             margin evaluation

        Exclusion Criteria:

          -  Initial core biopsy showing invasive lobular cancer

          -  Estrogen receptor and progesterone receptor negative tumor with clinical size > 1 cm

          -  Any Her 2+ breast cancer (immunohistochemistry 3+; or amplified by fluorescence in
             situ hybridization [FISH])

          -  Cancer in a patient with a known inherited susceptibility mutation in breast cancer
             (BRCA)1 or BRCA2

          -  Multicentric breast cancer (two foci of known cancer in the breast separated by
             greater than 5 cm, or in separate quadrants

          -  Clinically or pathologically positive axillary lymph nodes

          -  Any prior breast cancer

          -  Prior breast radiation therapy