Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery
Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery
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.
PRIMARY OBJECTIVE:

 I. For select patients with early stage breast cancer undergoing wide local excision followed
 by single fraction radiation therapy (SFRT), we will evaluate rates of observer-rated
 toxicity, cosmetic outcomes and patient satisfaction, objective measures of toxicity and
 quality of life as well as delivery of intended dose.

 SECONDARY OBJECTIVE:

 I. Locoregional control reported at five years.

 OUTLINE:

 Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once
 negative margins are obtained.

 After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and
 then every 6 months for 2 years.
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