Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer
Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill
 tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

 PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in
 treating women undergoing breast-conserving therapy for early stage breast cancer.
OBJECTIVES:

 -  To determine the cosmetic outcome resulting from partial breast irradiation using two
 different techniques.

 -  To determine patient satisfaction with partial breast irradiation as it pertains to
 their overall treatment experience as measured by a questionnaire.

 -  To determine if there are patient factors that limit a patient's suitability to receive
 partial breast irradiation delivered by a particular technique.

 -  To evaluate wound healing and overall complication rate after partial breast
 irradiation.

 -  To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.

 OUTLINE: Patients undergo partial breast irradiation comprising either MammoSite®
 brachytherapy twice daily for 5-10 days OR 3-dimensional conformal radiotherapy twice daily
 for 5-10 days.

 After completion of study therapy, patients are followed periodically for up to 5 years.
DISEASE CHARACTERISTICS:

 -  Histologically confirmed breast cancer, including the following histologic subtypes:

 -  Invasive ductal carcinoma

 -  Medullary ductal carcinoma

 -  Papillary ductal carcinoma

 -  Colloid (mucinous) ductal carcinoma

 -  Tubular ductal carcinoma

 -  The following histologic subtypes are not allowed:

 -  Invasive lobular carcinoma

 -  Extensive lobular carcinoma in situ

 -  Ductal carcinoma in situ (DCIS)

 -  Nonepithelial breast malignancies, such as lymphoma or sarcoma

 -  No extensive intraductal component by Harvard definition (i.e., more than 25% of the
 invasive tumor is DCIS or DCIS present in adjacent tissue)

 -  Stage I or II disease (T1, N0; T1, N1a; T2, N0; or T2, N1a)

 -  Lesion ≤ 3 cm

 -  No more than 3 positive lymph nodes

 -  Patients with 4 or more positive axillary lymph nodes found at the time of
 axillary lymph node dissection/sentinel lymph node biopsy are not eligible

 -  Has undergone tylectomy (lumpectomy) and axillary lymph node sampling (axillary node
 dissection or sentinel node biopsy)

 -  Negative resection margins with ≥ 2 mm margin from invasive or in situ cancer OR
 a negative re-excision margin

 -  Unifocal breast cancer

 -  No multicentric carcinoma (tumors in different quadrants of the breast or tumors
 separated by ≥ 4 cm)

 -  No palpable or radiographically suspicious contralateral axillary,
 ipsilateral or contralateral supraclavicular, infraclavicular, or internal
 mammary lymph nodes unless these are histologically confirmed negative

 -  No skin involvement of disease

 -  No Paget's disease of the nipple

 -  No distant metastatic disease

 -  Hormone-receptor status not specified

 PATIENT CHARACTERISTICS:

 -  Female

 -  Menopausal status not specified

 -  Not pregnant or lactating

 -  Negative pregnancy test

 -  Fertile patients must use effective contraception for ≥ 1 week prior to, during, and
 for ≥ 2 weeks after completion of study treatment

 -  No collagen vascular disorders, specifically systemic lupus erythematosus,
 scleroderma, or dermatomyositis

 -  No psychiatric, neurologic, or addictive disorders that would preclude obtaining
 informed consent

 -  No other malignancy within the past 5 years, except non-melanomatous skin cancer

 PRIOR CONCURRENT THERAPY:

 -  No prior radiotherapy to the breast

 -  No chemotherapy for at least 2 weeks before and 2 weeks after completion of study
 radiotherapy

 -  Concurrent hormonal therapy allowed