partial breast radiation therapy in treating women undergoing breast-conserving therapy for early stage breast cancer

Conditions: Breast Cancer

Summary: 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.

Eligibility criteria:
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

Keywords: stage i breast cancer stage ii breast cancer invasive ductal breast carcinoma medullary ductal breast carcinoma with lymphocytic infiltrate mucinous ductal breast carcinoma tubular ductal breast carcinoma papillary ductal breast carcinoma