3-dimensional conformal radiation therapy in treating women with stage i or stage ii breast cancer previously treated with lumpectomy and axillary node dissection

Conditions: Breast Cancer

Summary: rationale: 3-dimensional conformal radiation therapy delivers a high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. purpose: phase i/ii trial to study the effectiveness of 3-dimensional conformal radiation therapy in treating women who have undergone lumpectomy and axillary node dissection for stage i or stage ii breast cancer.

objectives: * determine the technical feasibility and reproducibility of three-dimensional conformal radiotherapy confined to the region of the lumpectomy cavity in women with stage i or ii breast cancer. * determine the cosmetic results in patients treated with this regimen. * determine the complication rates in patients treated with this regimen. * determine the local control rate in patients treated with this regimen. outline: this is a multicenter study. patients undergo three-dimensional conformal radiotherapy twice daily for 5 days beginning within 8 weeks after surgery. patients are followed at 6 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. projected accrual: a total of 19-46 patients will be accrued for this study within 6.3 to 15.3 months.

Eligibility criteria:
disease characteristics: * histologically confirmed invasive breast cancer * stage i or ii (t1, n0; t1, n1; t2, n0; or t2, n1) * unifocal disease (single focus that can be encompassed by one lumpectomy) * the following histologies are eligible: * invasive ductal * medullary * papillary * colloid (mucinous) * tubular * no invasive or extensive in situ lobular carcinoma or pure ductal carcinoma in situ (dcis) * no nonepithelial breast malignancies such as sarcoma or lymphoma * previously treated with lumpectomy of a lesion no greater than 3 cm and axillary dissection of at least 6 lymph nodes or a sentinel node biopsy * six surgical clips in place delineating the margins of the tylectomy cavity * negative, inked histologic margins of lumpectomy (greater than 2 mm) or re-excision specimen available for confirmation * negative mammography post-lumpectomy or post-excision if malignancy-associated microcalcifications were initially present * no prior lumpectomy so extensive that the cosmetic result is low or poor prior to radiotherapy * no more than 3 positive axillary nodes * no proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless negative by biopsy * no palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless nodes are histologically negative * no extensive intraductal carcinoma, indicated by one of the following according to the harvard definition: * more than 25 % of invasive tumor is dcis and dcis is in adjacent breast tissue * intraductal carcinoma with microinvasion * no previously treated contralateral breast cancer or synchronous ipsilateral breast cancer * no evidence of suspicious microcalcifications * no paget's disease of the nipple * no skin involvement by disease, regardless of tumor size * no distant metastases * hormone receptor status: * not specified patient characteristics: age * 18 and over sex * female menopausal status * not specified performance status * not specified life expectancy * at least 2 years hematopoietic * not specified hepatic * not specified renal * not specified other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * technically suitable for breast radiotherapy * no collagenous diseases (e.g., systemic lupus erythematosus, scleroderma, or dermatomyositis) * no other medical condition that would limit life expectancy * no psychiatric or addictive disorders that would preclude giving informed consent * no other malignancy within the past 5 years except nonmelanoma skin cancer prior concurrent therapy: biologic therapy * not specified chemotherapy * at least 2 weeks since prior chemotherapy * no concurrent chemotherapy during and for at least 2 weeks after completion of study therapy endocrine therapy * concurrent anastrozole or tamoxifen allowed radiotherapy * no prior radiotherapy for the current malignancy surgery * see disease characteristics other * no prior nonhormonal therapy for the current malignancy

Keywords: stage i breast cancer stage ii breast cancer