3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection
3-Dimensional Conformal Radiation Therapy In Treating Women With Stage I or Stage II Breast Cancer Previously Treated With Lumpectomy and Axillary Node Dissection
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.
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