Radiation Therapy in Treating Women With Stage I or Stage II Breast Cancer
Radiation Therapy in Treating Women With Stage I or Stage II Breast Cancer
RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.

 PURPOSE: Phase I/II trial to study the effectiveness of brachytherapy in treating women who
 have stage I or stage II breast cancer.
OBJECTIVES: I. Evaluate the technical feasibility and reproducibility, cosmetic results,
 complication rates, and local cancer control rate experience with brachytherapy used as the
 sole method of radiotherapy in women with stage I/II breast cancer treated with tylectomy who
 have histologically assessed negative surgical margins, less than 4 positive axillary nodes,
 and no extracapsular nodal extension or extensive intraductal component. II. Reduce the total
 treatment time of breast irradiation from 6 weeks to 4-5 days in these patients.

 OUTLINE: Treatment begins no sooner than 4 days and within 6 weeks after definitive surgery.
 All patients receive brachytherapy to the target volume (as defined by the excision cavity
 demarcated by post-tylectomy surgical clips plus 2 cm margin) using iridium-192 implants for
 dose distribution to five planes. Patients may be treated with either high-dose-rate or
 low-dose-rate brachytherapy at the institution's discretion. Patients are followed at 2 and 6
 weeks after treatment, then at 3, 6, 9 and 12 months, then every 4 months for 1 year, every 6
 months for 3 years, and then annually thereafter.

 PROJECTED ACCRUAL: A maximum of 46 patients will be accrued in each group (high-dose rate vs
 low-dose rate) over 2 years.
DISEASE CHARACTERISTICS: Histologically confirmed nonlobular invasive breast cancer of one
 of the following histologies: Ductal Papillary Medullary Colloid (mucinous) Tubular Stage
 I/II (T1-2 N0-1 M0) tumor no greater than 3 cm Prior tylectomy and axillary lymph node
 dissection required No more than 3 positive axillary lymph nodes and no extracapsular
 extension At least 6 lymph nodes sampled OR Negative sentinal node Surgical clips in place
 delineating margins of tylectomy cavity Negative, or close but negative, inked histologic
 margins of tylectomy or re-excision specimen Negative margins defined as no tumor at least
 2 mm away from the inked margins Close but negative margins defined as tumor within 2 mm of
 inked margin Positive margins defined as invasive or noninvasive tumor at inked resection
 margins Negative post-tylectomy or post-reexcision mammogram required if disease presented
 with malignancy-associated microcalcifications No remaining suspicious microcalcifications
 If catheters are placed at time of reexcision, the crieria may not be feasible but a post
 brachytherapy mammogram should be obtained as soon as possible No extensive intraductal
 carcinoma by the Harvard definition, i.e.: More than 25% of tumor is ductal carcinoma in
 situ (DCIS) and there is DCIS in adjacent breast tissue OR Intraductal carcinoma with
 microinvasion No proven multicentric carcinoma, i.e.: Tumor in different quadrants of the
 breast OR Tumor separated by at least 4 cm The following exclude: Skin or chest wall
 invasion Matted or fixed axillary adenopathy Metastatic internal mammary or supraclavicular
 nodes Paget's disease of the nipple Previously treated contralateral breast carcinoma or
 synchronous bilateral breast carcinoma Hormone receptor status: Not specified

 PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Not specified
 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified
 Renal: Not specified Other: No collagen vascular disease with a c-reactive protein level
 above normal or with an active skin rash (e.g., systemic lupus erythematosus, scleroderma,
 or dermatomyositis) No coexisting medical condition that reduces life expectancy to less
 than 2 years No second malignancy within 5 years except nonmelanomatous skin cancer Not
 pregnant or nursing Negative pregnancy test

 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
 chemotherapy for breast cancer Planned chemotherapy may begin at least 2 weeks after
 removal of brachytherapy catheters Endocrine therapy: Concurrent tamoxifen permitted
 Radiotherapy: No prior radiotherapy for breast cancer Surgery: See Disease Characteristics