Radiation Therapy in Treating Women With Early Stage Breast Cancer
Radiation Therapy in Treating Women With Early Stage Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation
 therapy in different ways may kill more tumor cells. Giving it after surgery may kill any
 tumor cells that remain after surgery.

 PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how
 well it works in treating women with early stage breast cancer.
OBJECTIVES:

 Primary

 -  To determine the freedom from local and regional failure in women with early stage
 breast cancer treated with accelerated, hypofractionated radiotherapy.

 -  To determine the acute and late toxicity of accelerated, hypofractionated radiotherapy
 using previously published toxicity scales.

 Secondary

 -  To measure cosmesis using the Harvard cosmesis scale in patients who have undergone
 lumpectomy.

 -  To identify co-variates responsible for poor cosmetic outcome in these patients.

 OUTLINE: Patients who have undergone lumpectomy undergo either intracavitary balloon
 brachytherapy boost and hypofractionated, accelerated whole breast irradiation (AWBI) OR
 3D-conformal radiotherapy (3D-CRT)/intensity-modulated radiotherapy (IMRT) boost and AWBI.
 Patients who have undergone mastectomy undergo hypofractionated, accelerated chest wall
 irradiation.

 -  Intracavitary balloon brachytherapy boost and AWBI (post-lumpectomy): Patients undergo
 intracavitary balloon brachytherapy boost twice daily for 2 days (total of 4 fractions).
 Beginning 5-21 days after completion of brachytherapy, patients undergo AWBI once daily
 5 days a week for approximately 2 weeks (total of 11 fractions).

 -  3D-CRT/IMRT boost and AWBI (post-lumpectomy): Patients undergo 3D-CRT/IMRT boost twice
 daily for 2 days (total of 4 fractions). Patients also undergo AWBI as above before or
 after boost radiotherapy.

 -  Accelerated chest wall irradiation (post-mastectomy): Patients undergo accelerated chest
 wall irradiation once daily 5 days a week for approximately 2 weeks (total of 11
 fractions).

 Patients who have undergone lumpectomy undergo frontal digital photography of the breasts at
 baseline, immediately before the initiation of radiotherapy, and then annually for 3 years
 after completion of radiotherapy. These patients also complete the Breast Cancer Treatment
 Outcome Scale at baseline and at 3 years after completion of radiotherapy. Physicians
 complete the Harvard Cosmesis scale at baseline and at 1 and 3 years after completion of
 radiotherapy.

 After completion of study treatment, patients are followed up at weeks 1, 4, and 8 and then
 every 4 months for 2 years, every 6 months for 3 years, and annually thereafter.
DISEASE CHARACTERISTICS:

 -  Histologically confirmed breast cancer, including 1 of the following subtypes:

 -  Ductal carcinoma in situ

 -  Invasive ductal carcinoma

 -  Invasive lobular carcinoma

 -  Medullary carcinoma

 -  Papillary carcinoma

 -  Colloidal (mucinous) carcinoma

 -  Tubular carcinoma

 -  Pathological stage 0-IIIA disease (pTis; pT1-2, N0-N2a, M0)

 -  Tumor size ≤ 5 cm

 -  Breast considered technically satisfactory for radiotherapy

 -  Has undergone lumpectomy or mastectomy and either sentinel node biopsy or axillary
 dissection (if invasive carcinoma is present)

 -  Negative inked histological margins (i.e., no invasive cells at surgical margin)
 or confirmed negative re-excision specimen

 -  Unifocal or multifocal (confined to 1 quadrant; tumors < 4 cm apart) disease with 1 or
 2 foci that can be encompassed by 1 lumpectomy

 -  No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor
 separated by ≥ 4 cm) with other clinically or radiographically suspicious areas in the
 ipsilateral breast unless confirmed to be negative for malignancy by biopsy

 -  No evidence of suspicious microcalcifications in the breast before the start of
 radiotherapy

 -  If malignancy-associated microcalcifications were initially present, the
 post-excision mammography must be negative

 -  No more than 9 positive axillary lymph nodes

 -  No palpable or radiographically suspicious contralateral axillary, supraclavicular,
 infraclavicular, or internal mammary nodes unless there is histologic confirmation
 that these nodes are negative for tumor

 -  No previously treated contralateral breast cancer or synchronous ipsilateral breast
 cancer

 -  No lobular carcinoma in situ alone (i.e., no invasive component) or non-epithelial
 breast malignancies (e.g., sarcoma or lymphoma)

 -  No Paget disease of the nipple

 -  No skin involvement, regardless of tumor size

 -  No distant metastases

 -  Hormone receptor status not specified

 PATIENT CHARACTERISTICS:

 -  Pre- or post-menopausal

 -  ECOG performance status 0-1

 -  No co-existing medical condition that would limit life expectancy to < 2 years

 -  Not pregnant or nursing

 -  Negative pregnancy test

 -  Fertile patients must use effective contraception

 -  No other malignancy within the past 5 years except for nonmelanoma skin cancer (the
 disease-free interval from any prior malignancy must be continuous)

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

 -  No psychiatric or addictive disorder that would preclude obtaining informed consent

 PRIOR CONCURRENT THERAPY:

 -  See Disease Characteristics

 -  No prior radiotherapy for the current breast cancer

 -  No tylectomies so extensive that the cosmetic result is low or poor prior to
 radiotherapy

 -  Chemotherapy allowed provided the following criteria are met:

 -  Chemotherapy is not administered prior to, during, and for ≥ 21 days after
 completion of radiotherapy (for patients receiving brachytherapy boost)

 -  Chemotherapy is not administered for ≥ 21 days before, during, and for ≥ 21 days
 after completion of radiotherapy (for patients receiving external beam
 radiotherapy boost or chest wall irradiation)

 -  Concurrent tamoxifen, anastrozole, or other hormonal therapy allowed

 -  May be initiated before, during, or after radiotherapy

 -  No other concurrent chemotherapy, immunotherapy, or experimental medications