Breast-Conserving Surgery Followed by Radiation Therapy With MRI-Detected Stage I or Stage II Breast Cancer
Breast-Conserving Surgery Followed by Radiation Therapy With MRI-Detected Stage I or Stage II Breast Cancer
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and
 may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays
 to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that
 remain after surgery.

 PURPOSE: This phase II clinical trial is studying how well breast-conserving surgery followed
 by radiation therapy works in treating patients with stage I or stage II breast cancer.
PRIMARY OBJECTIVES:

 I. To determine ipsilateral breast tumor recurrence rates as well as tumor bed recurrence
 rates. Patients will be followed for a period of five years following completion of radiation
 to determine these rates.

 II. To determine the cosmetic outcome resulting from breast conserving surgery and breast
 radiation.

 SECONDARY OBJECTIVES:

 I. To determine if there are patient factors which limit a patient's suitability to receive
 breast conserving therapy in the setting of multi-centric disease.

 II. To determine patient satisfaction of breast conserving therapy as it pertains to their
 overall treatment experience as measured by a questionnaire.

 III. To evaluate wound healing and overall complication rate after radiation as a component
 of breast conserving therapy.

 OUTLINE:

 Patients undergo breast-conserving surgery consisting of partial mastectomies followed by
 external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease
 progression or unacceptable toxicity.

 After completion of study treatment, patients are followed at 1 month, then every 3 months
 for 1 year, every 6 months for 1 year, and then annually for 5 years.
Inclusion

 -  Patients with multicentric carcinoma (tumors in different quadrants of the breast or
 tumors separated by at least 4 cm)

 -  All radiographically suspicious lesions must be biopsied and have histologically
 confirmed ductal carcinoma in-situ, invasive ductal, invasive lobular, medullary,
 papillary, colloid (mucinous), or tubular histologies

 -  A maximum of two radiographically detected malignant lesions

 -  Clinical Stage I-II breast carcinoma, with lesion size =< 5 cm for the dominant mass
 and the second lesion detected only on MRI, treated with lumpectomies; the MRI
 detected lesion must be pathologically =< 1 cm

 -  Axillary lymph node evaluation, either sentinel lymph node biopsy or axillary
 dissection as deemed appropriate by the treating surgeon for all patients with
 invasive cancer; no axillary lymph node sampling is needed for patients with DCIS

 -  Negative resection margins with at least a 2 mm margin from invasive and in-situ
 cancer or a negative re-excision

 -  A posterior margin =< 2 mm from DCIS is permissible provided fascia was taken

 -  Patients are eligible regardless of estrogen receptor, progesterone receptor, or
 Her-2/neu amplification

 -  Hormonal therapy is allowed; if adjuvant chemotherapy is planned, the chemotherapy
 should be delivered first and radiation must begin no earlier than three weeks and no
 later than eight weeks following completion of chemotherapy

 -  Signed study-specific informed consent prior to study entry

 Exclusion

 -  Extensive intraductal component by the Harvard definition (i.e., more than 25% of the
 invasive tumor is DCIS and DCIS present in adjacent breast tissue)

 -  Palpable or radiographically suspicious contralateral axillary, ipsilateral or
 contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless
 these are histologically confirmed negative

 -  Patients receiving neoadjuvant chemotherapy

 -  Patients with distant metastatic disease detected by radiographic imaging; specific
 studies for systemic imaging should be obtained as directed by localized symptoms or
 per available NCCN guidelines

 -  Patients with known BRCA 1/BRCA 2 mutations or those with predicted risk of carrying
 the mutation by BRCAPRO (44) risk assessment >= 50%

 -  Diffuse calcifications throughout the breast

 -  Patients with skin involvement or inflammatory breast cancer

 -  Patients with Paget's disease of the nipple

 -  Patients nonepithelial breast malignancies such as lymphoma or sarcoma

 -  Patients with collagen vascular disorders, specifically systemic lupus erythematosis,
 scleroderma, or dermatomyositis

 -  Patients with psychiatric, neurologic, or addictive disorders that would preclude
 obtaining informed consent

 -  Other malignancy, except non-melanomatous skin cancer, < 5 years prior to
 participation in this study

 -  Patients who are pregnant or lactating, due to potential fetal exposure to radiation
 and unknown effects of radiation on lactating females