Radiation Therapy in Treating Patients With Recurrent Breast Cancer

OBJECTIVES:

- To determine the in breast recurrence rate following repeat radiation to the breast.
These patients will be followed for a period of five years following completion of
radiation to determine these rates.

- To determine the cosmetic outcome resulting from partial breast re-irradiation using
different techniques, including both physician and patient rated scales.

- To determine patient satisfaction of partial breast re-irradiation as it pertains to
their overall treatment experience, as measured by a questionnaire.

- To determine if there are patient factors illuminated during a discussion of informed
consent, which limit a patient's suitability to receive partial breast re-irradiation
delivered by a particular technique.

- To evaluate tylectomy wound healing and overall complication rate after partial breast
re-irradiation.

- To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence
rates.These patients will be followed for a period of five years following completion of
the second course of radiation to determine these rates.

OUTLINE: Patients are stratified according to which modality is best suited for the patient.
Patients are assigned to 1 of 2 groups.

All patients undergo excisional biopsy or needle localization removal of the tumor. Patients
with margins < 2 mm undergo re-excision of the biopsy cavity.

- Group 1: Patients undergo partial breast irradiation delivered as a single
intra-operative radiation dose to the tumor bed.

- Group 2: Patients undergo partial breast irradiation delivered by Mammosite®
brachytherapy consisting of 10 fractions over 5 days.

Quality of life is assessed at baseline, 1 month after completion of radiotherapy, and then
at follow-up visits.

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

Inclusion Criteria:

- Patients' recurrences must have histologically confirmed ductal carcinoma in-situ,
invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.

- Lesion size ≤ 3 cm treated with a tylectomy and whole breast irradiation (with or
without tumor bed boost)

- Unifocal breast cancer recurrence

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

- Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered
first and chemotherapy must begin no earlier than two weeks following completion of
radiation.

- Signed study-specific informed consent prior to study entry.

Exclusion Criteria:

- Patients with distant metastatic disease

- Patients with invasive lobular carcinoma, extensive lobular carcinoma in-situ,
extensive ductal carcinoma in-situ (spanning more than 3 cm), or nonepithelial breast
malignancies such as lymphoma or sarcoma.

- Patients with multicentric carcinoma (tumors in different quadrants of the breast or
tumors separated by at least 4 cm). Palpable or radiographically suspicious
contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular,
or internal mammary lymph nodes unless these are histologically or cytologically
confirmed negative.

- Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25%
of the invasive tumor is DCIS and DCIS present in adjacent breast tissue. Presence of
an EIC increases the chance of local recurrence, and as such, one might not be a
candidate for repeat breast conservation.

- Patients with Paget's disease of the nipple.

- Patients with skin involvement.

- 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.

- Patients with known BRCA 1/BRCA 2 mutations.