Use of the Contura™ Catheter in Intermediate-Risk, Pathological Stage 0, I, or II (Up to 3.0 cm) Breast Cancer Patients

Inclusion Criteria:

• Patients with invasive breast cancer are required to have axillary staging which caninclude sentinel node biopsy alone if sentinel node is negative or axillary dissectionor sampling with a minimum total of 6 axillary nodes if sentinel node is positive.Axillary staging is not required for patients with DCIS.

• Estrogen receptor (ER) and progesterone receptor (PR) analysis must be negative.

• The patient must be ≥ 18 years old.

• If the patient is older than 49 years, she must meet at least one of the following 2conditions: i. 1-3 histologically positive axillary nodes ii. negative ER and PR analysis

• The patient should have a life expectancy of at least 10 years, excluding herdiagnosis of breast cancer.

• The tumor must be DCIS or invasive adenocarcinoma of the breast.

• Gross disease must be unifocal with pathologic tumor size 3.0 cm or less. Patientswith microscopic multifocality are eligible as long as total pathologic tumor size is 3.0 cm or less.

• The patient must have pathological stage 0, I, or II breast cancer.

• Surgical treatment of the breast must have been lumpectomy. The margins of theresected specimen must be histologically free of tumor (DCIS and invasive).Re-excision of surgical margins is permitted.

• The patient must be registered within 42 days following the last surgery for breastcancer.

• The target lumpectomy cavity/whole breast reference volume must be ≤ 30% based on thepostoperative CT scan.

Exclusion Criteria:

• The patient is < 18 years old.

• If the patient is older than 49 years, she has both an ER and PR positive tumor andhistologically negative axillary nodes.

• T2 (> 3.0 cm), T3, stage III, or stage IV breast cancer.

• "Marginal" or "borderline" ER or PR analysis results.

• More than 3 histologically positive axillary nodes.

• Axillary nodes with definite evidence of microscopic or macroscopic extracapsularextension.

• One or more positive non-axillary sentinel node(s). Intramammary nodes are staged asaxillary nodes.

• Non-epithelial breast malignancies such as sarcoma or lymphoma.

• Proven multicentric carcinoma in more than one quadrant or separated by 4 or morecentimeters.

• Paget's disease of the nipple.

• Synchronous bilateral invasive or non-invasive breast cancer.

• History of DCIS or invasive breast cancer.

• Surgical margins that cannot be microscopically assessed or are positive at pathologicevaluation.

• Clear delineation of the target lumpectomy cavity not possible.

• Any treatment with radiation therapy, chemotherapy, and/or biotherapy administered forthe currently diagnosed breast cancer prior to registration. The only exception ishormonal therapy, which may have been given for no more than a total of 28 daysanytime after diagnosis and before registration.

• Prior breast or thoracic radiotherapy for any condition.

• Collagen vascular disease, specifically dermatomyositis with a CPK level above normalor with an active skin rash, systemic lupus erythematosis, or scleroderma.

• Pregnancy or lactation at the time of proposed registration. Women of reproductivepotential must agree to use an effective non-hormonal method of contraception duringtherapy.

• Psychiatric or addictive disorders.