Yale Mammosite

Study #IRB121204

Condition / Intervention

Breast Cancer

Purpose

A phase II trial of mammosite breast brachytherapy optimization in the treatment of stage 0, I, IIA breast carcinoma.

Investigator

Sheida Mani, MD

Contact Information

For more information about this study and to inquire about eligibility, (203) 384-3611.

More Information

View this trial on ClinicalTrials.gov

Eligibility

Inclusion Criteria:

• Life expectancy of at least two years.
• Stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less.
• On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
• Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (>2mm, DCIS and invasive). Re-excision of surgical margins is permitted.
• Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less.)
• Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). (Axillary staging is NOT required for patients with DCIS.)
• The patient must have the MammoSite catheter placed within 4 weeks or 28 days of the final surgery for their breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure). Placement of a spacer for the MammoSite catheter is permitted at their final surgery.
• Patients with a history of non-ipsilateral breast malignancies are eligible if they have been disease-free for 2 or more years prior to randomization. Patients with the following cancers are eligible even if diagnosed and treated within the past 2 years: carcinoma in situ of the cervix, colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin. Patients with a prior diagnosis of ipsilateral breast cancer are ineligible.
• Must have 3 or fewer histologically positive axillary nodes with no extracapsular extension.
• Chemotherapy is permitted if planned for ≥2 weeks after removal of Mammosite catheter.
• Patient must be ineligible or have refused enrollment on the randomized trial RTOG 0413.

Exclusion Criteria

• T2 (>3.0 cm), T3, stage III or IV breast cancer.
• More then 3 histologically positive axillary nodes.
• Axillary nodes with evidence of extracapsular extension.
• Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless biopsy proven to be negative for tumor.
• Suspicious microcalcifications, densities or palpable abnormalities in either breast unless biopsy proven to be benign. Non-epithelial breast malignancies such as sarcoma or lymphoma.
• Proven multicentric carcinoma in more than one quadrant or separated by more than 3 centimeters.
• Paget's disease of the nipple.
• History of invasive breast cancer or DCIS in the same breast.
• Surgical margins that cannot be microscopically assessed or are less then 2 mm.
• Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.
• Pregnancy or lactation at the time of proposed radiation. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
• Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
• Patients with coexisting medical conditions in whom life expectancy is < 2 years.
• Patients with skin involvement, regardless of tumor size.
• Patients for whom treatment with the MammoSite catheter is not feasible, such as those with too little breast tissue between the skin and the catheter (<5mm).