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Yale Mammosite

Study #IRB121204

Condition / Intervention

Breast Cancer


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


Sheida Mani, MD

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

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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).

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