Using the Conture® Multi-Lumen Balloon to Deliver Accelerated Partial Breast Brachytherapy

Inclusion Criteria:

* Able and willing to sign informed consent
* Age 50 or older at diagnosis
* Life expectancy greater than 10 years (excluding diagnosis of breast cancer).
* Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria).
* On histologic examination, the tumor must be DCIS or invasive breast carcinoma. For patients with invasive breast cancer, an axillary staging procedure must be performed. Either:

  1. sentinel node biopsy (SNB) alone if sentinel node(s) is/are negative; or
  2. axillary dissection (minimum of six axillary nodes removed); and
  3. the axillary node(s) must be pathologically negative.
* The T stage must be Tis, T1, or T2. If T2, the tumor must be ≤ 3.0 cm in maximum diameter.
* Estrogen receptor positive tumor

Exclusion Criteria:

* Age \< 50 at diagnosis (regardless of histology)
* Pregnant or breast-feeding (if appropriate, patient must use birth control during the study)
* Active collagen-vascular disease
* Paget's disease of the breast
* History of DCIS or invasive breast cancer
* Prior breast or thoracic RT for any condition
* Multicentric carcinoma (DCIS or invasive)
* Synchronous bilateral invasive or non-invasive breast cancer
* Surgical margins that cannot be microscopically assessed or that are positive or close
* Positive axillary node(s)
* T stage of T2 with the tumor \> 3 cm in maximum diameter or a T stage \> 3
* Estrogen receptor negative tumor