This multiple site, prospective, non-randomized study has been designed to compile
information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected
patients through evaluation of dosimetric success as compared with a single central lumen
balloon device and through treatment outcomes.
Data collected during this study will include baseline patient demographics, information
related to the time of implant, radiation therapy details, and removal of the device as well
as recurrence data, cosmetic outcomes and toxicities. The patient's follow-up data will be
collected during the patient's standard follow-up visits.
- 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
- On histologic examination, the tumor must be DCIS or invasive breast carcinoma. For
patients with invasive breast cancer, an axillary staging procedure must be
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
- Estrogen receptor positive tumor
- Age < 50 at diagnosis (regardless of histology)
- Pregnant or breast-feeding (if appropriate, patient must use birth control during the
- 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
- 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