Status:
TERMINATED
Using the Conture® Multi-Lumen Balloon to Deliver Accelerated Partial Breast Brachytherapy
Lead Sponsor:
SenoRx, Inc.
Collaborating Sponsors:
C. R. Bard
Conditions:
Breast Cancer
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
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 evaluat...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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:
- sentinel node biopsy (SNB) alone if sentinel node(s) is/are negative; or
- axillary dissection (minimum of six axillary nodes removed); and
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT00699101
Start Date
June 1 2008
End Date
June 1 2013
Last Update
June 17 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0058