Safety and Feasibility of Short-Course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial
| City: |
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New Brunswick |
| State: |
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New Jersey |
| Zip Code: |
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08903 |
| Conditions: |
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Breast Cancer |
| Purpose: |
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To determine local disease control (recurrence) with shorter course of APBI delivered with a
breast brachytherapy applicator.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Life expectancy > 10 years
- Lumpectomy with clear margins (negative per NSABP criteria)
- DCIS and/or invasive carcinoma
- If invasive, nodes must be negative
- T stage is Tis, T1 or T2<=3 cm max diameter
- ER(+) or ER(-)/PR(+)
Exclusion Criteria:
- Pregnant or breast feeding
- Active collagen-vascular disease
- Paget's disease of the breast
- Prior history of breast cancer
- Prior breast or thoracic radiotherapy
- Multicentric carcinoma
- Synchronous bilateral breast cancer
- Surgical margins that cannot be assessed or that are positive
- T Stage is T2>3 cm or greater
- ER(-)/PR(-)
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| NCT ID: |
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NCT01072838 |
| Primary Contact: |
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Principal Investigator
Atif Khan, MD
Cancer Institute of New Jersey
Natasha Behrmann
Phone: 949-362-4800 ext. 145
Email: Natasha.Behrmann@crbard.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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New Brunswick, New Jersey 08903
United States
Atif Khan, MD
Phone: 732-235-6777
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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