Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:50 - Any
Updated:5/27/2013
Start Date:December 2009
Contact:Natasha Behrmann
Email:Natasha.Behrmann@crbard.com
Phone:949-362-4800

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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


To determine local disease control (recurrence) with shorter course of APBI delivered with a
breast brachytherapy applicator.


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(-)
We found this trial at
3
sites
Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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195 Little Albany St
New Brunswick, New Jersey 08903
(732) 235-2465
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School As New...
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New Brunswick, NJ
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3601 W 13 Mile Rd
Royal Oak, Michigan 48073
(248) 898-5000
William Beaumont Hospital-Royal Oak The largest Beaumont Hospital is located at 3601 W Thirteen Mile...
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Royal Oak, MI
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