Status:
COMPLETED
Treatment of T1N0 Invasive Breast Carcinoma by Local Excision Implant
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate radiation therapy directed to a small region of the breast in women who were recently diagnosed with early stage invasive breast cancer.
Detailed Description
* When participants undergo surgery to remove the tumor (lumpectomy), it will be followed by the placement of small flexible tubes throughout the region surrounding the site of operation. These tubes ...
Eligibility Criteria
Inclusion
- Low risk of multifocal disease within the breast whose tumor location is favorable for brachytherapy catheter placement
- Diagnosis of invasive breast carcinoma (biopsy or fine needle aspiration cytology) and be clinical stage T1N0 (primary tumor \< 2cm, clinically negative nodes)
- Location of primary tumor is not immediately adjacent to the nipple of chest wall
- No evidence of two or more separate tumors within the breast
- All histologic types and pathologic grades of primary tumor
- No extensive intraductal component (substantial intraductal carcinoma away from the primary tumor location)
- No lymphatic or vascular invasion
- Lymph node staging by sentinel node excision or axillary dissection confirms node negative status (If node positive, implant is used to deliver boost to tumor bed)
- Assessment of final surgical margins should be predominantly negative, but a single small region of focal positivity is allowable as it is for whole breast radiation
- 18 years of age or older
Exclusion
- Tumor is too close to the chest wall to allow placement of catheters
- Contraindications to radiation therapy are present, including a history of scleroderma, systemic lupus or other active connective tissue disease, pregnancy, or prior chest wall radiation
Key Trial Info
Start Date :
June 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00977275
Start Date
June 1 1997
End Date
May 1 2013
Last Update
April 11 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114