Treatment of T1N0 Invasive Breast Carcinoma by Local Excision Implant
Completed · Phase 1/Phase 2
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00977275
- Run by
- Massachusetts General Hospital
- People needed
- 45
- Starts
- 1997-06-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2017-04-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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