Treatment of T1N0 Invasive Breast Carcinoma by Local Excision Implant

Study Overview
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Brief Summary
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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
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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 will remain in place for 7-9 days following the surgery. The first 2-3 days, the tubes will not contain radioactivity. This time is used to do all the calculations necessary for treatment and to check the findings in the breast tissue that was removed. After 2-3 days, the tubes will be filled with a radioactive wire which will remain in place for the next 5 days. During this period of time, participants will be required to remain within the hospital. At the end of these 5 days, the radioactive wires and tubes will be removed.

Official Title
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The Treatment of T1N0 Invasive Breast Carcinoma by Local Excision and Interstitial Implant

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Interstitial Implant Brachytherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Interstitial Implant Brachytherapy|Via tubes placed at the time of wide local excision delivered over 5 days|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if interstitial implant brachytherapy to radical radiation doses is feasible following wide local excision of T1N0 breast carcinoma |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early stage invasive breast cancer, Partial breast irradiation, interstitial implant