Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the rate of early and intermediate toxicity related to the AccuBoost System for delivery of APBI in women with resected, early stage breast cancer.

Official Title
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ACCELERATED PARTIAL BREAST IRRADIATION USING NON-INVASIVE IMAGE-GUIDED BREAST BRACHYTHERAPY (ACCUBOOST) FOR EARLY STAGE BREAST CANCERS: A TOXICITY ASSESSMENT

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Accelerated partial breast irradiation
* Other: Extended Follow up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A confirmed histological diagnosis of invasive breast carcinoma or DCIS Age greater or equal to 50 years old Life expectancy > 6 months Treated by breast conserving surgery with axillary node dissection or sentinel lymph node biopsy Pathologic tumor size less than or equal to 2 cm Invasive ductal, mucinous, tubular or colloid histology Estrogen receptor positive for invasive carcinoma. Unifocal/unicentric disease Negative surgical margins greater than or equal to 2 mm Pathologic lymph node negative No evidence of lymphovascular invasion ECOG performance status of 0 or 1 (Appendix 1) Informed consent signed. Exclusion Criteria: Known BRCA 1/2 Mutation; (BRCA 1 and 2 testing is not required) Autoimmune disorder Pregnancy Breast implants Psychiatric or addictive disorder that would preclude attending follow-up Neoadjuvant chemotherapy (adjuvant chemotherapy is permitted) Suspicious remaining microcalcification on post-surgery mammogram (unless biopsy proven benign) Lobular features on histology (pure or mixed) or sarcoma histology Node positive on axillary dissection or in the sentinel lymph node biopsy; Extensive in situ carcinoma (EIC) Multicentric or multifocal disease Paget's disease of the nipple Distant metastases Lumpectomy cavity not well visualized on AccuBoost imaging Lumpectomy cavity with 1cm margin (PTV) not adequately encompassed by any applicator (PTV > 6cm) Breast separation with compression > 7cm. Overlap of skin between orthogonal treatment axes.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiation<br>AccuBoost APBI- 34.0 Gy in 10fx | Radiation: Accelerated partial breast irradiation<br>* Accuboost APBI 34.0 Gy in 10 fractions<br>|
| Experimental: Extended Follow up<br>This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed. | Other: Extended Follow up<br>* This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early and Intermediate Toxicity | Any toxicity related to the radiation treatment will be scored and graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0 (Appendix 4). Acute side effects are any side effects occurring within 3 months of treatment. Intermediate side effects are any side effects occurring between 3 months and 2 years. This is reported in the outcome table. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic Outcome | Cosmetic results will be evaluated at each follow-up visit by the treating radiation oncologist using the Harvard criteria inclusive of discomfort during treatment(Pain), Fatigue and Acute skin reaction. This is reported in the outcome table. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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invasive ductal cancer, tubular breast cancer, breast cancer, colloid, ER positive, radiation