Breast Cancer Clinical Trial
Partial Breast Irradiation Using Non Invasive Approach for Early Stage Breast Cancer
Summary
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.
Eligibility Criteria
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.
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There are 3 Locations for this study
Lakeland Florida, 33805, United States
Providence Rhode Island, 02903, United States
Providence Rhode Island, 02903, United States
Tacoma Washington, 98405, United States
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