Breast Cancer Clinical Trial
IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
Summary
This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.
Eligibility Criteria
Inclusion Criteria:
Female
ECOG performance status 0-1
Age 65 years or older
cT1 or cT2 (≤3.0 cm)
Invasive ductal carcinoma histology
Estrogen receptor positive (ER+)
Grade 1 or Grade 2
Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling
Suitable for breast conserving surgery and radiation therapy
Patient must be able to provide study-specific informed consent
Exclusion Criteria:
Multi-centric cancer not amenable to single lumpectomy
Prior ipsilateral whole breast radiation
Known BRCA 1 or BRCA 2 mutation
Status post neoadjuvant hormonal or chemotherapy
Invasive lobular histology
Pure ductal carcinoma in situ (DCIS)
Grade 3
Diffuse suspicious microcalcifications
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