NCT03536897Recruiting

IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Mount Carmel Health System

Start Date

2/27/2018

Completion Date

2/27/2028

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

Age Range: 65 years to No maximum

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

Interventions

RADIATION

IORT

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Conditions

Breast Cancer

Locations

Mount Carmel West Hospital

Columbus, Ohio 43222

United States