IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Recruiting now

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03536897

Run by

Mount Carmel Health System

People needed

168

Starts

2018-02-27

Expected to finish

2028-02-27

Last updated by the study team

2024-11-27

Who can join

Age: 65 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mount Carmel West Hospital — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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