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IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Intraoperative Radiation Therapy (IORT) Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Who can join

Ages 65 and older · Women

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

About the study

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.

What is being tested

• IORT (radiation)

Sponsor: Mount Carmel Health System · Participants: 168 · Started: Feb 27, 2018

Contact the study team

• Lynn Shaffer, PhD · Phone: 614-234-3625

Official record on ClinicalTrials.gov — NCT03536897

Locations in the U.S.

Conditions

• Breast Cancer

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.