IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Description

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.

Conditions

Breast Cancer

Study Overview

Study Details

Study overview

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.

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

IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Columbus

Mount Carmel West Hospital, Columbus, Ohio, United States, 43222

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mount Carmel Health System,

Malolan Rajagopalan, MD, PRINCIPAL_INVESTIGATOR, Mount Carmel Health System

Study Record Dates

2028-02-27