IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

Mount Carmel Health System

Status: Enrolling

Conditions: Breast Cancer

Treatments: Radiation: IORT

Study type: Observational

Funder types: Other

Identifiers

NCT03536897

180212-1

Details and patient eligibility

About

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.

Enrollment: 168 estimated patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

168 participants in 1 patient group

IORT

Description:

All patients will undergo a partial mastectomy with sentinel lymph node biopsy with the goal of achieving a margin-negative resection while maintaining good cosmetic outcome. Immediately following partial mastectomy and frozen section evaluation of the sentinel lymph nodes, IORT is to be delivered. Intraoperative radiation therapy will involve 50 kV xrays to a dose of 20 Gy during breast conserving surgery. After surgery, patients are followed based on the standard schedule determined by their surgeon for 5 years.

Treatment:

Radiation: IORT