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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 65 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
IORT 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.
  • Radiation: IORT
    Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy

Recruiting Locations

Mount Carmel West Hospital
Columbus, Ohio 43222
Contact:
Malolan S Rajagopalan, MD
614-234-5402
malolan.rajagopalan@mchs.com

More Details

Status
Recruiting
Sponsor
Mount Carmel Health System

Study Contact

Lynn Shaffer, PhD
614-234-3625
Lynn.Shaffer@mchs.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.