IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

NCT03536897 | Recruiting DMC

• 1 other identifier: 180212-1
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

breast cancer; invasive ductal carcinoma; intraoperative radiation therapy; iort

Outcome Measures

Primary Outcomes (1)

• In-Breast Tumor Recurrence (IBTR)

  Ipsilateral In-Breast Tumor Recurrence (IBTR): defined as biopsy-proved invasive or in situ breast cancer (except LCIS) in the ipsilateral breast.

  5 years

Secondary Outcomes (4)

• Late Toxicity

  5 years

• Acute Toxicity

  3 months

• Disease Free Survival

  5 yeras

• Overall Survival

  5 years

Study Arms (1)

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

Interventions

IORT RADIATION

Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy

IORT

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 65 and above with early stage breast cancer, ER+, low to intermediate grade invasive ductal carcinoma of the breast amenable to breast conserving surgery and radiation therapy.

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

Sponsors & Collaborators

• Mount Carmel Health System: lead

Study Sites (1)

Mount Carmel West Hospital

Columbus, Ohio, 43222, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Malolan Rajagopalan, MD

  Mount Carmel Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynn Shaffer, PhD

CONTACT

614-234-3625; Lynn.Shaffer@mchs.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 25, 2018
• Study Start: February 27, 2018
• Primary Completion (Estimated): February 27, 2028
• Study Completion (Estimated): February 27, 2028
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)