RecruitingNot Applicable

IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

United States168 participantsStarted 2018-02-27

Plain-language 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.

Who can participate

Age range65 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

In-Breast Tumor Recurrence (IBTR)

Timeframe: 5 years

Trial details

NCT IDNCT03536897

SponsorMount Carmel Health System

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-02-27

Contact for this trial

Lynn Shaffer, PhD

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

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