Actively Recruiting
IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
Led by Mount Carmel Health System · Updated on 2024-11-27
168
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- ECOG performance status 0-1
- Age 65 years or older
- Clinical tumor stage T1 or T2 (3.0 cm or smaller)
- Invasive ductal carcinoma histology
- Estrogen receptor positive (ER+)
- Grade 1 or Grade 2 cancer
- Clinically negative lymph nodes (cN0) by exam, imaging, or nodal sampling
- Suitable for breast conserving surgery and radiation therapy
- Able to provide study-specific informed consent
You will not qualify if you...
- Multi-centric cancer not suitable for single lumpectomy
- Prior radiation to the same breast
- Known BRCA 1 or BRCA 2 mutation
- Previous neoadjuvant hormonal or chemotherapy
- Invasive lobular carcinoma histology
- Pure ductal carcinoma in situ (DCIS)
- Grade 3 cancer
- Diffuse suspicious microcalcifications in the breast
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mount Carmel West Hospital
Columbus, Ohio, United States, 43222
Actively Recruiting
Research Team
L
Lynn Shaffer, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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