Breast Cancer Clinical Trial

IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

168

Study ID:

NCT03536897

Recruitment Status:

Recruiting

Sponsor:

Mount Carmel Health System

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There is 1 Location for this study

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Mount Carmel West Hospital
Columbus Ohio, 43222, United States More Info
Malolan S Rajagopalan, MD
Contact
614-234-5402
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

168

Study ID:

NCT03536897

Recruitment Status:

Recruiting

Sponsor:


Mount Carmel Health System

How clear is this clinincal trial information?

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