Actively Recruiting
Breast Re-irradiation After Second Ipsilateral Lumpectomy
Led by Youssef Zeidan · Updated on 2025-11-13
114
Participants Needed
2
Research Sites
391 weeks
Total Duration
On this page
Sponsors
Y
Youssef Zeidan
Lead Sponsor
B
Boca Raton Regional Hospital Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this research study is to test the safety and possible harms of treating breast cancer with reirradiation, after breast surgery. The researchers want to find out what effects (good and bad) reirradiation has on people who have already received radiation before surgery.
CONDITIONS
Official Title
Breast Re-irradiation After Second Ipsilateral Lumpectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with estrogen-receptor-positive, HER2-negative breast cancer
- Signed and dated informed consent form
- Willingness to comply with all study procedures and available for study duration
- Age 40 years or older
- Oncotype score less than 26 if postmenopausal, less than 16 if premenopausal, or low/ultra-low index
- At least 18 months since last breast radiation therapy session
- Prior radiation types allowed include brachytherapy, external beam MV photons, protons, or intraoperative radiation with total dose limit of 68 Gy (EQD2) if records available
- Ipsilateral recurrence unifocal less than 3 cm with negative margins, no lymph node involvement, and either carcinoma in situ or invasive
- Eastern Cooperative Oncology Group (ECOG) status 2 or less
- Planning target volume to whole breast ratio less than 1/2
- Life expectancy greater than 12 months
- Agreement to use highly effective contraception from screening through treatment and for 1 year after partial breast irradiation if able to become pregnant
You will not qualify if you...
- BRCA1/2 mutation or any other breast cancer receptor subtypes
- Assigned male at birth with breast cancer
- Pregnancy or breastfeeding
- Skin involvement by cancer
- Distant metastasis
- Initial high-risk triple negative or HER-2 enriched breast cancer
- Other malignancies except skin cancer
- Connective tissue disorders such as scleroderma or lupus
- Any condition that increases risk as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Lynn Cancer Institute at Baptist Health, Inc.
Boca Raton, Florida, United States, 33486
Actively Recruiting
2
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Actively Recruiting
Research Team
Y
Youssef Zeidan, M.D., Ph.D.
CONTACT
M
MCI Multisite Research Program
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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