Actively Recruiting
Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-02-09
86
Participants Needed
2
Research Sites
274 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to determine the feasibility of genomically guided radiation therapy (RT) in people with triple negative (HER2 negative, hormone receptor negative) breast cancer undergoing breast conservation therapy.
CONDITIONS
Official Title
Genomically Guided Radiation Therapy in the Management of Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have had breast conservation therapy with lumpectomy and axillary evaluation (sentinel node biopsy or axillary dissection)
- Confirmation of triple negative breast cancer by tissue biopsy
- Adequate tissue available to calculate the radiosensitivity index (RSI)
- HER2-negative status as defined by ASCO/CAP guidelines
- Hormone receptor expression less than 10% by immunohistochemistry as defined by ASCO/CAP guidelines
- Life expectancy greater than 16 weeks
- Karnofsky Performance Status (KPS) of 70 or higher
- Age 18 years or older
- Recovery from any surgery within 14 days and clearance by surgeon
- No limits on prior systemic therapies
- Women of childbearing potential and sexually active males must use effective contraception during the study
- Ability to sign informed consent (or have it signed by a family member or health care proxy) prior to enrollment
You will not qualify if you...
- Major surgery or significant traumatic injury not recovered from within 14 days before study start
- Women who are pregnant or breastfeeding
- Positive surgical margins
- History of allergy or hypersensitivity to study drugs or components
- Presence of metastatic breast cancer
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Morton Plant Hospital - Baycare Health System
Clearwater, Florida, United States, 33756
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
R
Robin Dowell
CONTACT
K
Kamran Ahmed, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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