Actively Recruiting
Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01
120
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
F
Florida Breast Cancer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of the study is to determine the frequency of systemic metastasis in node positive breast cancer following chemotherapy and surgery. Participants will be asked to spend about 6 months in this study. Participants will undergo a computed tomography (CT) screening of the thorax, abdomen, and pelvis at baseline prior to adjuvant radiation therapy and another CT screening of the thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.
CONDITIONS
Official Title
Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
- Node positive HER2+ and triple negative breast cancer following neoadjuvant chemotherapy
- HR+/HER2- patients with ypN2 or ypN3 disease after neoadjuvant chemotherapy and surgery
- Completed minimum 8 weeks of standard neoadjuvant chemotherapy including anthracycline and/or taxane-based regimen
- Age 18 years or older
- Life expectancy of at least 6 months
- Eastern Cooperative Oncology Group performance status 0 to 2
- Ability and willingness to understand and sign informed consent
- Willingness to comply with study procedures and availability for study duration
You will not qualify if you...
- Prior diagnosis of systemic metastases
- History of non-breast cancer malignancies unless no evidence of disease for 2 years (excluding certain skin, cervical, or bladder cancers)
- Contraindications to CT IV contrast
- Chronic kidney disease stage IV or V or end stage renal disease with creatinine clearance less than 30 ml/min
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
R
Rheese Mcnab
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
3
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