NCT06833502 · H. Lee Moffitt Cancer Center and Research Institute
Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer
What this study 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.
View original scientific description
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.
Interventions
OTHER
CT Scan
Participants will undergo a screening CT thorax, abdomen, pelvis at baseline prior to adjuvant radiation therapy and additional screening CT thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.
Primary outcome measures
Systemic Metastasis
Time frame: Baseline and 6 months
Proportion of participants with systemic metastasis at baseline and 6 months.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status.
- HR+ will be defined as ER and/or PR ≥ 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO / CAP Guidelines27. Triple negative will be classified as ER and PR \<10% and HER2-.
- Node positive HER2+ and triple negative breast cancer (ypN+) following receipt of neoadjuvant chemotherapy. HR+/HER2- patients should have ypN2 or ypN3 disease following receipt of neoadjuvant chemotherapy and surgery.
- Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen. To include HER2 directed therapy for HER2+ patients.
- Life expectancy ≥ 6 months.
- Eastern Cooperative Oncology Group performance status 0 to 2.
- Patients must be able to understand and the willingness to sign an informed consent for study procedures.
- Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion criteria
- Prior diagnosis of systemic metastases.
- Patients with prior history of non-breast cancer malignancies should have NED ≥ 2 years excluding adequately treated non-melanoma skin cancer, in situ cancer of the cervix or bladder.
- Contraindication towards CT IV contrast.
- Chronic kidney disease stage IV or V or end stage renal disease (CrCl \<30 ml/min).
Where
- Tampa, Florida
Collaborators
Florida Breast Cancer Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations