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Phase II Study of Systemic Screening in Node-Positive Breast Cancer

This study is looking at how often breast cancer spreads to other parts of the body (systemic metastasis) in people who have node-positive breast cancer after they have had chemotherapy and surgery. You would be eligible if you have a confirmed diagnosis of breast cancer with known ER/PR/HER2 status. This study involves getting CT scans of your chest, abdomen, and pelvis at the beginning of the study and again at 6 months if the first scan doesn't show any spread. The study aims to understand the frequency of systemic metastasis. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 120 participants. It is a Phase II study.
What's involved
You would participate for about 6 months, undergoing a CT scan at the start of the study and potentially another at 6 months.
Compensation
Not stated in the trial record.
Follow-up
Systemic metastasis will be measured at baseline and at 6 months.

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NCT06833502

Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer

Recruiting
PHASE2Ages 18+InterventionalScreening
H. Lee Moffitt Cancer Center and Research Institute
~120 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:CT Scan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Systemic Metastasis
Measured over Baseline and 6 months

Conditions

Breast Cancer
Node-positive Breast Cancer

Explore related trials

Breast CarcinomaERBB2 Gene

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Kamran Ahmed · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center
  • Matthew Mills · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Marian Hernandez
[email protected]
813-745-1807
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Age ≥ 18.
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

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).

What this trial measures

  • Systemic MetastasisBaseline and 6 months

    Proportion of participants with systemic metastasis at baseline and 6 months.