Screening for metastasis in node-positive breast cancer after treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the frequency of systemic metastasis in patients with node-positive breast cancer following chemotherapy and surgery. Participants will undergo computed tomography (CT) scans of the thorax, abdomen, and pelvis at the start of the study and again after six months if the initial scan is negative. The study will involve patients who have received neoadjuvant chemotherapy and have specific breast cancer subtypes. The goal is to improve understanding of metastasis patterns in this patient population.

Why it matters

Who can join: the full rules

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.
* 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 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 it's running

• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting

Study contacts

• Principal investigator: Kamran Ahmed — Moffitt Cancer Center
• Study coordinator: Marian Hernandez
• Email: marian.hernandez@moffitt.org
• Phone: 813-745-1807

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.