Screening for metastasis in node-positive breast cancer after treatment
Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer Following Neoadjuvant Chemotherapy and Surgery
This study is testing how often breast cancer spreads to other parts of the body in patients who have had chemotherapy and surgery, by using CT scans to check for any signs of metastasis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT06833502 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with node-positive breast cancer who have completed neoadjuvant chemotherapy.
Not a fit: Patients with non-node-positive breast cancer or those who have not undergone neoadjuvant chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better monitoring and management strategies for patients with node-positive breast cancer.
How similar studies have performed: Other studies have explored similar screening approaches in cancer, but this specific methodology in node-positive breast cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Kamran Ahmed — Moffitt Cancer Center
- Study coordinator: Rheese Mcnab
- Email: Rheese.Mcnab@moffitt.org
- Phone: 813-745-1780
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.