RecruitingInterventionalPhase 2

Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer Following Neoadjuvant Chemotherapy and Surgery

NCT ID: NCT06833502Sponsor: H. Lee Moffitt Cancer Center and Research InstituteLast updated: 2026-04-01

Summary

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.

Arms & interventions

OtherCT 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.

Outcome measures

Primary

Systemic Metastasis
Proportion of participants with systemic metastasis at baseline and 6 months.
Time frame: Baseline and 6 months

Secondary

Metastasis Treatment
Time frame: Up to 12 months
Metastasis Frequency
Time frame: Up to 12 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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).

Study locations (1)

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

Kamran Ahmed, MD · Principal Investigator

Matthew Mills, MD · Principal Investigator

Avan Armaghani, MD · Sub Investigator

Ricardo Costa, MD · Sub Investigator

Roberto Diaz, MD, PhD · Sub Investigator

Loretta Loftus, MD · Sub Investigator

Tracey O'Connor, MD · Sub Investigator

Hatem Soliman, MD · Sub Investigator

Aixa Soyano Muller, MD · Sub Investigator

Iman Washington, MD · Sub Investigator