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

Phase 2

Recruiting

• Conditions: Breast Cancer; Node-positive Breast Cancer

• Registration Number: NCT06833502
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-13
• Study First Posted: 2025-02-18
• Study Start: 2025-02-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Metastasis Treatment	Up to 12 months	Number of patients receiving surgery, radiation therapy, and/or systemic therapy to manage metastases.
Metastasis Frequency	Up to 12 months	Proportion of participants with metastasis up to 12 months from baseline CT.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States