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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Node-positive Breast Cancer
• Intervention / Treatment: Other: CT Scan

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Marian Hernandez; Phone Number: 813-745-1807; Email: marian.hernandez@moffitt.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Sub-Investigator: Roberto Diaz, MD, PhD
      • Sub-Investigator: Iman Washington, MD
      • Principal Investigator: Kamran Ahmed, MD
      • Sub-Investigator: Hatem Soliman, MD
      • Sub-Investigator: Avan Armaghani, MD
      • Sub-Investigator: Aixa Soyano Muller, MD
      • Sub-Investigator: Ricardo Costa, MD
      • Sub-Investigator: Tracey O'Connor, MD
      • Principal Investigator: Matthew Mills, MD
      • Sub-Investigator: Loretta Loftus, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Triple negative; Participants diagnosed with triple negative breast cancer.	Other: CT 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.
Other: HER2+; Participants diagnosed with HER2+ breast cancer.	Other: CT 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.
Other: Hormone receptor (HR)+; Participants diagnosed with hormone receptor (HR)+ breast cancer.	Other: CT 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic Metastasis	Proportion of participants with systemic metastasis at baseline and 6 months.	Baseline and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Florida Breast Cancer Foundation
• Investigators: Principal Investigator: Kamran Ahmed, Moffitt Cancer Center; Principal Investigator: Matthew Mills, Moffitt Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 30, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: MCC-23433

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No