NCT06833502

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
4mo left

Started Feb 2025

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Feb 2025Oct 2026

First Submitted

Initial submission to the registry

February 13, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

February 24, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

February 13, 2025

Last Update Submit

March 31, 2026

Conditions

Breast CancerNode-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Systemic Metastasis

    Proportion of participants with systemic metastasis at baseline and 6 months.

    Baseline and 6 months

Secondary Outcomes (2)

  • Metastasis Treatment

    Up to 12 months

  • Metastasis Frequency

    Up to 12 months

Study Arms (3)

Triple negative

OTHER

Participants diagnosed with triple negative breast cancer.

Other: CT Scan

HER2+

OTHER

Participants diagnosed with HER2+ breast cancer.

Other: CT Scan

Hormone receptor (HR)+

OTHER

Participants diagnosed with hormone receptor (HR)+ breast cancer.

Other: CT Scan

Interventions

CT ScanOTHER

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.

HER2+Hormone receptor (HR)+Triple negative

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kamran Ahmed

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

  • Matthew Mills

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rheese Mcnab

CONTACT

813-745-1780Rheese.Mcnab@moffitt.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 18, 2025

Study Start

February 24, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations

US(1)