Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06833502

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

Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-01

120

Participants Needed

1

Research Sites

83 weeks

Total Duration

On this page

Sponsors

H

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

F

Florida Breast Cancer Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
  • Node positive HER2+ and triple negative breast cancer following neoadjuvant chemotherapy
  • HR+/HER2- patients with ypN2 or ypN3 disease after neoadjuvant chemotherapy and surgery
  • Completed minimum 8 weeks of standard neoadjuvant chemotherapy including anthracycline and/or taxane-based regimen
  • Age 18 years or older
  • Life expectancy of at least 6 months
  • Eastern Cooperative Oncology Group performance status 0 to 2
  • Ability and willingness to understand and sign informed consent
  • Willingness to comply with study procedures and availability for study duration
Not Eligible

You will not qualify if you...

  • Prior diagnosis of systemic metastases
  • History of non-breast cancer malignancies unless no evidence of disease for 2 years (excluding certain skin, cervical, or bladder cancers)
  • Contraindications to CT IV contrast
  • Chronic kidney disease stage IV or V or end stage renal disease with creatinine clearance less than 30 ml/min

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

Loading map...

Research Team

R

Rheese Mcnab

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here