RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-01
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06833502

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status.
  2. * 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-.
  3. * 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.
  4. * 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.
  5. * Age ≥ 18.
  6. * Life expectancy ≥ 6 months.
  7. * Eastern Cooperative Oncology Group performance status 0 to 2.
  8. * Patients must be able to understand and the willingness to sign an informed consent for study procedures.
  9. * Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.
  1. * Prior diagnosis of systemic metastases.
  2. * 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.
  3. * Contraindication towards CT IV contrast.
  4. * Chronic kidney disease stage IV or V or end stage renal disease (CrCl \<30 ml/min).

Contacts and Locations

Study Contact

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

Principal Investigator

Kamran Ahmed
PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Matthew Mills
PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

  • Kamran Ahmed, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center
  • Matthew Mills, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01
Study Completion Date2026-08

Study Record Updates

Study Start Date2025-03-01
Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer
  • Node-positive Breast Cancer