Recruiting
Phase 2

Observational Study

Sponsor:

H. Lee Moffitt Cancer Center and Research Institute

Code:

NCT06833502

Conditions

Breast Cancer

Node-positive Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CT Scan

Study Details

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.

Conditions

Breast Cancer

Node-positive Breast Cancer

Study ID

NCT06833502

Start date

Feb 24, 2025

Status verified date

Jun, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Triple negative

Participants diagnosed with triple negative breast cancer.

other: HER2+

Participants diagnosed with HER2+ breast cancer.

other: Hormone receptor (HR)+

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

Interventions

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.

Primary outcome measure

  • Systemic Metastasis [ Time Frame: Baseline and 6 months ]

Central Contacts and Locations

Central contacts

Marian Hernandez

813-745-1807marian.hernandez@moffitt.org

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Principal Investigator:

Kamran Ahmed, MD

More Information

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute on 2026-07-02.