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NCT Number: NCT06833502

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

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.

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Node-positive Breast Cancer Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location status: Recruiting

Location contact

Aixa Soyano Muller, MD

SUB_INVESTIGATOR

Avan Armaghani, MD

SUB_INVESTIGATOR

Hatem Soliman, MD

SUB_INVESTIGATOR

Iman Washington, MD

SUB_INVESTIGATOR

Kamran Ahmed, MD

PRINCIPAL_INVESTIGATOR

Loretta Loftus, MD

SUB_INVESTIGATOR

Matthew Mills, MD

PRINCIPAL_INVESTIGATOR

Ricardo Costa, MD

SUB_INVESTIGATOR

Roberto Diaz, MD, PhD

SUB_INVESTIGATOR

Tracey O'Connor, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CT scan

Other

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 outcomes

  1. Systemic Metastasis

    Time frame: Baseline and 6 months

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

Secondary outcomes

  1. Metastasis Treatment

    Time frame: Up to 12 months

    Number of patients receiving surgery, radiation therapy, and/or systemic therapy to manage metastases.

  2. Metastasis Frequency

    Time frame: Up to 12 months

    Proportion of participants with metastasis up to 12 months from baseline CT.

Study contacts

Contact information is provided by the study sponsor or research team.

Marian Hernandez

CONTACT

[email protected]

813-745-1807

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • Florida Breast Cancer Foundation

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 18, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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