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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06833502

Enrollment

120

Registered

2025-02-18

Start date

2025-02-24

Completion date

2026-10-01

Last updated

2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Node-positive Breast Cancer

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.

Interventions

OTHERCT 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Systemic Metastasis	Baseline and 6 months	Proportion of participants with systemic metastasis at baseline and 6 months.

Secondary

Measure	Time frame	Description
Metastasis Treatment	Up to 12 months	Number of patients receiving surgery, radiation therapy, and/or systemic therapy to manage metastases.
Metastasis Frequency	Up to 12 months	Proportion of participants with metastasis up to 12 months from baseline CT.

Countries

United States

Contacts

CONTACTMarian Hernandez

marian.hernandez@moffitt.org813-745-1807

PRINCIPAL_INVESTIGATORKamran Ahmed

Moffitt Cancer Center

PRINCIPAL_INVESTIGATORMatthew Mills