Clinical trial NCT06833502: Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer
Official title: Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer Following Neoadjuvant Chemotherapy and Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Node-positive Breast Cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Florida Breast Cancer Foundation
First posted: 2025-02-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Systemic Metastasis
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Metastasis Treatment
timeFrame: Up to 12 months
measure: Metastasis Frequency
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Kamran Ahmed
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Matthew Mills
role: PRINCIPAL_INVESTIGATOR
References: