This clinical trial evaluates computed tomography (CT) as a screening tool for detecting disease that has spread from where it first started to other distant parts of the body (systemic metastases) after treatment in patients with breast cancer that has spread to the lymph nodes (node positive disease). A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Early detection of metastatic disease via CT may offer opportunities for definitive management and early intervention to avoid more advanced disease presentation.
Additional locations may be listed on ClinicalTrials.gov for NCT06833502.
Locations matching your search criteria
United States
Florida
Clearwater
Morton Plant HospitalStatus: Active
Contact: Ronica Hazariwala Nanda
Tampa
Moffitt Cancer CenterStatus: Active
Contact: Kamran Ahmed
Phone: 813-745-3320
PRIMARY OBJECTIVE:
I. To determine the frequency of asymptomatic systemic metastasis in high-risk node positive breast cancer following neoadjuvant chemotherapy and surgery by subtype.
SECONDARY OBJECTIVES:
I. Determine the presentation and treatment characteristics of asymptomatic systemic metastases in metastatic breast cancer by subtype following definitive neoadjuvant chemotherapy and surgery by subtype.
II. To determine progression free survival in asymptomatic systemic metastases in metastatic breast cancer by subtype following treatment.
III. Assess outcomes of locoregional radiation therapy and to sites of oligometastases (1-5 sites) as appropriate using criteria from NRG-BR002.
IV. Determine number of patients with metastases detected by standard of care imaging completed 12 months from baseline CT.
V. Assess quality of life from CT screening.
VI. Assess downstream procedures performed as a result of CT screening.
VII. To quantify circulating tumor-derived deoxyribonucleic acid (ctDNA) and blood biomarkers in high-risk node positive breast cancer following neoadjuvant chemotherapy and surgery and its association to metastatic disease.
OUTLINE:
Patients undergo a CT scan within 1 week of registration on the study (baseline). Patients whose baseline CT scan is negative for systemic metastases undergo a second CT scan 6 months later. Patients also undergo collection of blood samples at screening and on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorKamran Ahmed
