NCT02261389

Follow-up of Early Breast Cancer by Dynamic Evaluation of CEA and CA 15.3 Followed by 18FDG-PET

Three-monthly Dynamic Evaluation of CEA and CA 15.3 vs Usual Practice in the Follow-up of Early Breast Cancer Patients: a Randomized Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,507 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of follow-up in asymptomatic breast cancer patients during and after adjuvant treatment is to detect breast cancer recurrence and metastatic disease.The aim of this trial is to verify if, in asymptomatic patients, the serial measurement of serum CEA and CA 15.3, with diagnostic imaging procedures (18FDG-PET) performed only in case of a critical increase of serum CEA and CA 15.3 level, can anticipate the diagnosis of breast cancer local and distant recurrence compared to the usual follow-up practice.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Arm B, tumor markers assessment	Tumor markers assessment every three months through the study or until disease recurrence

Timeline

• Start date: 2014-09-01
• Primary completion: 2026-11-01
• Completion: 2030-12-01
• First posted: 2014-10-10
• Last updated: 2022-12-29

Locations

7 sites across 1 country: Italy