Short summary

The MONITOR-RCT study will be an international multicenter study. The design will be a parallel group comparative randomized trial comparing an experimental monitoring strategy based on FDG-PET/CT with a standard monitoring strategy based on CT. To ensure a smooth conduct of a planned RCT, we intend to perform a feasibility study (MONITOR-PILOT) checking the adequateness of all processes.

Rationale

The primary objective is to demonstrate that in patients with MBC, response monitoring based on FDG-PET/CT is superior to response monitoring based on CT with respect to overall survival. Secondary objectives of the MONITOR-RCT will be quality of life, time and exposure to treatment, and cost-effectiveness. The objective of MONITOR-PILOT is to determine the feasibility of the processes to be implemented in MONITOR-RCT and inform the final selection of patient-reported outcome measures (PROMs).

Description of the cohort

Criteria for inclusion will be patients aged ≥18 years, diagnosed with distant relapsed MBC (biopsy-verified) or de novo breast cancer (biopsy verification of primary tumor and disseminated disease at baseline scan), and considered eligible for first-line systemic treatment and subsequent response monitoring.

Data and biological material

Response monitoring based on FDG-PET/CT (intervention) will be compared with response monitoring based on CT (standard). The assessment of treatment response will be performed using standard response evaluation criteria for both modalities (RECIST 1.1 in the CT group and PERCIST-MBC in the FDG-PET/CT group). Patients will receive standard medical breast cancer-directed treatments as part of their daily clinical routine. These medical treatments are not the treatments under study and do not influence the conduct of the study. Quality of life will be measured by the following instruments: EORTC-QLQ-C30, EORTC QLQ-BR23, EORTC QLQBR45, FACT-B, and EQ-5D-5L in the MONITOR-PILOT study to evaluate the most optimal instruments to be used in the MONITOR-RCT. It will be measured at baseline, every three months during the first year ,and every six months later.

Collaborating researchers and departments

Department of Oncology, Odense University Hospital

• Marianne Vogsen

Department of Nuclear Medicine, Vejle Hospital

• Paw Christian Holdgaard

Department of Radiology and Nuclear Medicine, Esbjerg Hospital

• Mie Holm Vilstrup