Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone — RESPECT-MI  

Metastatic Breast Cancer Clinical Trial

Official title: Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study MILANO : RESPECT-MI

Status Active, not recruiting

Clinical Trial Summary

This is a non randomized, single arm study, where each patient will undergo imaging with Computed Tomography (CT) and Whole-body magnetic resonance imaging (WB-MRI) at different timepoint. The primary endpoint is time to progression as documented by CT or WB-MRI.

Clinical Trial Description

This is a monocentric study. All patients will undergo assessments by CT and WB-MRI at all time points.

• A baseline bone scan or Fluorodeoxyglucose-Position Emission Tomography (FDG-PET) will be performed.

• CT scans and WB--MRI are performed every 12 weeks until week 96, and then every 24 weeks until disease progression is evident (as defined in section 7.1.3).

• At the point of disease progression, a repeat bone scan or FDG-PET/CT will be obtained in addition to the CT and WB-MRI. Participation in the trials ends at the point of disease progression.

Patients will be reviewed in outpatient clinic:

• At baseline

• Every 12 weeks until week 96, with the results of their recent scans.

• As with the imaging, the trial visits will change to every 24 weeks after the week 96 visit.

At the week 12 and week 36 visits, the patients will undergo a clinical examination and perform a pain thermometer score and Patient Imaging Questionnaire. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

• NCT number: NCT06321666
• Study type: Interventional
• Source: European Institute of Oncology
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 12, 2019
• Completion date: December 31, 2024