Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone

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

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.

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.

Inclusion Criteria:

• Histological diagnosis of breast cancer
• Single or multiple bone metastases (additional extraosseous or non-bony metastatic disease permitted)
• Due to start a new line of either hormone therapy or chemotherapy (use of bisphosphonates / denosumab or targeted agents e.g. trastuzumab in addition to hormone therapy / chemotherapy permitted)
• Aged 18 and over
• Life expectancy of over 6 months
• No current active malignancy other than breast cancer

Exclusion Criteria:

• Radical treatment to sole site of metastatic disease e.g. Cyberknife to solitary bone metastasis
• Absolute contraindication to MRI studies, CT scans, bone scans or FDG-PET/CT
• Pregnancy
• Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions should be discussed with the patient as part of the informed consent process.