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

European Institute of Oncology

Status

Active, not recruiting

Conditions

Metastatic Breast Cancer

Treatments

Other: WB-MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT06321666

IEO 0986

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.