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

NCT ID: NCT06321666

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-12
• Study Completion Date: 2024-12-31

Brief 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.

Detailed 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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

WB-MRI and CT Scan

CT scan (neck/thorax/abdomen/pelvis) and WB-MRI

Group Type: OTHER

WB-MRI

Intervention Type: OTHER

All patients will undergo a CT scan (neck/thorax/abdomen/pelvis) and a WB-MRI

Interventions

WB-MRI

All patients will undergo a CT scan (neck/thorax/abdomen/pelvis) and a WB-MRI

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Petralia, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

IEO Istituto Europeo di Oncologia

Milan, , Italy

Countries

Italy

Other Identifiers

IEO 0986

Identifier Type: -

Identifier Source: org_study_id