RecruitingNot ApplicableNCT06328465

fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases

Sponsor

European Institute of Oncology

Enrollment

145 participants

Start Date

Nov 22, 2019

Study Type

INTERVENTIONAL

Conditions

Invasive Breast Cancer HER2-positive Breast Cancer

Summary

The aim of this study is to understand whether DWB-MRI (Diffusion Whole Body-Magnetic Resonance Imaging) is useful for early detection of locoregional or distant recurrence and whether early diagnosis influences the prognosis in high-risk populations thanks to the possibility of being able to use a more effective treatment. The primary objective is to evaluate 5-year overall survival (OS) in patients with Human Epidermal Growth Factor Receptor 2 positive (HER2+) or high-risk Triple Negative (TN) undergoing surveillance with DWB-MRI.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study (fREEDOM) tests whether whole-body MRI scans done at regular intervals after breast cancer surgery can detect early signs of the cancer spreading (metastases) before symptoms appear. Early detection of metastases — when there may be more treatment options — could improve outcomes for high-risk breast cancer patients. **You may be eligible if...** - You are pre- or post-menopausal - You have had surgery for stage II or III HER2-positive or triple-negative breast cancer - You had residual cancer remaining after pre-surgery chemotherapy (neoadjuvant treatment) - You have no evidence of distant spread at the time of surgery - You are in excellent health (ECOG performance status 0) - You can attend follow-up visits **You may NOT be eligible if...** - You have any absolute contraindication to MRI (e.g., pacemaker, certain implants) - You have relevant other health conditions - You already have known distant metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTDiffusion whole body MRI

Diffusion whole body MRI protocol, consisting of sagittal T1-weighted and T2-weighted sequences on the whole spine, axial T1 weighted, T2-weighted and diffusion-weighted images from head to mid-thigh, performed on a 1.5 T scanner.