Using MRI to detect early breast cancer metastases
fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases
This study is testing if a special type of MRI can help find early signs of breast cancer returning in high-risk patients to see if it can improve their chances of living longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 145 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06328465 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Diffusion Whole Body-Magnetic Resonance Imaging (DWB-MRI) in the early detection of locoregional or distant recurrence of breast cancer in high-risk patients. It focuses on individuals with HER2-positive or high-risk Triple Negative breast cancer, assessing whether early diagnosis can improve overall survival rates. The study will monitor patients over five years to determine the impact of DWB-MRI on treatment outcomes compared to traditional follow-up methods.
Who should consider this trial
Good fit: Ideal candidates include pre or post-menopausal women with histologically confirmed invasive breast cancer stage II-III who are HER2-positive or have high-risk Triple Negative breast cancer.
Not a fit: Patients with absolute contraindications to MRI or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of breast cancer metastases, potentially improving survival rates for high-risk patients.
How similar studies have performed: While there is ongoing research in imaging techniques for breast cancer, this specific approach using DWB-MRI for early detection in this patient population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pre or post-menopausal patient with histologically confirmed invasive breast cancer stage II - III HER2 + or TN operated breast carcinoma or patients underwent neoadjuvant treatment (included cT4d) with residual disease at definitive surgery * No evidence of distant metastases at baseline perioperative radiological staging (DWB-MRI, total body Computed Tomography (CT) or Positron Emission Tomography (PET/CT) must be performed +/- 1 month from surgery) * No relevant comorbidities * Eastern Cooperative Oncology Group (ECOG) performance status 0 * Geographically accessible for follow up * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Absolute contraindications that exclude the execution of the MRI investigation, regardless of the clinical indication * Relative contraindications that include situations in which the innocuousness of the examination is not documented with certainty that therefore do not recommend the execution, except for serious indications related to the patient's clinical need * Older age (\>75 years) * Previous or concomitant other malignancy except basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix * Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
Where this trial is running
Milan
- European Institute of Oncology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Monica Iorfida, MD — European Institute of Oncology
- Study coordinator: Monica Iorfida, MD
- Email: monica.iorfida@ieo.it
- Phone: +390257489970
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.