fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases

Launched by EUROPEAN INSTITUTE OF ONCOLOGY · Mar 21, 2024

Keywords

ClinConnect Summary

The fREEDOM study is looking at a new way to help find breast cancer that comes back after treatment. Researchers want to see if a type of imaging called Diffusion Whole Body-Magnetic Resonance Imaging (DWB-MRI) can catch these recurrences early in patients who are at high risk, specifically those with certain types of invasive breast cancer, like HER2-positive or triple-negative breast cancer. The main goal is to find out if using DWB-MRI can improve survival rates over five years for these patients by allowing for quicker and potentially more effective treatments.

To be part of this study, participants need to be women or men aged 18 to 75 who have been diagnosed with stage II or III breast cancer that is either HER2-positive or triple-negative. They should not have any signs of cancer spreading to other parts of the body at the time of the study. Participants will undergo regular DWB-MRI scans and will be monitored for their health over the next few years. It’s important for those interested to discuss their eligibility with their doctor, as there are certain health conditions and previous cancer treatments that could exclude someone from joining the trial.

Gender

ALL

Eligibility 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