fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases — fREEDOM  

Triple Negative Breast Cancer Clinical Trial

Official title: fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Breast cancer is the second most common cancer in the world and the most common cancer among women. In these patients, it is not the primary tumor, but its distant metastases that are the main cause of death. Follow-up may vary depending on the hospital or doctor, but the data available in the literature do not show an advantage in terms of survival or quality of life in patients subjected to intensive follow-up. However, the information that physicians have comes from past studies limited by the presence of bias regarding patient characteristics, therapies, follow-up intervals and tests used. In light of the better understanding of biology, breast cancer is no longer considered a single disease, but it is classified into at least four different molecular subtypes, based on the immunohistochemical classification: Luminal A-like, Luminal B-like, HER2 positive and Triple Negative. Nowadays it is known that not only the stage of diagnosis, but also the biology of the disease influences the risk of recurrence and death. Furthermore, a growing number of trials show that different biological subtypes differ in terms of time to relapse and disease pattern of metastatic spread (in particular, site of first relapse). These observations lead to the hypothesis that different types and different frequencies of follow-up strategies should vary depending on the biology of breast cancer. Furthermore, with improved management and the availability of new effective treatments, patients with oligometastatic disease treated with an aggressive multidisciplinary approach may be amenable to curative treatment. Based on this hypothesis, an early diagnosis of metastatic disease could lead to the identification of patients with low disease burden who can still be treated with curative intent. DWB-MRI is emerging as a promising tool for the detection and therapy monitoring of metastases in different tumor types and could be an important tool for the early detection of breast cancer metastases. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer
• Invasive Breast Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

• NCT number: NCT06328465
• Study type: Interventional
• Source: European Institute of Oncology
• Contact: Monica Iorfida, MD
• Phone: +390257489970
• Email: monica.iorfida@ieo.it
• Status: Recruiting
• Phase: N/A
• Start date: November 22, 2019
• Completion date: December 31, 2028