fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases (fREEDOM)

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.

Study Overview

• Status: Recruiting
• Conditions: Triple Negative Breast Cancer; HER2-positive Breast Cancer; Invasive Breast Cancer
• Intervention / Treatment: Diagnostic test: Diffusion whole body MRI

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 145
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Monica Iorfida, MD; Phone Number: +390257489970; Email: monica.iorfida@ieo.it

Study Locations

• Italy
  • Milan, Italy, 20141
    • Recruiting
    • European Institute of Oncology
    • Contact: Mara Negri; Phone Number: +390257489536; Email: mara.negri@ieo.it
    • Contact: Monica Iorfida, MD; Phone Number: +390257489970; Email: monica.iorfida@ieo.it
    • Principal Investigator: Monica Iorfida, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DWB-MRI; Surveillance with diffusion whole body MRI	Diagnostic test: Diffusion 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5-year overall survival	Number of alive patients at 5 years (considering deaths from any cause)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival of patients underwent local treatment	Number of patients undergoing local treatment (surgery or other localized technique) who are alive at 5 years (considering deaths from any cause)	5 years
Breast cancer specific survival	Number of alive patients at 5 years (considering only deaths related to breast cancer)	5 years
Safety of local treatment	Number of serious adverse event related to local treatment received	48 months
Anxiety assessment	Collection of Hamilton Anxiety Rating Scale questionnaire (minimum value: 0, maximum value: 4 - higher scores mean a worse outcome)	48 months
Health state assessment	Collection of 12-Item Short Form Survey (SF-12) questionnaire (minimum value: 0, maximum value: 6 - higher scores mean a better outcome)	48 months
Ability to Cope With Trauma assessment	Collection of Perceived Ability to Cope With Trauma (PACT) questionnaire (minimum value: 0, maximum value: 7 - higher scores mean a better outcome)	48 months
Personality assessment	Collection of Big Five Personality Inventory (BFI-10) questionnaire (minimum value: 0, maximum value: 5 - higher scores mean a greater agreement with the statement)	48 months
Acceptability and perception of DWB-MRI	Collection of Acceptance Questionnaire (minimum value: 0, maximum value: 5 - higher scores mean a worse outcome)	48 months

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Monica Iorfida, MD, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2019
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Triple Negative Breast Cancer; HER2-positive Breast Cancer; Invasive Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: IEO 1108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No