Invasive Breast CancerHER2-positive Breast CancerTriple Negative Breast Cancer
Investigational drug(s) / intervention(s)
Diffusion whole body MRI
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.
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
5-year overall survival — 5 years Number of alive patients at 5 years (considering deaths from any cause)
Trial sites (1)
Facility
City
Region
Status
European Institute of Oncology
Milan
Italy
Recruiting
More European Institute of Oncology trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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