NCT06328465

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Nov 2019Dec 2028

Study Start

First participant enrolled

November 22, 2019

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

9.1 years

First QC Date

March 13, 2024

Last Update Submit

January 2, 2026

Conditions

Invasive Breast CancerHER2-positive Breast CancerTriple Negative Breast Cancer

Keywords

Invasive Breast CancerHER2-positive Breast CancerTriple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 5-year overall survival

    Number of alive patients at 5 years (considering deaths from any cause)

    5 years

Secondary Outcomes (8)

  • Overall survival of patients underwent local treatment

    5 years

  • Breast cancer specific survival

    5 years

  • Safety of local treatment

    48 months

  • Anxiety assessment

    48 months

  • Health state assessment

    48 months

  • +3 more secondary outcomes

Study Arms (1)

DWB-MRI

EXPERIMENTAL

Surveillance with diffusion whole body MRI

Diagnostic Test: Diffusion whole body MRI

Interventions

Diffusion whole body MRIDIAGNOSTIC_TEST

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.

DWB-MRI

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Monica Iorfida, MD

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Monica Iorfida, MD

CONTACT

+390257489970monica.iorfida@ieo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 25, 2024

Study Start

November 22, 2019

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

January 6, 2026

Record last verified: 2026-01

Locations

IT(1)