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RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study

ConditionsRadiomicRadiomicsBreast Cancer MetastaticBreast Cancer Stage IVBreast CarcinomaBreast NeoplasmsBreast CancerBreast Cancer With Bone MetastasisBreast Cancer With Metastatic Bone DiseaseTrastuzumabHER2HER2 + Breast CancerHER2 Positive Breast CarcinomaHER2-positive Breast CancerHer2/Neu Positive Advanced Solid TumorsHER2/Neu-positive Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

RADIOSPHER2 study is a monocentric, retrospective, observational study aiming at identifying a radiomics signature able to predict HER2 expression (0 vs low vs overexpression) and trastuzumab deruxtecan efficacy in metastatic breast cancer patients. The study also encompasses translational analyses and inter-modal correlations in order to provide novel insights about HER2 spatial and temporal heterogeneity, at the macroscopic and microscopic levels.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with metastatic breast cancer underwent a liver, lung, pleural or bone biopsy in the metastatic setting, performed from 01Jan2005 to 01Jan2024.

Disqualifiers

Not available imaging (CT scan and/or PET-FdG scan) in the three months before the biopsy or before the last previous treatment interruption;

Unknown HER2 status;

Node, soft tissue or other visceral as biopsy site.

Trial population

The population of the study will consists with a cohort of patients with metastatic breast cancer underwent a liver, lung, pleural or bone biopsy in the metastatic setting at the Sponsor Institution with available imaging (CT scan and/or PET-FdG scan), performed from 01Jan2005 to 01Jan2024.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Trastuzumab deruxtecan (DS-8201a)

    Drug

    A subgroup of the study cohort treated with Trastuzumab Deruxtecan in the metastatic setting

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Metastatic breast cancer patients underwent tumor biopsy in a metastatic site1 intervention

Trial outcomes

Primary outcomes

1

HER2 protein expression

To identify a radiomic signature ("radiobiopsy") able to predict the HER2 status on a specific metastasic site of mBC patients based on radiologic images (CT scan, PET-FdG)

Time frame
Time of the metastatic biopsy (through study completion, an average of 1 year)
2

Progression-Free Survival

To test the accuracy of "radiobiopsy" in predicting PFS in a cohort of metastatic breast cancer patients treated with trastuzumab deruxtecan.

Time frame
From treatment start to disease progression or death (through study completion, up to 5 years)

Secondary outcomes

1

HER2 intratumoral heterogeneity

To identify a pathomic-based model able to predict intratumoral HER2 heterogeneity on pathology slides of HER2-positive and HER2-low mBC patients

Time frame
Time of the metastatic biopsy (through study completion, an average of 1 year)
2

HER2 interlesional heterogeneity

To test the concordance between intratumoral and inter-lesional HER2 heterogeneity in HER2-positive and HER2-low mBC patients.

Time frame
Time of the metastatic biopsy (through study completion, an average of 1 year)
3

Radiomics agnostic features

To correlate the features included in the radiomic model with the transcriptomics data obtain from bulk-RNAseq from biopsies, in order to explain agnostic features discovered with radiomics.

Time frame
Time of the imaging next to the metastatic biopsy (through study completion, an average of 1 year)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Lead sponsor

Source ClinicalTrials.gov
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