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

NCT07030569 | Recruiting FDA Drug

• 1 other identifier: INT34/24
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiomic; Radiomics; Breast Cancer Metastatic; Breast Cancer Stage IV; Breast Carcinoma; Breast Neoplasms; Breast Cancer; Breast Cancer With Bone Metastasis; Breast Cancer With Metastatic Bone Disease; Trastuzumab; HER2; HER2 + Breast Cancer; HER2 Positive Breast Carcinoma; HER2-positive Breast Cancer; Her2/Neu Positive Advanced Solid Tumors; HER2/Neu-positive Breast Cancer

Keywords

Radiomics; HER2 expression; Trastuzumab Deruxtecan; Pathomics; HER2 heterogeneity

Outcome Measures

Primary Outcomes (2)

• 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 of the metastatic biopsy (through study completion, an average of 1 year)

• Progression-Free Survival

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

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

Secondary Outcomes (3)

• HER2 intratumoral heterogeneity

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

• HER2 interlesional heterogeneity

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

• Radiomics agnostic features

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

Study Arms (1)

Metastatic breast cancer patients underwent tumor biopsy in a metastatic site

A cohort of patients with metastatic breast cancer underwent a liver, lung, pleural or bone biopsy in the metastatic setting at INT with available imaging (CT scan and/or PET-FdG scan), performed from 01Jan2005 to 01Jan2024. A subgroup of this cohort is treated with Trastuzumab Deruxtecan.

Drug: Trastuzumab deruxtecan (DS-8201a)

Interventions

Trastuzumab deruxtecan (DS-8201a) DRUG

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

Metastatic breast cancer patients underwent tumor biopsy in a metastatic site

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Study Sites (1)

Fondazione IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Archival Formalin-Fixed Paraffin-Embedded tumor blocks for transciptomic analysis

MeSH Terms

Conditions

Breast Neoplasms

Interventions

trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Claudio Vernieri, MD, PhD

CONTACT

+390223903066; claudio.vernieri@istitutotumori.mi.it

Leonardo Provenzano, MD

CONTACT

+390223903066; leonardo.provenzano@istitutotumori.mi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: June 22, 2025
• Study Start: February 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 22, 2025

Record last verified: 2025-01

Locations

IT (1)