A Composite Assay for HER2-positive Early-stage Breast Cancer Management

NCT06762977 | Recruiting

• 1 other identifier: INT 138/24
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this observational study is to assess the prognostic value of a genomic classifier (S18) and its refined version (S\*) in women with early-stage HER2-positive breast cancer. The study aims to determine whether these tools can predict event-free (EFS) and disease-free survival (DFS) in patients treated with neoadjuvant and/or adjuvant trastuzumab-based therapies.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3); HER2

Keywords

HER2-positive; operable breast cancer; gene-expression based classifier; prognosis

Outcome Measures

Primary Outcomes (1)

• Event-free survival (EFS) and Disease-free survival (DFS) according to the value of S18 and S*

  To assess the prognostic value of the gene expression based classifier, with or without the integration of clinical-pathological variables, in patients receiving neoadjuvant and/or adjuvant chemotherapy with trastuzumab ± pertuzumab, with respect to event-free survival (EFS) and disease-free survival (DFS).

  From the initiation of systemic therapy through to at least 3 years post-treatment.

Secondary Outcomes (2)

• Explorative evaluation of overall survival (OS) according to the value of S18 and S*

  From the initiation of therapy through to at least 3 years post-treatment.

• Evaluation of pathological complete response (pCR) according to the value of S18 and S*

  Assessed in the surgical specimen obtained from definitive surgery performed within up to 10 months of initiating neoadjuvant treatment.

Eligibility Criteria

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

Study Population

Clinical information and paraffin-embedded tumor tissue samples from HER2-positive operable breast cancer patients included in the study were prospectively and consecutively collected at the participating centers and are now being analyzed for the purpose of the protocol.

You may qualify if:

• Age ≥ 18 years
• Operable breast cancer (stage I-III)
• Any status of hormone receptor in the primary tumor, according to institutional guidelines
• HER2-positive primary tumor, according to ASCO guidelines, i.e., HER2-positive phenotype by immunohistochemistry (IHC) 3+ or 2+ with a positive result for ERBB2 gene amplification analysis using ISH techniques (CISH, SISH, FISH)
• Neoadjuvant and/or adjuvant therapy based on trastuzumab ± pertuzumab
• Written informed consent from patients

You may not qualify if:

• Patient in follow-up for less than 3 years after surgery
• A prior diagnosis of invasive cancer before the diagnosis of breast cancer

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale: collaborator
• Ospedale Di Summa-Perrino: collaborator

Study Sites (2)

Ospedale Di Summa-Perrino

Brindisi, 72100, Italy

RECRUITING

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Naples, 80131, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor tissue RNA

Study Officials

• Serena Di Cosimo, MD, PhD

  Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

  PRINCIPAL INVESTIGATOR

• Paolo Verderio, PhD

  Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

  STUDY CHAIR

Central Study Contacts

Serena Di Cosimo, MD, PhD

CONTACT

+39 02 2390 2700; serena.dicosimo@istitutotumori.mi.it

Paolo Verderio, PhD

CONTACT

+39 02 2390 3201; paolo.verderio@istitutotumori.mi.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 8, 2025
• Study Start: November 13, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

IT (2)