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

January 7, 2025 updated by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The population includes women aged 18 or older with stage I-III HER2-positive breast cancer who received trastuzumab ± pertuzumab. Data and tumor tissue samples from this population have been collected prospectively from Istituto Nazionale dei Tumori IRCCS Fondazione Pascale, Naples (cohort A), and from Ospedale "Di Summa-Perrino", Brindisi (cohort B). The study integrates clinical-pathological and genomic data to refine and validate the prognostic capabilities of the S18 classifier.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Brindisi, Italy, 72100
        • Recruiting
        • Ospedale Di Summa-Perrino
        • Contact:
        • Principal Investigator:
          • Laura Orlando, MD
      • Naples, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
        • Contact:
        • Principal Investigator:
          • Roberta Caputo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Operable breast cancer (stage I-III)
  3. Any status of hormone receptor in the primary tumor, according to institutional guidelines
  4. 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)
  5. Neoadjuvant and/or adjuvant therapy based on trastuzumab ± pertuzumab
  6. Written informed consent from patients

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Event-free survival (EFS) and Disease-free survival (DFS) according to the value of S18 and S*
Time Frame: From the initiation of systemic therapy through to at least 3 years post-treatment.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Explorative evaluation of overall survival (OS) according to the value of S18 and S*
Time Frame: From the initiation of therapy through to at least 3 years post-treatment.
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 overall survival (OS).
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*
Time Frame: Assessed in the surgical specimen obtained from definitive surgery performed within up to 10 months of initiating neoadjuvant treatment.
To evaluate the predictive value of the gene expression based classifier in relation to pathological complete response (i.e., absence of breast cancer cells in surgical specimens) following neoadjuvant therapy with chemotherapy plus trastuzumab ± pertuzumab.
Assessed in the surgical specimen obtained from definitive surgery performed within up to 10 months of initiating neoadjuvant treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Ospedale Di Summa-Perrino

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Serena Di Cosimo, MD, PhD, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
  • Study Chair: Paolo Verderio, PhD, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INT 138/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Our best efforts will be made to make IPD available in accordance with privacy, data security, and compliance with legal and ethical standards in place at the time of the study's conclusion. As of now, while the sharing of IPD remains a goal, these factors may occasionally present challenges that will need to be carefully addressed to ensure all necessary protections are in place at the appropriate time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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