Breast Cancer Early Stage Breast Cancer (Stage 1-3)HERCardNCT06762977
A Composite Assay for HER2-positive Early-stage Breast Cancer Management
An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3) and HER2, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), HER2
- How many people
- 180 participants
- Where
- 2 sitesItaly
- Study dates
- 13 Nov 2024to Aug 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patient in follow-up for less than 3 years after surgery
- A prior diagnosis of invasive cancer before the diagnosis of breast cancer
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Ospedale Di Summa-Perrino
Brindisi, 72100
Saverio Cinieri, MD, +39 0831537217, saverio.cinieri@gmail.com
Laura Orlando, MD
- Recruiting
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Naples, 80131
Michelino De Laurentiis, MD, +39 081 7461111 ext. +39 081590369, m.delaurentiis@istitutotumori.na.it
Roberta Caputo, MD
About this study
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.
Read the 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.
- Keywords
- HER2-positive, operable breast cancer, gene-expression based classifier, prognosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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*
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).
Measured: 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*
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.
Measured: Assessed in the surgical specimen obtained from definitive surgery performed within up to 10 months of initiating neoadjuvant treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start13 Nov 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 180 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Ospedale Di Summa-Perrino
- Responsible party
- Sponsor
- Investigators
- Serena Di Cosimo, MD, PhD, Principal investigator, Fondazione IRCCS Istituto Nazionale dei Tumori di MilanoPaolo Verderio, PhD, Study chair, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762977
- Sponsor's protocol ID
- INT 138/24
- Acronym
- HERCard
- Status last verified
- Jan 2025
- First submitted
- 20 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Composite Assay for HER2-positive Early-stage Breast Cancer Management
- ClinicalTrials.gov ID
- NCT06762977
- Acronym / sponsor ID
- HERCard / INT 138/24
- Keywords
- HER2-positive, operable breast cancer, gene-expression based classifier, prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoUniversity, hospital or other
- Collaborators
- Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale, Ospedale Di Summa-Perrino
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patient in follow-up for less than 3 years after surgery
- A prior diagnosis of invasive cancer before the diagnosis of breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Serena Di Cosimo, MD, PhD principal investigator
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Paolo Verderio, PhD study chair
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3) and HER2, run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serena Di Cosimo, MD, PhD (+39 02 2390 2700, serena.dicosimo@istitutotumori.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.