"Observational, Retrospective and Prospective, Non-interventional, Multicentre on the Use of Genomic Testing in the Management of Early Stage HR+/HER2- Breast Cancer" (GIM29-GIMOMIC)

March 11, 2025 updated by: Consorzio Oncotech

"Observational, Retrospective and Prospective, Non-interventional, Multicentre National Registry-based Study to Collect Information on the Use of Genomic Testing in the Management of Early Stage HR+/HER2- Breast Cancer"

The study aims to establish an Italian registry for the implementation of the use of genomic tests in patients with HR +/HER2- breast cancer at intermediate risk of recurrence after the entry into force of the Ministerial Decree of 18/05/2021. The decree has established the reimbursability of genomic testing for breast cancer patients, thereby influencing clinical decision-making and patient management within Breast Units. In addition, the study aims to evaluate the clinical impact of the use of genomic testing on the type of adjuvant treatment, in terms of change of treatment indication by breast units according to the test result.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The study is a retrospective and prospective, non-interventional, observational registry-based study that will enroll all patients with ER +/HER2-negative, T1-3 breast cancer with negative axillary lymph nodes or up to 3 positive axillary lymph nodes for whom Breast Units require genomic test to support adjuvant therapy decisions, according to current clinical practice. For prospective cohort: genomic tests will be performed on all patients who meet the criteria for access to testing as set out in the Ministerial Decree of 18/05/2021, unless otherwise agreed by the reference Breast Unit, in accordance with the specific diagnostic pathways activated by each site. For retrospective cohort: data for patient referred for genomic testing following Ministerial Decree 18/05/2021 will be collected. The patient's baseline demographic characteristics, tumor clinicopathological features, pre and post-test therapeutic indication (CET vs ET), the test results, the actual adjuvant treatment received and time around data will be recorded in a dedicated registry.

Study Type

Observational

Enrollment (Estimated)

1000

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 Backup

Study Locations

  • Italy
    • AV
      • Avellino, AV, Italy, 83100
        • A.O. San Giuseppe Moscati
        • Contact:
    • BG
      • Bergamo, BG, Italy, 24127
        • Ospedale Papa Giovanni Xxiii
        • Contact:
    • BO
      • Bologna, BO, Italy, 40138
    • BS
    • CB
    • CE
      • Caserta, CE, Italy, 81100
        • Azienda Ospedaliera" Sant'Anna e San Sebastiano"
        • Contact:
    • CN
      • Cuneo, CN, Italy, 12100
        • Azienda Ospedaliera S. Croce e Carle
        • Contact:
    • FE
      • Ferrara, FE, Italy, 44124
        • Azienda Ospedaliero-Universitaria Arcispedale S. Anna
        • Contact:
    • FI
      • Firenze, FI, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
        • Contact:
    • GE
      • Genova, GE, Italy, 16132
        • IRCCS Ospedale Policlinico San Martino
        • Contact:
    • MI
      • Milano, MI, Italy, 20132
        • IRCCS Ospedale San Raffaele
        • Contact:
      • Milano, MI, Italy, 20141
      • Rozzano, MI, Italy, 20089
    • PD
      • Aviano, PD, Italy, 33081
        • IRCCS Centro di Riferimento Oncologico (C.R.O.)
        • Contact:
    • PO
    • RE
      • Reggio Emilia, RE, Italy, 42123
        • Azienda USL IRCCS di Reggio Emilia
    • RM
      • Roma, RM, Italy, 00144
        • Istituto Nazionale Tumori Regina Elena
        • Contact:
    • RN
      • Rimini, RN, Italy, 47923
    • VI
      • Vicenza, VI, Italy, 36100

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study is a retrospective and prospective, non-interventional, observational registry-based study that will enroll all patients with ER +/HER2-negative, T1-3 breast cancer with negative axillary lymph nodes or up to 3 positive axillary lymph nodes for whom Breast Units require genomic test to support adjuvant therapy decisions, according to current clinical practice.

Description

Inclusion Criteria:

  1. . Age ≥ 18 years
  2. PS ECOG 0-1
  3. Histologically confirmed early breast carcinoma with positivity for hormone receptors (ER+ IHC >10%) and HER2 negative (IHC value 0 1+ and/or FISH not-amplified)

  4. Primary resective surgery for early breast cancer with adequate assessment of lymph node status (sentinel lymph node biopsy or complete axillary dissection), with one of the following diagnostic stages:

    • T1-3, N0, M0
    • T1-3, pN1mic, M0
    • T1-3, pN1a, M0
  5. Indication for adjuvant treatment with endocrine therapy (ET) or chemo endocrine therapy (CET), according to the decision of the reference Breast Unit

  6. Meeting the criteria for "intermediate" risk, i.e., no "low" or "high" risk of recurrence, as defined in the ministerial decree of 18/05/21:

    • Low risk defined by at least 5 of the following: G1, T1a-b, KI67 < 15, N neg, ER > 80%
    • High risk, defined by at least 4 of the following: G3, T > 2, Ki67 > 30, N pos, ER < 30%
  7. Indication for genomic test (Oncotype DX®, Mammaprint®, PAM50 Prosigna®, Breast Cancer Index®, EndoPredict®) by the Breast Unit
  8. Ability to provide written informed consent to participate in the registry study, approved by the local Ethics Committee.
  9. The patient underwent genomic testing starting from September 2021

Exclusion Criteria:

  1. Low-risk and High-risk patients as defined in the Ministerial Decree of 18/05/21
  2. ER negative and/or HER2 positive tumours
  3. More than 3 lymph nodes involved at clinical/pathological staging
  4. Invasive tumours <2mm evaluated by local pathologists
  5. Previous history of breast cancer
  6. Synchronous breast cancers
  7. Multifocal tumours
  8. Metastatic disease
  9. Contraindications to adjuvant treatments
  10. Performance status (PS ECOG) > 1 and / or other clinical factors that would make the patient a candidate and unsuitable for systemic adjuvant treatment or have received an exclusive indication for precautionary hormone therapy as part of the Breast Unit collegial assessment.
  11. Psychiatric diagnosis that may affect the ability to participate in this study

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

Cohorts and Interventions

Group / Cohort
Prospective cohort
For prospective cohort: genomic tests will be performed on all patients who meet the criteria for access to testing as set out in the Ministerial Decree of 18/05/2021, unless otherwise agreed by the reference Breast Unit, in accordance with the specific diagnostic pathways activated by each site.
Retrospective cohort
For retrospective cohort: data for patient referred for genomic testing following Ministerial Decree 18/05/2021 will be collected. The retrospective cohort will contribute to expanding our knowledge of the clinico-pathological characteristics of patients who underwent genomic testing. This comprehensive understanding of the clinico-pathological profile of patients undergoing genomic testing will enable a more thorough assessment of the clinical dynamics and therapeutic decisions associated with genomic testing results, including the analysis of their possible evolution over the years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establishment of a prospective Italian observational registry for the implementation of genomic tests in patients with HR +/HER2- breast cancer
Time Frame: Until November 2026
Establishment of a prospective Italian observational registry for the implementation of genomic tests in patients with HR +/HER2- breast cancer at intermediate risk of recurrence after the adoption of the Ministerial Decree of 18/05/2021
Until November 2026
Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only)
Time Frame: Until November 2026
Rate of adjuvant treatment choice's change following the genomic test result (Breast Unit's pre-test vs post-test indication)
Until November 2026
Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only)
Time Frame: Until November 2026
Saving in adjuvant chemotherapy compared to the pre-test indication
Until November 2026
Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only)
Time Frame: Until November 2026
Addition of adjuvant chemotherapy to endocrine therapy alone compared to the pre-test indication
Until November 2026
Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only)
Time Frame: Until November 2026
Type of adjuvant treatment the patient actually received
Until November 2026

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Record the predominant demographic and clinical characteristics of the patients for whom genomic testing was indicated.
Time Frame: Until November 2026
Record the predominant demographic and clinical characteristics of the patients for whom genomic testing was indicated.
Until November 2026
Describe which genomic tests are used and the factors involved in the selection of genomic tests.
Time Frame: Until November 2026
Describe which genomic tests are used and the factors involved in the selection of genomic tests.
Until November 2026
Identify any inequalities in access to the genomic tests in different geographical areas of the country.
Time Frame: Until November 2026
Identify any inequalities in access to the genomic tests in different geographical areas of the country.
Until November 2026
Record the distribution of demographic and clinical characteristics in the group of patients with changed treatment recommendation compared to the group of patients with unchanged indication after genomic test.
Time Frame: Until November 2026
patient age comorbidities, tumour size, number of positive lymph nodes, tumour grade
Until November 2026
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time Frame: Until November 2026
Time from diagnosis to request for genomic test
Until November 2026
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time Frame: Until November 2026
Time from request for the genomic test to result
Until November 2026
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time Frame: Until November 2026
Time from test result to activation of adjuvant chemotherapy, if indicated
Until November 2026
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time Frame: Until November 2026
Time from diagnosis to activation of adjuvant chemotherapy, if indicated
Until November 2026
Analyse the prescriptive adequacy and the compliance
Time Frame: Until November 2026
With the inclusion criteria for genomic tests.
Until November 2026

Collaborators and Investigators

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

Sponsor

Consorzio Oncotech

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 (Estimated)

March 1, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIM29-GIMOMIC

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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