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

NCT06871501 | Not Yet Recruiting

• 1 other identifier: GIM29-GIMOMIC
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 25

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Genomic testing

Outcome Measures

Primary Outcomes (5)

• Establishment of a prospective Italian observational registry for the implementation of genomic tests in patients with HR +/HER2- breast cancer

  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)

  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)

  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)

  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)

  Type of adjuvant treatment the patient actually received

  Until November 2026

Secondary Outcomes (9)

• 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.

  Until November 2026

• Identify any inequalities in access to the genomic tests in different geographical areas of the country.

  Until November 2026

• Analyse the prescriptive adequacy and the compliance

  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.

  Until November 2026

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 years
• PS ECOG 0-1
• 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)
• 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
• Indication for adjuvant treatment with endocrine therapy (ET) or chemo endocrine therapy (CET), according to the decision of the reference Breast Unit
• 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%
• Indication for genomic test (Oncotype DX®, Mammaprint®, PAM50 Prosigna®, Breast Cancer Index®, EndoPredict®) by the Breast Unit
• Ability to provide written informed consent to participate in the registry study, approved by the local Ethics Committee.
• The patient underwent genomic testing starting from September 2021

You may not qualify if:

• Low-risk and High-risk patients as defined in the Ministerial Decree of 18/05/21
• ER negative and/or HER2 positive tumours
• More than 3 lymph nodes involved at clinical/pathological staging
• Invasive tumours \<2mm evaluated by local pathologists
• Previous history of breast cancer
• Synchronous breast cancers
• Multifocal tumours
• Metastatic disease
• Contraindications to adjuvant treatments
• 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.
• Psychiatric diagnosis that may affect the ability to participate in this study

Sponsors & Collaborators

• Consorzio Oncotech: lead

Study Sites (25)

A.O. San Giuseppe Moscati

Avellino, AV, 83100, Italy

Location

Ospedale Papa Giovanni XXIII

Bergamo, BG, 24127, Italy

Location

Policlinico S. Orsola-Malpighi

Bologna, BO, 40138, Italy

Location

Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Location

Asrem - Azienda Sanitaria Regionale del Molise

Termoli, CB, 86039, Italy

Location

Azienda Ospedaliera" Sant'Anna e San Sebastiano"

Caserta, CE, 81100, Italy

Location

Azienda Ospedaliera S. Croce e Carle

Cuneo, CN, 12100, Italy

Location

Azienda Ospedaliero-Universitaria Arcispedale S. Anna

Ferrara, FE, 44124, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, FI, 50134, Italy

Location

IRCCS Ospedale Policlinico San Martino

Genova, GE, 16132, Italy

Location

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

Istituto Europeo di Oncologia

Milan, MI, 20141, Italy

Location

IRCCS Humanitas Research Hospital

Rozzano, MI, 20089, Italy

Location

IRCCS Centro di Riferimento Oncologico (C.R.O.)

Aviano, PD, 33081, Italy

Location

Ospedale S. Stefano

Prato, PO, 59100, Italy

Location

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, RE, 42123, Italy

Location

Istituto Nazionale Tumori Regina Elena

Roma, RM, 00144, Italy

Location

Ospedale Infermi di Rimini

Rimini, RN, 47923, Italy

Location

Ospedale San Bortolo di Vicenza

Vicenza, VI, 36100, Italy

Location

A.O.R.N. "A. Cardarelli"

Napoli, 80131, Italy

Location

AORN - Ospedali dei Colli

Napoli, 80131, Italy

Location

Azienda Ospedaliero Universitaria Federico II

Napoli, 80131, Italy

Location

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Napoli, 80131, Italy

Location

A.O.U. Maggiore della Carità di Novara

Novara, 28100, Italy

Location

P.O."Santa Maria delle Grazie" di Pozzuoli

Pozzuoli, 80078, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mario G Mario Giuliano, MD

CONTACT

0817463762; m.giuliano@unina.it

GIM29-GIMOMIC S GIM29-GIMOMIC Service

CONTACT

+39 089301545; helpdesk.gim29@oncotech.org

Study Design

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

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: March 1, 2025
• Primary Completion: May 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

IT (25)