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

NCT ID: NCT06871501

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2026-11-30

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.

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorzio Oncotech

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

A.O. San Giuseppe Moscati

Avellino, AV, Italy

Ospedale Papa Giovanni XXIII

Bergamo, BG, Italy

Policlinico S. Orsola-Malpighi

Bologna, BO, Italy

Spedali Civili di Brescia

Brescia, BS, Italy

Asrem - Azienda Sanitaria Regionale del Molise

Termoli, CB, Italy

Azienda Ospedaliera" Sant'Anna e San Sebastiano"

Caserta, CE, Italy

Azienda Ospedaliera S. Croce e Carle

Cuneo, CN, Italy

Azienda Ospedaliero-Universitaria Arcispedale S. Anna

Ferrara, FE, Italy

Azienda Ospedaliera Universitaria Careggi

Florence, FI, Italy

IRCCS Ospedale Policlinico San Martino

Genova, GE, Italy

IRCCS Ospedale San Raffaele

Milan, MI, Italy

Istituto Europeo di Oncologia

Milan, MI, Italy

IRCCS Humanitas Research Hospital

Rozzano, MI, Italy

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

Aviano, PD, Italy

Ospedale S. Stefano

Prato, PO, Italy

Azienda USL IRCCS di Reggio Emilia

Reggio Emilia, RE, Italy

Istituto Nazionale Tumori Regina Elena

Roma, RM, Italy

Ospedale Infermi di Rimini

Rimini, RN, Italy

Ospedale San Bortolo di Vicenza

Vicenza, VI, Italy

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

Napoli, , Italy

AORN - Ospedali dei Colli

Napoli, , Italy

Azienda Ospedaliero Universitaria Federico II

Napoli, , Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale

Napoli, , Italy

A.O.U. Maggiore della Carità di Novara

Novara, , Italy

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

Pozzuoli, , Italy

Countries

Italy

Central Contacts

Mario G Mario Giuliano, MD

Role: CONTACT

m.giuliano@unina.it

0817463762 ext. 3762

GIM29-GIMOMIC S GIM29-GIMOMIC Service

Role: CONTACT

helpdesk.gim29@oncotech.org

+39 089301545 ext. 1545

Facility Contacts

Giuseppe C Giuseppe Colantuoni, MD

Role: primary

gicolantuoni@gmail.com

0825203945 ext. 3945

Elena RC Elena Rota Caremoli, MD

Role: primary

ecrota@asst-pg23.it

0352673694 ext. 3694

Claudio Z Claudio Zamagni, MD

Role: primary

zamagniclaudio.sper@aosp.bo.it

0512144548 ext. 4548

Rebecca P Rebecca Pedersini, MD

Role: primary

rebecca.pedersini@gmail.com

Francesco C Francesco Carrozza, MD

Role: primary

francesco.carrozza@asrem.molise.it

Michele O Michele Orditura, MD

Role: primary

michele.orditura@aorncaserta.it

0823232515 ext. 2515

Anna Maria V Anna Maria Vandone, MD

Role: primary

vandone.a@ospedale.cuneo.it

0171616350 ext. 6350

Alessio S Alessio Schirone, MD

Role: primary

a.schirone@ospfe.it

0532236167 ext. 6167

Icro M Icro Meattini, MD

Role: primary

icro.meattini@unifi.it

0552751828 ext. 1828

Davide S. Davide Soldato, MD

Role: primary

davide.soldato@hsanmartino.it

0105557300 ext. 7300

Luca L Luca Licata, MD

Role: primary

licata.luca@hsr.it

0226436530 ext. 6530

Giuseppe C Giuseppe Curigliano, MD

Role: primary

giuseppe.curigliano@ieo.it

Alberto Z Alberto Zambelli, MD

Role: primary

alberto.zambelli@hunimed.eu

Fabio P Fabio Puglisi, MD

Role: primary

fabio.puglisi@cro.it

0434659253 ext. 9253

Laura B Laura Biganzoli, MD

Role: primary

laura.biganzoli@uslcentro.toscana.it

0574802531 ext. 2531

Paola M Paola Malaguti, MD

Role: primary

paola.malaguti@ifo.it

0652666771 ext. 6771

Lorenzo G Lorenzo Gianni, MD

Role: primary

lorenzo.gianni@auslromagna.it

0541705413 ext. 5413

Lucia B Lucia Borgato, MD

Role: primary

lucia.borgato@aulss8.veneto.it

0444753836 ext. 3836

Ferdinando R Ferdinando Riccardi, MD

Role: primary

ferdinando.riccardi@aocardarelli.it

Vincenzo M Vincenzo Montesarchio, MD

Role: primary

vincenzo.montesarchio@ospedalideicolli.it

0817062855 ext. 2855

Mario G Mario Giuliano, MD

Role: primary

m.giuliano@unina.it

081 746 3762 ext. 3762

Michelino DL Michelino De Laurentiis, MD

Role: primary

delauren@breastunit.org;m.delaurentiis@istitutotumori.na.it

08117770432 ext. 0432

Alessandra G Alessandra Gennari, MD

Role: primary

alessandra.gennari@uniupo.it

03213732296 ext. 2296

Angela R Angela Ruggiero, MD

Role: primary

angela.ruggiero@aslnapoli2nord.it

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

GIM29-GIMOMIC

Identifier Type: -

Identifier Source: org_study_id