Breast CancerGIM29-GIMOMICNCT06871501
"Observational, Retrospective and Prospective, Non-interventional, Multicentre on the Use of Genomic Testing in the Management of Early Stage HR+/HER2- Breast Cancer"
An observational study of Breast Cancer, run by Consorzio Oncotech at 25 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 1,000 participants
- Where
- 25 sitesItaly
- Study dates
- Mar 2025to Nov 2026
- 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
- Adult, Older adult
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.
Who may be able to join
- . 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
Italy25 sites
A.O. San Giuseppe Moscati
Avellino, AV, 83100
Giuseppe C Giuseppe Colantuoni, MD, 0825203945 ext. 3945, gicolantuoni@gmail.com
IRCCS Centro di Riferimento Oncologico (C.R.O.)
Aviano, PD, 33081
Fabio P Fabio Puglisi, MD, 0434659253 ext. 9253, fabio.puglisi@cro.it
Ospedale Papa Giovanni XXIII
Bergamo, BG, 24127
Elena RC Elena Rota Caremoli, MD, 0352673694 ext. 3694, ecrota@asst-pg23.it
Policlinico S. Orsola-Malpighi
Bologna, BO, 40138
Claudio Z Claudio Zamagni, MD, 0512144548 ext. 4548, zamagniclaudio.sper@aosp.bo.it
Spedali Civili di Brescia
Brescia, BS, 25123
Rebecca P Rebecca Pedersini, MD, rebecca.pedersini@gmail.com
Azienda Ospedaliera" Sant'Anna e San Sebastiano"
Caserta, CE, 81100
Michele O Michele Orditura, MD, 0823232515 ext. 2515, michele.orditura@aorncaserta.it
Azienda Ospedaliera S. Croce e Carle
Cuneo, CN, 12100
Anna Maria V Anna Maria Vandone, MD, 0171616350 ext. 6350, vandone.a@ospedale.cuneo.it
Azienda Ospedaliero-Universitaria Arcispedale S. Anna
Ferrara, FE, 44124
Alessio S Alessio Schirone, MD, 0532236167 ext. 6167, a.schirone@ospfe.it
Azienda Ospedaliera Universitaria Careggi
Florence, FI, 50134
Icro M Icro Meattini, MD, 0552751828 ext. 1828, icro.meattini@unifi.it
IRCCS Ospedale Policlinico San Martino
Genova, GE, 16132
Davide S. Davide Soldato, MD, 0105557300 ext. 7300, davide.soldato@hsanmartino.it
IRCCS Ospedale San Raffaele
Milan, MI, 20132
Luca L Luca Licata, MD, 0226436530 ext. 6530, licata.luca@hsr.it
Istituto Europeo di Oncologia
Milan, MI, 20141
Giuseppe C Giuseppe Curigliano, MD, giuseppe.curigliano@ieo.it
A.O.R.N. "A. Cardarelli"
Naples, 80131
Ferdinando R Ferdinando Riccardi, MD, ferdinando.riccardi@aocardarelli.it
AORN - Ospedali dei Colli
Naples, 80131
Vincenzo M Vincenzo Montesarchio, MD, 0817062855 ext. 2855, vincenzo.montesarchio@ospedalideicolli.it
Azienda Ospedaliero Universitaria Federico II
Naples, 80131
Mario G Mario Giuliano, MD, 081 746 3762 ext. 3762, m.giuliano@unina.it
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Naples, 80131
Michelino DL Michelino De Laurentiis, MD, 08117770432 ext. 0432, delauren@breastunit.org;m.delaurentiis@istitutotumori.na.it
A.O.U. Maggiore della Carità di Novara
Novara, 28100
Alessandra G Alessandra Gennari, MD, 03213732296 ext. 2296, alessandra.gennari@uniupo.it
P.O."Santa Maria delle Grazie" di Pozzuoli
Pozzuoli, 80078
Angela R Angela Ruggiero, MD, angela.ruggiero@aslnapoli2nord.it
Ospedale S. Stefano
Prato, PO, 59100
Laura B Laura Biganzoli, MD, 0574802531 ext. 2531, laura.biganzoli@uslcentro.toscana.it
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, RE, 42123
Ospedale Infermi di Rimini
Rimini, RN, 47923
Lorenzo G Lorenzo Gianni, MD, 0541705413 ext. 5413, lorenzo.gianni@auslromagna.it
Istituto Nazionale Tumori Regina Elena
Roma, RM, 00144
Paola M Paola Malaguti, MD, 0652666771 ext. 6771, paola.malaguti@ifo.it
IRCCS Humanitas Research Hospital
Rozzano, MI, 20089
Alberto Z Alberto Zambelli, MD, alberto.zambelli@hunimed.eu
Asrem - Azienda Sanitaria Regionale del Molise
Termoli, CB, 86039
Francesco C Francesco Carrozza, MD, francesco.carrozza@asrem.molise.it
Ospedale San Bortolo di Vicenza
Vicenza, VI, 36100
Lucia B Lucia Borgato, MD, 0444753836 ext. 3836, lucia.borgato@aulss8.veneto.it
About this study
Official title: "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.
Read the 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
- Keywords
- Breast Cancer, Genomic testing
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Until November 2026
Secondary outcomes (9)
Record the predominant demographic and clinical characteristics of the patients for whom genomic testing was indicated.
Record the predominant demographic and clinical characteristics of the patients for whom genomic testing was indicated.
Measured: Until November 2026
Describe which genomic tests are used and the factors involved in the selection of genomic tests.
Describe which genomic tests are used and the factors involved in the selection of genomic tests.
Measured: Until November 2026
Identify any inequalities in access to the genomic tests in different geographical areas of the country.
Identify any inequalities in access to the genomic tests in different geographical areas of the country.
Measured: Until November 2026
Analyse the prescriptive adequacy and the compliance
With the inclusion criteria for genomic tests.
Measured: 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.
patient age comorbidities, tumour size, number of positive lymph nodes, tumour grade
Measured: Until November 2026
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time from diagnosis to request for genomic test
Measured: Until November 2026
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time from request for the genomic test to result
Measured: Until November 2026
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time from test result to activation of adjuvant chemotherapy, if indicated
Measured: Until November 2026
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time from diagnosis to activation of adjuvant chemotherapy, if indicated
Measured: Until November 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorzio Oncotech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871501
- Sponsor's protocol ID
- GIM29-GIMOMIC
- Acronym
- GIM29-GIMOMIC
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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"
- ClinicalTrials.gov ID
- NCT06871501
- Acronym / sponsor ID
- GIM29-GIMOMIC / GIM29-GIMOMIC
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Genomic testing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Consorzio OncotechUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 12 Mar 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- . 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:
- Indication for adjuvant treatment with endocrine therapy (ET) or chemo endocrine therapy (CET), according to the decision of the reference Breast Unit
Key exclusion criteria (11 listed)
- 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
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
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
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)
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
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
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
9 secondary outcomes
Record the predominant demographic and clinical characteristics of the patients for whom genomic testing was indicated.
Time frame: Until November 2026
Describe which genomic tests are used and the factors involved in the selection of genomic tests.
Time frame: Until November 2026
Identify any inequalities in access to the genomic tests in different geographical areas of the country.
Time frame: Until November 2026
Analyse the prescriptive adequacy and the compliance
Time frame: 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
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time frame: Until November 2026
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time frame: Until November 2026
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time frame: Until November 2026
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time frame: Until November 2026
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 13 Mar 2025.
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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.
25 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, run by Consorzio Oncotech at 25 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 14 inclusion and 11 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: opening soon, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 Mario G Mario Giuliano, MD (0817463762 ext. 3762, m.giuliano@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. 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 13 Mar 2025.