Clinical trial NCT06871501: "Observational, Retrospective and Prospective, Non-interventional, Multicentre on the Use of Genomic Testing in the Management of Early Stage HR+/HER2- Breast Cancer"
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"
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Keywords: Breast Cancer
Genomic testing
Lead sponsor: Consorzio Oncotech
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
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.

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.

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

Primary outcomes:
measure: Establishment of a prospective Italian observational registry for the implementation of genomic tests in patients with HR +/HER2- breast cancer
timeFrame: Until November 2026
measure: Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only)
timeFrame: Until November 2026
measure: Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only)
timeFrame: Until November 2026
measure: Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only)
timeFrame: Until November 2026
measure: Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only)
timeFrame: Until November 2026
Secondary outcomes:
measure: Record the predominant demographic and clinical characteristics of the patients for whom genomic testing was indicated.
timeFrame: Until November 2026
measure: Describe which genomic tests are used and the factors involved in the selection of genomic tests.
timeFrame: Until November 2026
measure: Identify any inequalities in access to the genomic tests in different geographical areas of the country.
timeFrame: Until November 2026
measure: Analyse the prescriptive adequacy and the compliance
timeFrame: Until November 2026
measure: 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.
timeFrame: Until November 2026
measure: Evaluate the impact of the test on the timing of activation of adjuvant treatment
timeFrame: Until November 2026
measure: Evaluate the impact of the test on the timing of activation of adjuvant treatment
timeFrame: Until November 2026
measure: Evaluate the impact of the test on the timing of activation of adjuvant treatment
timeFrame: Until November 2026
measure: Evaluate the impact of the test on the timing of activation of adjuvant treatment
timeFrame: Until November 2026
Other outcomes:
Locations:
city: Avellino
country: Italy
facility: A.O. San Giuseppe Moscati
state: AV
city: Bergamo
country: Italy
facility: Ospedale Papa Giovanni XXIII
state: BG
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi
state: BO
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
state: BS
city: Termoli
country: Italy
facility: Asrem - Azienda Sanitaria Regionale del Molise
state: CB
city: Caserta
country: Italy
facility: Azienda Ospedaliera" Sant'Anna e San Sebastiano"
state: CE
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S. Croce e Carle
state: CN
city: Ferrara
country: Italy
facility: Azienda Ospedaliero-Universitaria Arcispedale S. Anna
state: FE
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: FI
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
state: GE
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
state: MI
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
state: MI
city: Rozzano
country: Italy
facility: IRCCS Humanitas Research Hospital
state: MI
city: Aviano
country: Italy
facility: IRCCS Centro di Riferimento Oncologico (C.R.O.)
state: PD
city: Prato
country: Italy
facility: Ospedale S. Stefano
state: PO
city: Reggio Emilia
country: Italy
facility: Azienda USL IRCCS di Reggio Emilia
state: RE
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
state: RM
city: Rimini
country: Italy
facility: Ospedale Infermi di Rimini
state: RN
city: Vicenza
country: Italy
facility: Ospedale San Bortolo di Vicenza
state: VI
city: Napoli
country: Italy
facility: A.O.R.N. "A. Cardarelli"
city: Napoli
country: Italy
facility: AORN - Ospedali dei Colli
city: Napoli
country: Italy
facility: Azienda Ospedaliero Universitaria Federico II
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità di Novara
city: Pozzuoli
country: Italy
facility: P.O."Santa Maria delle Grazie" di Pozzuoli
Study officials:
References: