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

Официальное название

"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"

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Establishment of a prospective Italian observational registry for the implementation of genomic tests in patients with HR +/HER2- breast cancer [Срок оценки: Until November 2026]
• Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only) [Срок оценки: Until November 2026]
• Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only) [Срок оценки: Until November 2026]
• Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only) [Срок оценки: Until November 2026]
• Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only) [Срок оценки: Until November 2026]

Вторичные конечные точки (9)

• Record the predominant demographic and clinical characteristics of the patients for whom genomic testing was indicated. [Срок оценки: Until November 2026]
• Describe which genomic tests are used and the factors involved in the selection of genomic tests. [Срок оценки: Until November 2026]
• Identify any inequalities in access to the genomic tests in different geographical areas of the country. [Срок оценки: Until November 2026]
• Analyse the prescriptive adequacy and the compliance [Срок оценки: 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. [Срок оценки: Until November 2026]
• Evaluate the impact of the test on the timing of activation of adjuvant treatment [Срок оценки: Until November 2026]
• Evaluate the impact of the test on the timing of activation of adjuvant treatment [Срок оценки: Until November 2026]
• Evaluate the impact of the test on the timing of activation of adjuvant treatment [Срок оценки: Until November 2026]
• Evaluate the impact of the test on the timing of activation of adjuvant treatment [Срок оценки: Until November 2026]

Критерии участия

Критерии включения

• . 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 25 центров

• A.O. San Giuseppe Moscati — Avellino
• Ospedale Papa Giovanni XXIII — Bergamo
• Policlinico S. Orsola-Malpighi — Bologna
• Spedali Civili di Brescia — Brescia
• Asrem - Azienda Sanitaria Regionale del Molise — Termoli
• Azienda Ospedaliera" Sant'Anna e San Sebastiano" — Caserta
• Azienda Ospedaliera S. Croce e Carle — Cuneo
• Azienda Ospedaliero-Universitaria Arcispedale S. Anna — Ferrara
• … и ещё 17 центров

Идентификаторы

NCT: NCT06871501 · GIM29-GIMOMIC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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