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

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06871501
• Lead Sponsor: Consorzio Oncotech

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.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-05
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establishment of a prospective Italian observational registry for the implementation of genomic tests in patients with HR +/HER2- breast cancer	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)	Until November 2026	Type of adjuvant treatment the patient actually received

Secondary Outcome Measures

Name	Time	Method
Record the predominant demographic and clinical characteristics of the patients for whom genomic testing was indicated.	Until November 2026	Record the predominant demographic and clinical characteristics of the patients for whom genomic testing was indicated.
Describe which genomic tests are used and the factors involved in the selection of genomic tests.	Until November 2026	Describe which genomic tests are used and the factors involved in the selection of genomic tests.
Identify any inequalities in access to the genomic tests in different geographical areas of the country.	Until November 2026	Identify any inequalities in access to the genomic tests in different geographical areas of the country.
Analyse the prescriptive adequacy and the compliance	Until November 2026	With the inclusion criteria for genomic tests.
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	patient age comorbidities, tumour size, number of positive lymph nodes, tumour grade
Evaluate the impact of the test on the timing of activation of adjuvant treatment	Until November 2026	Time from diagnosis to activation of adjuvant chemotherapy, if indicated

Trial Locations

Locations (25)

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; 🇮🇹 Firenze, FI, Italy

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genova, GE, Italy

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