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

Launched by CONSORZIO ONCOTECH · Mar 6, 2025

Keywords

ClinConnect Summary

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...

Gender

ALL

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