"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

This clinical trial is focused on understanding how genomic testing can help manage early-stage breast cancer, specifically in patients whose tumors are hormone receptor-positive (HR+) and HER2-negative (HER2-). The goal is to create a registry in Italy that tracks how these tests are used in treatment decisions for patients at intermediate risk of their cancer returning. Genomic testing can provide important information that helps doctors decide on the best treatments after surgery, potentially changing how patients receive care based on their test results.

To be eligible for this study, participants need to be at least 18 years old and have been diagnosed with early breast cancer that meets certain criteria, such as having specific hormone receptor characteristics and a certain cancer stage. They should also be recommended for hormone therapy or a combination of hormone and chemotherapy. If you or a loved one have undergone genomic testing since September 2021 and fit the criteria, you could potentially participate. The study is not yet recruiting participants, but when it does, those involved can expect to contribute to important research that may influence future breast cancer care.

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