"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
Trial Information
Current as of April 22, 2025
Not yet recruiting
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
About Consorzio Oncotech
Consorzio Oncotech is a distinguished clinical trial sponsor dedicated to advancing cancer research and treatment through innovative therapeutic solutions. Comprising a collaborative network of leading researchers, healthcare professionals, and industry partners, the consortium focuses on the design and implementation of cutting-edge clinical trials aimed at evaluating novel oncological therapies. With a commitment to improving patient outcomes and fostering scientific excellence, Consorzio Oncotech plays a pivotal role in translating groundbreaking research into effective clinical applications, thereby contributing to the global fight against cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milano, Mi, Italy
Vicenza, Vi, Italy
Cuneo, Cn, Italy
Napoli, , Italy
Brescia, Bs, Italy
Milano, , Italy
Firenze, Fi, Italy
Napoli, , Italy
Avellino, Av, Italy
Roma, Rm, Italy
Bergamo, Bg, Italy
Rimini, Rn, Italy
Novara, , Italy
Rozzano, Milano, Italy
Genova, Ge, Italy
Bologna, Bo, Italy
Napoli, , Italy
Reggio Emilia, Re, Italy
Termoli, Cb, Italy
Caserta, Ce, Italy
Ferrara, Fe, Italy
Aviano, Pd, Italy
Prato, Po, Italy
Napoli, , Italy
Pozzuoli, , Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported