ClinConnect ClinConnect Logo
Search / Trial NCT06871501

"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

Breast Cancer Genomic Testing

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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported