Clinical trial · Observational
"Observational, Retrospective and Prospective, Non-interventional, Multicentre on the Use of Genomic Testing in the Management of Early Stage HR+/HER2- Breast Cancer"
"Observational, Retrospective and Prospective, Non-interventional, Multicentre National Registry-based Study to Collect Information on the Use of Genomic Testing in the Management of Early Stage HR+/HER2- Breast Cancer"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Prospective cohort
- description
- 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.
- label
- Retrospective cohort
- description
- For retrospective cohort: data for patient referred for genomic testing following Ministerial Decree 18/05/2021 will be collected. The retrospective cohort will contribute to expanding our knowledge of the clinico-pathological characteristics of patients who underwent genomic testing. This comprehensive understanding of the clinico-pathological profile of patients undergoing genomic testing will enable a more thorough assessment of the clinical dynamics and therapeutic decisions associated with genomic testing results, including the analysis of their possible evolution over the years.
Primary outcomes (5)
- measure
- Establishment of a prospective Italian observational registry for the implementation of genomic tests in patients with HR +/HER2- breast cancer
- timeFrame
- Until November 2026
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available