An observational study in Breast Cancer, sponsored by Consorzio Oncotech. Not yet recruiting at 25 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by Consorzio Oncotech · Observational
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.
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 accordance with the specific diagnostic pathways activated by each site. For retrospective cohort: data for patient referred for genomic testing following Ministerial Decree 18/05/2021 will be collected. The patient's baseline demographic characteristics, tumor clinicopathological features, pre and post-test therapeutic indication (CET vs ET), the test results, the actual adjuvant treatment received and time around data will be recorded in a dedicated registry.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Consorzio Oncotech is the lead sponsor of 24 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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:
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:
Exclusion Criteria:
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.
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.
Establishment of a prospective Italian observational registry for the implementation of genomic tests in patients with HR +/HER2- breast cancer
Establishment of a prospective Italian observational registry for the implementation of genomic tests in patients with HR +/HER2- breast cancer at intermediate risk of recurrence after the adoption of the Ministerial Decree of 18/05/2021
Time frame: Until November 2026
Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only)
Rate of adjuvant treatment choice's change following the genomic test result (Breast Unit's pre-test vs post-test indication)
Time frame: Until November 2026
Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only)
Saving in adjuvant chemotherapy compared to the pre-test indication
Time frame: Until November 2026
Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only)
Addition of adjuvant chemotherapy to endocrine therapy alone compared to the pre-test indication
Time frame: Until November 2026
Measurement of the impact of genomic testing on adjuvant treatment choice (CET vs ET only)
Type of adjuvant treatment the patient actually received
Time frame: Until November 2026
Record the predominant demographic and clinical characteristics of the patients for whom genomic testing was indicated.
Record the predominant demographic and clinical characteristics of the patients for whom genomic testing was indicated.
Time frame: Until November 2026
Describe which genomic tests are used and the factors involved in the selection of genomic tests.
Describe which genomic tests are used and the factors involved in the selection of genomic tests.
Time frame: Until November 2026
Identify any inequalities in access to the genomic tests in different geographical areas of the country.
Identify any inequalities in access to the genomic tests in different geographical areas of the country.
Time frame: Until November 2026
Analyse the prescriptive adequacy and the compliance
With the inclusion criteria for genomic tests.
Time frame: Until November 2026
Record the distribution of demographic and clinical characteristics in the group of patients with changed treatment recommendation compared to the group of patients with unchanged indication after genomic test.
patient age comorbidities, tumour size, number of positive lymph nodes, tumour grade
Time frame: Until November 2026
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time from diagnosis to request for genomic test
Time frame: Until November 2026
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time from request for the genomic test to result
Time frame: Until November 2026
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time from test result to activation of adjuvant chemotherapy, if indicated
Time frame: Until November 2026
Evaluate the impact of the test on the timing of activation of adjuvant treatment
Time from diagnosis to activation of adjuvant chemotherapy, if indicated
Time frame: Until November 2026
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Consorzio Oncotech