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.
. Age ≥ 18 years
PS ECOG 0-1
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)
T1-3, N0, M0
Low-risk and High-risk patients as defined in the Ministerial Decree of 18/05/21
ER negative and/or HER2 positive tumours
More than 3 lymph nodes involved at clinical/pathological staging
Invasive tumours <2mm evaluated by local pathologists
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.
Cohort
Other
Not listed
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
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)
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
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
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.
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.
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.
Analyse the prescriptive adequacy and the compliance
With the inclusion criteria for genomic tests.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
