An observational study in Breast Cancer, sponsored by Fondazione Sandro Pitigliani. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Fondazione Sandro Pitigliani · Observational
In some cases of hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer the benefit of adding adjuvant chemotherapy to hormonal treatment, estimated on the basis of the classical clinico-pathological parameters, is unclear. In these cases the application of a genomic test could be useful in guiding the therapeutic choice.
Oncotype Dx (ODx) is a 21-gene assay that classifies primary ER+ breast tumors into three categories of recurrence risk: High (HR), Intermediate (IR) and Low (LR).
Available data show that
In this study, the investigators aim to evaluate the capability of ODx to help in guiding the choice of systemic adjuvant treatment in a group of patients with ER+ and HER2- , node negative (pN0) or micrometastatic (pNmi) breast cancer with uncertain biological behavior for whom there is uncertainty about the indication of adjuvant chemotherapy.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 258 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fondazione Sandro Pitigliani is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
primary care clinic
Exclusion Criteria:
the proportion of tumor samples with a useful OncotypeDx
number of low risk and high risk at OncotypeDx divided by the total number of tests
Time frame: 15 days
the proportion of patients in which the result of the test has induced a modification in the initial treatment plan
number of cases with a therapeutic change divided by the total number of tested cases
Time frame: 15 days
the proportion of tumor samples with an intermediate risk or not evaluable at OncotypeDx
number of intermediate risk and not evaluable at OncotypeDx divided by the total number of tests
Time frame: 15 days
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Fondazione Sandro Pitigliani