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 1. patients with ODx low score breast cancer perform well without chemotherapy, 2. chemotherapy has an additive value to endocrine therapy in patients with ODx high score tumors, and 3. the role of chemotherapy is unknown in patients with ODx intermediate score cancer. 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.
Study Type
OBSERVATIONAL
Enrollment
258
Hospital of Prato
Prato, Italy
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
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