NCT06363812

Probability of OncotypeDx to Reallocate As Low or High Risk of Recurrence Breast Cancer Patients with Uncertain Biology

Prospective Study Evaluating the Probability of OncotypeDx to Allocate At Low or High Risk of Recurrence Early ER Positive HER2 Negative Breast Cancer Patients with Uncertain Biological Behavior Evaluated by Pathological Parameters

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 258 (actual)
• Sponsor: Fondazione Sandro Pitigliani · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Timeline

• Start date: 2018-03-08
• Primary completion: 2021-05-15
• Completion: 2024-12-31
• First posted: 2024-04-12
• Last updated: 2025-02-28

Locations

1 site across 1 country: Italy