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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06363812

Enrollment

258

Registered

2024-04-12

Start date

2018-03-08

Completion date

2024-12-31

Last updated

2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

estrogen receptor positive, HER2 negative

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histological diagnosis of infiltrating ductal or lobular ER+ HER2- early breast cancer adequately treated with surgery * Nodal status: no regional lymph node metastasis (pN0) or micrometastatic regional lymph node (pN1mic) * Uncertain biological behavior defined by all of the following parameters: ER \>20% and progesterone receptor (PgR) \>20% and Ki67 between 14% and 30% and G2 * Written informed consent

Exclusion criteria

* pathologic tumor stage (pT) \> 5 cm (not applicable to the internal control group) * Prior neoadjuvant therapy * Evidence of metastatic disease * No axillary exploration (sentinel lymph node biopsy or axillary dissection) * Multifocal or multicentral or bilateral tumors

Design outcomes

Primary

Measure	Time frame	Description
the proportion of tumor samples with a useful OncotypeDx	15 days	number of low risk and high risk at OncotypeDx divided by the total number of tests

Secondary

Measure	Time frame	Description
the proportion of patients in which the result of the test has induced a modification in the initial treatment plan	15 days	number of cases with a therapeutic change divided by the total number of tested cases
the proportion of tumor samples with an intermediate risk or not evaluable at OncotypeDx	15 days	number of intermediate risk and not evaluable at OncotypeDx divided by the total number of tests

Countries

Italy

Outcome results