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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT06363812
• Lead Sponsor: Fondazione Sandro Pitigliani

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.

Study Timeline

• Study Start: 2018-03-08
• Primary Completion: 2021-05-15
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-12
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital of Prato; 🇮🇹 Prato, Italy