Impact of Oncotype DX® on Treatment Recommendation and Its Economic Evaluation Under the Brazilian Society Perspective

Completed

• Conditions: Breast Cancer; Adjuvant Treatment
• Interventions: Genetic: Oncotype DX® Assay; Other: Cost

• Registration Number: NCT05100277
• Lead Sponsor: Hospital Perola Byington

Brief Summary

155 Pérola Byington Hospital patients presenting early stage luminal BC were submitted to Oncotype Dx® evaluation. Changes in treatment recommendations and costs were obtained from Pérola Byington Hospital. Oncotype DX® incorporation in the Brazilian Public Health System should be considered, as it results in high clinical impact for patient and high economic impact for health system, being a tool that safely and accurately delimits the subgroup of patients who really need AC.

Detailed Description

Background: It is known that there is significant over administration (and under administration) of adjuvant chemotherapy (AC) when standard clinical parameters (SCP) are used for patients diagnosed with early stage RE+ breast cancer (BC). Although absolute clinical benefit of AC may be modest, its toxicity and economic burden is highly significant; therefore, selecting appropriate patients for AC remains an important issue. Oncotype DX® identifies high-risk patients who are likely to benefit from AC, which otherwise might not be identified through SCP and low-risk patients who will not benefit from AC, thus avoiding toxicities and inherent risks. This study aimed to evaluate the impact of the Oncotype DX® test on treatment decisions in N0 and N1 early-stage breast cancer patients at a Public Brazilian hospital and to estimate the incremental cost-effectiveness ratio (ICER) and budget impact (BI) of incorporating Oncotype DX® under the perspective of the Brazilian Society.

Changes in treatment recommendations and costs will be obtained from Pérola Byington Hospital. Additional data will be obtained from literature. Medical costs (test, chemotherapy and adverse events), productivity loss, transportation and employment leave will be considered.

Study Timeline

• Study Start: 2018-08-08
• Primary Completion: 2019-02-04
• Study Completion: 2019-02-04
• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-10-17
• Study First Posted: 2021-10-29
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-15
• Last Update Posted: 2022-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

Women ≥ 18 years Early stage breast cancer, ER and/or PR positive with HER2 negative breast cancer.

Exclusion Criteria

More than one operable primary breast tumor; Multifocal or multicentric tumors; 4 or more lymph node involvement; Metastatic breast cancer; Previous history of breast cancer; Invasive tumor <2 mm ; Performance status > 2 and / or other clinical factors that would make the patient a non-viable candidate for adjuvant chemotherapy; Previous hormonal or chemotherapy treatment; Current medical condition that would interfere with their ability to consent (psychiatric illness, for example)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single arm	Cost	All patients will have the test
Single arm	Oncotype DX® Assay	All patients will have the test

Primary Outcome Measures

Name	Time	Method
Economic evaluation	up to 5 years	The costs of each scenario
The proportion of patients whose choice of treatment is changed as a result of Oncotype Test Low risk	up to 3 weeks	Changes based on initial clinical measures

Trial Locations

Locations (1)

Andre Mattar; 🇧🇷 São Paulo, SP, Brazil