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

NCT05100277 | Completed

• 1 other identifier: 1/2020
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Adjuvant Treatment

Outcome Measures

Primary Outcomes (2)

• The proportion of patients whose choice of treatment is changed as a result of Oncotype Test Low risk

  Changes based on initial clinical measures

  up to 3 weeks

• Economic evaluation

  The costs of each scenario

  up to 5 years

Study Arms (1)

Single arm

All patients will have the test

Genetic: Oncotype DX® Assay; Other: Cost

Interventions

Oncotype DX® Assay GENETIC

After surgery, tumoral tissue was used to perform Oncotype Dx®. Patients were evaluated and therapy recommendations - adjuvant chemotherapy (CT) plus hormone therapy (HT) or HT alone - were captured before and after revealing the test results. Results from TAILORx10 were used to guide decisions for or against CT for individual patients. Changes in treatment recommendations were obtained.

Single arm

Cost OTHER

Changes in treatment costs were estimated from Pérola Byington Hospital.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with early stage breast cancer, positive ER and negative HER2 with negative lymph node or positive lymph node.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital Perola Byington: lead
• Fleury Laboratory: collaborator

Study Sites (1)

Andre Mattar

São Paulo, São Paulo, 04112080, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Costs and Cost Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: October 29, 2021
• Study Start: August 8, 2018
• Primary Completion: February 4, 2019
• Study Completion: February 4, 2019
• Last Updated: January 6, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be available when the paper is published upon request
• Access Criteria: described above

Locations

BR (1)