Clinical trial NCT05100277: Impact of Oncotype DX® on Treatment Recommendation and Its Economic Evaluation Under the Brazilian Society Perspective
Official title: Impact of Oncotype DX® on Treatment Recommendation of for Early-stage Hormone Receptor-positive Breast Cancer and Its Economic Evaluation Under the Brazilian Society Perspective
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Adjuvant Treatment
Lead sponsor: Hospital Perola Byington
Sponsor class: OTHER_GOV
Collaborators: name: Fleury Laboratory
First posted: 2021-10-29
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The proportion of patients whose choice of treatment is changed as a result of Oncotype Test Low risk
timeFrame: up to 3 weeks
measure: Economic evaluation
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Andre Mattar
state: SP
Study officials:
References: