Ignite Creation Date:
2024-05-06 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05100277
Status:
COMPLETED
Last Update Posted:
2022-01-06
First Post:
2021-05-18
Brief Title:
Impact of Oncotype DX on Treatment Recommendation and Its Economic Evaluation Under the Brazilian Society Perspective
Sponsor:
Hospital Perola Byington
Organization:
Hospital Perola Byington
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None