Breast CancerNCT05100277
Impact of Oncotype DX® on Treatment Recommendation and Its Economic Evaluation Under the Brazilian Society Perspective
An observational study of Breast Cancer and Adjuvant Treatment, run by Hospital Perola Byington at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Adjuvant Treatment
- What is being tested?
- Oncotype DX® Assay and Cost
- How many people
- 155 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Aug 2018to 4 Feb 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with early stage breast cancer, positive ER and negative HER2 with negative lymph node or positive lymph node.
Who may be able to join
- Women ≥ 18 years Early stage breast cancer, ER and/or PR positive with HER2 negative breast cancer.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer, Adjuvant Treatment
- Being tested
- Oncotype DX® Assay, Cost
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncotype DX® AssayGenetic
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.
CostOther
Changes in treatment costs were estimated from Pérola Byington Hospital.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | All patients will have the test Receives: Genetic: Oncotype DX® Assay; Other: Cost |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients whose choice of treatment is changed as a result of Oncotype Test Low risk
Changes based on initial clinical measures
Measured: up to 3 weeks
Economic evaluation
The costs of each scenario
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start8 Aug 2018
- Primary completion4 Feb 2019
- Study completion4 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hospital Perola Byington
- Sponsor type
- Other government
- Collaborators
- Fleury Laboratory
- Responsible party
- Principal investigator, Andre Mattar, Hospital Perola Byington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100277
- Sponsor's protocol ID
- 1/2020
- Status last verified
- Dec 2021
- First submitted
- 18 May 2021
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available upon request
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05100277
- Acronym / sponsor ID
- 1/2020
- Conditions
- Breast Cancer, Adjuvant Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Hospital Perola ByingtonOther government
- Collaborators
- Fleury Laboratory
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Genetic: Oncotype DX® Assay, Other: CostAll patients will have the test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with early stage breast cancer, positive ER and negative HER2 with negative lymph node or positive lymph node.
Key inclusion criteria (1 listed)
- Women ≥ 18 years Early stage breast cancer, ER and/or PR positive with HER2 negative breast cancer.
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncotype DX® AssayAfter 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. | Genetic | Single arm |
| CostChanges in treatment costs were estimated from Pérola Byington Hospital. | Other | Single arm |
Primary outcome
The proportion of patients whose choice of treatment is changed as a result of Oncotype Test Low risk
Time frame: up to 3 weeks
Changes based on initial clinical measures
Economic evaluation
Time frame: up to 5 years
The costs of each scenario
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
- Individual participant dataSharing planned: Yes. All data will be available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Adjuvant Treatment, run by Hospital Perola Byington at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients whose choice of treatment is changed as a result of Oncotype Test Low risk (time frame: up to 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.