Prospective Study of the Prosigna Assay on Neoadjuvant Clinical Decision-making in Women With HR+/Her2- Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
As the investigators understanding of how ER-positive breast cancer (a type of cancer in which the cells need the hormone estrogen to grow) improves, more treatment decisions are being tailored to an individual's unique genetic makeup. National medical guidelines now include the routine use of tumor profiling tests, like the Prosigna® assay, which look at the gene activity of a person's cancer cells to determine the likely outcome or course of a disease (prognosis) and predict the benefit of chemotherapy or endocrine therapy after breast surgery.
Currently, the Prosigna® assay (also called PAM-50) is FDA approved as a tool that physicians can use to help make decisions about a patient's treatment after their breast surgery. In these cases, physicians run this test using tumor tissue from a patient's breast surgery. However, the Prosigna® assay is not approved for use preoperatively, or before surgery.
Previous studies showed that the Prosigna® assay was able to identify tumor types that were more likely to benefit from treatment before surgery (whether it's hormonal therapy or chemotherapy). In this study, the investigators will use tumor tissue from the participant's biopsy to run the Prosigna® assay. The test may give both the participant and the investigators more information about the best possible treatment option for the participant before surgery.
This study is being done to determine how Prosigna® assay results may affect the physician's choice of treatment before surgery and how well patients understand the test and its implications.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients pre- or post-menopausal must have histologically confirmed early stage/locally advanced invasive breast cancer
- ER or PR ≥ 1% by immunohistochemistry (IHC)
- HER2-negative status, according to guidelines by ASCO CAP guidelines:
https://www.asco.org/practice-guidelines/quality-guidelines/guidelines/breast-cancer#/9751
- Tumor size ≥ 0.5cm (clinical or radiographic measurements)
- Any nodal status allowed
- Age > 18 years old
- Felt to be a possible candidate for neoadjuvant systemic therapy by their treating physician
Exclusion Criteria:
- ER-negative and PR-negative invasive breast cancer (< 1% by IHC)
- Known metastatic disease
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Prosigna Assay
|
Looks at the gene activity of a person's cancer cells to determine the likely outcome or course of a disease (prognosis) and predict the benefit of chemotherapy or endocrine therapy after breast surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The extent to which the Prosigna test results will change physician's pre-test decision regarding neoadjuvant treatment of patients with stage II-III ER/PR+, HER2-negative breast cancer
Time Frame: 2 years
|
Questionnaires will be used to record neoadjuvant treatment decisions pre- and post-test.
Data will be summarized in a contingency table, and the extent to which decisions changed will be estimated as the proportion of discordant responses and reported with a two-sided exact 95% confidence interval.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The association of pCR/RCB following neoadjuvant therapy with Risk of recurrence (ROR).
Time Frame: 2 years
|
The association of the Prosigna test results to pathologic outcomes will be explored marginally in all patients who receive neoadjuvant treatment, and non-parametric Wilcoxon rank sum and Spearman test of correlation with two-sided alpha = 0.05 will be used to make inferences.
Non-linear spline regression techniques will be used to explore the relationship between pre-treatment molecular phenotypes of response to neoadjuvant treatment.
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2 years
|
|
To assess if treatment change was based on ROR score, intrinsic subtype or both
Time Frame: 2 years
|
Non-linear spline regression techniques will be used to explore the relationship between pre-treatment molecular phenotypes and response to neoadjuvant treatment.
On the "Post-Prosigna Physician Questionnaire" physicians will be asked which of these item (ROR score, instrinsic subtype, or both) contributed to their neoadjuvant treatment decision-making.
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2 years
|
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To evaluate physicians' confidence in their therapy before and after the test
Time Frame: 2 years
|
Physicians will complete pre-test and post-test questionnaires that measure their confidence at each timepoint.
The pre-test questionnaire will examine the percentage of physicians who are confident about their treatment recommendation.
The same questions about confidence in diagnosis and treatment will be realized after Prosigna results and rates will be compared.
|
2 years
|
|
To evaluate patients' confidence in their therapy before and after the test
Time Frame: 2 years
|
Patients will complete pre-test and post-test questionnaires to measure their confidence at each timepoint.
The pre-test questionnaire will examine the percentage of patients who understand their diagnosis and how Prosigna works and who are confident in treatment recommendation.
The same question about diagnosis and treatment will be realized after Prosigna results and rates will be compared.
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sara Tolaney, MD, Dana-Farber Cancer Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-281
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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