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Prospective Study of the Prosigna Assay on Neoadjuvant Clinical Decision-making in Women With HR+/Her2- Breast Cancer

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ClinicalTrials.gov Identifier: NCT03749421
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
NanoString Technologies, Inc.
Information provided by (Responsible Party):
Sara Tolaney, Dana-Farber Cancer Institute

Brief Summary:
This research study is evaluating a genomic analysis called Predictor Analysis of Microarray 50 (PAM50, by Prosigna®) as a tool to possibly guide the participant and the treating physician to choose the most personalized pre-operative treatment for breast cancer.

Condition or disease Intervention/treatment
Breast Cancer Other: Prosigna PAM-50 assay

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prospective Study of the Prosigna Assay on Neoadjuvant Clinical Decision-making in Women With HR+/Her2- Breast Cancer
Actual Study Start Date : March 21, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Prosigna Assay
  • Biopsy specimen will be subject to molecular profiling via the Prosigna PAM-50 assay
  • The results of Prosigna assay will be provided to the study team in a standardized report.
  • This report will include the patient's intrinsic subtype, ROR score, and general risk (high, intermediate, low).
Other: Prosigna PAM-50 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients that are considered possible candidates for neoadjuvant treatment, irrespective whether chemotherapy or endocrine therapy, by clinical-pathologic features.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749421


Contacts
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Contact: Sara Tolaney, MD 617-632-2335 Sara_Tolaney@dfci.harvard.edu

Locations
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United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sara Tolaney, MD    617-632-2335    Sara_Tolaney@dfci.harvard.edu   
Principal Investigator: Sara Tolaney, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
NanoString Technologies, Inc.
Investigators
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Principal Investigator: Sara Tolaney, MD Dana-Farber Cancer Institute

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Responsible Party: Sara Tolaney, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03749421     History of Changes
Other Study ID Numbers: 18-281
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sara Tolaney, Dana-Farber Cancer Institute:
Breast Cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases