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EndoPredict® Extended Endocrine Trial (EXET)

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ClinicalTrials.gov Identifier: NCT04016935
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.

Brief Summary:
The purpose of this study is to evaluate how EndoPredict® is used clinically to inform treatment decisions for extended endocrine therapy.

Condition or disease
Breast Cancer

Detailed Description:
The EndoPredict® molecular test is validated to predict late recurrence after 5 years of endocrine therapy with or without treatment with adjuvant chemotherapy, and can be used to identify patients who can safely forego extended endocrine therapy. The purpose of this study is to evaluate how EndoPredict® is used clinically to inform treatment decisions for extended endocrine therapy.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: EndoPredict® Extended Endocrine Trial (EXET): A Prospective Registry to Evaluate the Impact of EndoPredict® in Decisions Regarding Extended Endocrine Treatment
Estimated Study Start Date : July 27, 2019
Estimated Primary Completion Date : June 27, 2022
Estimated Study Completion Date : September 27, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Node-positive patients
Approximately about 200 Node-positive patients
Node-negative patients
Approximately about 200 Node-negative patients



Primary Outcome Measures :
  1. To see what the adherence rate is to follow EndoPredict test results when making decision regarding extended endocrine therapy [ Time Frame: 3 years ]
    To see what the adherence rate is to follow EndoPredict test results (EPclin risk classification: Low or High) when making decision regarding extended endocrine therapy in women with ER+, human epidermal growth factor receptor 2 (HER2) breast cancer. The EndoPredict test gives a EPclin risk Score on a scale of 1 to 6. It takes into consideration the EP molecular score, tumor size and nodal status when determining the EPclin Risk Score. To determine actual treatment decisions, chart review will be performed 1 year after review of EndoPredict® test results. Comparison of actual treatment to EndoPredict® test results will indicate if treatment was consistent with test results.


Secondary Outcome Measures :
  1. To see what the adherence rate is to follow EndoPredict test results when making decision regarding extended endocrine therapy for certain criteria. [ Time Frame: 3 years ]
    To see what the adherence rate is to follow EndoPredict test results when making decision regarding extended endocrine therapy for the following: Nodal status, whether patients received adjuvant chemotherapy, EPclin risk classification. Also evaluate all objectives in the subset of women between 4 and <5.5 years and >5.5 and 7 years post diagnosis.The EndoPredict test gives a EPclin risk Score on a scale of 1 to 6. It takes into consideration the EP molecular score, tumor size and nodal status when determining the EPclin Risk Score. To determine actual treatment decisions, chart review will be performed 1 year after review of EndoPredict® test results. Comparison of actual treatment to EndoPredict® test results will indicate if treatment was consistent with test results.


Other Outcome Measures:
  1. To see what the adherence rate is to follow EndoPredict test results when making decision regarding extended endocrine therapy for certain clinical and pathologic criteria. [ Time Frame: 3 years ]
    To see what the adherence rate is to follow EndoPredict test results when making decision regarding extended endocrine therapy for the following clinical and pathologic criteria: Breast cancer type, number of positive nodes, Menopausal status at time of extended endocrine decision, Tumor grade, Ki67 status, and Adjuvant chemotherapy regimen.The EndoPredict test gives a EPclin risk Score on a scale of 1 to 6. It takes into consideration the EP molecular score, tumor size and nodal status when determining the EPclin Risk Score. To determine actual treatment decisions, chart review will be performed 1 year after review of EndoPredict® test results. Comparison of actual treatment to EndoPredict® test results will indicate if treatment was consistent with test results.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The primary objective of this study is to evaluate adherence to EndoPredict® test results (EPclin risk classification: Low or High) when making decisions regarding extended endocrine therapy in women with ER+, HER2- breast cancer.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ER+, HER2- breast cancer female patients currently on endocrine therapy at 4-7 years post diagnosis
Criteria

Inclusion Criteria:

  • Female
  • At least 18 years of age at time of enrollment
  • Able to provide informed consent
  • ER+, HER2- breast tumor
  • Currently receiving endocrine therapy
  • Are between 4 and 7 years post-breast cancer diagnosis
  • Have all available information to produce an EPclin score, including tumor stage, nodal status, and sufficient amount of remaining tissue or resection to perform genetic testing.
  • Patient and physicians are willing to consider a change in endocrine therapy

Exclusion Criteria:

  • Currently active additional cancer diagnosis, except non-melanoma skin cancer
  • Currently enrolled in an interventional clinical trial or other clinical trial that precludes freely making decisions regarding extended endocrine therapy
  • More than 3 positive nodes
  • Received neo-adjuvant treatment (new-adjuvant chemotherapy or neo-adjuvant endocrine therapy)
  • Are beyond 7 years post-breast cancer diagnosis

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): NCT04016935


Contacts
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Contact: Diana Vogel 801-746-6532 dvogel@myriad.com
Contact: Megan Roberts 801-746-6564 mastle@myriad.com

Locations
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United States, South Carolina
Carolina Blood and Cancer Care Associates Recruiting
Rock Hill, South Carolina, United States, 29732
Contact: Dhwani Mehta       dmehta@cbcca.net   
Principal Investigator: Niyati Nathwani, MD         
Sponsors and Collaborators
Myriad Genetic Laboratories, Inc.
Investigators
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Principal Investigator: Joyce O'Shaunessey, MD US Oncology

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Responsible Party: Myriad Genetic Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT04016935     History of Changes
Other Study ID Numbers: ONC-010
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 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 Myriad Genetic Laboratories, Inc.:
ER+ and HER2- Breast Cancer patients
Extended Endocrine Therapy
EndoPredict