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Trial record 1 of 1 for:    NCT04016935
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EndoPredict® Extended Endocrine Trial (EXET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04016935
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.

Tracking Information
First Submitted Date June 26, 2019
First Posted Date July 12, 2019
Last Update Posted Date December 21, 2020
Actual Study Start Date July 2, 2019
Estimated Primary Completion Date June 1, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 7, 2020)
Evaluate DRFS of women 5-10 years post diagnosis with ER+, HER2-breast cancer who are low risk according to their EPclin scores [ Time Frame: 10 Years ]
The primary objective of this study is to evaluate distant recurrence-free survival (DRFS) between years 5 and 10 post-diagnosis of women with ER+, HER2- breast cancer who are classified as low risk according to their EPclin score and who did not receive extended endocrine therapy
Original Primary Outcome Measures
 (submitted: July 9, 2019)
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.
Change History
Current Secondary Outcome Measures
 (submitted: October 14, 2020)
  • Evaluate DRFS between years 5 and 10 post-diagnosis in women classified as low risk according to their EPclin who received extended endocrine therapy [ Time Frame: 10 Years ]
    Evaluate DRFS between years 5 and 10 post-diagnosis in women classified as low risk according to their EPclin who received extended endocrine therapy
  • Evaluate DRFS between years 5 and 10 post-diagnosis in women classified as high risk according to their EPclin score based on treatment decisions. [ Time Frame: 10 Years ]
    Evaluate DRFS between years 5 and 10 post-diagnosis in women classified as high risk according to their EPclin score based on treatment decisions.
  • Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy [ Time Frame: 1 Year ]
    Evaluate the proportion of patients classified as EPclin low who forgo extending endocrine and the proportion of EPclin high who extend endocrine therapy beyond 5 years
  • Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy according to whether patients received adjuvant chemotherapy. [ Time Frame: 1 Year ]
    Evaluate the proportion of patients who received adjuvant chemotherapy classified as EPclin low who forgo extending endocrine and those classified as EPclin high who extend endocrine therapy beyond 5 years
  • Evaluate disease-free survival in patients stratified based on EPclin risk classification and actual treatment. [ Time Frame: 10 Years ]
    Evaluate disease-free survival in patients stratified based on EPclin risk classification and actual treatment.
Original Secondary Outcome Measures
 (submitted: July 9, 2019)
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.
Current Other Pre-specified Outcome Measures
 (submitted: October 7, 2020)
  • Compare previous chemotherapy treatment decisions to chemotherapy treatment recommendations based on EndoPredict® risk classification. [ Time Frame: 1 Year ]
    Compare previous chemotherapy treatment decisions to chemotherapy treatment recommendations based on EndoPredict® risk classification.
  • Repeat all primary and secondary objectives in subsets of patients based on variables such as clinicopathologic features and treatment. [ Time Frame: 10 Years ]
    Repeat all primary and secondary objectives in subsets of patients based on variables such as clinicopathologic features and treatment.
Original Other Pre-specified Outcome Measures
 (submitted: July 9, 2019)
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.
 
Descriptive Information
Brief Title EndoPredict® Extended Endocrine Trial (EXET)
Official Title EndoPredict® Extended Endocrine Trial (EXET): A Prospective Registry to Evaluate the Impact of EndoPredict® Test on Extended Endocrine Treatment Decisions and Patient Outcomes.
Brief Summary The purpose of this study is to evaluate the impact of using EndoPredict® clinically to inform treatment decisions for extended endocrine therapy, and the subsequent impact on patient outcomes.
Detailed Description

The EndoPredict® molecular test is validated to predict late distant recurrence after 5 years of endocrine therapy in women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) early stage breast cancer, with or without treatment with adjuvant chemotherapy. The test provides an individualized EPclin score based on the tumor gene expression, tumor size and nodal status, and categorizes patients as High or Low risk of distant recurrence.

The primary objective of this study is to evaluate the distant recurrence-free survival (DRFS) at 5-10 years in patients with ER+/HER2- early stage breast cancer with EPclin Low scores that did not extend endocrine therapy.

Data collection is prospective and patient enrollment is expected to occur over 24 months. The study will enroll patients who are near the 5-year post-diagnosis time point when decisions on extending endocrine therapy are being made. Patient breast cancer tumors, stored from surgical collection after initial diagnosis, will be tested with EndoPredict and a report generated. The provider will convey the report results to the patient and establish a treatment plan to continue or forgo endocrine therapy. Patients will then be followed for 6 years with data collection every year, and outcomes (distant and local disease recurrence, second primary breast cancer, etc.) recorded.

The associations between outcomes and treatment, EPclin score and risk category, EP molecular score, and clinicopathologic features will be investigated in all patients and in subpopulations (node negative, node positive, treated with or without chemotherapy, etc.).

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 6 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Approximately 2,800 patients with ER+, HER2- breast cancer will be enrolled in this study across multiple sites. These patients will include both node-positive and node negative patients, with a minimum of 1673 patients with low-risk EPclin scores including 1,505 who forego extended endocrine therapy. Patients will be eligible for the study if they meet the following inclusion criteria.
Condition Primary Invasive Breast Cancer
Intervention Other: Observational
Observational
Study Groups/Cohorts Patients with primary invasive ER+ HER2- breast cancer
Distant recurrence-free survival (DRFS) between years 5 and 10 post-diagnosis of women with ER+, HER2- breast cancer who are classified as low risk according to their EPclin score and who did not receive extended endocrine therapy
Intervention: Other: Observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 7, 2020)
2800
Original Estimated Enrollment
 (submitted: July 9, 2019)
400
Estimated Study Completion Date June 1, 2029
Estimated Primary Completion Date June 1, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Female
  • At least 18 years of age at time of enrollment
  • Able to provide informed consent
  • ER+, HER2- breast tumor
  • Stage T1-T3
  • Currently receiving endocrine therapy
  • Are between 4 and 6.5 years post-invasive breast cancer diagnosis
  • Have all available information to produce an EPclin score, including treatment-naïve tumor stage, nodal status, and sufficient amount of remaining tissue from biopsy or resection to perform genomic testing (section 9)
  • Patient and physician are willing to consider a change in endocrine therapy

Exclusion Criteria:

  • Metastatic disease or currently active additional cancer diagnosis (except non- melanoma skin cancer) or any second primary breast cancer (includes ductal and/or lobular carcinoma in situ)
  • Patient received systemic chemotherapy within 1 year of enrollment
  • 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
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: The primary objective of this study is to evaluate distant recurrence-free survival (DRFS) between years 5 and 10 post-diagnosis of women with ER+, HER2- breast cancer who are classified as low risk according to their EPclin score and who did not receive extended endocrine therapy.
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jon Nelson 801-505-5114 jonelson@myriad.com
Contact: Bethlyn C. Parada 801-505-5181 bcraner@myriad.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04016935
Other Study ID Numbers ONC-010
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Myriad Genetic Laboratories, Inc.
Study Sponsor Myriad Genetic Laboratories, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Joyce O'Shaunessey, MD US Oncology
PRS Account Myriad Genetic Laboratories, Inc.
Verification Date December 2020