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Trial record 1 of 1 for:    NCT04016935
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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 : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.

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.

Condition or disease Intervention/treatment
Primary Invasive Breast Cancer Other: Observational

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.).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2800 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Years
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.
Actual Study Start Date : July 2, 2019
Estimated Primary Completion Date : June 1, 2029
Estimated Study Completion Date : June 1, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
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
Other: Observational
Observational




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



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:   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.
Accepts Healthy Volunteers:   No
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.
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

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: Bethlyn C. Parada 801-505-5181 bcraner@myriad.com

Locations
Show Show 29 study locations
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    
Other Study ID Numbers: ONC-010
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
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
Additional Relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases