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Patients with primary invasive ER+ HER2- breast cancer for Breast Cancer

N/A
Waitlist Available
Led By Joyce O'Shaunessey, MD
Research Sponsored by Myriad Genetic Laboratories, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

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.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate DRFS of women 5-10 years post diagnosis with ER+, HER2-breast cancer who are low risk according to their EPclin scores
Secondary outcome measures
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 DRFS between years 5 and 10 post-diagnosis in women classified as low risk according to their EPclin who received extended endocrine therapy
Evaluate adherence to EndoPredict® test results when making decisions regarding extended endocrine therapy
+2 more
Other outcome measures
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.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients with primary invasive ER+ HER2- breast cancerExperimental Treatment1 Intervention
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

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Who is running the clinical trial?

Myriad Genetic Laboratories, Inc.Lead Sponsor
31 Previous Clinical Trials
13,783 Total Patients Enrolled
2 Trials studying Breast Cancer
1,837 Patients Enrolled for Breast Cancer
Joyce O'Shaunessey, MDPrincipal InvestigatorUS Oncology
~139 spots leftby Sep 2025
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