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Eli Lilly/NSABP B-58

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer (monarchE)

Status:

Recruiting | Phase III 

Official Title: 

A Randomized, Open-Label, Phase III Study of Abemaciclib combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative Breast Cancer (MonarchE- I3Y-MC-JPCF- NSABP B-58)

Study Purpose: 

To determine if adding abemaciclib to standard adjuvant endocrine therapy can prevent or lengthen the time to recurrence when compared to endocrine therapy alone.

Interventions:    

  • Targeted Therapy: Abemaciclib (Verzenio)   
  • Lab Biomarker Analysis
  • Quality of Life questionnaires
  • ARM I: Abemaciclib for 2 years and endocrine therapy for at least 5 years 
  • ARM II: Endocrine therapy alone for at least 5 years

After completion of study therapy, patients are followed up every 6 months for 5 years from registration, then every year for 10 years from registration.

Key Participation Requirements

Gender: 

Male or Female

Age: 

19 years and older

Diagnosis: 

Breast cancer patients who have had surgery and whose cancer has higher risk features (i.e. – positive lymph nodes, high grade, high Ki67 score, and/or large size)

Cell Types: 

Must be ER and/or PR positive and Her-2 negative

Prior Therapy: 

Patients must have had surgery and completed chemotherapy (before or after surgery). They may or may not have had radiation.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

Eli Lilly/NSABP B-58 

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!