IRB #

STUDY00017504

Title

MonarchE: Protocol 13Y-MC-JPCF A Randomized, Open-Label, Phase 3 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

Principal Investigator

Jacqueline Vuky

Study Purpose

The purpose of this study is to compare any good and bad effects of using abemaciclib (the study drug) along with the usual adjuvant endocrine therapy to using the usual adjuvant endocrine therapy approach alone. The addition of abemaciclib to the usual endocrine therapy could shrink your cancer/prevent it from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

Medical Condition(s)

High risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer

Eligibility Criteria

Female or male ≥18 years of age
Confirmed HR+, HER2-negative (HER2-), early stage resected invasive breast cancer without evidence of distant metastases.
Must have undergone definitive surgical treatment for the current malignancy

Age Range

18 - 120

Healthy Volunteers Needed

No

Duration of Participation

Your length in time in the study, including the screening, treatment, and follow-up periods, will be about 10 years.

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503 494-1080

Sponsor

Eli Lilly and Company

Recruitment End

12/31/2030

Compensation Provided

No


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