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Abemaciclib + Hormone Therapy for Breast Cancer (BRE-09 Trial)

Phase 4
Recruiting
Research Sponsored by University of Illinois at Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed early-stage HR+HER2- breast cancer documented by biopsy who are prescribed adjuvant abemaciclib
Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This trial is for patients with early-stage breast cancer that has a high risk of coming back. The patients will be given a drug called abemaciclib along with hormone therapy. After the treatment,

Who is the study for?
This trial is for individuals with early-stage HR+HER2- breast cancer who are prescribed adjuvant abemaciclib. Participants must be in good physical condition (ECOG 0-2), able to consent, not pregnant or breastfeeding, and willing to follow study procedures throughout.
What is being tested?
The ADE-MI trial tests if increasing the dose of Abemaciclib can maintain its effectiveness when given alongside standard endocrine therapy for high-risk early-stage breast cancer after initial treatment.
What are the potential side effects?
Abemaciclib may cause diarrhea, fatigue, low white blood cell counts which can increase infection risk, nausea, abdominal pain, decreased appetite and potential harm to an unborn baby.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have early-stage HR+HER2- breast cancer and am prescribed abemaciclib.
Select...
I am not pregnant or breastfeeding, and I have a negative pregnancy test.
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I am able to care for myself and perform daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84
Secondary outcome measures
Disease Free Survival (DFS)
How many days with Grade 2 or greater of diarrhea in the first month
Overall Survival (OS)
+2 more

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Who is running the clinical trial?

University of Illinois at ChicagoLead Sponsor
632 Previous Clinical Trials
1,567,665 Total Patients Enrolled
11 Trials studying Breast Cancer
1,342,334 Patients Enrolled for Breast Cancer
~33 spots leftby Nov 2030
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