No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
University of Illinois at Chicago · Other
Who this trial is looking for
This trial is looking for women with early-stage HR+HER2- breast cancer who can receive a treatment called abemaciclib along with hormone therapy. Participants will take these treatments and may continue based on their doctor's advice.
Are You a Good Fit for This Trial?
You may be able to join if
I have early-stage HR+HER2- breast cancer.
I can give written consent for my health information to be used.
I am not pregnant or breastfeeding.
I have an ECOG performance status of 0 to 2.
I understand and can follow the study procedures.
You may not be able to join if
I have a chronic history of diarrhea.
I have an active infection that needs treatment.
I have uncontrolled HIV/AIDS or active viral hepatitis.
I am pregnant or nursing.
I have another cancer that could affect the study.
I have other significant health issues as determined by the study doctor.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This is a post-marketing single arm, phase IV trial in which patients with high-risk early-stage HR+HER2- breast cancer will receive adjuvant abemaciclib in combination with endocrine therapy (ET) After study intervention, participants will remain on combination abemaciclib + ET at the discretion of their treating providers
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
Inclusion Criteria:
* ECOG 0-2
* Histologically confirmed early-stage HR+HER2- breast cancer documented by biopsy who are prescribed adjuvant abemaciclib
* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional …
Inclusion Criteria:
* ECOG 0-2
* Histologically confirmed early-stage HR+HER2- breast cancer documented by biopsy who are prescribed adjuvant abemaciclib
* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
* Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
* As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
Exclusion Criteria:
* Chronic history of diarrhea
* Active infection requiring systemic therapy
* Uncontrolled HIV/AIDS or active viral hepatitis
* Pregnant or nursing
* Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
* Other major comorbidity as determined by study PI
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