Using abemaciclib with endocrine therapy for early-stage breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase IV trial investigates the use of abemaciclib in combination with endocrine therapy for patients with high-risk early-stage HR+HER2- breast cancer. The study aims to gradually increase the dose of abemaciclib over 2-3 weeks to reduce the incidence of severe diarrhea, allowing more patients to maintain the intended dosage. Participants will continue the combination therapy at the discretion of their healthcare providers after the intervention period. The trial is designed to assess the tolerability and effectiveness of this dosing strategy.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Illinois
  Chicago, Illinois, United States Recruiting
• Iowa Holden Comprehensive Cancer Center
  Iowa City, Iowa, United States Recruiting
• Ohio State University Comprehensive Cancer Center
  Columbus, Ohio, United States Recruiting

Study contacts

• Principal investigator: VK Gadi, MD, PhD — University of Illinois Chicago
• Study coordinator: Meredith Russell
• Email: mrussel3@uic.edu
• Phone: 312-355-5112

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.