Study on Adjusting Abemaciclib Dose to Maintain Treatment Intensity for High-Risk Early-Stage HR+HER2- Breast Cancer

Sponsor: University of Illinois at Chicago

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06169371

Provider View

This clinical trial is testing a method to gradually increase the dose of abemaciclib, a medication used with hormone therapy, to reduce side effects like severe diarrhea in patients with high-risk early-stage HR+HER2- breast cancer.

Patient Parameters

Program Overview

The study aims to find out if slowly increasing the dose of abemaciclib over 3-4 weeks can help reduce severe diarrhea, allowing more patients to stay on the intended dose. This approach is being tested in patients with high-risk early-stage HR+HER2- breast cancer who are receiving abemaciclib along with hormone therapy after their initial treatment.

Description

This study is focused on patients with high-risk early-stage HR+HER2- breast cancer. It explores whether gradually increasing the dose of abemaciclib, a drug used alongside hormone therapy, can help reduce the occurrence of severe diarrhea. This method, known as dose escalation, has been shown to improve how well patients tolerate similar treatments.

Participants in this study will start with a lower dose of abemaciclib, which will be gradually increased over 3-4 weeks. The goal is to see if this approach allows more patients to stay on the full intended dose by reducing side effects. After the study period, patients may continue with the combination of abemaciclib and hormone therapy based on their doctor's advice.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of early-stage HR+HER2- breast cancer and are prescribed abemaciclib as part of their treatment.
  • Be in good general health with an ECOG performance status of 0 to 2, meaning fully active or able to carry out light work.
  • Be able to understand and agree to the study procedures and provide written consent.
  • Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.

Exclusion Criteria

  • Have a long-term history of diarrhea.
  • Have an active infection that requires treatment.
  • Have uncontrolled HIV/AIDS or active hepatitis.
  • Be pregnant or nursing.
  • Have another cancer or health condition that could interfere with the study, as determined by the study doctor.

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