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Recruiting NCT06169371

Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Phase IV Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Abemaciclib, Abemaciclib, Abemaciclib.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

Dose escalation (DE) was shown to minimize the rates of Grade 3 diarrhea in the setting for HER2+ breast cancer. DE can improve tolerability for drugs such as abemaciclib. 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

In this study, the investigators we will test the hypothesis that gradual up-titration of abemaciclib dose over a course of 2-3 weeks will decrease the rate of G3 or worse diarrhea, permitting more patients to remain at the intended dose when evaluated at day 84

Interventions

  • Drug Abemaciclib
    Week 1 50mg orally BID
  • Drug Abemaciclib
    Week 2 100mg orally BID
  • Drug Abemaciclib
    Week 3+ 150mg orally BID

Primary outcome measures

  • Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84 [Time frame: Day 84]
Secondary outcome measures (8)
  • How many days with Grade 2 or greater of diarrhea in the first month [Time frame: 1 month]
  • Rate of Grade 3 or greater of diarrhea in the first 3 months [Time frame: 3 months]
  • Disease Free Survival (DFS) [Time frame: 1 year]
  • Disease Free Survival (DFS) [Time frame: 2 years]
  • Overall Survival (OS) [Time frame: 1 year]
  • Overall Survival (OS) [Time frame: 2 years]
  • Overall Survival (OS) [Time frame: 3 years]
  • Subject reported outcomes regarding adverse events [Time frame: 5 years]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • University of Illinois — Chicago
  • Iowa Holden Comprehensive Cancer Center — Iowa City
  • Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT06169371 · 2023-0433

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗