Clinical trial NCT06169371: Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
Official title: Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Breast Cancer
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

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

Primary outcomes:
measure: Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84
timeFrame: Day 84
Secondary outcomes:
measure: How many days with Grade 2 or greater of diarrhea in the first month
timeFrame: 1 month
measure: Rate of Grade 3 or greater of diarrhea in the first 3 months
timeFrame: 3 months
measure: Disease Free Survival (DFS)
timeFrame: 1 year
measure: Disease Free Survival (DFS)
timeFrame: 2 years
measure: Overall Survival (OS)
timeFrame: 1 year
measure: Overall Survival (OS)
timeFrame: 2 years
measure: Overall Survival (OS)
timeFrame: 3 years
measure: Subject reported outcomes regarding adverse events
timeFrame: 5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois
state: Illinois
city: Iowa City
country: United States
facility: Iowa Holden Comprehensive Cancer Center
state: Iowa
Study officials:
References: