Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI) | NCT06169371

Studies
Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

NCT06169371

Sponsor

University of Illinois at Chicago

Status

Recruiting

Last Update Posted

Jul 7, 2026Actual

Enrollment

50Estimated

Phase

Phase 4

Conditions

Breast Cancer

Interventions

Abemaciclib
Abemaciclib
Abemaciclib

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 28, 2023Actual

Primary Completion Date

Nov 2030Estimated

Completion Date

Nov 2030Estimated

First Submitted Date

Nov 28, 2023

First Submission Date that Met QC Criteria

Dec 5, 2023

First Posted Date

Dec 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2026

Last Update Posted Date

Jul 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single arm adjuvant abemaciclib	Other	Participants will receive adjuvant abemaciclib which will be dose escalated. Abemaciclib will be taken at 50 mg by mouth twice a day during Week 1, 100 mg by mouth twice a day during Week 2, and 150 mg by mouth twice a day starting Week 3.	Drug: Abemaciclib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Abemaciclib	Drug	Week 1 50mg orally BID	Single arm adjuvant abemaciclib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84	Number of subjects that continue to receive Abemaciclib 150mg BID for 84 days	Day 84

Secondary Outcomes

Measure	Description	Time Frame
How many days with Grade 2 or greater of diarrhea in the first month	Number of days with Grade 2 or greater in the first month	1 month
Rate of Grade 3 or greater of diarrhea in the first 3 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michelle Karan	Contact	224-563-7137		makaran2@uic.edu
VK Gadi, MD, PhD	Contact	312-4135309		vkgadi@uic.edu

Overall Officials

Name	Affiliation	Role
VK Gadi, MD, PhD	University of Illinois at Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Illinois	Recruiting	Chicago	Illinois	60612	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases