NCT06169371

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4 breast-cancer

Timeline
54mo left

Started Dec 2023

Longer than P75 for phase_4 breast-cancer

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Dec 2023Nov 2030

First Submitted

Initial submission to the registry

November 28, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

December 28, 2023

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2030

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

6.8 years

First QC Date

November 28, 2023

Last Update Submit

January 12, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 (8)

  • How many days with Grade 2 or greater of diarrhea in the first month

    1 month

  • Rate of Grade 3 or greater of diarrhea in the first 3 months

    3 months

  • Disease Free Survival (DFS)

    1 year

  • Disease Free Survival (DFS)

    2 years

  • Overall Survival (OS)

    1 year

  • +3 more secondary outcomes

Study Arms (1)

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

AbemaciclibDRUG

Week 1 50mg orally BID

Single arm adjuvant abemaciclib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

Iowa Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

abemaciclib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • VK Gadi, MD, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Karan

CONTACT

224-563-7137makaran2@uic.edu

VK Gadi, MD, PhD

CONTACT

312-4135309vkgadi@uic.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 13, 2023

Study Start

December 28, 2023

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2030

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)