Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT06169371
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Dec 28, 2023
Status verified
Jan 2026
Primary completion
Nov 30, 2030
Completion
Nov 30, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Single arm adjuvant abemaciclib
    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.

Primary Outcome Measure

Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84 [ Time Frame: Day 84 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of IllinoisChicagoIllinois60612
Michelle Karan
[email protected]
224-563-7137
VK Gadi, MD, PhD
[email protected]
312-413-5309
Iowa Holden Comprehensive Cancer CenterIowa CityIowa52242
Sneha Phadke, DO
[email protected]
1-319-356-4200
Abigayle Wehrheim
[email protected]
1-319-335-2119
Sneha Phadke, DO (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Robert Wesolowski, MD
[email protected]
614-366-8541
Jenna Cody
[email protected]
800-293-5066
Robert Wesolowski, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Illinois· Chicago, ILIowa Holden Comprehensive Cancer Center· Iowa City, IAOhio State University Comprehensive Cancer Center· Columbus, OH

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