Health TrialsbyHealthPanel

Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Chronic history of diarrhea

Active infection requiring systemic therapy

Uncontrolled HIV/AIDS or active viral hepatitis

Pregnant or nursing

Trial design

Design model

Single group

Treatments tested in this trial

  • Abemaciclib

    Drug

    Week 1 50mg orally BID

  • Abemaciclib

    Drug

    Week 2 100mg orally BID

  • Abemaciclib

    Drug

    Week 3+ 150mg orally BID

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Single arm adjuvant abemaciclibOther 1 intervention

Trial outcomes

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

Time frame
Day 84

Secondary outcomes

1

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

Time frame
1 month
2

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

Nuber of subjects who experienced Grade 3 or greater by the total number of subjects enrolled

Time frame
3 months
3

Disease Free Survival (DFS)

Number of subjects that have DFS from D1 of treatment until the criteria for disease progression as defined by RECIST 1.1 or death

Time frame
1 year
4

Disease Free Survival (DFS)

Number of subjects that have DFS from D1 of treatment until the criteria for disease progression as defined by RECIST 1.1 or death

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

Source ClinicalTrials.gov
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