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
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
Treatments tested in this trial
- Abemaciclib
- Abemaciclib
- Abemaciclib
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov