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RecruitingPhase 4

Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a plan to raise the dose of abemaciclib, given with hormone therapy. It is for people with early-stage breast cancer at high risk of coming back whose cancer uses hormones to grow (HR+) and is HER2-negative.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You can do all or most daily tasks and can care for yourself (ECOG score 0–2).
  • A biopsy confirms early-stage HR-positive, HER2-negative breast cancer, and you have been prescribed abemaciclib as added treatment.
  • You can sign a consent form to join and give permission to share your health information.
  • If you could become pregnant, you must not be pregnant or breastfeeding and must have a negative pregnancy test.
  • The study doctor or their chosen staff member believes you can understand and follow study steps for the whole study.

Who can't join

  • You have a long-term history of diarrhea.
  • You have an active infection that needs medicine that works throughout the body.
  • You have uncontrolled HIV/AIDS or active viral hepatitis, a virus that affects the liver.
  • You are pregnant or breastfeeding.
  • You have had or currently have another cancer that your cancer doctor believes could affect how the study measures treatment safety or how well it works.
  • The lead study doctor decides you have another major health condition that prevents you from joining.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (3)

IA

IL

OH