Breast Cancer study: Abemaciclib
Official title Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
ClinicalTrials.gov ID: NCT06169371
What this study is testing
What is Abemaciclib?
An investigational oral medicine being studied for early‑stage hormone‑receptor positive breast cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study looks at whether increasing the dose of abemaciclib while keeping the same treatment schedule can be done safely and how it affects side‑effects and cancer control.
- Who it's for
- Women with early‑stage, hormone‑receptor positive, HER2‑negative breast cancer who are at high risk of the cancer coming back after surgery.
- What's involved
- Participants will take abemaciclib at a higher dose together with their usual hormone therapy. They will have regular clinic visits and blood tests to monitor safety and side‑effects.
- Time commitment
- The trial lasts about 5 years, with visits every few weeks during the first months and then every few months thereafter to check health and treatment tolerance.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Women of childbearing potential must not be pregnant or breast-feeding.
- As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study...
You likely can't join 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 how well it works assessment...
- Other major comorbidity as determined by study PI
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Columbus, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States; Iowa City, Iowa, United States; Columbus, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.