NCT06169371 Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
| NCT ID | NCT06169371 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Illinois Chicago |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-12-28 |
| Primary Completion | 2030-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2023-12-28 with a primary completion date of 2030-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
VK Gadi, MD, PhD
PRINCIPAL INVESTIGATOR
University of Illinois Chicago
Frequently Asked Questions
Who can join the NCT06169371 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06169371 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06169371 currently recruiting?
Yes, NCT06169371 is actively recruiting participants. Contact the research team at mrussel3@uic.edu for enrollment information.
Where is the NCT06169371 trial being conducted?
This trial is being conducted at Chicago, United States, Iowa City, United States, Columbus, United States.
Who is sponsoring the NCT06169371 clinical trial?
NCT06169371 is sponsored by University of Illinois Chicago. The principal investigator is VK Gadi, MD, PhD at University of Illinois Chicago. The trial plans to enroll 100 participants.
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