Breast Cancer
Conditions
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
Detailed description
Dose escalation (DE) was shown to minimize the rates of Grade 3 diarrhea in the setting for HER2+ breast cancer. DE can improve tolerability for drugs such as abemaciclib. 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 In this study, the investigators we will test the hypothesis that gradual up-titration of abemaciclib dose over a course of 2-3 weeks will decrease the rate of G3 or worse diarrhea, permitting more patients to remain at the intended dose when evaluated at day 84
Interventions
DRUGAbemaciclib
Week 1 50mg orally BID
Sponsors
University of Illinois at Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84 | Day 84 | Number of subjects that continue to receive Abemaciclib 150mg BID for 84 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| How many days with Grade 2 or greater of diarrhea in the first month | 1 month | Number of days with Grade 2 or greater in the first month |
| Rate of Grade 3 or greater of diarrhea in the first 3 months | 3 months | Nuber of subjects who experienced Grade 3 or greater by the total number of subjects enrolled |
| Disease Free Survival (DFS) | 1 year | Number of subjects that have DFS from D1 of treatment until the criteria for disease progression as defined by RECIST 1.1 or death |
| Overall Survival (OS) | 1 year | OS is defined as the time from D1 of treatment until death |
| Subject reported outcomes regarding adverse events | 5 years | Toxicity grade as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
Countries
United States
Contacts
CONTACTMichelle Karan
CONTACTVK Gadi, MD, PhD
PRINCIPAL_INVESTIGATORVK Gadi, MD, PhD
University of Illinois at Chicago
Outcome results
None listed