Breast CancerPhase 4BRE-09NCT06169371
Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
A Phase 4 study testing Abemaciclib in people with Breast Cancer, run by University of Illinois Chicago at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Abemaciclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Dec 2023to Nov 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Illinois
Chicago, Illinois, 60612
Meredith Russell, 312-355-5112, mrussel3@uic.edu
VK Gadi, MD, PhD, 312-413-5309, vkgadi@uic.edu
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Robert Wesolowski, MD, 614-366-8541, Robert.Wesolowski@osumc.edu
Jenna Cody, 614-293-7551, jenna.cody@osumc.edu
- Recruiting
Iowa Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Sneha Phadke, DO, 319-356-4200, sneha-phadke@uiowa.edu
Olivia Barritt, 1-319-356-4200, Olivia-Barritt@uiowa.edu
About this study
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
Read the 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
- Conditions
- Breast Cancer
- Being tested
- Abemaciclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbemaciclibDrug
Week 1 50mg orally BID
AbemaciclibDrug
Week 2 100mg orally BID
AbemaciclibDrug
Week 3+ 150mg orally BID
| Study group | Role | What they receive |
|---|---|---|
| Single arm adjuvant abemaciclib | Other | Participants will receive adjuvant abemaciclib which will be dose escalated. Abemaciclib will be taken at 50 mg by mouth twice a day during Week 1, 100 mg by mouth twice a day during Week 2, and 150 mg by mouth twice a day starting Week 3. Receives: Drug: Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84
Number of subjects that continue to receive Abemaciclib 150mg BID for 84 days
Measured: Day 84
Secondary outcomes (8)
How many days with Grade 2 or greater of diarrhea in the first month
Number of days with Grade 2 or greater in the first month
Measured: 1 month
Rate of Grade 3 or greater of diarrhea in the first 3 months
Nuber of subjects who experienced Grade 3 or greater by the total number of subjects enrolled
Measured: 3 months
Disease Free Survival (DFS)
Number of subjects that have DFS from D1 of treatment until the criteria for disease progression as defined by RECIST 1.1 or death
Measured: 1 year
Disease Free Survival (DFS)
Number of subjects that have DFS from D1 of treatment until the criteria for disease progression as defined by RECIST 1.1 or death
Measured: 2 years
Overall Survival (OS)
OS is defined as the time from D1 of treatment until death
Measured: 1 year
Overall Survival (OS)
OS is defined as the time from D1 of treatment until death
Measured: 2 years
Overall Survival (OS)
OS is defined as the time from D1 of treatment until death
Measured: 3 years
Subject reported outcomes regarding adverse events
Toxicity grade as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start28 Dec 2023
- Primary completionNov 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vijayakrishna Krishnamurthy Gadi, University of Illinois Chicago
- Investigators
- VK Gadi, MD, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169371
- Sponsor's protocol ID
- 2023-0433
- Acronym
- BRE-09
- Status last verified
- Nov 2026
- First submitted
- 28 Nov 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)
- ClinicalTrials.gov ID
- NCT06169371
- Acronym / sponsor ID
- BRE-09 / 2023-0433
- Conditions
- Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 28 Dec 2023 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm adjuvant abemaciclib | Other | Drug: AbemaciclibParticipants will receive adjuvant abemaciclib which will be dose escalated. Abemaciclib will be taken at 50 mg by mouth twice a day during Week 1, 100 mg by mouth twice a day during Week 2, and 150 mg by mouth twice a day starting Week 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbemaciclibWeek 1 50mg orally BID | Drug | Single arm adjuvant abemaciclib |
| AbemaciclibWeek 2 100mg orally BID | Drug | Single arm adjuvant abemaciclib |
| AbemaciclibWeek 3+ 150mg orally BID | Drug | Single arm adjuvant abemaciclib |
Primary outcome
Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84
Time frame: Day 84
Number of subjects that continue to receive Abemaciclib 150mg BID for 84 days
8 secondary outcomes
How many days with Grade 2 or greater of diarrhea in the first month
Time frame: 1 month
Rate of Grade 3 or greater of diarrhea in the first 3 months
Time frame: 3 months
Disease Free Survival (DFS)
Time frame: 1 year
Disease Free Survival (DFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 1 year
Overall Survival (OS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 3 years
Subject reported outcomes regarding adverse events
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
VK Gadi, MD, PhD principal investigator
University of Illinois Chicago
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abemaciclib in people with Breast Cancer, run by University of Illinois Chicago at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meredith Russell (312-355-5112, mrussel3@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase the proportion of subjects on FDA approved dose of Abemaciclib (150mg BID) at day 84 (time frame: Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.