AbemaciclibPhase 4DOSABEMANCT07490509
Pharmacokinetic Model of Abemaciclib: Correlation With Severe Diarrhea as the Primary Toxicity Endpoint in Patients With Localized Hormone Receptor-positive Breast Cancer
A Phase 4 study testing Blood samples for PK and Questionnaire in people with Abemaciclib and Abemaciclib-related Diarrhea, run by Poitiers University Hospital.
Trial summary
Remarkable progress has recently been made in the treatment of locally advanced, hormone receptor-positive, HER2-negative breast cancer with a high risk of recurrence, thanks to the addition of abemaciclib to endocrine therapy. This combination has led to a significant improvement in invasive disease-free survival. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abemaciclib, Abemaciclib-related Diarrhea, Breast Cancer
- What is being tested?
- Blood samples for PK and Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 235 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2029
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥ 18 years old
- Having breast cancer of all histologies combined
- Type Luminal A or B with positive hormone receptors (>10% expression for estrogen receptor and/or progesterone receptor) and HER2 negative or low epidermal growth receptor (according to GEFPICS1 definition)
- Stage 2 or stage 3 according to the international classification, translated into the SENORIF recommendation
- Having undergone complete excision surgery (R0 on the invasive tumor and/or on the ductal entity in situ) after neoadjuvant chemotherapy or not
- Defined as high risk of recurrence according to the Monarch-E study, at initial diagnosis of the disease: either ≥ 4 affected axillary lymph nodes (≥N2 involvement), or 1-3 affected axillary lymph nodes (≥N1 involvement) associated with an Elston Ellis grade 3 or a tumor ≥ 5 cm
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- Initiation of adjuvant treatment with abemaciclib in combination with hormone therapy
- Patient ECOG performance status between 0 and 2
- Patients with a neutrophil count (NCC) defined as normal prior to the first dose of abemaciclib, i.e., an absolute NCC ≥ 1500/ mm3 (≥ 1.5 x 109/L) without granulocyte colony-stimulating factor (GCSF) injection within 15 days prior to laboratory testing, as well as a platelet count ≥ 100,000/mm3 and a hemoglobin level ≥ 8g/dL.
- Patient with the psychological and mental capacity to understand the protocol and sign the consent form independently
- Must be affiliated with the social security system or receive benefits through a third party
- Have signed the study consent form after reading the information sheet
Who cannot join
- Hypersensitivity to any of the excipients listed in section 6.1 of the abemaciclib (Verzenios) SPC
- History of treatment with an anti-CDK4/6 (palbociclib, ribociclib, abemaciclib) for any indication
- History of invasive cancer of any histology within the last 2 years, except for superficial skin tumors, not considered to be in complete remission
- Presence of functional or inflammatory colorectal disease (Crohn's disease, ulcerative colitis) causing chronic diarrhea (as defined by the WHO as at least 3 bowel movements per day and/or liquid stools for at least 1 month)
- Patient who has undergone total gastrectomy or suffers from short bowel syndrome
- Patient unable to sign the consent form for societal reasons (illiteracy) or somatic reasons (central nervous system disease).
- Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by judicial or administrative decision, persons staying in a health or social care institution, adults under legal protection, and finally patients in emergency situations.
- Pregnant or breastfeeding women, women of childbearing age who are not using highly effective contraceptive methods (e.g., double-barrier contraception) during treatment and for at least 3 weeks after stopping treatment (The duration of contraception required for concomitant treatments, if any, should also be taken into account.)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Celine ABONNEAU, Project manager contact
About this study
Remarkable progress has recently been made in the treatment of locally advanced, hormone receptor-positive, HER2-negative breast cancer with a high risk of recurrence, thanks to the addition of abemaciclib to endocrine therapy. This combination has led to a significant improvement in invasive disease-free survival. However, despite the combination's acceptable safety profile, 38% of patients experience grade 3 or higher diarrhea, and 23% experience grade 3 or higher neutropenia. This toxicity can lead to the premature discontinuation of treatment, limiting the benefits of this molecule. As with all oral therapies, the pharmacokinetics of abemaciclib lie at the intersection of efficacy and toxicity and can be modified by several external factors.
The hypothesis of the study is that abemaciclib's toxicity is correlated with its plasma levels and that its concentration is modified by certain patient characteristics. To this end, a pharmacokinetic model of abemaciclib could be developed using a prospective, multicenter, real-world blood dosage study. This study will describe the relationship between abemaciclib concentration and diarrhea and severe neutropenia, as classified by CTCAE, as well as potential clinical and drug interactions.
It is hoped that this model demonstrates the importance of monitoring abemaciclib concentrations. This could lead to a therapeutic trial in which the abemaciclib dose is adjusted according to concentration to limit toxicity while maintaining efficacy.
- Conditions
- Abemaciclib, Abemaciclib-related Diarrhea, Breast Cancer
- Being tested
- Blood samples for PK, Questionnaire
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for PKBiological
Three additional blood tubes will be collected during routine biological tests.
QuestionnaireOther
EQ-5D-5L
| Study group | Role | What they receive |
|---|---|---|
| Patient treated with abemaciclib | Experimental | All new patients who benefit from the addition of abemaciclib to adjuvant hormone therapy and who meet the inclusion criteria may be included in the study.
This single-arm study involves enrolled patients undergoing blood tests and completing self-administered questionnaires at various points during their treatment. Receives: Biological: Blood samples for PK; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the relationship between the probability of occurrence of a severe diarrheal adverse event and plasma exposure to abemaciclib and its metabolites in patients with RH+HER2- breast cancer at high risk of recurrence receiving adjuvant abemaciclib
The probability of severe diarrhea (grades 2, 3, and 4 according to CTCAE v5.0) occurring based on exposure to abemaciclib and its metabolites (M2 and M20) will be characterized by a joint mixed-effects model combining longitudinal, pharmacokinetic (continuous type), and toxicity data (survival type).
Measured: From enrollment to 6 months of treatment
Secondary outcomes (3)
Determine the relationship between the occurrence of severe neutropenic adverse events and plasma exposure to abemaciclib and its metabolites in patients with HR+, HER2- breast cancer at high risk of recurrence who are receiving adjuvant abemaciclib
The probability of severe neutropenia (grades 3 and 4 according to the current CTCAE) occurring based on exposure to abemaciclib and its metabolites (M2 and M20) will be characterized by a joint mixed-effects model combining longitudinal pharmacokinetic (continuous) and pharmacodynamic (neutrophil concentration, continuous) data. pharmacokinetic (continuous type) and pharmacodynamic (concentration of neutrophils, continuous type) data.
Measured: From enrollment to 6 months of treatment
Develop a joint pharmacokinetic/pharmacodynamic (PK/PD) mixed-effects model that includes data on abemaciclib and metabolite concentrations, neutrophil counts, and severe diarrhea
The mixed-effects PK/PD model was validated using standard diagnostic tools, such as data fit diagnostic plots, visual predictive checks, estimation accuracy, and shrinkage.
Measured: From enrollment to 6 months of treatment
Evaluate the free fraction (fu) of abemaciclib concentrations at different protocol treatment times in the target population (only at Poitiers University Hospital)
Free concentrations of abemaciclib will only be measured for patients enrolled at Poitiers University Hospital.
The "fu" of abemaciclib concentrations will be modeled within the mixed-effects PK/PD model and any correlation with clinical-biological covariates will be evaluated.
This exploratory analysis will only be performed on patients enrolled at Poitiers University Hospital for pre-analytical technical reasons. The technique has only been validated on the mass spectrometer in the pharmacology department at Poitiers University Hospital.
Measured: From enrollment to 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbemaciclibStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Model description
- pharmacokinetic model
- Masking
- None (open label)
- Enrolment
- 235 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490509
- Sponsor's protocol ID
- 2025-521696-31-00
- Other IDs
- 2025-521696-31-00, 2025
- Acronym
- DOSABEMA
- Status last verified
- Jul 2026
- First submitted
- 18 Mar 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Model of Abemaciclib: Correlation With Severe Diarrhea as the Primary Toxicity Endpoint in Patients With Localized Hormone Receptor-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07490509
- Acronym / sponsor ID
- DOSABEMA / 2025-521696-31-00
- Conditions
- Abemaciclib, Abemaciclib-related Diarrhea, Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 235 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 24 Mar 2026 (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.
Remarkable progress has recently been made in the treatment of locally advanced, hormone receptor-positive, HER2-negative breast cancer with a high risk of recurrence, thanks to the addition of abemaciclib to endocrine therapy. This combination has led to a significant improvement in invasive disease-free survival. However, despite the combination's acceptable safety profile, 38% of patients experience grade 3 or higher diarrhea, and 23% experience grade 3 or higher neutropenia. This toxicity can lead to the premature discontinuation of treatment, limiting the benefits of this molecule. As with all oral therapies, the pharmacokinetics of abemaciclib lie at the intersection of efficacy and toxicity and can be modified by several external factors.
The hypothesis of the study is that abemaciclib's toxicity is correlated with its plasma levels and that its concentration is modified by certain patient characteristics. To this end, a pharmacokinetic model of abemaciclib could be developed using a prospective, multicenter, real-world blood dosage study. This study will describe the relationship between abemaciclib concentration and diarrhea and severe neutropenia, as classified by CTCAE, as well as potential clinical and drug interactions.
It is hoped that this model demonstrates the importance of monitoring abemaciclib concentrations. This could lead to a therapeutic trial in which the abemaciclib dose is adjusted according to concentration to limit toxicity while maintaining efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pharmacokinetic model
| Arm | Type | Receives |
|---|---|---|
| Patient treated with abemaciclib | Experimental | Biological: Blood samples for PK, Other: QuestionnaireAll new patients who benefit from the addition of abemaciclib to adjuvant hormone therapy and who meet the inclusion criteria may be included in the study. This single-arm study involves enrolled patients undergoing blood tests and completing self-administered questionnaires at various points during their treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Women ≥ 18 years old
- Having breast cancer of all histologies combined
- Type Luminal A or B with positive hormone receptors (>10% expression for estrogen receptor and/or progesterone receptor) and HER2 negative or low epidermal growth receptor (according to GEFPICS1 definition)
- Stage 2 or stage 3 according to the international classification, translated into the SENORIF recommendation
- Having undergone complete excision surgery (R0 on the invasive tumor and/or on the ductal entity in situ) after neoadjuvant chemotherapy or not
Key exclusion criteria (8 listed)
- Hypersensitivity to any of the excipients listed in section 6.1 of the abemaciclib (Verzenios) SPC
- History of treatment with an anti-CDK4/6 (palbociclib, ribociclib, abemaciclib) for any indication
- History of invasive cancer of any histology within the last 2 years, except for superficial skin tumors, not considered to be in complete remission
- Presence of functional or inflammatory colorectal disease (Crohn's disease, ulcerative colitis) causing chronic diarrhea (as defined by the WHO as at least 3 bowel movements per day and/or liquid stools for at least 1 month)
- Patient who has undergone total gastrectomy or suffers from short bowel syndrome
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 |
|---|---|---|
| Blood samples for PKThree additional blood tubes will be collected during routine biological tests. | Biological | Patient treated with abemaciclib |
| QuestionnaireEQ-5D-5L | Other | Patient treated with abemaciclib |
Primary outcome
Determine the relationship between the probability of occurrence of a severe diarrheal adverse event and plasma exposure to abemaciclib and its metabolites in patients with RH+HER2- breast cancer at high risk of recurrence receiving adjuvant abemaciclib
Time frame: From enrollment to 6 months of treatment
The probability of severe diarrhea (grades 2, 3, and 4 according to CTCAE v5.0) occurring based on exposure to abemaciclib and its metabolites (M2 and M20) will be characterized by a joint mixed-effects model combining longitudinal, pharmacokinetic (continuous type), and toxicity data (survival type).
3 secondary outcomes
Determine the relationship between the occurrence of severe neutropenic adverse events and plasma exposure to abemaciclib and its metabolites in patients with HR+, HER2- breast cancer at high risk of recurrence who are receiving adjuvant abemaciclib
Time frame: From enrollment to 6 months of treatment
Develop a joint pharmacokinetic/pharmacodynamic (PK/PD) mixed-effects model that includes data on abemaciclib and metabolite concentrations, neutrophil counts, and severe diarrhea
Time frame: From enrollment to 6 months of treatment
Evaluate the free fraction (fu) of abemaciclib concentrations at different protocol treatment times in the target population (only at Poitiers University Hospital)
Time frame: From enrollment to 6 months of treatment
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 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Celine ABONNEAU, Project manager contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood samples for PK and Questionnaire in people with Abemaciclib and Abemaciclib-related Diarrhea, run by Poitiers University Hospital.
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 12 inclusion and 8 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: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Matthieu BAINAUD, MD (05 49 44 33 89, dosabema@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the relationship between the probability of occurrence of a severe diarrheal adverse event and plasma exposure to abemaciclib and its metabolites in patients with RH+HER2- breast cancer at high risk of recurrence receiving adjuvant abemaciclib (time frame: From enrollment to 6 months of treatment). 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 21 Jul 2026.