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Clinical Trial NCT07490509 (DOSABEMA) for Abemaciclib, Abemaciclib-related Diarrhea, Breast Cancer is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Pharmacokinetic Model of Abemaciclib: Correlation With Severe Diarrhea as the Primary Toxicity Endpoint in Patients With Localized Hormone Receptor-positive Breast Cancer (DOSABEMA) Phase 4 235 Real-World Evidence

Not yet recruiting
Clinical Trial NCT07490509 (DOSABEMA) is designed to study Treatment for Abemaciclib, Abemaciclib-related Diarrhea, Breast Cancer. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on 1 April 2026 until the study accrues 235 participants. Led by Poitiers University Hospital, this study is expected to complete by 1 April 2029. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
Brief 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. However, despite the combination's acceptable safety profile, 38% of patients experience grade 3 or hig...Show More
Official Title

Pharmacokinetic Model of Abemaciclib: Correlation With Severe Diarrhea as the Primary Toxicity Endpoint in Patients With Localized Hormone Receptor-positive Breast Cancer

Conditions
AbemaciclibAbemaciclib-related DiarrheaBreast Cancer
Other Study IDs
  • DOSABEMA
  • 2025-521696-31-00
  • 2025-521696-31-00 (EU Study (CTIS) Number)
NCT ID Number
NCT07490509
Start Date (Actual)
2026-04
Last Update Posted
2026-03-24
Completion Date (Estimated)
2029-04
Enrollment (Estimated)
235
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPatient treated with abemaciclib
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.
Blood samples for PK
Three additional blood tubes will be collected during routine biological tests.
Questionnaire
EQ-5D-5L
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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).
From enrollment to 6 months of treatment
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
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.
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.
From enrollment to 6 months of treatment
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • 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
  • 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

  • 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.)
Poitiers University Hospital logoPoitiers University Hospital
Study Central Contact
Contact: Matthieu BAINAUD, MD, 05 49 44 44 44, [email protected]
Contact: Celine ABONNEAU, Project manager
No location data.