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

Sponsor
Poitiers University Hospital
Study ID
NCT07490509
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Blood samples for PK — BIOLOGICAL
    Three additional blood tubes will be collected during routine biological tests.
  • Questionnaire — OTHER
    EQ-5D-5L

Study Details

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.

Key Dates

First listed
Mar 24, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
235 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patient 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.

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 ]

Central Contacts

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