Pharmacokinetic Model of Abemaciclib: Correlation With Severe Diarrhea as the Primary Toxicity Endpoint in Patients With Localized Hormone Receptor-positive Breast Cancer
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
You may not be if
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.)
Clareo Health | Pharmacokinetic Model of Abemaciclib: Correlation With Severe Diarrhea as the Primary Toxicity Endpoint in Patients With Localized Hormone Receptor-positive Breast Cancer
