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DOSABEMA-Pharmacokinetic model of abemaciclib: correlation with severe diarrhea as the primary toxicity endpoint in patients with hormone receptor-positive localized breast cancer
EU CTIS ID: 2025-521696-31-00
What this study is testing
To determine the relationship between the probability of occurrence of a serious diarrhoeal adverse event (grade 2 and +) and plasma exposure to abemaciclib and its metabolites (M2 and M20), in patients with HR+, HER2- breast cancer at high risk of recurrence receiving adjuvant abemaciclib.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Women aged ≥ 18 with breast cancer of any histology
- Must be affiliated to the social security system or benefit from it through a third party
- Have signed the consent form for the study after reading the information note
- Type Luminous A or B with positive hormone receptors (>10% expression for oestrogen receptor and/or progesterone receptor) and negative or low HER2 epidermal growth factor receptor (as defined by GEFPICS1)
- Stage 2 or stage 3 according to the international classification, translated into the SENORIF recommendation
- Who have undergone complete excision surgery (R0 on the invasive tumour and/or on the ductal entity in situ) after neoadjuvant or non-neoadjuvant chemotherapy;
You likely can't join if
- Previous treatment with an anti-CDK4/6 (palbociclib, ribociclib, abemaciclib) for any indication.
- History of invasive cancer of any histology in the last 2 years, with the exception of superficial skin tumours, not considered to be in complete remission.
- Presence of functional or inflammatory colorectal disease (Crohn's disease, ulcerative colitis) causing chronic diarrhoea (as defined by the WHO as at least 3 bowel movements per day and/or liquid stools for at least 1 month).
- Patients who have undergone total gastrectomy or suffer from short bowel syndrome
- Patients unable to sign the consent form for social reasons (illiteracy) or physical 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.
See the full eligibility criteria
Who can join
- Women aged ≥ 18 with breast cancer of any histology
- Must be affiliated to the social security system or benefit from it through a third party
- Have signed the consent form for the study after reading the information note
- Type Luminous A or B with positive hormone receptors (>10% expression for oestrogen receptor and/or progesterone receptor) and negative or low HER2 epidermal growth factor receptor (as defined by GEFPICS1)
- Stage 2 or stage 3 according to the international classification, translated into the SENORIF recommendation
- Who have undergone complete excision surgery (R0 on the invasive tumour and/or on the ductal entity in situ) after neoadjuvant or non-neoadjuvant chemotherapy;
- Defined as being at high risk of recurrence according to the Monarch-E study, at the initial diagnosis of the disease: either ≥ 4 axillary nodes involved (involvement ≥N2), or 1-3 axillary nodes involved (involvement ≥N1) associated with an Elston Ellis grade 3 or a tumour ≥ 5 cm
- Initiation of adjuvant abemaciclib therapy combined with hormone therapy
- Patient ECOG performans status between 0 ≤2
- Patient with a PNN count defined as normal prior to the first dose of abemaciclib, i.e. an absolute PNN count ≥ 1500/mm3 (≥ 1.5 x 109/L) without GCSF injection within 15 days prior to the biological work-up, as well as a platelet count ≥ 100 000/mm3 and a haemoglobin level ≥ 8g/dL.
- Patient with the psychological and mental capacity to understand the protocol and sign the consent form alone
What rules you out
- Previous treatment with an anti-CDK4/6 (palbociclib, ribociclib, abemaciclib) for any indication.
- History of invasive cancer of any histology in the last 2 years, with the exception of superficial skin tumours, not considered to be in complete remission.
- Presence of functional or inflammatory colorectal disease (Crohn's disease, ulcerative colitis) causing chronic diarrhoea (as defined by the WHO as at least 3 bowel movements per day and/or liquid stools for at least 1 month).
- Patients who have undergone total gastrectomy or suffer from short bowel syndrome
- Patients unable to sign the consent form for social reasons (illiteracy) or physical 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 contraception (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.)
- Hypersensitivity to any of the excipients listed in section 6.1 of the abemaciclib (Verzenios) summary of product characteristics.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.