Can blood tests predict severe diarrhea from breast cancer drug?
NCT ID NCT07490509
First seen Jun 24, 2026 · Last updated Jul 22, 2026 · Updated 3 times
Summary
This study will enroll 235 women with hormone receptor-positive, HER2-negative breast cancer who are taking abemaciclib after surgery. Researchers want to see if higher levels of the drug in the blood are linked to severe diarrhea, a common side effect. By understanding this link, doctors may one day adjust doses to reduce side effects while keeping the drug effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- abemaciclib
- What this could lead to
- If successful, this could lead to personalized dosing of abemaciclib to reduce severe diarrhea while maintaining its cancer-fighting benefits.
- What could go wrong
- This is an observational study, not a treatment trial. It may not find a clear link between drug levels and side effects, and any dosing adjustments would need further testing.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 235 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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.)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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