[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"abemaciclib-related-diarrhea\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:abemaciclib-related-diarrhea":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100613316","observational-study-of-gut-microbiota-in-abemaciclib-treated-patients-with-and-without-diarrhea-100613316",false,"NCT07264998","Observational Study of Gut Microbiota in Abemaciclib-Treated Patients With and Without Diarrhea","Gut Microbiota Changes in Breast Cancer Patients Treated With Abemaciclib and Correlation With Drug-Induced Diarrhea: An Observational Cohort Study","Inclusion Criteria:\n\n1. Aged 18 to 75 years.\n2. Diagnosed with hormone receptor-positive (HR⁺) breast cancer.\n3. Currently receiving treatment with Abemaciclib (either as monotherapy or in combination with endocrine therapy) for a duration of at least 2 weeks.\n4. Willing and able to provide written informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. History of major gastrointestinal diseases, such as inflammatory bowel disease, Crohn's disease, ulcerative colitis, or intestinal obstruction, or having undergone major gastrointestinal surgery.\n2. Recent use (within 1 month) of antibiotics, probiotics, or traditional Chinese medicine that may alter gut function.\n3. Pregnant or lactating women.\n4. Unwilling to provide informed consent or considered by the investigator to be unsuitable for the study for any other reason.","ALL","18 Years","75 Years",{"count":20,"type":21},60,"ESTIMATED","OBSERVATIONAL","Why is this study being done? Many patients with a type of breast cancer (called HR-positive) take a medicine called Abemaciclib. While this medicine is effective, a very common side effect is diarrhea, which can be severe enough to disrupt treatment and reduce quality of life. The reason why some patients get diarrhea and others do not is not well understood. This study aims to investigate whether the natural bacteria living in the gut (known as the gut microbiome) play a role in this side effect. Researchers will compare the gut bacteria of patients who develop diarrhea with those who do not.\n\nWhat will happen in the study? This is an observational study, which means that patients will receive their normal cancer treatment and will not be given any new or experimental drugs as part of this initial phase.\n\n* Patients who are already being treated with Abemaciclib will be invited to join.\n* They will be placed into one of two groups: those who experience diarrhea and those who do not.\n* Participants will be asked to provide stool (feces) samples and may also provide optional blood samples at specific times during their treatment.\n* Researchers will analyze these samples in the lab to study the types and functions of the gut bacteria.\n\nWho can participate?\n\n* Adult women (aged 18-75) diagnosed with HR-positive breast cancer.\n* Currently receiving treatment with Abemaciclib for at least 2 weeks.\n* Must be willing to provide informed consent and follow the study procedures.\n\nWhat are the potential benefits? Participants will not receive any direct medical benefit from taking part in this study. However, the information learned may help researchers better understand why diarrhea occurs and, in the future, could lead to new ways to prevent or treat this side effect for other cancer patients.\n\nHow is privacy protected? All personal information and samples collected will be de-identified using a unique code. This means that the data used for analysis cannot be directly linked back to the participant's identity. All data is stored securely according to strict ethical guidelines.",[25,26,27,28,29,30,31],"Breast Neoplasms","Hormone Receptor-Positive Breast Cancer","Abemaciclib","Abemaciclib-related Diarrhea","Drug-induced Diarrhea","Gastrointestinal Microbiome (Focus)","Microbiome",[27,33,34,31,35,36,37],"Hormone receptor-positive breast cancer","Drug-induced diarrhea","Gastrointestinal microbiome","Microbiome biomarkers","Abemaciclib-related diarrhea","RECRUITING","2026-04-01",{"date":41,"type":42},"2026-04-03","ACTUAL",{"date":44,"type":42},"2025-12-21",{"date":46,"type":21},"2026-07",{"name":48,"class":49},"Hubei Cancer Hospital","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":58,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100630656","phase-4-pharmacokinetic-model-of-abemaciclib-correlation-with-severe-diarrhea-as-the-primary-toxicity-endpoint-in-patients-with-localized-hormone-receptor-positive-breast-cancer-100630656","NCT07490509","Pharmacokinetic Model of Abemaciclib: Correlation With Severe Diarrhea as the Primary Toxicity Endpoint in Patients With Localized Hormone Receptor-positive Breast Cancer","DOSABEMA","Inclusion Criteria:\n\n* Women ≥ 18 years old\n* Having breast cancer of all histologies combined\n* Type Luminal A or B with positive hormone receptors (\\>10% expression for estrogen receptor and\u002For progesterone receptor) and HER2 negative or low epidermal growth receptor (according to GEFPICS1 definition)\n* Stage 2 or stage 3 according to the international classification, translated into the SENORIF recommendation\n* Having undergone complete excision surgery (R0 on the invasive tumor and\u002For on the ductal entity in situ) after neoadjuvant chemotherapy or not\n* 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\n* Initiation of adjuvant treatment with abemaciclib in combination with hormone therapy\n* Patient ECOG performance status between 0 and 2\n* Patients with a neutrophil count (NCC) defined as normal prior to the first dose of abemaciclib, i.e., an absolute NCC ≥ 1500\u002F mm3 (≥ 1.5 x 109\u002FL) without granulocyte colony-stimulating factor (GCSF) injection within 15 days prior to laboratory testing, as well as a platelet count ≥ 100,000\u002Fmm3 and a hemoglobin level ≥ 8g\u002FdL.\n* Patient with the psychological and mental capacity to understand the protocol and sign the consent form independently\n* Must be affiliated with the social security system or receive benefits through a third party\n* Have signed the study consent form after reading the information sheet\n\nExclusion Criteria:\n\n* Hypersensitivity to any of the excipients listed in section 6.1 of the abemaciclib (Verzenios) SPC\n* History of treatment with an anti-CDK4\u002F6 (palbociclib, ribociclib, abemaciclib) for any indication\n* History of invasive cancer of any histology within the last 2 years, except for superficial skin tumors, not considered to be in complete remission\n* 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\u002For liquid stools for at least 1 month)\n* Patient who has undergone total gastrectomy or suffers from short bowel syndrome\n* Patient unable to sign the consent form for societal reasons (illiteracy) or somatic reasons (central nervous system disease).\n* 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.\n* 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.)","FEMALE",{"count":60,"type":21},235,"INTERVENTIONAL",[63],"PHASE4","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.\n\nThe 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.\n\nIt 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.",[27,28,66],"Breast Cancer","NOT_YET_RECRUITING","2026-03-26",{"date":39,"type":42},{"date":71,"type":21},"2026-04",{"date":73,"type":21},"2029-04",{"name":75,"class":49},"Poitiers University Hospital"]