[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"abemaciclib\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:abemaciclib":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,51,76,105,129,193],{"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",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":101,"leadSponsor":103,"locationsCount":50},"100627064","evaluation-of-adherence-to-cell-cycle-inhibitors-used-as-adjuvant-therapy-in-patients-with-localized-breast-cancer-at-high-risk-of-recurrence-100627064","NCT07443774","Evaluation of Adherence to Cell Cycle Inhibitors Used as Adjuvant Therapy in Patients With Localized Breast Cancer at High Risk of Recurrence.","Evaluation of Adherence to Cell Cycle Inhibitors Used as Adjuvant Therapy in Patients With Localized Breast Cancer at High Risk of Recurrence","AdheRA","Inclusion Criteria\n\n* Male or female patients aged ≥18 years.\n* Operable invasive breast carcinoma of no special type, hormone receptor-positive \u002F HER2-negative (estrogen receptor expression \\>10% with or without progesterone receptor expression \\>10%; HER2-negative defined as score 0, 1+, or 2+ non-amplified).\n* M0 disease according to the TNM 2018 classification.\n* Having undergone curative surgery of the primary breast tumor.\n* Having received adjuvant radiotherapy, if indicated.\n* Indication for combined adjuvant endocrine therapy and iCDK4\u002F6 therapy validated during a multidisciplinary tumor board meeting.\n* Initiation of adjuvant endocrine therapy combined with a CDK4\u002F6 inhibitor between June 2023 and June 2028.\n* No objection to participation in the study.\n* Affiliation with the national health insurance system.\n\nNon-Inclusion Criteria\n\n* Medical, geographical, sociological, psychological, or legal conditions that could prevent the patient from completing the study or from providing informed non-opposition.\n* Locally advanced, non-operable disease or metastatic disease not amenable to curative-intent treatment",{"count":85,"type":21},81,"Hormone receptor-positive (HR+) breast cancers represent the most common histological subtype of breast cancer, accounting for approximately 75% of cases, regardless of HER2 (human epidermal growth factor receptor 2) status (1). Adjuvant endocrine therapy (ET), including tamoxifen and aromatase inhibitors (AIs), is an effective pharmacological treatment for improving the prognosis of HR+ breast cancer, reducing the risk of recurrence by up to 50% (2-3-4-6). Despite its proven prognostic benefit, the full potential of endocrine therapy is not realized due to patient non-adherence (i.e., failure to comply with prescribed treatment). Adjuvant endocrine therapy is generally prescribed for a duration of 5 to 10 years. However, up to 40% of patients discontinue treatment prematurely, and 30% take the medication less frequently than prescribed. Poor adherence and low treatment persistence carry a substantial mortality burden: non-adherence is associated with a 49% increase in all-cause mortality. A retrospective analysis of a large database including more than 8,700 patients showed a 10-year survival rate of 80.7% among women who continued treatment, compared with 73.6% among those who discontinued adjuvant therapy prematurely (p \\\u003C 0.001). Among patients who continued treatment, the survival rate was 82% in those who were fully adherent, versus 78% in those who were only partially adherent (7-16).\n\nThe literature has documented a wide range of risk factors associated with non-adherence to or discontinuation of long-term adjuvant endocrine therapy. Treatment-related adverse effects, including hot flashes, joint stiffness, and sexual dysfunction, are common and may lead to treatment discontinuation. Fear of side effects may also prevent some patients from initiating or maintaining endocrine therapy. Others may not be fully convinced of the necessity of adjuvant endocrine therapy, particularly in the absence of overt signs of cancer. In addition, supportive care required to manage side effects is often inadequately reimbursed, making low income-combined with broader socioeconomic factors-a potential barrier to optimal adherence. Some patients may also experience difficulties remembering to take their medication regularly. The relative importance and contribution of these factors to non-adherence may evolve over time. Other factors may also play a role, including sociodemographic characteristics (low income, living alone, or unemployment).\n\nNevertheless, a residual risk of recurrence persists after five years of well-conducted standard endocrine therapy, extending up to two decades after diagnosis, particularly in patients with early-stage breast cancer stages II and III. In this higher-risk population, two phase III trials, monarchE and NATALEE, have recently evaluated the addition of a cell cycle inhibitor (CDK4\u002F6 inhibitor) to standard adjuvant endocrine therapy and reported positive results with a reduction in the risk of relapse.\n\nIn the NATALEE trial, quality of life was assessed in all patients in the ribociclib plus aromatase inhibitor group (n = 2,549) versus the aromatase inhibitor alone group (n = 2,552). Mean scores did not differ significantly from baseline for any of the analyzed domains. Similarly, no significant change from baseline was observed in either treatment group.\n\nHowever, it is important to note that 33.8% of patients discontinued ribociclib and 20% discontinued both endocrine therapy and ribociclib in the NATALEE trial, which is consistent with data from the literature.\n\nIn the monarchE trial, 16.6% of patients discontinued abemaciclib, and 6% discontinued both abemaciclib and endocrine therapy, while only 0.8% discontinued endocrine therapy in the control group. These findings are not consistent with previously published data.\n\nTo our knowledge, no real-world study has evaluated CDK4\u002F6 inhibitors in combination with endocrine therapy in the adjuvant treatment of HR+\u002FHER2-negative breast cancer.\n\nAdheRA is a prospective multicenter cohort study of patients with early-stage HR+\u002FHER2-negative breast cancer at high risk of recurrence, eligible for a combination of endocrine therapy and a CDK4\u002F6 inhibitor such as abemaciclib or ribociclib in the adjuvant setting, aiming to assess treatment adherence and the reasons for non-adherence.",[88,66,89,90,27,91],"ER+ Breast Cancer","Early Breast Cancer","Endocrine Therapy","Ribociclib",[93,94,95,96],"early breast cancer","celle cycle inhibitors","endocrine therapy","adjuvant setting","2026-02-26",{"date":99,"type":42},"2026-03-02",{"date":39,"type":21},{"date":102,"type":21},"2031-12",{"name":104,"class":49},"University Hospital, Grenoble",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":61,"phases":115,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":50},"100607583","phase-3-adjuvant-abemaciclib-for-locoregional-recurrence-of-hr-positive-her2-negative-breast-cancer-jcog2313-aura-100607583","NCT07190443","Adjuvant Abemaciclib for Locoregional Recurrence of HR-positive, HER2-negative Breast Cancer (JCOG2313, AURA)","Randomized Phase III Trial for Evaluating the Efficacy of Adjuvant Abemaciclib in Patients With Locoregional Recurrence of Hormone Receptor-positive, HER2-negative Breast Cancer. JCOG2313, AURA Trial.","AURA","Inclusion criteria:\n\n1. The patient has been diagnosed with the first locoregional recurrence (LRR) after receiving definitive treatment for primary breast cancer. LRR includes one or more of the following:\n\n   (i) Ipsilateral breast tumor recurrence (ii) Ipsilateral chest wall recurrence (iii) Regional lymph node recurrence\n2. At least one LRR lesion must be confirmed by a biopsy, surgical specimen, or cell block from cytology, and must meet all of the following:\n\n   (i) Pathologically confirmed as invasive breast cancer, or diagnosed as breast cancer in a cytology cell block (in cases where only a cell block is available, the initial primary breast cancer must have been invasive).\n\n   (ii) Hormone receptor (HR) expression is positive. (iii) HER2 expression is negative.\n\n   ※ If multiple lesions are pathologically evaluated and any lesion is HR-negative or HER2-positive, the patient is ineligible.\n3. No prior diagnosis of distant metastasis of breast cancer.\n4. Imaging assessment before registration confirms:\n\n   No lymph nodes ≥10 mm in short axis No evidence of distant metastasis\n5. Age ≥18 years at the time of registration.\n6. ECOG Performance Status of 0 or 1.\n7. Chemotherapy for LRR is allowed prior to enrollment.\n8. The patient does not have bilateral breast cancer.\n9. No prior history of treatment with CDK4\u002F6 inhibitors.\n10. Written informed consent has been obtained for participation in this clinical trial.\n\nExclusion Criteria:\n\n1. Presence of active double cancer (synchronous malignancy requiring treatment).\n2. Ongoing infectious disease requiring systemic therapy.\n3. Fever ≥38.0°C at the time of registration.\n4. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding; men whose partners intend to become pregnant.\n5. Psychiatric illness or symptoms that interfere with daily living and may compromise trial participation.\n6. Ongoing systemic administration (oral or IV) of steroids equivalent to ≥10 mg\u002Fday of prednisolone or other immunosuppressive agents.\n7. Unstable angina (developed or worsened within the past 3 weeks) or myocardial infarction within the past 6 months.\n8. Uncontrolled hypertension.\n9. Uncontrolled diabetes mellitus despite continuous insulin or oral antidiabetic therapy.\n10. Positive for HBs antigen or HCV antibodies (Patients positive for HCV antibodies are not excluded if HCV-RNA is undetectable.)\n11. Positive for HIV antibodies (HIV testing is not mandatory.)\n12. Presence of interstitial pneumonia, pulmonary fibrosis, or severe emphysema as diagnosed by chest CT.",{"count":114,"type":21},290,[116],"PHASE3","The JCOG2313 trial is a multicenter, randomized, phase III study designed to evaluate the efficacy and safety of adjuvant abemaciclib in combination with endocrine therapy versus endocrine therapy alone in patients with hormone receptor (HR)-positive, HER2-negative breast cancer who have undergone curative treatment for their first locoregional recurrence (LRR).\n\nAlthough HR-positive, HER2-negative breast cancer generally has a favorable prognosis, LRR-such as ipsilateral breast tumor recurrence (IBTR), chest wall recurrence, or regional lymph node recurrence-remains a clinically significant event that increases the risk of distant metastasis. While endocrine therapy is standard in this setting, the benefit of adding chemotherapy or other agents remains unclear, and treatment strategies vary widely.\n\nAbemaciclib, a CDK4\u002F6 inhibitor, has shown survival benefit in the adjuvant setting for high-risk early breast cancer. However, its role in post-LRR adjuvant treatment has not been evaluated in a randomized setting. This study aims to determine whether the addition of abemaciclib to endocrine therapy can improve invasive disease-free survival (IDFS) in patients after LRR.\n\nEligible patients are randomized 1:1 to receive either endocrine therapy alone or endocrine therapy plus abemaciclib (150 mg twice daily for 2 years). The primary endpoint is IDFS. Secondary endpoints include distant recurrence-free survival, breast cancer-specific survival, overall survival, and safety. A total of 290 patients will be enrolled. Randomization is stratified by site of recurrence, endocrine resistance, perioperative chemotherapy, and institution.\n\nAdditionally, a prospective ancillary study will assess circulating tumor DNA (ctDNA) as a biomarker for molecular residual disease (MRD). Plasma samples will be collected at predefined time points to evaluate the prognostic and predictive value of ctDNA for relapse and treatment response.\n\nThe JCOG2313 trial addresses an unmet need in the management of HR-positive, HER2-negative LRR and may contribute to the establishment of a new standard systemic therapy and personalized monitoring strategies.",[66,119,27,90],"Locoregional Recurrence","2025-09-24",{"date":122,"type":42},"2025-09-29",{"date":124,"type":42},"2025-02-07",{"date":126,"type":21},"2035-02-06",{"name":128,"class":49},"Japanese Foundation for Cancer Research",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":139,"conditions":140,"keywords":177,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100578016","predicting-clinical-outcomes-during-first-line-cdk46-inhibitors-plus-endocrine-therapy-in-patients-with-advanced-hormone-receptor-positive-her2-negative-breast-cancer-the-retrospective-prospective-multicenter-italian-palmares-2-study-100578016","NCT06805812","Predicting clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","Predictive Impact of Peripheral Blood Lymphocytes on clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","PALMARES-2","Inclusion Criteria:\n\n* Diagnosis of HR+\u002FHER2- advanced Breast Cancer (aBC), as defined as at least 1% estrogen receptor (ER) and\u002For progesterone receptor (PgR) positivity at IHC. HER2 negativity is defined on the basis of an IHC score of 0, 1+, or 2+ with absence of gene amplification at in situ hybridization (ISH) analyses.\n* Have received or are candidate to receive treatment with palbociclib, ribociclib or abemaciclib in combination with endocrine therapy as first-line treatment for HR+\u002FHER2- aBC.\n\nExclusion Criteria:\n\n* Less than 3 months of follow up from the CDK4\u002F6i start to the date of data cut-off;\n* Have received CDK4\u002F6i as monotherapy;\n* Have received CDK4\u002F6i as adjuvant treatment for localized disease.",{"count":138,"type":21},3500,"PALMARES-2 is a retrospective\u002Fprospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+\u002FHER2- aBC patients treated with first-line CDK4\u002F6i plus ET. The present study has the objective to collect data coming from different sources, i.e. RWD, medical images and biological samples, from patients treated with CDK4\u002F6i as first-line of therapy for HR+\u002FHER2- aBC. In consideration of the complexity of data collected and different objectives of the study, this master protocol foresees different sub-studies, which encompasses different methodologies for data collection, data extraction and analyses.",[141,142,143,144,145,25,146,66,147,148,149,150,151,152,153,154,155,156,157,26,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,91,27,175,176],"Breast Adenocarcinoma","Breast Cancer Stage IV","Breast Cancer, Metastatic","Breast Carcinoma","Breast Diseases","Breast Neoplasms, Male","Breast Cancer With Metastatic Bone Disease","Breast Cancers","Breast Neoplasm","Breast Tumors","HR+ HER2- Men, Pre\u002FPostmenopausal Advanced Breast Cancer","HR+ Advanced or Metastatic Breast Cancer","HR+\u002FHER2- Breast Cancer","HRpos Breast Neoplasms","HR-positive, HER2-negative Advanced Breast Cancer","HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer","HR-positive Breast Cancer","Hormone Receptor Positive Breast Adenocarcinoma","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Breast Neoplasms","Hormone Receptor Positive HER-2 Negative Breast Cancer","Hormone Receptor Positive Malignant Neoplasm of Breast","Hormone Receptor Positive Metastatic Breast Cancer","Hormone Receptor Positive, HER2 Negative Breast Cancer","Hormone Receptor Negative Breast Cancer","Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer","Hormone Receptor Positive Breast Cancer","Hormone Receptor Positive (ER+\u002FPR+, and Her2-) Metastatic Breast Cancer","Hormone Receptor Positive, HER2-negative Neoplasms","Hormone Receptor Positive, HER2-low Neoplasms","Hormone Receptor Positive (HR+), HER2-negative Breast Cancer","Hormone Receptor (HR)-Positive Breast Cancer","Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer","Palbociclib","CDK4\u002F6 Inhibitor","CDK4\u002F6 Inhibitors",[178,179,174,91,27,180,181,182],"HR+\u002FHER2- Advanced Breast Cancer","HR+\u002FHER2- Metastatic Breast Cancer","CDK4\u002F6i","Cyclin-Dependent Kinase 4\u002F6 inhibitors","Metastatic Breast Cancer","2025-01-28",{"date":185,"type":42},"2025-02-03",{"date":187,"type":42},"2023-05-01",{"date":189,"type":21},"2040-12-31",{"name":191,"class":49},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",24,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":203,"conditions":204,"keywords":208,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":50},"100563845","retrospective-observational-study-of-the-safety-and-toxicity-management-of-abemaciclib-in-combination-with-adjuvant-hormone-therapy-in-patients-with-rh-her2-nonoveramplified-breast-cancer-real-life-data-monarche29-100563845","NCT06621459","Retrospective Observational Study of the Safety and Toxicity Management of Abemaciclib in Combination with Adjuvant Hormone Therapy in Patients with RH+ ,HER2-nonoveramplified Breast Cancer, Real-life Data (MONARCHE29)","Retrospective Observational Study of the Safety and Toxicity Management of Abemaciclib in Combination with Adjuvant Hormone Therapy in Patients with RH+ ,HER2-nonoveramplified Breast Cancer, Real-life Data","MONARCHE29","Inclusion Criteria:\n\n* Adult patient\n* Patient who has received adjuvant ABEMACICLIB in combination with hormone therapy\n* Patient with localized RH+ HER2 non-amplified breast cancer and eligible for treatment with ABEMACICLIB according to the recommendations of the MA (Marketing Authorization) as defined below:\n\n  * 4 ipsilateral positive axillary lymph nodes OR\n\n    1. to 3 ipsilateral positive axillary lymph node(s) with at least one of the following two criteria: histological grade 3 or primary tumor size ≥5 cm\n\nExclusion Criteria:\n\n* Patients under legal protection (guardianship, trusteeship, etc.)\n* Refusal to participate",{"count":202,"type":21},30,"Overall survival at 8 years under treatment for localized hormone-dependent breast cancer is 93.3% (1). Adjuvant therapy, especially hormone therapy, helps reduce the risk of recurrence.\n\nHowever, the risk of relapse remains significant, estimated at around 20% according to studies. The SOFT study, which compares the type of hormone therapy used in premenopausal patients, estimates a relapse risk of 21.1% at 8 years (1), especially when there is initial lymph node involvement. In fact, in cases of lymph node involvement, the cumulative relapse rate at 10 years after stopping hormone therapy ranges between 19% and 36% (2), and the risk of death from breast cancer 20 years after stopping hormone therapy is estimated at 28% to 49% (2).\n\nCDK4\u002F6 inhibitors first demonstrated their efficacy at the metastatic stage. Abemaciclib improved median survival to 46.7 months compared to a median of 37.3 months with hormone therapy alone (Monarch 2 (3) and Monarch 3 (4)). Palbociclib showed in PALOMA-2 (5) an improvement in progression-free survival (24.8 months versus 14.5 months) without an improvement in overall survival. Ribociclib, in turn, demonstrated in MONALEESA 2 (6) an improvement in PFS (25.3 months versus 16 months) and in overall survival (63.9 months versus 51.4 months). These treatments have become the standard first-line treatment for patients with RH+ HER2 non-amplified breast cancer.\n\nGiven the results in advanced lines, CDK4\u002F6 inhibitors have been the subject of studies in localized breast cancer, particularly in this high-risk population where the recurrence rate remains significant.\n\nThe MONARCH-E study, published on September 20, 2020 (7), led to the approval of Abemaciclib by European authorities at the time of the initial publication (median follow-up of 15.4 months) and to reimbursement starting in May 2023 after a second interim analysis (8) in this at-risk population, with a 5.6% reduction in relapse risk after 42 months of follow-up compared to hormone therapy alone.\n\nIt is crucial to clearly define the at-risk population in order to offer them treatment intensification while maintaining a satisfactory quality of life. The group benefiting from Abemaciclib presented grade III toxicity in 43% of cases and grade IV toxicity in 2.5%.\n\nReal-world data are needed to better understand the management and toxicity of this treatment.",[205,27,206,207,25],"Brest Cancer","Adjuvant Therapy","Antineoplastic Combined Chemotherapy Protocols",[27,206,207,66,209,210],"Real-life","Real Word Data","2024-09-27",{"date":213,"type":42},"2024-10-01",{"date":215,"type":21},"2024-09-26",{"date":217,"type":21},"2025-10-31",{"name":219,"class":49},"University Hospital, Brest"]