[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ribociclib\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ribociclib":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100622209","phase-2-the-efficacy-of-leucogen-in-preventing-the-risk-of-ribociclib-associated-neutropenia-in-early-breast-cancer-100622209",false,"NCT07380646","the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast Cancer","A Single-Arm, Phase II, Multicenter Clinical Trial to Evaluate the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Patients With Hormone Receptor-Positive, HER2-Negative Early Breast Cancer","Inclusion Criteria:\n\n1. The patient has signed and dated the informed consent form.\n2. Age \\> 18 years at the time of signing informed consent.\n3. The patient is a female with known menopausal status at the time of signing informed consent or initiation of adjuvant endocrine therapy (whichever is earlier). Postmenopausal status is defined as: bilateral oophorectomy, age \\> 60 years, or age \\\u003C 60 years with amenorrhea ≥ 12 months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression), and follicle-stimulating hormone and plasma estradiol levels within the local postmenopausal normal range.\n4. Histologically confirmed unilateral primary invasive breast cancer, with the date of initial cytological or histological diagnosis within 18 months before enrollment. Patients with multicentric and\u002For multifocal tumors are eligible if all pathologically examined lesions meet criteria 5 and 6 below.\n5. Estrogen receptor (ER) and\u002For progesterone receptor (PgR) positivity in the breast cancer, based on the most recent analyzed tissue sample from the local laboratory.\n6. HER2-negative breast cancer, defined as negative by in situ hybridization or immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization result is required to confirm HER2-negative status (based on the most recent analyzed tissue sample from the local laboratory).\n7. The patient has undergone surgical resection with complete tumor removal, negative microscopic margins on the final surgical specimen, and belongs to one of the following categories:\n\n   Anatomic Stage II, with any of the following: T0-2N1, T3N0, T2N0 with Grade 2 and Ki-67 ≥ 20%, T2N0 with Grade 2 and high-risk genomic assay result, T2N0 with Grade 3.\n\n   Anatomic Stage III. High-risk genomic assay is defined as Oncotype DX Recurrence Score ≥ 26, or high-risk group by Prosigna PAM50, MammaPrint, or EndoPredict.\n8. If clinically indicated, the patient has completed adjuvant and\u002For neoadjuvant chemotherapy according to guidelines before screening.\n9. If clinically indicated, the patient has completed adjuvant radiotherapy according to guidelines before screening.\n10. The patient has no contraindications to the adjuvant endocrine therapy in the trial and plans to receive endocrine therapy for 5 years or longer starting from the randomization date.\n11. The patient may have received any standard neoadjuvant endocrine therapy at the time of signing informed consent, but enrollment must occur within 12 months of the first endocrine therapy initiation. Note: Endocrine therapy for ovarian suppression or short-term fertility preservation is not considered neoadjuvant\u002Fadjuvant endocrine therapy. If the patient is using tamoxifen as adjuvant endocrine therapy, a washout period of 5 half-lives is required before enrollment, during which the patient may take an aromatase inhibitor.\n12. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n13. Adequate bone marrow and organ function defined by meeting the following local laboratory values:\n\n    Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL Platelet count ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 9.0 g\u002FdL Estimated glomerular filtration rate (eGFR) by MDRD formula ≥ 30 mL\u002Fmin\u002F1.73m² Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN) Aspartate aminotransferase (AST) ≤ 2.5 × ULN Serum total bilirubin \\\u003C ULN; or for patients with documented Gilbert's syndrome: total bilirubin ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN International normalized ratio (INR) ≤ 1.5 (unless the patient is on anticoagulant therapy and the INR is within the expected therapeutic range for that anticoagulant within 7 days before enrollment)\n14. The following laboratory parameters must be within normal limits or corrected to normal range with supplementation (corrected local laboratory values should be recorded as normal):\n\n    Sodium Potassium Magnesium Total calcium (corrected for serum albumin)\n15. Standard 12-lead electrocardiogram assessed by the local institution meeting the following:\n\n    Screening QTcF interval \\\u003C 450 ms Resting heart rate 50-90 beats per minute (determined by ECG)\n16. The patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.\n17. Females of childbearing potential must have a negative serum pregnancy test (for β-hCG) within 14 days before enrollment. Females of childbearing potential must be willing to use highly effective contraception. A female is considered to be of childbearing potential unless she has had natural amenorrhea for 12 months with appropriate clinical features (i.e., age-appropriate history of vasomotor symptoms), or has undergone bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before randomization. In the case of oophorectomy alone, only after the female's reproductive status has been confirmed by subsequent hormone level assessment is she considered not of childbearing potential.\n18. Contraception must be continued during the trial treatment and for 21 days after treatment discontinuation.\n\nExclusion Criteria:\n\n1. Previous treatment with any CDK4\u002F6 inhibitor.\n2. Use of tamoxifen, raloxifene, or aromatase inhibitors for breast cancer risk reduction (\"chemoprevention\") and\u002For osteoporosis treatment within 2 years before signing informed consent.\n3. Prior anthracycline cumulative dose reaching or exceeding: doxorubicin 450 mg\u002Fm², or epirubicin 900 mg\u002Fm².\n4. Known hypersensitivity to any excipient of ribociclib and\u002For the endocrine therapy and\u002For leucogen (e.g., rare hereditary galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, or soy allergy).\n5. Evidence of distant metastasis of breast cancer beyond regional lymph nodes (AJCC 8th edition Stage IV) and\u002For recurrence after curative surgery.\n6. Concurrent use of other anticancer therapies, except adjuvant endocrine therapy.\n7. Major surgery, chemotherapy, or radiotherapy within 14 days before enrollment.\n8. Clinical and laboratory acute toxicities related to prior anticancer therapy have not recovered to Grade 1 or lower (per NCI CTCAE version 4.03) on the day of enrollment. Exceptions: alopecia and amenorrhea of any grade are allowed.\n9. Current invasive malignancy, or previous invasive malignancy completed treatment within 2 years before signing informed consent. Note: Patients with past or concurrent in situ malignancy are eligible if they have undergone adequate curative treatment before enrollment.\n10. Known history of human immunodeficiency virus (HIV) infection.\n11. Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n12. Clinically significant, uncontrolled cardiac disease and\u002For cardiac repolarization abnormalities, including any of the following:\n\n    Documented history of myocardial infarction, angina, symptomatic pericarditis, or coronary artery bypass grafting within 6 months before trial enrollment.\n\n    Documented cardiomyopathy. Left ventricular ejection fraction \\\u003C 50% as measured by multigated acquisition scan or echocardiography.\n\n    Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or presence of any of the following risk factors: risk factors for torsades de pointes including uncorrected hypokalemia or hypomagnesemia, history of heart failure, or history of clinically significant\u002Fsymptomatic bradycardia. Concurrent use of medications known to prolong the QT interval and\u002For known to cause TdP that cannot be discontinued or switched to a safe alternative (e.g., within 5 half-lives or 7 days before starting trial treatment). Inability to determine QTcF interval.\n\n    Clinically significant arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular block (e.g., bifascicular block, Mobitz type II, and third-degree AV block).\n\n    Uncontrolled hypertension with systolic blood pressure \\> 160 mmHg.\n13. Use of any of the following within 7 days before enrollment:\n\n    Concomitant medications, herbal supplements, and\u002For fruits (e.g., grapefruit, pomelo, carambola, Seville oranges) and their juices that are known potent inhibitors or inducers of CYP3A4\u002F5.\n\n    Drugs with a narrow therapeutic window that are predominantly metabolized by CYP3A4\u002F5.\n14. Systemic corticosteroid therapy within ≤ 2 weeks before starting trial treatment, or not fully recovered from side effects of such therapy.\n15. Treatment with immunomodulators or other drugs affecting leukocytes (e.g., thymosin, batyl alcohol, IL-11, GM-CSF, G-CSF) within ≤ 4 weeks before starting trial treatment.\n16. Impaired gastrointestinal function or gastrointestinal disease that may significantly alter absorption of oral trial drugs (e.g., uncontrolled ulcerative disease, uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, or small bowel resection).\n17. Any other concurrent severe and\u002For uncontrolled medical condition that, in the investigator's judgment, would pose an unacceptable safety risk, contraindicate participation in the clinical trial, or affect compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infection, active infection requiring systemic antimicrobial therapy, etc.), or would limit life expectancy to ≤ 5 years.\n18. Participation in another interventional study with investigational product treatment (or use of an investigational device) within 30 days before enrollment, or within 5 half-lives of the investigational product (whichever is longer).\n19. Complete blood count within 1 week before ribociclib administration showing white blood cell or neutrophil count below the lower limit of normal of the testing institution.\n20. Pregnancy or lactation, or planning to become pregnant or breastfeed during the trial period.","ALL","18 Years",{"count":19,"type":20},94,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is a multicenter, single-arm, open-label Phase II exploratory clinical trial designed to evaluate whether prophylactic use of leucogen can reduce the incidence of Grade 3 or higher neutropenia in early-stage HR+\u002FHER2- breast cancer patients receiving ribociclib combined with endocrine therapy. The study plans to enroll 97 patients using a Simon two-stage design, with the primary endpoint being the incidence of severe neutropenia within 4 treatment cycles (4 months) after initiation. Secondary endpoints include the incidence of all-grade neutropenia, febrile neutropenia, ribociclib treatment intensity, and safety. The study will systematically assess the preventive efficacy and safety of leucogen to provide a basis for subsequent Phase III randomized controlled trials.",[26,27,28,29],"Leucogen","Ribociclib","Neutropenia (Low White Blood Cell Count)","Breast Cancer","RECRUITING","2026-04-26",{"date":33,"type":34},"2026-04-30","ACTUAL",{"date":36,"type":34},"2026-01-07",{"date":38,"type":20},"2028-06-01",{"name":40,"class":41},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":42},"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":52,"type":20},81,"OBSERVATIONAL","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.",[56,29,57,58,59,27],"ER+ Breast Cancer","Early Breast Cancer","Endocrine Therapy","Abemaciclib",[61,62,63,64],"early breast cancer","celle cycle inhibitors","endocrine therapy","adjuvant setting","NOT_YET_RECRUITING","2026-02-26",{"date":68,"type":34},"2026-03-02",{"date":70,"type":20},"2026-04-01",{"date":72,"type":20},"2031-12",{"name":74,"class":41},"University Hospital, Grenoble",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":85,"conditions":86,"keywords":125,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"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":84,"type":20},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.",[87,88,89,90,91,92,93,29,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,27,59,123,124],"Breast Adenocarcinoma","Breast Cancer Stage IV","Breast Cancer, Metastatic","Breast Carcinoma","Breast Diseases","Breast Neoplasms","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 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",[126,127,122,27,59,128,129,130],"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":133,"type":34},"2025-02-03",{"date":135,"type":34},"2023-05-01",{"date":137,"type":20},"2040-12-31",{"name":139,"class":41},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",24]