[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hr-positive-her2-negative-advanced-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hr-positive-her2-negative-advanced-breast-cancer":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,68,95,116,184],{"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":37,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100564176","phase-1-open-label-study-of-bbo-10203-in-subjects-with-advanced-solid-tumors-100564176",false,"NCT06625775","Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)","Inclusion Criteria:\n\n* Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive\u002FHER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)\n* Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)\n* Stable brain metastases\n* Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC)\n* Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy\n* BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4\u002F6i\n* BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted\n* BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required\n\nExclusion Criteria:\n\n* Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR\u002FMSI-H tumors\n* Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1\u002FBRAF\u002FRET\u002FMET\u002FEGFR exon20 insertion\u002FNTRK\u002FHER2)\n* Patients with untreated and\u002For non-stable brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol","ALL","18 Years",{"count":19,"type":20},392,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.",[26,27,28,29,30,31,32,33,34,35,36],"Solid Tumor, Adult","Metastatic Breast Cancer","Advanced Breast Cancer","HER2 Mutation-Related Tumors","HER2-positive Metastatic Breast Cancer","KRAS Mutant Metastatic Colorectal Cancer","Metastatic Lung Cancer","Metastatic Colorectal Cancer","Advanced Lung Cancer","HR-positive, HER2-negative Advanced Breast Cancer","HER2-positive Advanced Breast Cancer",[38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54],"BREAKER-101","BridgeBio Oncology Therapeutics","BBOT","Phase1","Phase 1a\u002F1b","Trastuzumab","Breast","Colorectal","Non-Small Cell Lung Cancer","CRC","NSCLC","Metastatic Cancer","Advanced Cancer","HER2-positive","HR-positive","HR-positive, HER2-negative","HER2-negative","RECRUITING","2026-06-18",{"date":58,"type":59},"2026-06-23","ACTUAL",{"date":61,"type":59},"2024-10-29",{"date":63,"type":20},"2028-11",{"name":65,"class":66},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)","INDUSTRY",40,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":75,"minAge":17,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"100614883","phase-2-different-doses-of-dalpicicl-combined-with-letrozole-in-the-first-line-treatment-of-hr-positive-her2-negative-advanced-breast-cancer-100614883","NCT07285382","Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer","A Multicenter, Randomized, Double-cohort Study of Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer","Inclusion Criteria:\n\n* Female patients aged ≥18 years and ≤75 years, who are postmenopausal or premenopausal\u002Fperimenopausal, and meet one of the following conditions:\n\n  1. Have undergone bilateral oophorectomy in the past, or be aged ≥60 years; or\n  2. Aged \\\u003C60 years, in a natural postmenopausal state (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), with E2 and FSH at postmenopausal levels; or\n  3. Premenopausal or perimenopausal female patients can also be enrolled, but must be willing to receive LHRH agonist treatment during the study period\n* Patients with breast cancer confirmed by pathological examination to be HR-positive and HER2-negative, with evidence of focal recurrence or metastasis, not suitable for surgical resection or radiotherapy with the goal of cure, and without clinical indications for chemotherapy.\n\n  1. ER-positive and\u002For PR-positive is defined as: the proportion of tumor cells with positive staining among all tumor cells is ≥1% (reviewed and confirmed by the investigator at the participating trial center);\n  2. HER2-negative is defined as: standard immunohistochemistry (IHC) test result is 0\u002F1+; ISH test shows that the HER2\u002FCEP17 ratio is less than 2.0 or the HER2 gene copy number is less than 4 (reviewed and confirmed by the investigator at the participating trial center)\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1\n* Have not previously received any systemic antineoplastic treatment for focal recurrent or metastatic disease\n* Have measurable lesions in line with RECIST 1.1 criteria or only bone metastatic lesions (including osteolytic lesions or mixed osteolytic\u002Fosteoblastic lesions)\n* Have sufficient organ and bone marrow function\n* Women of childbearing potential must be willing to use a medically approved highly effective contraceptive method during the study period and within 3 months after the last administration of the study drug\n* All acute toxic effects of previous antineoplastic treatment have resolved to grade 0-1 (according to NCI-CTCAE Version 5.0) or to the level specified in the inclusion\u002Fexclusion criteria. Except for other toxicities such as alopecia that the investigator deems to pose no safety risk to the patient\n* Have given informed consent and signed the informed consent form, and be willing and able to comply with the planned visits, study treatment plan, laboratory tests and other trial procedures\n\nExclusion Criteria:\n\n* Previously diagnosed with HER2-positive breast cancer by pathological examination\n* Inflammatory breast cancer\n* Disease progression or recurrence at 12 months or within 12 months after completion of previous neoadjuvant or adjuvant endocrine drug treatment\n* Patients judged by the investigator to be unsuitable for endocrine treatment. Including advanced patients with symptoms, disseminated to internal organs, and at risk of life-threatening complications in the short term (including those with uncontrollable large effusions \\[pleural, pericardial, peritoneal\\], lymphangitis of the lung, and patients with more than 50% liver involvement) Confirmed to have brain metastatic lesions by cranial CT or MRI examination\n* Have previously received any CDK4\u002F6 inhibitor drug treatment\n* Underwent major surgery, chemotherapy, radiotherapy, any investigational drug or other anticancer treatment within 2 weeks before entering the study Diagnosed with any other malignant tumor within 3 years before entering the study, except for non-melanoma skin cancer, basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix that have undergone radical treatment Human Immunodeficiency Virus (HIV) infection or known to have Acquired Immunodeficiency Syndrome (AIDS), active hepatitis B (HBV DNA ≥1000 IU\u002Fml), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the lower limit of detection of the analytical method), or co-infection with hepatitis B and hepatitis C\n* Within 6 months before entering the study, the following occurred: myocardial infarction, severe\u002Funstable angina pectoris, NYHA class 2 or higher cardiac insufficiency, persistent arrhythmia of grade ≥2 (according to NCI-CTCAE Version 5.0), atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass surgery, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism)\n* Complicated with severe infection within 4 weeks before the first administration (e.g., requiring intravenous infusion of antibiotics, antifungal or antiviral drugs according to clinical diagnosis and treatment norms), or unexplained fever \\>38.5℃ during the screening period\u002Fbefore the first administration\n* Inability to swallow, intestinal obstruction, or other factors that affect drug administration and absorption\n* Known allergy to the study drug or any excipients\n* Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation\n* Known history of psychiatric drug abuse or drug addiction\n* Patients currently participating in other studies\n* Have other serious physical or mental diseases or laboratory test abnormalities that may increase the risk of participating in the study, interfere with the study results, and are deemed unsuitable for participating in this study by the investigator","FEMALE","75 Years",{"count":78,"type":20},120,[80],"PHASE2","This study is a prospective, open-label, randomized, multicenter, two-cohort phase II clinical trial. Starting from December 1, 2024, it plans to enroll 120 patients with advanced first-line HR-positive, HER2-negative breast cancer. A centralized randomization system (IWRS) will be used for randomization, and stratification will be performed based on the following factors during randomization: 1) Visceral metastasis (yes vs no); 2) Disease-free interval (previously untreated vs 12 \\\u003C DFI ≤ 24 vs DFI \\> 24).\n\nCohort A: Dalpiciclib 125mg + Letrozole 2.5mg Cohort B: Dalpiciclib 150mg + Letrozole 2.5mg Imaging assessment will be conducted in accordance with the RECIST 1.1 criteria, and tumor imaging evaluation will be performed by investigators from the participating centers.\n\nPatients receiving dalpiciclib will undergo a safety visit 28 days after the last dose, followed by survival follow-up until the patient's death or trial termination (whichever comes first).\n\nPharmacokinetic assessment: Blood samples will be collected once before dosing on Cycle 1 Day 15 (C1D15), 4 hours after dosing on C1D15, before dosing on Cycle 2 Day 1 (C2D1), and before dosing on Cycle 4 Day 1 (C4D1) to explore the population pharmacokinetic characteristics of dalpiciclib and the factors affecting its pharmacokinetics. The first dosing time of the subjects, each blood collection time, the dalpiciclib dosing time within three days before blood collection, and the dalpiciclib dosing time on the day of C1D15 blood collection must be accurately recorded. If dalpiciclib is not administered within 14 days before the planned PK blood collection, no PK blood collection will be performed on the day of that visit. If possible, PK samples should be collected simultaneously with samples for other laboratory tests.",[83],"HR Positive HER2 Negative Advanced Breast Cancer","2025-12-02",{"date":86,"type":59},"2025-12-16",{"date":88,"type":59},"2025-06-25",{"date":90,"type":20},"2028-12-31",{"name":92,"class":93},"wanghaibo","OTHER",2,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":94},"100589105","phase-1-study-of-tyk-00540-tablets-in-patients-with-advanced-solid-tumors-100589105","NCT06950086","Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors","A Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of the CDK2\u002F4\u002F6 Inhibitor TYK-00540 Tablets in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years, gender requirements:\n\n   Monotherapy dose-escalation phase: No gender restriction.\n\n   Combination dose-selection phase: No gender restriction.\n\n   Monotherapy and combination expansion phases:\n\n   Cohort A-1: Females only.\n\n   Other cohorts: No gender restriction.\n\n   Monotherapy Dose-Escalation Phase:\n2. Histologically or cytologically confirmed locally advanced\u002Fmetastatic solid tumors with no standard treatment available, failure of\u002Fintolerance to standard treatment, or refusal of standard treatment.\n\n   Monotherapy Dose-Expansion Phase:\n\n   Cohort A-1: Histologically or cytologically confirmed advanced platinum-resistant epithelial ovarian cancer (EOC)\u002Ffallopian tube cancer\u002Fprimary peritoneal cancer:\n\n   Platinum resistance defined as: Disease recurrence\u002Fprogression \\\u003C6 months after completion of prior platinum-based chemotherapy (≥4 cycles) or progression during initial\u002Frecurrent treatment.\n\n   Disease recurrence\u002Fprogression requires:\n   1. Objective radiographic progression; OR\n   2. Persistent CA125 elevation (confirmed after 1 week) with clinical symptoms or signs of progression.\n\n      * 3 prior lines of chemotherapy for recurrent\u002Fmetastatic disease, with ≤1 systemic therapy after platinum resistance.\n\n   Cohort A-2: HR+\u002FHER2- advanced breast cancer with confirmed resistance to CDK4\u002F6 inhibitors (≥1 documented instance).\n\n   Combination Dose-Selection Phase:\n\n   HR+\u002FHER2- advanced breast cancer with confirmed resistance to CDK4\u002F6 inhibitors (≥1 documented instance).\n\n   Combination Dose-Expansion Phase:\n\n   Cohort B-1: HR+\u002FHER2- advanced breast cancer with prior endocrine therapy resistance and either:\n\n   No prior CDK4\u002F6 inhibitor treatment; OR\n\n   CDK4\u002F6 inhibitor-treated in the adjuvant setting with recurrence \\>1 year after completion (no confirmed resistance).\n\n   Cohort B-2: HR+\u002FHER2- advanced breast cancer with progression during\u002Fafter endocrine + CDK4\u002F6 inhibitor therapy:\n\n   For adjuvant CDK4\u002F6 inhibitor resistance: Recurrence during or ≤1 year after treatment;\n\n   ≥1 documented CDK4\u002F6 inhibitor resistance.\n\n   Note for Cohorts A-2, Combination Dose-Selection, and Combination Expansion Phases:\n   * 2 prior endocrine therapy regimens for recurrent\u002Fmetastatic disease (adjuvant endocrine therapy leading to recurrence within 1 month of completion counts as 1 regimen).\n   * 1 prior chemotherapy or ADC regimen for recurrent\u002Fmetastatic disease.\n\n   Prior CDK4\u002F6 inhibitor use:\n   1. Duration ≥6 months;\n   2. Adjuvant CDK4\u002F6 inhibitor use with progression \\>1 year after completion does not count as resistance;\n   3. Switching CDK4\u002F6 inhibitors due to intolerance is permitted.\n3. For female patients in Combination Phases:\n\n   Meet ≥1 of the following:\n   1. Bilateral oophorectomy;\n   2. Age ≥60 years;\n   3. Age \\\u003C60 years with natural menopause ≥12 months (without chemotherapy, tamoxifen, toremifene, or ovarian suppression in the past year), confirmed by postmenopausal FSH and estradiol levels;\n   4. Age \\\u003C60 years on tamoxifen\u002Ftoremifene with postmenopausal FSH and estradiol levels.\n\n   Non-postmenopausal patients must use LHRH agonists\u002Fantagonists throughout the study.\n4. Baseline Lesions:\n\n   Monotherapy dose-escalation: Extracranial evaluable\u002Fmeasurable lesions.\n\n   Combination phases: Extracranial measurable lesions (RECIST 1.1).\n5. ECOG performance status 0-1, no deterioration within 2 weeks prior to first dose (Appendix II).\n6. Life expectancy ≥3 months.\n7. Adequate Organ Function:\n\n   Liver:TBIL ≤1.5×ULN, ALT\u002FAST ≤2.5×ULN (≤5×ULN for liver metastases; ≤3×ULN for combination with fulvestrant).\n\n   Kidney:Serum creatinine ≤1.5×ULN, creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula, Appendix III).\n\n   Hematology:Platelets ≥90×10\\^9\u002FL, ANC ≥1.5×10\\^9\u002FL, Hb ≥90 g\u002FL (without transfusion\u002FG-CSF within 2 weeks).\n\n   Cardiac:LVEF ≥50% (echocardiogram), QTcF \\\u003C470 ms. Coagulation:INR ≤1.5, APTT ≤1.5×ULN (without anticoagulation).\n8. Contraception:Females of childbearing potential: Negative pregnancy test and commitment to highly effective contraception\u002Fabstinence from screening until 6 months post-treatment (Appendix IV).Males: Commitment to contraception\u002Fabstinence during the same period.For fulvestrant combination: Contraception until 1 year after last dose.\n9. Voluntary signed ICF (or by legal guardian) and willingness to comply with study procedures.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any excipient of TYK-00540 or contraindication to fulvestrant (for Combination Dose-Selection and Combination Expansion Phases).\n2. Prior\u002Fconcurrent therapies:\n\n   Systemic anticancer therapies within 28 days prior to first dose: chemotherapy, large-molecule targeted therapy, immunotherapy.\n\n   Endocrine therapy, small-molecule targeted therapy, or fluorouracil-based oral agents within 14 days prior to first dose.\n\n   Nitrosoureas or mitomycin within 6 weeks prior to first dose. Anticancer herbal medicine or traditional Chinese medicine within 7 days prior to first dose.\n\n   Local radiotherapy (e.g., thoracic\u002Frib) or palliative radiotherapy for bone metastases within 7 days prior to first dose.\n\n   Major surgery (excluding minor procedures, e.g., appendectomy, tumor biopsy) within 4 weeks prior to first dose.\n\n   Proton pump inhibitor (PPI) use within 7 days prior to first dose or during the study.\n\n   Concurrent use of medications known to prolong QTc interval or induce torsades de pointes (Appendix V).\n\n   Participation in other interventional clinical trials within 28 days prior to first dose (non-interventional trials excluded).\n\n   Prior allogeneic bone marrow transplantation. For Combination Phases: prior use of fulvestrant, other SERDs, or SERCAs.\n3. History of other malignancies, except:Cured basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma, ductal carcinoma in situ of the breast, or malignancies with disease-free survival \\>3 years.\n4. Residual toxicity from prior therapy \\>Grade 1 (except alopecia or platinum-related neuropathy).\n5. Central nervous system (CNS) disease:Primary CNS tumors, CNS metastases with prior local treatment failure, or newly diagnosed CNS metastases.Exception: Asymptomatic, stable CNS metastases (no steroids\u002FCNS-specific treatment ≥14 days, radiologically confirmed stability at screening).\n6. Spinal cord compression caused by tumor.\n7. Visceral crisis.\n8. Clinically uncontrolled pleural effusion, ascites, or pericardial effusion requiring repeated drainage\u002Fmedical intervention (within 14 days prior to first dose).\n9. Clinically significant ECG abnormalities at baseline (e.g., QTc ≥470 ms, complete LBBB, acute\u002Findeterminate-age myocardial infarction, ST-T changes suggesting ischemia, second-\u002Fthird-degree AV block, severe bradycardia\u002Ftachycardia).\n10. Cardiovascular events within 6 months:Myocardial infarction, long QT syndrome, torsades de pointes, arrhythmias (sustained ventricular tachycardia\u002Ffibrillation), severe conduction defects (e.g., bifascicular block, third-degree AV block), unstable angina, coronary\u002Fperipheral bypass, symptomatic CHF (NYHA Class III\u002FIV), stroke, TIA, symptomatic pulmonary embolism, or clinically significant thromboembolism.Persistent NCI CTCAE ≥Grade 2 arrhythmia, atrial fibrillation (asymptomatic atrial fibrillation ≥Grade 2).\n\n    Exception: Patients with cardiac pacemakers\u002Fdevices and QTcF \\>470 ms may be eligible after discussion with the medical monitor.\n11. Unstable or uncontrolled medical conditions affecting safety\u002Fcompliance, including:Uncontrolled hypertension (systolic BP \\>160 mmHg and\u002For diastolic BP \\>100 mmHg).Uncontrolled diabetes, active bleeding, ocular disease, severe psychiatric\u002Fneurological\u002Fcardiovascular\u002Frespiratory disorders.\n12. Active\u002Funcontrolled infections or immunodeficiencies:Active HBV (HBsAg-positive with HBV DNA ≥2000 copies\u002FmL \\[or 500 IU\u002FmL\\]).Active HCV (HCV antibody-positive with HCV RNA-positive).HIV-positive.Exception: Asymptomatic chronic HBV\u002FHCV carriers.\n13. Lung disease:Radiation pneumonitis requiring steroids, interstitial lung disease (ILD)\u002Fpneumonitis (active or drug-induced), acute\u002Fprogressive pulmonary fibrosis, or high-risk factors for ILD per investigator judgment.\n14. Clinically significant gastrointestinal disorders affecting drug absorption (e.g., dysphagia, uncontrolled vomiting, active ulcers, inflammatory bowel disease, chronic diarrhea, bowel obstruction, chronic PPI-dependent conditions).\n15. Hypercoagulability with thromboembolic events within 6 months (e.g., stroke, DVT, pulmonary embolism).\n16. Pregnancy, lactation.\n17. The investigator concluded that the patient was not suitable to participate in the study (such as not conforming to the most beneficial treatment for the patient, patient compliance, etc.).",{"count":103,"type":20},180,[23,80],"This study is to evaluate the safety, pharmacokinetics, and preliminary antitumor activity of TYK-00540 as monotherapy or combined with fulvestrant in advanced solid tumors.",[35],"2025-04-22",{"date":109,"type":59},"2025-04-29",{"date":111,"type":59},"2024-01-02",{"date":113,"type":20},"2026-11",{"name":115,"class":66},"TYK Medicines, Inc",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":126,"phases":4,"briefSummary":127,"conditions":128,"keywords":169,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":183},"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":125,"type":20},3500,"OBSERVATIONAL","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.",[129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,35,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168],"Breast Adenocarcinoma","Breast Cancer Stage IV","Breast Cancer, Metastatic","Breast Carcinoma","Breast Diseases","Breast Neoplasms","Breast Neoplasms, Male","Breast Cancer","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 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","Ribociclib","Abemaciclib","CDK4\u002F6 Inhibitor","CDK4\u002F6 Inhibitors",[170,171,164,165,166,172,173,27],"HR+\u002FHER2- Advanced Breast Cancer","HR+\u002FHER2- Metastatic Breast Cancer","CDK4\u002F6i","Cyclin-Dependent Kinase 4\u002F6 inhibitors","2025-01-28",{"date":176,"type":59},"2025-02-03",{"date":178,"type":59},"2023-05-01",{"date":180,"type":20},"2040-12-31",{"name":182,"class":93},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",24,{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":75,"minAge":17,"maxAge":76,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":193,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"100507661","a-study-of-chidamide-plus-endocrine-in-maintenance-treatment-of-hrher2--breast-cancer-after-first-line-chemotherapy-100507661","NCT05890287","A Study of Chidamide Plus Endocrine in Maintenance Treatment of HR+\u002FHER2- Breast Cancer After First-line Chemotherapy","An Open, Single-center, Exploratory Cohort Study of Chidamide in Combination With Endocrine in Maintenance Therapy After First-line Chemotherapy for HR+\u002FHER2- Breast Cancer","Inclusion Criteria:\n\n1. Postmenopausal\u002Fpremenopausal women aged ≥18 years and ≤70 years;\n2. HR + \u002F HER2 breast cancer confirmed by histology (note: her2-negative is defined as: (1) IHC1 + \u002F IHC0; ②IHC2+ : FISH-);\n3. Confirmed by the histology of locally advanced breast cancer (local treatment) to radical or recurrent metastatic breast cancer;\n4. In the late stage of untreated or experienced a CDK4\u002F6 with endocrine therapy of patients;\n5. Researchers think that for selecting patients with chemotherapy (step 2022 guidelines recommend for internal transfer, always endocrine therapy resistance or preferred to rescue patients with endocrine therapy best choice of chemotherapy);\n6. One line finish cycle disease after chemotherapy (4 to 8 cycles) to alleviate or stable, quasi follow-up maintenance treatment: a. late stage A gleam of unused CDK4\u002F6 inhibitors + endocrine group subjects into the queue for A; b. Used in the late phase line CDK4\u002F6 inhibitors queue B + endocrine subjects into groups;\n7. Into the former group at least one measurable lesions (RECIST v1.1 standard); 8.ECOG score 0 to 2 points;\n\n9.Always all the acute toxic reaction caused by antineoplastic therapy in screening before easing to 0 and 1 level (according to the NCI CTCAE 5.0 judgment; Hair loss, other than toxicity that the investigator believes does not pose a safety risk to the subject); 10. Functions: bone marrow neutrophils absolute acuity 1.5 x 109 \u002F L, platelet acuity 100 x 109 \u002F L, 90 g\u002FL or higher hemoglobin; 11. Liver and kidney function: TBIL acuities were 1.5 x ULN; ALT and AST≤2.5 x ULN; In case of liver metastasis, ALT and AST≤ 5×ULN; BUN and Cr≤1.5×ULN and creatinine clearance ≥50 ml\u002Fmin; 12.Voluntary participation in the clinical trials, signed written informed consent.\n\nExclusion Criteria:\n\n1. Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;\n2. Always received HDACi anti-tumor treatment;\n3. This scheme known drug components have allergy history;\n4. Always with other malignant tumours within five years, not including has cured thyroid papillary carcinoma, cervical carcinoma in situ, basal cell carcinoma or skin squamous cell carcinoma of the skin;\n5. Within 4 weeks before into the group participated in other clinical trials;\n6. A history of immune deficiency, including test positive for HIV, or has other acquired, congenital immunodeficiency disease, or has a history of organ transplantation;\n7. Unable to control the important cardiovascular disease: a history of clinical significance of long QT, stage or screen between QTc \\> 450 ms; Severe cardiovascular injury (greater than a New York Heart Association (NYHA) Class II history of congestive heart failure), unstable angina or myocardial infarction within the last 6 months, or severe arrhythmia;\n8. Pregnancy and lactation women patients or in infertile women baseline pregnancy test positive; Or participants of childbearing age who were unwilling to use effective contraception during the study period and for at least 8 weeks after the last dosing;\n9. According to the researcher's judgment, there is serious to endanger the safety of patients, the patients completed studies or associated with disease (such as severe hypertension, diabetes, thyroid disease, active infection, etc.);\n10. Always have a clear history of neurological or psychiatric disorders, including epilepsy or dementia, etc.;\n11. Reference: subjects had active hepatitis (hepatitis b positive HBsAg and HBV DNA of 500 IU\u002Fml or more; Hepatitis C reference: HCV antibody positive and HCV virus copy number \\> upper limit of normal);\n12. The researchers determine doesn't fit to the researchers.",{"count":192,"type":20},60,[194],"NA","To explore the efficacy and safety of Chidamide combined with endocrine for maintenance therapy after first-line chemotherapy for HR+\u002FHER2- breast cancer",[83],"2023-05-26",{"date":199,"type":59},"2023-06-06",{"date":201,"type":59},"2023-05-16",{"date":203,"type":20},"2026-10-01",{"name":205,"class":93},"Tianjin Medical University Cancer Institute and Hospital",1]