[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hormone-receptor-positive-breast-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hormone-receptor-positive-breast-adenocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,74],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100594490","phase-1-a-study-of-225acac-aky-1189-in-patients-with-solid-tumors-100594490",false,"NCT07020117","A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors","NECTINIUM-2: A Phase 1b, 2 Part, Multicenter, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of a Nectin-4 Radiopharmaceutical ([225Ac]Ac-AKY-1189) in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Histologic or cytologic confirmation of locally advance or metastatic disease\n* Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1\n* ECOG Performance Status of 0 or 1\n* Adequate end-organ function\n* Ability to give informed consent and comply with study requirements\n* Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids\n* Documented disease progression on prior line of therapy for metastatic disease\n\nExclusion Criteria:\n\n* Prior treatment with a therapeutic radiopharmaceutical\n* Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin\n* Received an investigational agent within the previous 28days\n* Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment\n* Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\\[225Ac\\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.",[26,27,28,29,30,31,32],"Urothelial Carcinoma Bladder","Triple Negative Breast Cancer (TNBC)","Hormone Receptor Positive Breast Adenocarcinoma","Non Small Cell Lung Cancer","Cervical Adenocarcinoma","Colorectal Adenocarcinoma","Head and Neck Cancer","RECRUITING","2026-04-17",{"date":36,"type":37},"2026-04-21","ACTUAL",{"date":39,"type":37},"2025-08-22",{"date":41,"type":20},"2032-06",{"name":43,"class":44},"Aktis Oncology, Inc.","INDUSTRY",9,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100573401","phase-1-study-of-68ga-r10602-100573401","NCT06745804","Study of 68Ga-R10602","Phase 1 Imaging Study of 68Ga-R10602-101 in Hormone Receptor-Positive Breast Cancer","Inclusion Criteria:\n\n1. Breast Cancer Eligibility:\n\n   * Population 1: Pathologically confirmed ER and\u002For PR positive, locoregionally recurrent or metastatic breast cancer that is refractory to endocrine therapy (progression on at least one line of endocrine therapy and determined by the investigator that Study Participant would not benefit from additional endocrine therapy) who have received at least one line of chemotherapy or antibody drug conjugate in the metastatic setting (recurrence within 6 months of adjuvant chemotherapy counts as one line of therapy). There is no limit on prior number of lines of endocrine therapy. Prior treatment with CDK4\u002F6, AKT, PI3K and\u002For mTOR inhibitors is permitted.\n   * Population 2: Pathologically confirmed ER positive and HER2 negative locoregional or metastatic breast adenocarcinoma that is not amenable to resection, with progression on at least one line of prior endocrine therapy in the adjuvant or metastatic setting and starting next line of therapy that will include endocrine therapy, such as tamoxifen, fulvestrant, aromatase inhibitor, or elacestrant with or without ovarian suppression.\n   * Population 3: Study Participants with pathologically confirmed, estrogen and\u002For progesterone receptor (ER and\u002For PR) positive and HER2 negative breast adenocarcinoma who are ineligible for Population 1 or 2.\n2. At least one target or non-target lesion per RECIST 1.1\n3. Male or non-pregnant, non-lactating female Study Participant age ≥18 years. Female Study Participant of child-bearing potential and male Study Participant (if sexually active) must agree to use adequate method(s) of effective contraception during their participation in the study.\n\n   1. Medically acceptable adequate contraception for sexually active females with child-bearing potential include: 1) surgical sterilization (such as tubal ligation or hysterectomy), 2) approved hormonal contraceptives, 3) barrier method (such as condom or diaphragm) used with a spermicide, or 4) intrauterine device (IUD).\n   2. Medically acceptable adequate contraception for sexually active males include: 1) surgical sterilization (such as vasectomy), 2) a condom used with a spermicide.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.\n5. Adequate hepatic function as defined below (within 28 days of dosing with 68Ga R10602):\n\n   1. Serum alanine aminotransaminase (ALT)\u002F aspartate aminotransaminase (AST) ≤3 × upper limit of normal (ULN) or ≤5 × ULN if liver metastases are present, and\n   2. Serum bilirubin: total ≤1.5 × ULN (unless due to Gilbert's syndrome or hemolysis in which case total ≤3.0 × ULN).\n6. Adequate renal function as measured by creatinine clearance calculated by the Cockcroft-Gault formula (≥60 mL\u002Fminute), determined within 28 days of dosing with 68Ga-R10602.\n7. Able to understand and willing to sign an informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Received a radionuclide within a period of less than 10 physical half-lives of the administered radionuclide prior to dosing with 68Ga-R10602.\n2. Radiotherapy ≤14 days prior to dosing with 68Ga-R10602.\n3. Major surgery ≤21 days prior to dosing with 68Ga-R10602 or has not recovered from adverse effects of such procedure.\n4. Severe or unstable medical condition, such as congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, as well as an uncontrolled cardiac arrhythmia requiring medication (≥Grade 2, according to NCI-CTCAE Version 5.0), myocardial infarction within 6 months prior to starting Investigational Product, or any other significant or unstable concurrent cardiac illness. Note: Stable chronic atrial fibrillation is allowed.\n5. History of cerebrovascular accident within 6 months or that resulted in ongoing neurologic instability.\n6. Major active infection requiring antibiotics.\n7. Known active human immunodeficiency virus infection or active infection with Hepatitis B or C.\n8. Acute illness within 14 days prior to dosing with 68Ga-R10602 unless mild in severity, as assessed by the Investigator.\n9. Any other condition that in the opinion of the Investigator would place the Study Participant at an unacceptable risk or cause the Study Participant to be unlikely to fully participate or comply with study procedures.",{"count":54,"type":20},36,[23],"A phase 1 imaging study of 68Ga-R10602 in hormone-receptor positive breast cancer.",[58,59,28],"Locoregionally Recurrent Hormone-receptor Positive Breast Cancer","Metastatic Hormone Receptor Positive Breast Cancer",[61,62,63],"Hormone Receptor Positive Breast Cancer","Endocrine resistant","Radioisotope","2026-03-11",{"date":66,"type":37},"2026-03-13",{"date":68,"type":37},"2024-12-10",{"date":70,"type":20},"2026-07",{"name":72,"class":44},"Radionetics Oncology",6,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":126,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":142},"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":83,"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.",[87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,28,107,108,109,110,111,112,113,114,61,115,116,117,118,119,120,121,122,123,124,125],"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 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 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 (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",[127,128,121,122,123,129,130,131],"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":134,"type":37},"2025-02-03",{"date":136,"type":37},"2023-05-01",{"date":138,"type":20},"2040-12-31",{"name":140,"class":141},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano","OTHER",24]