[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"American Society of Clinical Oncology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100545127","phase-3-the-cdk46-inhibitor-dosing-knowledge-cdk-study-100545127",false,"NCT06377852","The CDK4\u002F6 Inhibitor Dosing Knowledge (CDK) Study","Comparing Oral Drug Dosing Strategies in Older Patients With Metastatic Breast Cancer to Maximize Tolerance and Reduce Discontinuation: The CDK4\u002F6 Inhibitor Dosing Knowledge (CDK) Study","Inclusion Criteria:\n\n1. Hormone receptor positive (HR+) HER2 negative metastatic breast cancer. Cut-off values for positive\u002Fnegative staining should be as per standard practice in accordance with ASCO\u002FCAP (American Society of Clinical Oncology\u002FCollege of American Pathologists) guidelines. Verification of histology is preferred at the time of recurrence and where not possible or necessary in the judgment of the treating physician, the study will accept histology from the initial diagnosis.\n2. Candidate for planned endocrine therapy in combination with 1st use of palbociclib or ribociclib, in the metastatic setting. The planned endocrine partner can be an aromatase inhibitor (letrozole, anastrozole, exemestane) or fulvestrant, selected through patient\u002Fprovider choice.\n3. Aged 65 years or older\n4. Adequate bone marrow and organ function. Laboratory values must be within normal institutional limits, or within ranges as indicated below, or demonstrate minor abnormalities that are deemed clinically non-significant by the investigator.\n\n   * Absolute neutrophil count ≥ 1,000\u002FµL\n   * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (participants with documented Gilbert's disease are allowed total bilirubin up to 5X ULN)\n   * AST (SGOT)\u002FALT (SGPT) \\\u003C3 x institutional ULN, or ≤ 5 x ULN for subjects with documented metastatic disease to the liver.\n5. Baseline QTc ≤ 480 ms (only for ribociclib patients)\n6. Ability to understand and the willingness to provide informed consent. Note: Remote consent is allowed per institutional guidelines.\n\nExclusion Criteria:\n\n1. Previous treatment with a CDK4\u002F6 inhibitor for metastatic breast cancer, or previous treatment within the past 12 months with a CDK4\u002F6 inhibitor in the neo\u002Fadjuvant breast cancer setting.\n2. Received greater than 30 days (in the metastatic setting) of the specific endocrine therapy agent planned as partner to the CDK4\u002F6 inhibitor in the study at the time of randomization.\n3. Known history of intolerance or allergy to the planned agents used in this trial.\n4. Uncontrolled intercurrent illness that, as evaluated by the treating clinician, would hinder compliance with study requirements.\n5. Concurrent therapy with other investigational agents.\n6. Rapidly progressive brain metastases.\n7. Active or chronic Hepatitis B or C are eligible provided they meet liver function laboratory criteria and are not on medication with a known interaction with the study agents.\n8. Current use of drugs that have known potential to prolong the QT interval (e.g., antiarrhythmic drugs), for patients on ribociclib. Note: If concomitant use cannot be avoided, monitor ECG when initiating, during concomitant use, and as clinically indicated. Refer to crediblemeds.org as a resource.\n9. Prior or concurrent malignancies that are undergoing active treatment.","ALL","65 Years",{"count":19,"type":20},500,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","The purpose of this study is to generate evidence on an alternative dosing strategy for CDK4\u002F6 inhibitors to help more patients with Metastatic Breast Cancer (MBC) (age ≥ 65 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs.\n\nThe primary objective of the CDK Study is to compare time to treatment discontinuation (TTD) on the approved dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle) or ribociclib (600 mg orally daily on days 1-21 of 28-day cycle) vs. TTD using titrated dosing approach with the same schedule but starting at a lower dose of palbociclib (100 mg or 75 mg) or ribociclib (400 mg or 200 mg) and escalating the dose if well-tolerated in combination with provider\u002Fpatient choice endocrine therapy (aromatase inhibitor (AI) or fulvestrant) in patients age 65 or older with HR+\u002FHER2- MBC. The secondary and exploratory objectives will generate evidence needed to personalize treatment decisions by comparing patient-centric secondary outcomes and evaluating baseline factors.\n\nTogether with their treating physician, participants will choose the CDK4\u002F6 inhibitor (palbociclib or ribociclib) and which endocrine therapy (aromatase inhibitor or fulvestrant) of their choice but will be randomized to either Arm 1 (indicated dosing) or Arm 2 (titrated dosing).\n\nNote: Telehealth visits are allowed at any time per institutional guidelines. In addition, the study allows for remote consenting per institutional guidelines.",[26],"Metastatic Breast Cancer",[28],"MBC","RECRUITING","2026-06-26",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":33},"2024-10-29",{"date":37,"type":20},"2028-09-01",{"name":39,"class":40},"American Society of Clinical Oncology","OTHER",73,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100262277","phase-2-tapur-testing-the-use-of-food-and-drug-administration-fda-approved-drugs-that-target-a-specific-abnormality-in-a-tumor-gene-in-people-with-advanced-stage-cancer-100262277","NCT02693535","TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer","Targeted Agent and Profiling Utilization Registry (TAPUR) Study","TAPUR","Inclusion Criteria:\n\n* 12 years of age or older (\\*Restrictions apply. Not all therapies are available for patients \\\u003C18)\n* Histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefiting from standard anti-cancer treatment or for whom, in the opinion of the treating physician, no such treatment is available or indicated\n* Performance status 0-2 (Per Eastern Cooperative Oncology Group (ECOG) criteria)\n* Patients must have acceptable organ function as defined below. However, as noted above, drug-specific inclusion\u002Fexclusion criteria specified in the protocol appendix for each agent will take precedence for this and all inclusion criteria:\n\n  1. Absolute neutrophil count ≥ 1.5 x 106\u002Fµl\n  2. Hemoglobin \\> 9.0 g\u002Fdl\n  3. Platelets \\> 75,000\u002Fµl\n  4. Total bilirubin \\\u003C 2.0 mg\u002F dl, except in patients with Gilbert's Syndrome\n  5. Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) \\\u003C 2.5 x institutional upper limit of normal (ULN) (or \\\u003C 5 x ULN in patients with known hepatic metastases)\n  6. Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL\u002Fmin\u002F1.73 m2\n* Patients must have disease that can be objectively measured by physical or radiographic exam (per RECIST v1.1 for solid tumor, Lugano criteria for non-Hodgkin lymphoma or International Myeloma Working Group criteria for multiple myeloma), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or a subcutaneous or superficial lesion that can be measured with calipers by clinical exam. For lymph nodes, the short axis must be ≥15 mm. Patient's whose disease cannot be objectively measured by physical or radiographic examination (e.g., elevated serum tumor marker only, bone-only disease without an identifiable soft tissue component, or patients with only assessable non-measurable disease) are NOT eligible.\n* Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited or New York State accredited (for labs offering services to residents of NY) laboratory. Labs that have registered the test with the NIH Genetic Testing Registry or that provide a report that has been designated as optimized for TAPUR participation are preferred, but not required. The genomic or IHC test used to qualify a patient for participation in TAPUR may have been performed on any specimen of the patient's tumor obtained at any point during the patient's care at the discretion of the patient's treating physician. Genomic assays performed on cell-free DNA in plasma (\"liquid biopsies\") will also be acceptable if the genomic analysis is performed in a laboratory that meets the criteria described above.\n* Ability to understand and the willingness to sign a written informed consent\u002Fassent document.\n* Have a tumor genomic profile for which single agent treatment with one of the FDA approved targeted anti-cancer drugs included in this study has potential clinical benefit based on the criteria described in protocol.\n* For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.\n* Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study or if she is the partner of a male participant in this study and becomes pregnant while he is participating in this study, she should inform her or her partner's treating physician immediately as well as her obstetrician. Female study patients who become pregnant must immediately discontinue treatment with any study therapy. Male patients should avoid impregnating a female partner. Male study patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and for a specified amount of time the last dose of study drug, or completely abstain from sexual intercourse.\n\nNote: TAPUR does not explicitly exclude any type of solid tumor, but the patient must have measurable and evaluable disease per RECIST v1.1.\n\nExclusion Criteria:\n\n* Patients whose disease is not measurable or cannot be assessed by radiographic imaging or physical examination (e.g., elevated serum tumor marker only) are not eligible\n* Patients with primary brain tumors or new, untreated or progressive leptomeningeal metastases are excluded\n* Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to registration. All patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month prior to study enrollment.\n* Patients with known progressive brain metastases are eligible but additional eligibility criteria apply.\n\nNote: there are additional exclusion criteria that may apply","12 Years",{"count":52,"type":20},4200,[54],"PHASE2","The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.\n\nNOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact TAPUR@asco.org, or if a patient, your nearest participating TAPUR site (see participating centers).\n\n\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\n\nResults in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org\u002Fnews. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress.\n\n\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*",[57,58,59],"Lymphoma, Non-Hodgkin","Multiple Myeloma","Advanced Solid Tumors",[61,62,63,64],"cancer","off-label","precision medicine","targeted therapy","2026-05-27",{"date":67,"type":33},"2026-05-29",{"date":69,"type":33},"2016-03-14",{"date":71,"type":20},"2028-12-31",{"name":39,"class":40},181,""]