[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yeon Hee Park\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":61},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100581410","phase-2-fulvestrant-with-ribociclib-versus-physicians-choice-treatments-recurred-after-completion-of-adjuvant-cyclin-dependent-kinase-46-inhibitors-in-hr-her2--metastatic-breast-cancer-100581410",false,"NCT06849947","Fulvestrant With Ribociclib Versus Physician's Choice Treatments Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4\u002F6 Inhibitors in HR+, HER2- Metastatic Breast Cancer","Randomized Phase II Trial of Fulvestrant With Ribociclib Versus Physician's Choice Treatments for the Patients Who Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4\u002F6 Inhibitors in HR+, HER2- Metastatic Breast Cancer as First Line Treatment (CLEE011AKR06R)","Inclusion Criteria:\n\n1. Participants must be at least 19 years of age at the time of signing the informed consent.\n2. Patient has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.\n3. Patient has HR-positive\u002FHER2-negative invasive breast cancer (based on most recently analyzed biopsy)\n\n   1. HER2 status is defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing, according to ASCO\u002FCAP guidelines for HER2 testing (Wolff et al. 2018).\n   2. HR status is defined as positive in ER expression by IHC, according to the relevant ASCO\u002FCAP Guidelines (Allison et al. 2020)\n4. Patient must have received either at least 1 year of adjuvant abemaciclib or ribociclib.\n5. Recurrence of advanced breast cancer was diagnosed ≥1 year from the last dose of adjuvant CDK4\u002F6 inhibitor.\n6. Patients must have received a minimum of 2 years of adjuvant endocrine therapy (either alone or in combination with CDK4\u002F6 inhibitors)\n7. Patient has an ECOG PS 0 or 1.\n8. Must have at least one measurable lesion according to RECIST v1.1. Patients without measurable lesions must have at least one lytic bone lesion.\n9. Patient has adequate bone marrow and organ function as defined by the following laboratory values:\n\n   1. Absolute neutrophil count ≥ 1.5 × 109\u002FL\n   2. Platelets ≥ 100 × 109\u002FL\n   3. Hemoglobin ≥ 9.0 g\u002FdL\n   4. Serum creatinine \\\u003C 1.5 mg\u002FdL or CCr ≥ 50 mL\u002Fday\n   5. In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 × upper limit of normal(ULN). If the patient has liver metastases, ALT and AST should be \\\u003C 5 × ULN\n   6. Total serum bilirubin \\\u003C ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin \\\u003C1.5 x ULN of the local laboratory in patients with well documented Gilbert's Syndrome\n10. Patient must be able to swallow study therapy\n11. Patient must be able to communicate with the investigator and comply with the requirements of the study procedures\n12. Patient must be willing to remain at the clinical site as required by the protocol.\n\nExclusion Criteria:\n\n1. Patients whose cancer recurs one year or later after completing adjuvant endocrine therapy\n2. Patients who have been free from endocrine therapy for at least 2 years\n3. Patient whose disease recurred during or within 1 year from adjuvant CDK4\u002F6 inhibitor treatment.\n4. Patient who did receive adjuvant palbociclib irrespective of disease-free interval.\n5. Patients who did not receive adjuvant CDK4\u002F6 inhibitor treatment or who received less than 1 year of adjuvant CDK4\u002F6 inhibitor treatment.\n6. Patients who have received fulvestrant in adjuvant setting before randomization.\n7. Patients who have received any line of systemic treatment for advanced breast cancer is not eligible.\n8. Participant has not recovered from clinical, and laboratory acute toxicities related to prior anticancer therapies to NCI CTCAE version 4.03 Grade ≤1. Exception to this criterion: participants with grade 2 taxane-induced neuropathy, any grade of alopecia, amenorrhea or other toxicities not considered a safety risk for the participant as per investigator's discretion, are allowed to enter the study.\n9. Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.\n10. Patient with symptomatic, unstable CNS metastases. Note: Symptomatic CNS metastases should be locally treated prior enrollment.\n11. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n12. Patient has a known history of HIV infection (testing not mandatory).\n13. Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation in the clinical study (e.g., chronic pancreatitis, chronic active hepatitis, etc.).\n14. Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality, including but not limited to any of the following:\n\n    1. History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry\n    2. Documented cardiomyopathy\n    3. Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: ① Risk factors for Torsades de Pointe (TdP) including uncorrected hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant\u002Fsymptomatic bradycardia ② Concomitant medication(s) with a known risk to prolong the QT interval and\u002For known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication (e.g., within 5 half-lives or 7 days prior to starting study drug) ③ Inability to determine the QTcF interval\n    4. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third-degree AV block)\n15. Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to Cycle 1 Day 1:\n\n    1. Concomitant medications, herbal supplements, and\u002For fruits (e.g., grapefruit, pummelos, star fruit, Seville oranges) and their juices that are strong inducers or inhibitors of CYP3A4\u002F5\n    2. Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4\u002F5.\n16. Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects of surgery.\n17. Patient who has received any investigational drug(s) within 14 days prior to first day treatment or within 5 half-lives of the investigational product (whichever is longer).\n18. Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment.\n\n    Note: The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).\n19. Patient is concurrently using other antineoplastic agents (except for adjuvant endocrine treatment monotherapy)\n20. Patient who has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to randomization, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia) and\u002For if ≥ 25% of the bone marrow was irradiated.\n21. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.\n22. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and after stopping study medication.\\* Highly effective contraception methods include:\n\n    \\* Ribociclib : For at least 3 weeks after the last dose, Fulvestrant : For 2 years after the last dose, Everolimus : For up to 8 weeks after the last dose.\n\n    \\- Effective contraception must be used as follows.\n    1. Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n    2. Total hysterectomy (surgical removal of the uterus and cervix) or tubal ligation (getting your \"tubes tied\") at least six weeks before taking study treatment.\n    3. Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.\n    4. Combination of the following: Barrier methods of contraception: Condom and intrauterine devices (IUDs) (e.g., loop insertion)\n23. Not able to understand and to comply with study instructions and requirements.","ALL","19 Years",{"count":19,"type":20},272,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","▪ Fulvestrant With Ribociclib versus Physician's choice treatments for the patients who recurred after completion of Adjuvant Cyclin-Dependent Kinase 4\u002F6 Inhibitors in HR+, HER2- Metastatic Breast Cancer as first line treatment",[26],"Breast Cancer Metastatic","NOT_YET_RECRUITING","2025-12-17",{"date":30,"type":31},"2025-12-24","ACTUAL",{"date":33,"type":20},"2026-02-01",{"date":35,"type":20},"2031-12-31",{"name":37,"class":38},"Yeon Hee Park","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":49,"conditions":50,"keywords":4,"overallStatus":51,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":60},"100563501","phase-2-prevention-of-sacituzumab-govitecan-related-neutropenia-in-patients-with-metastatic-triple-negative-breast-cancer-100563501","NCT06616987","Prevention of Sacituzumab Govitecan-related Neutropenia in Patients With Metastatic Triple Negative Breast Cancer","A Multicenter, Open-label, Single-arm, Clinical Trial to Evaluate the Preventive Effect of Pegylated G-CSF (PG) on Neutropenia in Patients With Metastatic Triple-negative Breast Cancer (mTNBC) Receiving Sacituzumab Govitecan (SG)","Inclusion Criteria:\n\n1. Signed Informed Consent Form (ICF) prior to participation in any study-related activities.\n2. Patients aged ≥19 years at the time of signing ICF.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Life expectancy of ≥ 12 weeks.\n5. Histologically confirmed TNBC per American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) criteria based on local testing on the most recent analyzed biopsy. Triple-negative is defined as \\\u003C1% expression for estrogen receptor (ER) and progesterone receptor (PgR) and negative for human epidermal growth factor receptor 2 (HER2) (0-1+ by IHC or 2+ and negative by in situ hybridization \\[ISH) test\\].\n6. Metastatic disease documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.\n7. Refractory to at least one, and no more than two, prior standard of care chemotherapy regimens for unresectable locally advanced or MBC. PARP inhibitor could have been counted as prior chemotherapy for purposes of study eligibility.\n8. All patients must have been previously treated with taxanes regardless of disease stage (adjuvant, neoadjuvant, or advanced), unless contraindicated for a given patient.\n9. Measurable or non-measurable, but evaluable disease, as per RECIST v.1.1. Patients with bone-only metastases are also eligible.\n10. Brain MRI must be done for patients with suspicion of brain metastases and patient must have stable central nervous system (CNS) disease for at least 4 weeks after local therapy, without neurological symptoms, and off anticonvulsants and steroids (no more than 10mg\u002Fday prednisone or its equivalent) for at least 2 weeks before first dose of study treatment.\n11. Meet the following organ function requirements:\n\n    * Hemoglobin ≥ 9 g\u002FdL\n    * ANC ≥ 1500\u002Fmm3\n    * Platelets ≥ 100,000\u002FμL\n    * Bilirubin ≤ 1.5 X IULN or ≤ 3X IULN for patients with documented Gilbert's syndrome\n    * AST and ALT ≤ 2.5 X IULN or ≤ 5 X IULN if known liver metastases\n    * Serum albumin \\> 3 g\u002FdL\n    * Creatinine clearance ≥ 60 mL\u002Fmin or ≥ 30 mL\u002Fmin as assessed by the Cockcroft-Gault equation\n    * INR\u002FPT and PTT or aPTT ≤ 1.5 X IULN unless patient is currently receiving therapeutic anticoagulant therapy\n12. Resolution of all acute AEs of prior anti-cancer therapy to grade 1 as determined by the NCI-CTCAE v.5.0 (except for alopecia or other toxicities not considered a safety risk for the patient at investigator discretion).\n13. Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use institution specified method(s) of contraception during treatment with sacituzumab govitecan and for 6months after the last dose.\n\n    * Required contraception for female of childbearing potential patients using hormonally based method, intrauterine device (IUD), bilateral tubal occlusion, female condom with spermicide should during study period and continue until 6 months after the last dose of latest administered study drug\n    * Required contraception for male patients using abstinence, male condom with spermicide, vasectomy should during study period and continue until 6 months after the last dose of latest administered study drug\n14. Patients must have completed all prior cancer treatments at least 2 weeks prior to 1st infusion of study drug including chemotherapy (includes also endocrine treatment), radiotherapy, and major surgery.\n\n    * Prior anticancer biologic agent must have been completed at least 4 weeks prior to 1st infusion of study drug.\n\nExclusion Criteria:\n\n1. Prior treatment with topoisomerase 1 inhibitors as a free form or as other formulations.\n2. Received any prior treatment with a Trop-2-directed ADC.\n3. Patients with carcinomatous meningitis.\n4. Known hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances.\n5. Patients positive for HIV-1 or -2 with a history of Kaposi sarcoma and\u002For Multicentric Castleman Disease.\n6. Have active hepatitis B virus (HBV) (defined as having a positive hepatitis B surface antigen test) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.\n\n   1. Patients who test positive for hepatitis B surface antigen will be excluded.\n   2. Patients who test positive for hepatitis B core antibody will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease. Patients with positive hepatitis B core antibody but negative viral load by PCR may be eligible if they are being monitored for potential viral reactivation or are willing to start or maintain antiviral treatment during study conduction (as dictated by their local and institutional standard practice or guidelines). A patient with a history of HBV infection and presence of hepatitis B surface antibody may participate in the study. In this last scenario, viral load (HBV DNA) is not mandated.\n   3. Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require an HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease.\n7. Scheduled surgery during the study, other than minor surgery which would not delay study drug (eg, port insertion, tooth extraction, any procedure that requires \\\u003C 1-hour general anesthesia. Procedures performed under local or intravenous (IV)\u002Fmonitored sedation that lasts \\\u003C 2 hours are acceptable).\n8. Have an active second malignancy. Note: Patients with a history of malignancy that has been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision carcinoma in situ, or similar) are eligible.\n9. Known history of clinically significant bleeding, intestinal obstruction, or gastrointestinal perforation within 6 months of study initiation.\n10. Active or prior documented inflammatory bowel disease (i.e. Crohn's disease, ulcerative colitis, or a preexisting chronic condition resulting in baseline grade ≥1 diarrhea).\n11. Infection requiring antibiotic use within 1 week of 1st infusion of study drug.\n12. Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n13. Women who are pregnant or lactating.\n14. Concomitant participation in other interventional clinical trial. Note: Patients participating in observational studies are eligible.\n15. Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the patient's participation in the study\n16. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drug.",{"count":47,"type":20},40,[23],"Prevention of Sacituzumab Govitecan-related Neutropenia in Patients with metastatic Triple Nagative Breast Cancer who have received at least one, and no more than two, prior standard of care chemotherapy regimens",[26],"RECRUITING","2025-08-21",{"date":54,"type":31},"2025-08-28",{"date":56,"type":31},"2025-07-03",{"date":58,"type":20},"2027-12-31",{"name":37,"class":38},1,""]