[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locoregional-recurrence\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locoregional-recurrence":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,68,93],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100475205","phase-2-ribociclib-and-endocrine-treatment-of-physicians-choice-for-locoregional-recurrent-resected-hormone-receptor-positive-her2-negative-breast-cancer-100475205",false,"NCT05467891","Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer","A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer","RaPhLRR","Eligibility Criteria to Collect Optional Correlative Blood and Tissue at Local Recurrence\n\n* Written informed consent (stage I) and HIPAA authorization for release of personal health information obtained prior to performing any study-specific procedures. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n* Male or female age ≥ 18 years at the time of consent.\n* Patient has a histologically and\u002For cytologically confirmed diagnosis of estrogen-receptor positive and\u002For progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.\n* Patient has HER2-negative breast cancer 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 and based on the most recently analyzed tissue sample. If there is insufficient tissue from the most recently collected sample, earlier tissue may be used on a case-by-case basis if permission is granted by the sponsor investigator.\n* Patient has locoregional recurrence of breast cancer: locoregional recurrence is defined as invasive recurrence in the ipsilateral breast, axilla, regional nodes, or chest wall.\n\nInclusion Criteria for Treatment Phase:\n\nSubject must meet all of the following applicable inclusion criteria to participate in this study:\n\n* Written informed consent (stage II\u002F main consent) and HIPAA authorization for release of personal health information obtained prior to performing any study-specific screening procedures. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n* Male or female age ≥ 18 years at the time of consent. NOTE: Both pre- and post-menopausal women are eligible. Post-menopausal status is defined as:\n\n  * Prior bilateral oophorectomy\n  * Age ≥60\n  * Age \\\u003C60 and amenorrhea for the last 12 or more months(in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range.\n* ECOG Performance Status of 0-1 within 28 days prior to registration.\n* If patient is receiving tamoxifen or toremifene, a washout period of 5 half-lives (i.e. 35 days) prior to registration is required (during that period the participant can take AI).\n* Patient has a histologically and\u002For cytologically confirmed diagnosis of estrogen-receptor positive and\u002For progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.\n* Patient has HER2-negative breast cancer 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 and based on the most recently analyzed tissue sample. If there is insufficient tissue from the most recently collected sample, earlier tissue may be used on a case-by-case basis if permission is granted by the sponsor investigator.\n* Patients have had adequate local treatment for locoregional recurrence (LRR) of breast cancer.\n\n  * Locoregional recurrence is defined as recurrence in the ipsilateral breast, axilla, regional lymph nodes, or chest wall.\n  * Local treatment is defined as either surgery, radiation therapy, or a combination of both if indicated.\n  * Adequate local therapy is surgery with negative microscopic margins. Radiation therapy is mandated for patients with microscopically involved margins and recommended for all patients who had not received radiotherapy as part of their primary treatment.\n  * Patients who have distant metastatic disease will not be eligible.\n  * Prior treatment with neoadjuvant and adjuvant chemotherapy and ET is allowed.\n* Patients must enroll within 6 months of the last local treatment, either local surgery or radiation; or systemic chemotherapy (if patient is receiving chemotherapy), whichever occurred last. Chemotherapy after local therapy is allowed. ET for recurrent disease is allowed for up to 12 months prior to enrollment.\n* Patient has no contraindication to the adjuvant ET in the trial and is planned to be treated or continue treatment with ET.\n* Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.\n\n  * Hematological\n\n    * Absolute Neutrophil Count (ANC): ≥ 1.5 x 109\u002FL\n    * Platelets: ≥ 100 x 109\u002FL\n    * Hemoglobin (Hgb): ≥ 9.0 g\u002FdL\n  * Renal\n\n    ---Estimated glomerular filtration rate (eGFR): ≥ 30 mL\u002Fmin\u002F1.73m2 according to the Modification of Diet in Renal Disease (MDRD) formula\n  * Hepatic\n\n    * Bilirubin: ≤ upper limit of normal (ULN) except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN\n    * Aspartate aminotransferase (AST): ≤ 2.5 × ULN except for patients with liver metastasis, who are only included if the AST is \\\u003C 5 × ULN\n    * Alanine aminotransferase (ALT): ≤ 2.5 × ULN except for patients with liver metastasis, who are only included if the ALT is \\\u003C 5 × ULN\n  * Coagulation\n\n    ---International Normalized Ratio (INR) : ≤ 1.5 × ULN (unless is receiving anticoagulants and the INR is within the therapeutic range of intended use for that anticoagulant within 7 days prior to the first dose of study drug)\n  * Electrolytes ---Potassium, Magnesium, and Total Calcium (corrected for serum albumin): Within normal limits or corrected to within normal limits with supplements.\n* Standard 12-lead ECG values defined as\n\n  * QTcF interval at screening \\\u003C 450 msec (QT interval using Fridericia's correction)\n  * Resting heart rate 50-90 bpm (determined from the ECG)\n* Females of childbearing potential who are sexually active with a male able to father a child must have a negative pregnancy test (serum or urine) within 14 days prior to registration and must be willing to use a highly effective method of contraception that does not contain estrogen and\u002For progesterone. See the protocol for definition of childbearing potential.\n* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n* Ability to swallow and retain oral medication.\n\nExclusion Criteria for Treatment Phase:\n\nSubjects meeting any of the criteria below may not participate in the study:\n\n* Patient with a known hypersensitivity to any of the excipients of ribociclib.\n* Patient who has received prior CDK4\u002F6 inhibitor for recurrent disease. Patients who received a CDK4\u002F6 inhibitor in the adjuvant setting may participate if they have been off therapy for at least 1 year prior to diagnosis of recurrent disease.\n* Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.\n* Pregnant or breastfeeding or planning to become pregnant during the trial (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial.\n* Patients with distant metastases of breast cancer beyond regional lymph nodes as defined by AJCC (8th edition).\n* Treatment with any investigational drug within 30 days prior to registration or participation in any other type of medical research judged not to be scientifically or medically compatible with this study. Enrollment or planned enrollment in another study that does not involve an investigational drug will be allowed at the discretion of the treating investigator.\n* Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n* Patient has any other concurrent severe and\u002For uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol: (e.g., chronic pancreatitis, chronic active hepatitis, HIV, active untreated or uncontrolled fungal, bacterial or viral infections, etc.). Testing to be done at investigator's discretion.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality, including any of the following:\n\n  * History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry\n  * Documented cardiomyopathy\n  * History of Left Ventricular Ejection Fraction (LVEF) \\\u003C 50%\n  * Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:\n\n    * Risk factors for Torsades de Pointe (TdP) including uncorrected hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant\u002Fsymptomatic bradycardia\n    * 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)\n    * Inability to determine the QTcF interval\n  * 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)\n  * Systolic Blood Pressure (SBP) \\>160 or \\\u003C90 mmHg\n* Patient is currently receiving any of the following substances and cannot be discontinued 7 days prior to Cycle 1 Day 1:\n\n  * 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  * Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4\u002F5.\n* 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. Note: The following uses of corticosteroids are permitted: a short duration (\\\u003C5 days) of systemic corticosteroids; any duration of topical applications (e.g. for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).\n* Patient with an uncontrolled psychiatric condition that, in the investigator's judgment, may cause unacceptable safety risks, impede research integrity and compliance, or interfere with the objectives of the study.","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.",[27,28,29],"Locoregional Recurrence","Hormone Receptor-positive Breast Cancer","HER2-negative Breast Cancer","RECRUITING","2026-04-02",{"date":33,"type":34},"2026-04-08","ACTUAL",{"date":36,"type":34},"2022-09-13",{"date":38,"type":21},"2029-08-15",{"name":40,"class":41},"Oana Danciu","OTHER",20,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100550854","postoperative-re-irradiation-with-and-without-hyperthermia-toxicity-quality-of-life-and-survival-in-patients-with-locoregional-recurrent-breast-cancer-100550854","NCT06452485","Postoperative Re-irradiaTion With and Without HYPERthermia: Toxicity, Quality of Life and Survival in Patients With Locoregional Recurrent Breast Cancer","RT-HYPE","Inclusion Criteria:\n\n* WHO performance scale ≤2\n* \\>=18 years\n* Patients with a LRR breast cancer after postoperative irradiation of the primary breast cancer. LRR is defined as a local and\u002For regional recurrence, including patients with a second primary ipsilateral breast cancer.\n* Patients treated with salvage mastectomy with high-risk\\* tumor characteristics or local excision with an indication for postoperative re-irradiation.\n* Previously treated with whole or partial breast irradiation.\n* (Neo)adjuvant systemic therapy (NST) is allowed.\n* Use of (FES\u002FFDG-)PET-CT in staging of nodal and disseminated disease.\n* Oligometastases in lymph nodes in the mediastinum, neck, contralateral axillary\u002Fsupraclavicular region (up to a maximal number of five) is allowed.\n* Adequate communication and understanding skills of the Dutch language.\n\nExclusion Criteria:\n\n* Diagnosed with primary breast sarcoma\n* Have a low-risk LRR after previous breast-conserving surgery\u002Ftherapy",{"count":51,"type":21},500,"OBSERVATIONAL","In the Netherlands, breast cancer patients with locoregional recurrence (LRR) and high-risk factors are treated with postoperative re-irradiation with or without hyperthermia. Retrospective studies showed that 3-year locoregional control after postoperative re-irradiation with hyperthermia was 68-83%, and severe toxicity in up to 40% of LRR patients. Unfortunately, no prospective (randomized) data are available on clinical outcomes. Consequently, variation exists in hyperthermia-treatment and re-irradiation schedules. Prospective real-world data on oncological outcomes, toxicity and quality of life is highly needed for shared decision-making between patients and professionals. These data will be used in the design of a future randomized trial comparing postoperative re-irradiation and hyperthermia-treatment in high-risk LRR patients.",[27,55,56,57],"Breast Cancer","Re-irradiation","Hyperthermia","2025-09-30",{"date":60,"type":34},"2025-10-06",{"date":62,"type":34},"2024-01-01",{"date":64,"type":21},"2027-05",{"name":66,"class":41},"Amsterdam UMC, location VUmc",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":67},"100607583","phase-3-adjuvant-abemaciclib-for-locoregional-recurrence-of-hr-positive-her2-negative-breast-cancer-jcog2313-aura-100607583","NCT07190443","Adjuvant Abemaciclib for Locoregional Recurrence of HR-positive, HER2-negative Breast Cancer (JCOG2313, AURA)","Randomized Phase III Trial for Evaluating the Efficacy of Adjuvant Abemaciclib in Patients With Locoregional Recurrence of Hormone Receptor-positive, HER2-negative Breast Cancer. JCOG2313, AURA Trial.","AURA","Inclusion criteria:\n\n1. The patient has been diagnosed with the first locoregional recurrence (LRR) after receiving definitive treatment for primary breast cancer. LRR includes one or more of the following:\n\n   (i) Ipsilateral breast tumor recurrence (ii) Ipsilateral chest wall recurrence (iii) Regional lymph node recurrence\n2. At least one LRR lesion must be confirmed by a biopsy, surgical specimen, or cell block from cytology, and must meet all of the following:\n\n   (i) Pathologically confirmed as invasive breast cancer, or diagnosed as breast cancer in a cytology cell block (in cases where only a cell block is available, the initial primary breast cancer must have been invasive).\n\n   (ii) Hormone receptor (HR) expression is positive. (iii) HER2 expression is negative.\n\n   ※ If multiple lesions are pathologically evaluated and any lesion is HR-negative or HER2-positive, the patient is ineligible.\n3. No prior diagnosis of distant metastasis of breast cancer.\n4. Imaging assessment before registration confirms:\n\n   No lymph nodes ≥10 mm in short axis No evidence of distant metastasis\n5. Age ≥18 years at the time of registration.\n6. ECOG Performance Status of 0 or 1.\n7. Chemotherapy for LRR is allowed prior to enrollment.\n8. The patient does not have bilateral breast cancer.\n9. No prior history of treatment with CDK4\u002F6 inhibitors.\n10. Written informed consent has been obtained for participation in this clinical trial.\n\nExclusion Criteria:\n\n1. Presence of active double cancer (synchronous malignancy requiring treatment).\n2. Ongoing infectious disease requiring systemic therapy.\n3. Fever ≥38.0°C at the time of registration.\n4. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding; men whose partners intend to become pregnant.\n5. Psychiatric illness or symptoms that interfere with daily living and may compromise trial participation.\n6. Ongoing systemic administration (oral or IV) of steroids equivalent to ≥10 mg\u002Fday of prednisolone or other immunosuppressive agents.\n7. Unstable angina (developed or worsened within the past 3 weeks) or myocardial infarction within the past 6 months.\n8. Uncontrolled hypertension.\n9. Uncontrolled diabetes mellitus despite continuous insulin or oral antidiabetic therapy.\n10. Positive for HBs antigen or HCV antibodies (Patients positive for HCV antibodies are not excluded if HCV-RNA is undetectable.)\n11. Positive for HIV antibodies (HIV testing is not mandatory.)\n12. Presence of interstitial pneumonia, pulmonary fibrosis, or severe emphysema as diagnosed by chest CT.",{"count":77,"type":21},290,[79],"PHASE3","The JCOG2313 trial is a multicenter, randomized, phase III study designed to evaluate the efficacy and safety of adjuvant abemaciclib in combination with endocrine therapy versus endocrine therapy alone in patients with hormone receptor (HR)-positive, HER2-negative breast cancer who have undergone curative treatment for their first locoregional recurrence (LRR).\n\nAlthough HR-positive, HER2-negative breast cancer generally has a favorable prognosis, LRR-such as ipsilateral breast tumor recurrence (IBTR), chest wall recurrence, or regional lymph node recurrence-remains a clinically significant event that increases the risk of distant metastasis. While endocrine therapy is standard in this setting, the benefit of adding chemotherapy or other agents remains unclear, and treatment strategies vary widely.\n\nAbemaciclib, a CDK4\u002F6 inhibitor, has shown survival benefit in the adjuvant setting for high-risk early breast cancer. However, its role in post-LRR adjuvant treatment has not been evaluated in a randomized setting. This study aims to determine whether the addition of abemaciclib to endocrine therapy can improve invasive disease-free survival (IDFS) in patients after LRR.\n\nEligible patients are randomized 1:1 to receive either endocrine therapy alone or endocrine therapy plus abemaciclib (150 mg twice daily for 2 years). The primary endpoint is IDFS. Secondary endpoints include distant recurrence-free survival, breast cancer-specific survival, overall survival, and safety. A total of 290 patients will be enrolled. Randomization is stratified by site of recurrence, endocrine resistance, perioperative chemotherapy, and institution.\n\nAdditionally, a prospective ancillary study will assess circulating tumor DNA (ctDNA) as a biomarker for molecular residual disease (MRD). Plasma samples will be collected at predefined time points to evaluate the prognostic and predictive value of ctDNA for relapse and treatment response.\n\nThe JCOG2313 trial addresses an unmet need in the management of HR-positive, HER2-negative LRR and may contribute to the establishment of a new standard systemic therapy and personalized monitoring strategies.",[55,27,82,83],"Abemaciclib","Endocrine Therapy","2025-09-24",{"date":86,"type":34},"2025-09-29",{"date":88,"type":34},"2025-02-07",{"date":90,"type":21},"2035-02-06",{"name":92,"class":41},"Japanese Foundation for Cancer Research",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":104,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":4},"100515177","locoregional-recurrence-of-breast-cancer-100515177","NCT05988112","Locoregional Recurrence of Breast Cancer","Locoregional Recurrence After Radiotherapy in Breast Cancer Patients Based on Molecular Subtypes","Inclusion Criteria:\n\n* Age ≥ 18\n* Male or female\n* Histological proven breast cancer (IDC \u002F ILC)\n* with known receptor status\n* Patient did mastectomy or breast conservative surgery +\u002F- lymph node dissection .\n* received radiotherapy\n* on regular follow up\n\nExclusion Criteria:\n\n* Metastatic from the start (stage 4)",{"count":101,"type":21},265,"our study will be retrospective on breast cancer patients to detect relation between the locoregional recurrence of breast cancer after radiotherapy and the molecular subtypes",[27],"NOT_YET_RECRUITING","2024-07-15",{"date":107,"type":34},"2024-07-16",{"date":109,"type":21},"2024-08-01",{"date":111,"type":21},"2025-09-01",{"name":113,"class":41},"Assiut University"]