[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adjuvant-drug-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adjuvant-drug-therapy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,75,105],{"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":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100613958","aspects-of-adjuvant-cdk46-inhibitors-in-older-breast-cancer-patients---focusing-on-geriatric-screening-100613958",false,"NCT07273357","Aspects of Adjuvant CDK4\u002F6 Inhibitors in Older Breast Cancer Patients - Focusing on Geriatric Screening","Follow-Up After adjuvanT CDK4\u002F6i Use in oldeR brEast Cancer Patients - Aspects on Geriatric Screening, Toxicities, and Quality of Life (FUTURE)","FUTURE","Inclusion Criteria:\n\n* ≥70 years old\n* Female\u002Fmale\n* Completed surgery (primary or after neoadjuvant therapy)\n* Starting adjuvant CDK4\u002F6i and endocrine therapy\n* Cognitive performance to be able answer questionaries\n* No language difficulties\n\nExclusion Criteria:\n\n* Impaired cognitive function not able to understand the study intention or perform questionaries\n* Declining adjuvant CDK4\u002F6i","ALL","70 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","Older breast cancer patients should not be categorically excluded from adjuvant therapies, including the recommended CDK4\u002F6 inhibitors (CDK4\u002F6i) administered in combination with endocrine therapy. Nevertheless, this population frequently presents with comorbidities that may increase susceptibility to treatment-related toxicities, including impacts on quality of life, which must be carefully considered when selecting therapeutic regimens. Given the limited representation of older patients in the clinical trials behind the recommendations for adjuvant CDK4\u002F6i therapy, coupled with the uncertain magnitude of clinical benefit and the reported rates of toxicity and treatment discontinuation, it is essential to critically evaluate both efficacy and safety in this specific patient subgroup. National and international guidelines recommend the integration of geriatric assessments into routine clinical practice to facilitate individualized treatment decisions; however, such assessments are not yet widely implemented in many oncology departments and are not routinely in use to guide adjuvant CDK4\u002F6i therapy.\n\nThis study aims to investigate the implementation of geriatric assessments in older breast cancer patients (≥70 years) and to examine multiple dimensions of CDK4\u002F6i treatment in this cohort, including short- and medium-term effects on quality of life, dose intensity, and clinical outcomes. By doing so, the investigators seek to more accurately delineate the benefits and risks of adjuvant CDK4\u002F6i therapy in this specific patient population.",[25,26,27],"Geriatric Assessment","Adjuvant Drug Therapy","Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[29,30,31,32],"Older patients","Geriatric screening","Adjuvant CDK4\u002F6 inhibitors","Breast cancer","RECRUITING","2026-06-09",{"date":36,"type":37},"2026-06-10","ACTUAL",{"date":39,"type":37},"2026-04-01",{"date":41,"type":21},"2039-08-01",{"name":43,"class":44},"Region Jönköping County","OTHER_GOV",5,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100637248","phase-3-sac-tmt-sequential-capecitabine-versus-capecitabine-in-early-stage-high-risk-triple-negative-breast-cancer-without-brca-mutations-100637248","NCT07628504","Sac-TMT Sequential Capecitabine Versus Capecitabine in Early-Stage High-Risk Triple-Negative Breast Cancer Without BRCA Mutations","Sacituzumab Tirumotecan (Sac-TMT) Sequential Capecitabine Versus Capecitabine as Adjuvant Regimen for Triple-Negative Breast Cancer With Early-Stage, High-Risk, Non-BRCA Mutated Status: A Phase III, Randomized, Controlled, Open-Label, Multicenter Clinical Trial","STARTER","Inclusion Criteria:\n\n1. Female aged ≥ 18 years old.\n2. Diagnosis of operable primary invasive breast cancer.\n3. Negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER2), defined as follows: ER-negative is defined as \\\u003C10 % positive tumor cells by immunohistochemistry (IHC); PR-negative is defined as \\\u003C10 % positive tumor cells by IHC; HER2-negative is defined as IHC score of 0 or 1+, or IHC score of 2+ with negative (non-amplified) results confirmed by fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH).\n4. Non-mutated for BRCA1\u002F2 genes.\n5. Patients must satisfy any one of the following conditions:\n\n   1. Baseline clinical lymph node-positive (cLN+) or pathological lymph node-positive (pN+) status with non-pathological complete response (non-pCR), who have completed adequate neoadjuvant therapy (at least 6 cycles of chemotherapy containing anthracycline and\u002For taxane, with or without PD-1 inhibitor immunotherapy).\n   2. Pathological lymph node-positive (pN+) status without prior neoadjuvant therapy, who have undergone adequate surgery, adjuvant chemotherapy (at least 6 cycles of taxane- and\u002For anthracycline-containing regimen with or without carboplatin), and adjuvant radiotherapy (if applicable).\n6. No evidence of distant metastasis shown by imaging examinations performed within 3 months prior to randomization.\n7. Adequate organ and bone marrow function.\n8. Acute toxicities from any prior therapy have recovered to baseline levels or resolved to Grade ≤ 1 per NCI CTCAE Version 5.0 (excluding adverse events deemed non-safety risks at the investigator's discretion).\n9. Post-menopausal status or documented non-childbearing potential. For women of childbearing potential, urine pregnancy tests must be negative at post-surgery screening and baseline visits. All participants and their male partners of childbearing potential must use effective medical contraception from the date of informed consent signature until 6 months after the last dose of study treatment.\n10. Voluntarily participate in the study, provide written informed consent, and be able to comply with protocol-specified visits and procedures.\n\nExclusion Criteria:\n\n1. Patients with Stage T4 disease, including those with inflammatory breast cancer;\n2. Patients with Stage N3 disease;\n3. Patients with positive supraclavicular or internal mammary lymph nodes;\n4. Previous history of breast cancer;\n5. Significant cardiovascular diseases such as baseline left ventricular ejection fraction (LVEF) \\\u003C 50% assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan at screening, or New York Heart Association (NYHA) Class III or IV cardiomyopathy;\n6. Prior treatment with TROP2-targeted therapy and\u002For topoisomerase I inhibitors;\n7. History of other malignant neoplasms within the past 5 years, excluding cured carcinoma in situ of the cervix, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma;\n8. Known hypersensitivity to study drugs and their components, history of immunodeficiency, or history of organ transplantation;\n9. History of non-infectious interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid therapy, current ILD or non-infectious pneumonia, or suspected ILD\u002Fnon-infectious pneumonia that cannot be ruled out by imaging at screening; clinically significant severe pulmonary impairment secondary to concomitant pulmonary diseases, including but not limited to any underlying pulmonary disorders (e.g., pulmonary embolism within 3 months prior to first dose, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion) or any autoimmune, connective tissue, or inflammatory diseases potentially involving the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis), or prior pneumonectomy;\n10. Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or history of corneal disorders that hinder delayed corneal healing;\n11. Active autoimmune diseases requiring systemic therapy within the past 2 years (hormone replacement therapy is not considered systemic therapy, e.g., type 1 diabetes mellitus, hypothyroidism managed with thyroid hormone replacement only, adrenal or pituitary insufficiency managed with physiological-dose glucocorticoid replacement only);\n12. Active infections requiring systemic therapy within 2 weeks prior to the first dose;\n13. Patients with malabsorption syndromes affecting glucuronosyltransferase (Gl) function, history of gastric or small bowel resection, or inability to swallow capecitabine tablets;\n14. Concomitant severe diseases that jeopardize patient safety or interfere with study completion as judged by the investigator, including but not limited to uncontrolled hypertension, severe diabetes mellitus, and active infections;\n15. Any other conditions rendering the patient ineligible for study participation in the investigator's opinion.","FEMALE","18 Years",{"count":57,"type":21},420,"INTERVENTIONAL",[60],"PHASE3","The goal of this clinical trial is to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT) sequential capecitabine versus single-agent capecitabine as adjuvant intensified therapy in patients with high-risk early-stage triple-negative breast cancer (TNBC) without BRCA mutations.\n\nThe main questions it aims to answer are:\n\n1. Does sacituzumab tirumotecan (sac-TMT) sequential capecitabine improve survival outcomes compared with capecitabine monotherapy in this patient population?\n2. What is the safety profile of sacituzumab tirumotecan (sac-TMT)-containing adjuvant therapy versus capecitabine monotherapy? Researchers will compare the sacituzumab tirumotecan (sac-TMT)-sequential-capecitabine experimental arm with the capecitabine-alone control arm to see if the experimental regimen provides superior adjuvant anti-tumor efficacy with acceptable safety.\n\nParticipants will be randomized in a 1:1 to Receive assigned study treatment as follows:\n\nExperimental arm: Sacituzumab tirumotecan (sac-TMT) 4 mg\u002Fkg intravenously on Day 1 of each 3-week cycle for 8 cycles, followed by sequential capecitabine at stratified doses; patients with prior PD-1\u002FL1 inhibitor exposure will continue PD-1\u002FL1 inhibitor therapy for up to 1 year Control arm: Capecitabine monotherapy at stratified doses; patients with prior PD-1\u002FL1 inhibitor exposure will continue PD-1\u002FL1 inhibitor therapy for up to 1 year",[26],"NOT_YET_RECRUITING","2026-06-04",{"date":66,"type":37},"2026-06-05",{"date":68,"type":21},"2026-05-18",{"date":70,"type":21},"2035-03-30",{"name":72,"class":73},"Fudan University","OTHER",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":58,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":5},"100631602","phase-3-the-power-trial-personalised-dose-optimisation-with-adjuvant-tamoxifen-therapy-in-breast-cancer-100631602","NCT07502820","The POWER Trial: Personalised Dose Optimisation With Adjuvant Tamoxifen Therapy in Breast cancER","The POWER Trial: A Randomised, Two-armed Open Label Phase 3 Clinical Trial on Personalised Dose Optimisation With Adjuvant Tamoxifen Therapy After Breast Cancer to Investigate the Impact on Discontinuation and Efficacy Compared to Standard of Care","POWER","Inclusion Criteria:\n\n* Patients with primary breast cancer, recommended for adjuvant tamoxifen treatment with or without concomitant goserelin\n* Premenopausal or perimenopausal, defined according to SOC for therapy decision\n* Eastern Cooperative Oncology Group (ECOG) WHO Performance Scale 0 - 2\n* Participants must use non-hormonal contraception during the trial.\n\nExclusion Criteria:\n\n* Previous use of tamoxifen, endoxifen, or aromatase inhibitors.\n* Previous medical history of:\n\nDeep venous thrombosis or pulmonary embolism; bleeding disorder or coagulopathy; macular disorders, retinal disorders, severe cataract or glaucoma.\n\n* Current use of warfarin.\n* Not willing to abstain from strong and moderate CYP2D6 inhibitors or CYP3A4 inducers during the tamoxifen treatment\n* Current pregnancy, breastfeeding, or already at start of tamoxifen planning to become pregnant within the next two years\n* Use of systemic menopausal hormonal therapy (MHT).\n* Prior invasive malignancy during the last five years. Prior or current in situ cancers are allowed.",{"count":84,"type":21},1100,[60],"In Sweden, approximately 7000 women are diagnosed with hormone-sensitive breast cancer annually. According to international and national guidelines, most of these women are recommended anti-hormonal therapy for five to ten years to improve prognosis. Tamoxifen, one of the most widely used anti-hormonal agents globally, reduces the risk of recurrence by 40% and breast cancer mortality by 30%.\n\nTamoxifen is a pro-drug that undergoes hepatic metabolism to form endoxifen and other active metabolites. Variability in metabolic capacity affects therapeutic efficacy: poor metabolisers produce insufficient endoxifen and other active metabolites, risking therapeutic failure, while ultrarapid metabolisers generate excessive amounts, leading to intolerable adverse effects. Today, 30-50% of patients discontinue treatment prematurely due to severe side effects, resulting in suboptimal outcomes.\n\nCurrently, tamoxifen is uniformly prescribed at a daily dose of 20 mg, and so far, no clinical trials have tested whether individualised dosing could enhance adherence and improve survival outcomes. The primary objective is to evaluate whether individualised tamoxifen dosing reduces discontinuation rates and enhances patient outcomes in breast cancer treatment.",[88,26],"Breast Cancer",[90,91,92,93,94,95],"Early-stage breast cancer","Adjuvant","Endocrine therapy","Tamoxifen","Therapeutic drug monitoring TDM","Precision medicine","2026-03-27",{"date":98,"type":37},"2026-03-31",{"date":100,"type":21},"2026-03",{"date":102,"type":21},"2036-08",{"name":104,"class":73},"Karolinska Institutet",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":58,"phases":114,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":130},"100606895","phase-2-sequential-chemotherapy-with-befotertinib-in-non-small-cell-lung-cancer-nsclc-patients-with-resistance-to-third-generation-egfr-tki-100606895","NCT07181499","Sequential Chemotherapy With Befotertinib in Non-Small Cell Lung Cancer (NSCLC) Patients With Resistance to Third-Generation EGFR-TKI","A Study Evaluating the Efficacy and Safety of Pemetrexed Combined With Platinum-Based Chemotherapy Followed by Befotertinib in Patients With Non-Small Cell Lung Cancer After Third-Generation EGFR TKI Resistance","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Histologically or cytologically confirmed advanced or metastatic non-squamous NSCLC; and prior resistance to third-generation EGFR TKIs, with EGFR-sensitive mutations confirmed via tissue or blood samples (defined as: 19 Del or 21 L858R);\n3. Exclusion of small cell lung cancer (SCLC) or squamous cell carcinoma (SqCC) transformation, and known NSCLC with clear targetable mutations for targeted therapy, such as HER2, MET amplification (GCN ≥ 5), KRAS G12C mutation, BRAF V600E mutation, RET fusion mutation, ALK fusion mutation, NTRK fusion mutation, etc.;\n4. ECOG performance status (PS) score of 0-2;\n5. Life expectancy of at least 12 weeks;\n6. Ability to swallow oral medications;\n7. Adequate organ system function, defined as follows and determined based on investigator judgment:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹\u002FL\n   2. Platelets ≥ 100 x 10⁹\u002FL;\n   3. Hemoglobin ≥ 9 g\u002FdL (≥ 90 g\u002FL). Note: Blood transfusions are permitted to achieve the required hemoglobin level;\n   4. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN);\n   5. If no liver metastases: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; if liver metastases present: ≤ 5 × ULN;\n   6. Creatinine ≤1.5 × ULN. If ≥1.5 × ULN, patients remain eligible if the Cockcroft-Gault-calculated creatinine clearance ≥50 mL\u002Fmin (0.83 mL\u002Fs);\n8. Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days prior to study drug initiation and agree to use a medically approved highly effective contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 3 months after the last study drug administration; Male subjects with female partners of childbearing potential must be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after the last study dose.\n9. Voluntarily agree and be capable of adhering to the trial and follow-up procedures.\n10. Be able to understand the nature of the trial and complete the written informed consent form.\n\nExclusion Criteria:\n\n1. Rare EGFR mutations;\n2. Prior treatment with pemetrexed and platinum-based chemotherapy regimens;\n3. Advanced and\u002For symptomatic brain metastases (measurable or non-measurable) and\u002For leptomeningeal metastases;\n4. Active hepatitis B (serum HBV DNA ≥10⁴ copies\u002FmL \\[i.e., 20,000 IU\u002FmL\\]), hepatitis C virus antibody positive, HIV antibody positive, or treponema pallidum antibody positive;\n5. Women of childbearing potential with a positive serum pregnancy test within 7 days prior to treatment initiation, pregnant or lactating women, or male and female subjects not using effective contraception or planning pregnancy during treatment and for 3 months post-treatment;\n6. Patients who used or require concomitant use of the following drugs within 14 days prior to the first dose or during treatment: drugs associated with QTc prolongation and\u002For risk of torsades de pointes ventricular tachycardia; strong CYP3A inhibitors or inducers;\n7. Patients who underwent major surgery or immunotherapy within 4 weeks prior to the first dose; patients who received radiotherapy within 2 weeks prior to the first dose.\n8. Imaging (CT or MRI) demonstrating tumor invasion of major vessels, or a high likelihood of tumor invasion into critical vessels causing fatal hemorrhage during the study period;\n9. History of interstitial lung disease, drug-induced interstitial disease, or any clinically evident active interstitial lung disease; presence of idiopathic pulmonary fibrosis identified on baseline CT scan;\n10. Other severe acute or chronic medical conditions, including uncontrolled diabetes, medical or psychiatric disorders, or laboratory abnormalities, that in the investigator's judgment may increase study-related risks or interfere with interpretation of study results;\n11. Other conditions deemed by the investigator to be unsuitable for participation in this trial.",{"count":113,"type":21},28,[115],"PHASE2","Non-small cell lung cancer (NSCLC) accounts for over 85% of lung cancers. Approximately 30-40% of East Asian adenocarcinoma patients harbor EGFR mutations. Third-generation EGFR-TKIs achieve a median PFS of about 20 months as first-line therapy, but resistance eventually develops. Studies like MARIPOSA-2 confirm that amivantamab combined with chemotherapy ± lazertinib or immunotherapy regimens (ivucitinib\u002Fsintilimab + bevacizumab + chemotherapy) can extend median PFS post-resistance from approximately 4 months to 6-8 months. As a third-generation TKI, befitinib has demonstrated PFS of 16-22 months in both first-line and post-T790M mutation settings. This study aims to further evaluate the feasibility and safety of \"pemetrexed + carboplatin followed by befotertinib\" for patients resistant to third-generation TKIs.",[118,26,119],"NSCLC","EGFR","2025-09-28",{"date":122,"type":37},"2025-09-30",{"date":124,"type":21},"2025-09",{"date":126,"type":21},"2028-12",{"name":128,"class":129},"Betta Pharmaceuticals Co., Ltd.","INDUSTRY",2]