[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"West German Study Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100522332","phase-3-neoadj-therapy-comparing-sacituzumab-govitecan-sg-vs-sgpembrolizumab-in-low-risk-triple-neg-ebc-adapt-tn-iii-100522332",false,"NCT06081244","NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)","NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Sacituzumab Govitecan Versus Sacituzumab Govitecan+Pembrolizumab in Low-risk, Triple-negative Early Breast Cancer (ADAPT-TN-III)","ADAPT-TN-III","Inclusion Criteria:\n\n1. ER + PR negative or low positive (≤10% positive cells in IHC), and HER2 negative (i.e., IHC 0 - 1+ or IHC 2+ with FISH negative) breast cancer\n2. All patients, independent from gender\n3. ≥18 years at diagnosis\n4. Histologically confirmed unilateral, primary invasive carcinoma of the breast Note: bilateral, multicentric, or multifocal carcinoma may be included, if there is a clear target lesion, that is subject to treatment decisions and solely evaluated and documented for study purposes.\n5. Clinical stage I: cT1a-c, cN0 (clinical stage II only, if patient does not qualify for neoadjuvant polychemotherapy+PEM, e.g., elderly population, per investigator´s decision)\n6. No clinical evidence for distant metastasis (M0)\n7. Tumour block available for central pathology review\n8. Performance Status ECOG ≤ 1 or KI ≥ 80%\n9. Negative pregnancy test (urine or serum) within 7 days prior to registration in premenopausal patients\n10. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements\n11. The patient must be willing and able to comply with the requirements and restrictions in this protocol and accessible for treatment and follow-up\n12. Laboratory requirements:\n\n    * Leucocytes ≥3.5 109\u002FL,\n    * Neutrophils \\> 1.5 109\u002FL,\n    * Platelets ≥100 109\u002FL,\n    * Haemoglobin ≥10 g\u002FdL,\n    * AP \\\u003C 5.0 ULN,\n    * AST ≤2.5 x ULN,\n    * ALT ≤2.5 x ULN,\n    * Total bilirubin ≤1 x ULN,\n    * Creatinine ≤1.5 × ULN OR clearance ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n13. Clinical assessments:\n\n    • LVEF within normal limits of each institution, measured by echocardiography and normal ECG (within 42 days prior to treatment)\n14. The following age-specific requirements apply:\n\n    * Women aged \\\u003C50 years will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the site.\n    * Women aged ≥ 50 years will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments.\n15. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to randomization\u002Fstudy enrolment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.\n16. Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 1 (see Section 4.4.2), from the time of screening and must agree to continue using such precautions for 7 months after the last dose of IMP. Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IMP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic, or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n17. Female patients must not donate, or retrieve for their own use, ova from the time of randomisation and throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrolment in this study.\n18. A male participant must agree to use a contraception as detailed in Appendix C of this protocol during the treatment period and for at least 7 months after the last dose of study treatment and refrain from donating sperm during this period.\n\nExclusion Criteria:\n\n1. Known hypersensitivity reaction to the compounds or incorporated substances of the IMPs\n2. Prior malignancy with a disease-free survival of \\\u003C 5 years, except curatively treated basalioma of the skin or pTis of the cervix uteri\n3. Any history of invasive breast cancer\n4. Previous or concurrent treatment with cytotoxic agents for any non-oncological reason unless clarified with sponsor\n5. Concurrent treatment with other experimental drugs\n6. Participation in another interventional clinical trial with or without any investigational not marketed drug within 30 days prior to study entry\n7. Concurrent pregnancy; patients of childbearing potential or potentially childbearing partners of male patients must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment\n8. Breast feeding woman\n9. Reasons indicating risk of poor compliance\n10. Patients not able to consent\n11. Known polyneuropathy ≥ grade 2\n12. Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study including recovery from major surgery, autoimmune disease, known psychiatric\u002Fsubstance abuse disorders, acute cystitis, ischuria, and chronic kidney disease\n13. Uncontrolled infection requiring i.v. antibiotics, antivirals, or antifungals\n14. History of pneumonitis\n15. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients should be tested for HIV prior to randomisation if required by local regulations or ethics committee (EC).\n16. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.\n\n    * Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease.\n    * 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 a HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease.\n17. Patients who test positive for HIV antibody.","FEMALE","18 Years",{"count":20,"type":21},348,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","TNBC is known for poor prognosis, aggressive patterns of disease, and significant molecular heterogeneity. (Neo)adjuvant chemotherapy (NACT) is standard of care in all node-positive and in node-negative patients with a tumour size \\>5 mm according to current National Comprehensive Cancer Network (NCCN) guidelines. However, TNBC patients with lower stage disease do clearly have a better prognosis compared to more advanced stages. Patients with stage I-II node-negative disease have 3-5 year iDFS rates of 80-90% (with majority of relapses within the first three years) as shown in several trials.Although survival results appear much better in the lower vs. higher stages, there is a high clinical need in this most common group of TNBC patients in Western Europe and USA.",[27],"Triple Negative Breast Cancer",[29,30,31,32,33,34],"TNBC","Early breast cancer","Sacituzumab govitecan","pembrolizumab","chemotherapy","low recurrence risk","RECRUITING","2026-07-30",{"date":38,"type":39},"2026-08-03","ACTUAL",{"date":41,"type":39},"2024-10-10",{"date":43,"type":21},"2029-09",{"name":45,"class":46},"West German Study Group","OTHER",43,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100493413","phase-2-neoadjuvant-therapy-with-trastuzumab-deruxtecan-versus-chemotherapytrastuzumabpertuzumab-in-her2-early-breast-cancer-100493413","NCT05704829","NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer","NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Trastuzumab-deruxtecan Versus Pacli-\u002FDocetaxel+Carboplatin+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer","ADAPTHER2-IV","Inclusion Criteria:\n\nPatients eligible for inclusion in this study must meet all the following criteria:\n\n1\\. Female patients with invasive, untreated HER2+ breast cancer (as assessed by local pathology) maximum 6 weeks before registration (standard-of-care diagnostic biopsy according to current AGO guidelines) 2. Age ≥18 years 3a. Cohort 1: low- to intermediate-risk for recurrence as per investigator´s decision (recommendation: cT1c - cT2 (1 - ≤3cm) AND cN0; cT1a\u002Fb, cN0 excluded), OR 3b. Cohort 2: intermediate- to high-risk for recurrence as per investigator´s decision (recommendation: cT2 (\\>3 - ≤5cm), cN0) 3c. Cohort 3: intermediate- to high-risk for recurrence as per investigator´s decision, (recommendation: clinical stage II (cT2, cN0); cT1c, cN0 only if neoadjuvant treatment intended) 4. Written informed consent 5. LVEF ≥ 50% within 28 days before randomisation 6. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 7. Adequate bone marrow and organ function within 14 days before randomisation as defined by the following laboratory values:\n\n* absolute neutrophil count ≥ 1.5 × 109\u002FL,\n* platelets ≥ 100 × 109\u002FL,\n* haemoglobin ≥ 9.0 g\u002FdL:\n* estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin by a Cockcroft-Gault formula,\n* INR ≤ 1.5,\n* serum creatinine \\\u003C 1.5 mg\u002FdL,\n* total bilirubin \\\u003C 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 transaminase (AST) \\\u003C 2.5 × ULN,\n* alanine transaminase (ALT) \\\u003C 2.5 × ULN. 8. Adequate treatment washout period before randomisation (refer to protocol for detailed information) 9. Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential (refer to protocol for detailed information) Post-menopausal status is accepted for women, who at the time of initiation of study medication, either\n* had underwent bilateral oophorectomy, or\n* are ≥ 60 years of age, or\n* are \\\u003C 60 years of age and amenorrhoeic for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression)\n* and\u002For whose FSH- and oestradiol-blood values are within the postmenopausal range per local laboratory normal range.\n\n  10\\. Female subjects must not donate, or retrieve for their own use, ova from the time of randomisation and throughout the study treatment period, and for at least 7 months after the final study drug administration.\n\nExclusion Criteria:\n\nPatients eligible for inclusion in this study must not meet any of the following criteria:\n\n1. 1\\. Non-operable breast cancer including inflammatory breast cancer\n2. cT1a\u002Fb, cN0 breast cancer\n3. Any previous history of invasive breast cancer\n4. Primary malignancies within 5 years, with the exception of\n\n   * adequately resected non-melanoma skin cancer\n   * curatively treated in-situ disease\n5. Any evidence for existing metastatic disease (confirmed by CT Thorax\u002FAbdomen, bone scan, or other methods according to clinical practice\n6. Previous or concurrent treatment with cytotoxic agents for any reason (except non-oncological reasons)\n7. Concurrent treatment with other experimental drugs and participation in another clinical trial with any investigational drug within 30 days prior to study entry\n8. Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study\u002Finadequate organ function\n9. Reasons indicating risk of poor compliance\n10. Woman of child-bearing potential defined as a woman physiologically capable of becoming pregnant, and not using highly effective methods of contraception during the study treatment and for 7 months after stopping the treatment.\n11. Use of oral (oestrogen and progesterone), transdermal, injected, or implanted hormonal methods of contraception as well as hormonal replacement therapy.\n12. Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.\n13. Patients with a medical history of myocardial infarction (MI) within 6 months before randomisation, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), Subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrolment to rule out MI.\n14. Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) based on average of the screening 12-lead ECG.\n15. History of (non-infectious) ILD \u002F pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n16. Lung criteria:\n\n    * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder\n    * Any autoimmune, connective tissue or inflammatory disorders (e.g., Rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of randomisation.\n    * Prior pneumonectomy (complete)\n    * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals\n17. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients should be tested for HIV prior to randomisation if required by local regulations or ethics committee (EC).\n18. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan or carboplatin.\n\n    Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IMP.\n19. Known allergy or hypersensitivity to study treatment (T-DXd), to comparator (SoC-) treatment, or any of the study drug \u002F comparator (SoC-) excipients.\n20. History of severe hypersensitivity reactions to other monoclonal antibodies.\n21. Pregnant or breastfeeding female patients, or patients who are planning to become pregnant",{"count":57,"type":21},702,[59],"PHASE2","ADAPT-HER2-IV will address question of optimal neoadjuvant therapy in patients with less advanced -HER2+ EBC.\n\nADAPT-HER2-IV is planned as a superiority trial to demonstrate higher pCR rates in both clinically relevant subgroups of low-intermediate risk HER2+ EBC. Moreover, it aims to demonstrate excellent survival in patients treated by T-DXd (with the use of standard chemotherapy at investigator´s decision restricted only to patients with substantial residual tumour burden after T-DXd-treatment).",[62],"HER2-positive Early Breast Cancer",[64,65,66,67,68,69,70,71,72],"HER2+","T-DXd","Trastuzumab-deruxtecan","pCR","intermediate risk","high risk","low risk","recurrence","neoadjuvant","2026-06-05",{"date":75,"type":39},"2026-06-09",{"date":77,"type":39},"2024-02-05",{"date":79,"type":21},"2030-09",{"name":45,"class":46},44,""]