[{"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:":196},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,77,99,135,167],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100606682","phase-3-neoadjuvant-therapy-comparing-sacituzumab-govitecanpembrolizumab-vs-soc-chemotherapy-in-clinical-stage-ii-iii-triple-negative-early-breast-cancer-100606682",false,"NCT07178730","NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer","NeoAdjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer","ADAPT-TN-IV","Inclusion Criteria:\n\nMinimal eligibility criteria to be met for registration in the clinical trial:\n\n1. TNBC: ER = 0%, PR = 0%, and HER2- (i.e., immunohistochemistry \\[IHC\\] with DAKO score ≤ 1 or fluorescence in situ hybridization \\[FISH\\]-negative)\n2. or TNBC-like: ER ≤ 10% positive cells in IHC, PR \\\u003C 10% positive cells in IHC, and HER2- (i.e., IHC with DAKO score ≤ 1 or FISH negative)\n3. All patients, independent from gender\n4. ≥18 years at diagnosis\n5. Histologically confirmed unilateral, primary invasive carcinoma of the breast Note: bilateral, multicentric, or multifocal carcinoma may be included, if there is a clear target (primary) lesion, that is subject to treatment decisions and solely evaluated and documented for study purposes. Histological confirmation of all lesions as TNBC is mandatory.\n6. Clinical stage II-III at baseline\n7. No clinical evidence for distant metastasis (M0)\n8. Cognitive and language skills to complete quality of life (QoL) questionnaires\n\n   Additional eligibility criteria to be met for assignment to cohort I or II:\n9. Completed 9-12 weeks of NACT with CARBO + PEM or PAC q1w + PEM q3w with the last dose of NACT given less than 2 weeks ago. Patients may also be considered if their NACT treatment was switched to nab-PAC due to intolerance to PAC.\n\n   * Patients with progressive disease during taxane-CARBO treatment are allowed to participate in cohort II after consultation with sponsor, provided that at least 6-9 weeks of NACT with taxane-CARBO q1w and PEM q3w have been administered\n   * Patients experiencing toxicities due to PEM, in case of contraindications or other medical reasons against PEM administration (with or without permanent discontinuation of PEM) can nevertheless be included, even if PEM will not be administered anymore. The number of patients starting the study without PEM is limited to 10%.\n10. Tumour block available for central pathology review\n11. Performance Status ECOG ≤ 1 or Karnofsky Index ≥ 80%\n12. 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\n13. The patient must be capable of giving informed consent and be willing and able to comply with the requirements and restrictions in this protocol and accessible for treatment and follow-up\n14. Laboratory requirements (female and male patients, ≤ 14 days old)\n\n    * Neutrophils \\> 1.5 109\u002FL,\n    * Platelets \\> 100 109\u002FL,\n    * Total bilirubin \\\u003C 1 x upper level of normal (ULN),\n    * ASAT (sGOT) \\\u003C 2.5 x ULN,\n    * ALAT (sGPT) \\\u003C 2.5 x ULN,\n    * Creatinine ≤1.5 × ULN OR clearance ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n15. Clinical assessments:\n\n    \\- Normal Electrocardiogram (ECG) (within 42 days prior to induction treatment)\n16. Negative pregnancy test (urine or serum) within ≤ 14 days prior to registration in premenopausal patients and immediate implementation of adequate contraceptive measures.\n\n    Note: Pregnancy testing is to be repeated according to Schedule of Activities.\n17. 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.\n18. 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 and need to 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 participate without use of a contraceptive method.\n19. 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 enrolment 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.\n20. Female patients must not donate, or retrieve for their own use, ova from the time of randomization 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.\n21. 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 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 or 5 half-lives of the respective drug, whichever is longer, prior to study entry. In case of other interventional trial contact Sponsor.\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 haemolytic anaemia, myocarditis, sclerosing cholangitis and exocrine pancreatic insufficiency, medical history of allogenic stem cell transplants, or solid organ transplant\n15. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection. Patients should be tested for HIV prior to randomization if required by local regulations or ethics committee. Patients who test positive for HIV-antibody are excluded.\n16. Active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with the following detectable viral loads will be excluded.\n17. 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.\n18. 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 test at enrolment and will only require HCV RNA by quantitative PCR for confirmation of active disease.\n19. Patients who received live vaccines within 30 days prior to randomization.\n20. Patients who are submitted to an institution by virtue of an order of a court or a governmental authority must be excluded from participation.","ALL","18 Years",{"count":20,"type":21},765,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","TNBC is a heterogeneous disease with distinct pathological, genetic, and clinical features among subtypes. Treatment results for high-risk primary TNBC remain poor compared to other breast cancer subtypes. Preoperative chemotherapy is the standard of care for patients with stage II or III primary TNBC. Multiple lines of clinical evidence demonstrate that TNBC patients who achieve a pCR to NACT, (ypT0\u002Fis ypN0), have an excellent long-term prognosis. A meta-analysis of individual patient data confirmed a strong association of pCR after NACT with improved long-term event-free survival (EFS, hazard ratio \\[HR\\] 0.24) and overall survival (OS, HR 0.16) benefit. Taxane- and anthracycline-based neoadjuvant regimens generally result in pCR rates between 25-50% \\[REFs\\], whereas the addition of platinum increases pCR rates to approximately 50-55%.\n\nThe KEYNOTE-522 trial has demonstrated that the addition of the immune-checkpoint inhibitor PEM to anthracycline- (AC), taxane- and platinum-based NACT resulted in a significant increase in pCR rates to nearly 65%, associated with a significant reduction of recurrences (EFS, HR 0.65 at 5 years) and improvement of OS (HR 0.66). Based on these results, the KEYNOTE-522 regimen has been approved by the FDA and EMA and has become the standard of care for patients with stage II or III TNBC.\n\nDespite this significant progress, two major questions remain unresolved which will be investigated in the ADAPT-TN-IV trial:\n\n1. Do all patients require the full 6 months of NACT as per KEYNOTE-522 or is there a subgroup of patients who are sufficiently treated with 12 weeks of NACT plus PEM?\n2. Can incorporation of ADCs into the KEYNOTE-522 regimen improve response and outcomes in patients without an optimal early response? The outcome of patients with residual disease after 24 weeks of NACT and PEM remains suboptimal and there is an urgent need for more effective strategies. ADCs such as SG have demonstrated superior efficacy compared to standard chemotherapy in metastatic TNBC, resulting in substantially higher response rates and improved progression-free (PFS) and OS. Combination studies of ADCs and immunotherapy in metastatic TNBC have demonstrated significant activity, suggesting possible synergistic activity It is therefore a logical next step to investigate, whether the incorporation of SG in the NACT regimen can improve pCR rates and EFS results in patients who have residual clinical disease after 12 weeks of NACT with CARBO\u002FPAC + PEM.",[27,28],"Breast Cancer","Triple-negative Breast Cancer","NOT_YET_RECRUITING","2026-06-05",{"date":32,"type":33},"2026-06-08","ACTUAL",{"date":35,"type":21},"2026-06-30",{"date":37,"type":21},"2033-03-31",{"name":39,"class":40},"West German Study Group","OTHER",26,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"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","FEMALE",{"count":52,"type":21},702,[54],"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).",[57],"HER2-positive Early Breast Cancer",[59,60,61,62,63,64,65,66,67],"HER2+","T-DXd","Trastuzumab-deruxtecan","pCR","intermediate risk","high risk","low risk","recurrence","neoadjuvant","RECRUITING",{"date":70,"type":33},"2026-06-09",{"date":72,"type":33},"2024-02-05",{"date":74,"type":21},"2030-09",{"name":39,"class":40},44,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100611574","phase-3-marker---adjusted-therapy-comparing-adjuvant-elacestrant-with-standard-endocrine-treatment-in-genomically-andor-clinically-high-risk-erher2--ebc-100611574","NCT07242352","Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and\u002For Clinically High-risk ER+\u002FHER2- eBC","Dynamic Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and\u002For Clinically High-risk ER+\u002FHER2- Early Breast Cancer (ADAPTela)","ADAPTela","Inclusion Criteria:\n\n1. All patients, independent from gender\n2. Patient must be ≥18 years at diagnosis\n3. The patient must be capable of giving informed consent and be willing and able to comply with the requirements and restrictions in this protocol and accessible for treatment and follow-up\n4. Sign informed consent prior to any study-specific procedures.\n5. Histologically confirmed unilateral, primary invasive carcinoma of the breast Note: bilateral, multicentric, or multifocal carcinoma may only be included after consultation of Sponsor.\n6. Histologically confirmed diagnosis of primary hormone-receptor-positive (HR+) (i.e., oestrogen-receptor (ER) ≥ 10% and progesterone-receptor PR ≥ 10%) early breast cancer by local laboratory Note: ER positive according to ASCO \u002F AGO Guidelines, ER 1-10% (low) is not defined as HR+.\n7. 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 (based on the most recently analysed tissue sample and all tested by a local laboratory).\n8. No evidence of distant metastasis (confirmed by CT thorax \u002F abdomen, X-ray chest, ultrasound liver, bone scan, or PET-CT, respectively, performed within clinical routine).\n9. High genomic risk assessment within clinical routine (Oncotype DX® preferred; In those cases, where Oncotype Dx® is not possible in clinical routine, Oncotype Dx® should be assessed retrospectively after inclusion of the patient and as a study specific measure, provided sufficient tumour tissue from primary diagnosis is available.)\n10. 10\\. Completed 2-6 weeks of endocrine induction treatment and Ki-67 response assessment Note: 2-4 weeks recommended, up to 6 weeks allowed. Endocrine induction is highly recommended, but if endocrine induction therapy could not be performed or ET response is not representative, clinical factors should be used.\n11. 11\\. Completed (neo)adjuvant chemotherapy, if applicable\n12. Completed radiotherapy, if applicable\n13. Patient meets any of the following three conditions at end of primary treatment (including endocrine induction treatment, biopsy\u002Fsurgery, and if necessary, chemotherapy and radiotherapy and up to 12 months standard-of-care endocrine treatment, excluding previous treatment \\> 4 weeks with any SERD):\n\n    Pathological Stage \\* Genomical High-Risk (Oncotype Dx®)\\*\\* Age Clinical High-Risk Factors Stage I T1 N0\n\n    RS\\>25 Any age High risk (≤ 1 factor applies):\n    * ET non-response (post ET Ki-67 \\>10%)\\*\\*\\*\n    * No Chemotherapy\n    * G3 or PR negative and Ki-67 \\>25%\\*\\*\\*\n    * Non-pCR after NACT\\*\n\n    RS 16-25 Age \\\u003C50 High risk (≤ 1 factor applies):\n    * ET non-response (post ET Ki-67 \\>10%)\\*\\*\\*\n    * No Chemotherapy\n    * G3 or PR negative and Ki-67 \\>25%\\*\\*\\*\n    * Non-pCR after NACT\\* Any genomic risk Any age G3 and Ki-67\\>40%\n\n    Stage IIa with T2 N0\n\n    RS 0-25 Age\\>50 High risk (≤ 1 factor applies):\n    * ET non-response (post ET Ki-67 \\>10%)\\*\\*\\*\n    * G3 and Ki-67\\>40%\n    * G3 or PR negative and Ki-67 \\>25%\\*\\*\\*\n    * Non-pCR after NACT\\*\n\n    RS 0-15 Age\\\u003C50 No chemotherapy AND high risk (≤ 1 factor applies):\n    * ET non-response (post ET Ki-67 \\>10%)\\*\\*\\*\n    * G3 and Ki-67\\>40%\n    * G3 or PR negative and Ki-67 \\>25%\\*\\*\\*\n    * Non-pCR after NACT\\*\n\n    RS 16-25 Age\\\u003C50 No chemotherapy, AND\u002FOR high risk (≤ 1 factor applies):\n    * ET non-response (post ET Ki-67 \\>10%)\\*\\*\\*\n    * G3 and Ki-67\\>40%\n    * G3 or PR negative and Ki-67 \\>25%\\*\\*\\*\n    * Non-pCR after NACT\\*\n\n    RS \\>25 Any age Any clinical risk\n\n    Any genomic risk Any age G3 and Ki-67 \\>40%\n\n    Stage IIa with T1 N1, G1-2\n\n    RS 0-25 Age\\>50 High risk (≤ 1 factor applies):\n    * ET non-response (post ET Ki-67 \\>10%)\\*\\*\\*\n    * PR negative and Ki-67 \\>25%\\*\\*\\*\n    * Non-pCR after NACT\\*\n    * 3 positive LN\n\n    RS 0-25 Age \\\u003C50 No chemotherapy, AND\u002FOR high risk (≤ 1 factor applies):\n    * ET non-response (post ET Ki-67 \\>10%)\\*\\*\\*\n    * PR negative and Ki-67 \\>25%\\*\\*\\*\n    * Non-pCR after NACT\\*\n    * 3 positive LN\n\n    RS\\>25 Any age Any clinical risk\n\n    Stage IIb with T3 N0 or T2 N1, G1-2 Any genomic risk Any age Any clinical risk\n\n    \\* In patients treated by neoadjuvant chemotherapy, clinical stage should be used for inclusion\n\n    \\*\\* In stage I-IIa and N0 patients with unknown genomic risk prior to inclusion, Oncotype Dx® Test should be performed on untreated tumour tissue within clinical routine.\n\n    Results of other genomic tests, if already performed within the clinical routine, may be considered. In such cases, inclusion is only possible if clinical high-risk criteria apply and after consultation with sponsor.\n\n    In those cases, where Oncotype Dx® is missing from clinical routine and in the N1-situation, Oncotype Dx® should be assessed retrospectively after inclusion of the patient and as a study specific measure, provided sufficient tumour tissue from primary diagnosis is available.\n\n    \\*\\*\\* Use of clinical factors is recommended in patients with unknown or not representative ET response.\n14. No contraindication for adjuvant SoC endocrine treatment\n15. No contraindication for elacestrant treatment\n16. No contraindication for ribociclib treatment, if medically indicated, and adequate washout time for CYP3A4 inducers\u002Finhibitors and QT time-prolonging drugs is given\n17. Tumour block for central pathology review (core biopsy of initial diagnosis and biopsy\u002Fsurgery sample of definite surgery), if available\n18. Performance Status ECOG ≤ 1 or Karnofsky Index ≥ 80%\n19. Laboratory requirements (female and male patients, not older than 14 days prior to date of informed consent)\n\n    * absolute neutrophil count ≥ 1.5 × 109\u002FL,\n    * platelets ≥ 100 × 109\u002FL,\n    * haemoglobin ≥ 9.0 g\u002FdL,\n    * INR ≤ 1.5,\n    * serum creatinine \\\u003C 1.5 × ULN OR clearance ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\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,\n    * Screening lipid panel fasting levels: total cholesterol ≤400 mg\u002FdL AND\u002FOR triglycerides \\\u003C500 mg\u002FdL.\n\n    Note: Patients with lipid panel fasting levels NOT meeting the above criteria may consider initiating therapy for lipid management per local guidelines and will be allowed to be included once the lipid levels meet the inclusion criteria.\n20. Clinical assessments:\n\n    • normal electrocardiogram within 6 weeks prior to randomization (QTcF interval at screening \\\u003C450msec using Fridericia's correction, mean resting heart rate 50-90 bpm)\n21. Ability to swallow tablets\n22. Contraception\n\nA. Female patients of childbearing potential at inclusion must have a negative pregnancy test (serum) and additionally fulfil either one of the following conditions:\n\n* surgically sterile,\n* or carry a non-hormone releasing intrauterine device (combined with a barrier method),\n* or having received tubal ligation\u002Focclusion (combined with a barrier method),\n* or using a highly effective contraceptive method from the time they sign consent, during participation in the study until end of study, at least 4 months (120 days) after the last dose of ELA, and for at least 21 days after the last dose of RIBO) to prevent pregnancy; ova donation or preservation is also not allowed within this time frame\n* Total\u002Ftrue abstinence: When the patient refrains from any form of sexual intercourse and this is in line with their usual and\u002For preferred lifestyle; this must continue from the time they sign consent, during participation in the study until end of study, at least 4 months (120 days) after the last dose of ELA, and for at least 21 days after the last dose of RIBO) to prevent pregnancy;\n* Vasectomised sexual partner (with participant assurance that partner received post-vasectomy confirmation of azoospermia) combined with a barrier method or sexual partner with bilateral orchiectomy.\n* Hormonal contraception is not acceptable. B. Male patients must either be\n* surgically sterile\n* or using a highly effective method of contraception from the time they sign consent, during participation in the study until end of study, at least 4 months (120 days) after the last dose of ELA, and for at least 21 days after the last dose of RIBO) to prevent pregnancy in a partner; sperm donation or preservation is also not allowed within this time frame\n* Male patients who intend to be sexually active with a woman of childbearing potential, must use a condom plus spermicide from the time they sign consent, during participation in the study until end of study, at least 4 months (120 days) after the last dose of ELA, and for at least 21 days after the last dose of RIBO) to prevent pregnancy in a partner;\n* Highly effective methods of contraception should be considered in female partners of men taking elacestrant and\u002For ribociclib who are of childbearing potential.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any of the compounds or incorporated substances of the IMPs\n2. Prior malignancy with a disease-free survival of \\\u003C5 years, except curatively treated basalioma of the skin or pTis of the cervix uteri\n3. Any history of invasive cancer within the last 10 years Note: adequately treated, basal or squamous-cell skin carcinoma, non-melanomatous skin cancer, curatively resected cervical cancer, and contralateral DCIS treated by mastectomy (contralateral in relation to current invasive breast cancer diagnosis) are excepted. Previous ipsilateral DCIS, irrespective of treatment, is excluded!\n4. Patient with distant metastases of breast cancer beyond regional lymph nodes.\n5. Concurrent treatment with cytotoxic agents for any non-oncological reason unless clarified with sponsor\n6. Concurrent treatment with other experimental drugs\n7. Participation in another interventional clinical trial with or without any investigational, not marketed drug within 30 days or 5 half-lives of the respective drug, whichever is longer, prior to study entry. In case of other interventional trial contact Sponsor.\n8. Previous treatment (\\>4 weeks) with any SERD\n9. 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\n10. Breast feeding woman\n11. Use of oral, transdermal, injected, or implanted hormonal methods of contraception as well as hormonal replacement therapy (oestrogen or progesterone).\n12. Reasons indicating risk of poor compliance\n13. Patient not able to consent\n14. Patient has not recovered from clinical and laboratory acute toxicities related to prior anticancer therapies to NCI CTCAE version 5.0 Grade ≤ 1.\n15. Severe and relevant co-morbidity that would interact with the application of endocrine treatment of any kind or the participation in the study\n16. For patients planned for ribociclib treatment: Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality, including any of the following:\n\n    * history of myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft (CABG) within 6 months prior to study entry,\n    * documented cardiomyopathy,\n    * left ventricular ejection fraction (LVEF) \\\u003C 50 % as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO),\n    * long QT syndrome, family history of idiopathic sudden death, congenital long QT syndrome, or any of the following:\n\n      * risk factors for Torsades de Pointe (TdP, polymorphic ventricular tachycardia in patients with long QT syndrome) including uncorrected hypokalaemia or hypomagnesemia, history of cardiac failure, or history of clinically significant\u002F symptomatic bradycardia,\n      * concomitant medications 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., bi-fascicular block, Mobitz type II, and 3rd-degree AV block),\n      * systolic blood pressure (SBP) \\> 160 or \\\u003C 90 mmHg.\n17. 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, diarrhoea, malabsorption syndrome, or small-bowel resection).\n18. Uncontrolled infection requiring i.v. antibiotics, antivirals, or antifungals\n19. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection. Patients should be tested for HIV prior to randomization if required by local regulations or ethics committee (EC). Patients who test positive for HIV-antibody are excluded.\n20. Patient has known active hepatitis-B-virus (HBV) or hepatitis-C-virus (HCV) infection. Screening for HBV or HBC-infection and testing for hepatitis-B or -C is highly recommended according to current valid (local) clinical guidelines, but neither part of the interventional study procedures, nor required for enrolment.\n21. Patient has received live vaccines within 30 days prior to randomization.\n22. Patient was submitted to an institution by virtue of an order of a court or a governmental authority must be excluded from participation.",{"count":86,"type":21},1520,[24],"In this clinical trial, the Sponsor plans to investigate whether patients with HR+\u002FHER2- eBC identified during routine clinical assessments and treatments as having intermediate to high-risk (based on Oncotype DX® or similar tests and on response assessment to 2-6 weeks of preoperative ET) achieve a survival benefit from an initial 5-years use of elacestrant (with or without a CDK 4\u002F6 inhibitor) followed by SoC ET for further 0-2.5 years in comparison to at least 5 up to 7.5 years SoC ET therapy (+\u002F- CDK4\u002F6 inhibitor).\n\nBased on several studies in the metastatic setting, it is reasonable to assume that the adjuvant use of elacestrant with or without CDK 4\u002F6 inhibitors will prevent or delay the activation of mechanisms conferring resistance to ET (e.g., ESR1 mutations).",[27,90],"HR+\u002FHER2- Breast Cancer","2026-04-29",{"date":93,"type":33},"2026-05-06",{"date":91,"type":33},{"date":96,"type":21},"2033-09-30",{"name":39,"class":40},1,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":116,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100614610","phase-3-phase-iii-study-to-evaluate-the-safety-efficacy-and-impact-on-quality-of-life-of-capivasertib-alongside-standard-of-care-endocrine-treatment-in-patients-with-hrher2--advanced-breast-cancer-and-progression-on-prior-endocrine-based-treatment-100614610","NCT07281833","Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+\u002FHER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment","An Interventional, Open-label, Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+\u002FHER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment","CAPIcorn","Inclusion Criteria:\n\n1. Females (≥18 years, pre-, peri- or post-menopausal) and males (≥18 years) at the time of signing the informed consent form\n\n   a. Pre-menopausal (and peri-menopausal, i.e., those that do not meet the criteria for post menopausal defined below) women can be enrolled if amenable to treatment with an GNRH agonist. Patients are to have commenced concomitant treatment with GNRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue it for the duration of the study.\n\n   b. Post-menopausal women are defined as: i. aged ≥60 years of age, OR ii. aged \\\u003C60 years of age and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments\u002Fchemotherapy\u002Fovarian suppression\u002Ftamoxifen or similar. These patients should also have serum oestradiol and follicle stimulating hormone (FSH) levels confirmed as being within the standard laboratory reference range for post-menopausal females, OR iii. documented bilateral oophorectomy.\n2. Histologically confirmed HR+\u002FHER2- breast cancer determined from the most recent tumour sample (primary or metastatic) as per WHO classification. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor.\n\n   Therefore, tumours must be:\n\n   a. ER+ defined as ≥1% of tumour cells stain positive for ER on immunohistochemistry (IHC) or, if no percentage is available, then an Allred IHC score of ≥3\u002F8, b. Progesterone receptor positive defined as ≥1% of tumour cells stain positive for progesterone receptor on IHC or, if no percentage is available, then an Allred IHC score of ≥3\u002F8; or progesterone receptor negative defined as \\\u003C1% of tumour cells stain positive for progesterone receptor on IHC or, if no percentage is available, then an Allred IHC score of ≤2\u002F8; or progesterone receptor unknown, and c. HER2- defined as 0 or 1+ intensity on IHC, or 2+ intensity on IHC and no evidence of amplification on in situ hybridisation (ISH), or if IHC not done, no evidence of amplification on ISH.\n3. Metastatic or locally advanced disease with radiological or objective evidence of recurrence or progression (the cancer should have shown progression during or after most recent therapy); locally advanced disease must not be amenable to resection with curative intent (patients who are considered suitable for surgical or ablative techniques following potential down-staging with study treatment are not eligible).\n4. Patients are to have received treatment with an ET (endocrine-based therapy) containing regimen (single agent or in combination) and have:\n\n   a. Radiological evidence of breast cancer recurrence or progression while on, or within 12 months of the end of (neo)adjuvant treatment with an ET, OR b. Radiological evidence of progression while on prior ET administered as a treatment line for locally advanced or metastatic breast cancer (this does not need to be the most recent therapy).\n5. Presence of one or more of the PIK3CA\u002FAKT1\u002FPTEN biomarkers, preferably determined in tumour tissue\\*\n6. Decision to newly initiate capivasertib\n7. Informed consent provided by patient prior to participation in the trial and before initiation of any study-specific measures\n8. A. Female patients of childbearing potential at inclusion must have a negative pregnancy test (serum) and additionally, - surgically sterile, - carry an intrauterine device (combined with a barrier method),\n\n   * having received a bilateral tubal ligation\u002Focclusion (combined with a barrier method),\n   * or using a highly effective method of contraception for the duration of the study (from the time they sign consent) and for 3 months after the last dose of capivasertib \u002F GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy.\n   * Total\u002Ftrue abstinence When the patient refrains from any form of sexual intercourse and this is in line with their usual and\u002For preferred lifestyle; this must continue for the duration of the study and for 3 months after the last dose of capivasertib\u002F GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy.\n   * Vasectomised sexual partner (with participant assurance that partner received post-vasectomy confirmation of azoospermia) combined with a barrier method or sexual partner with bilateral orchiectomy\n   * Hormonal contraception is not acceptable.\n\n8\\. B. Male patients must either be\n\n* surgically sterile\n* or using an highly effective method of contraception for the duration of the study (from the time they sign consent) and for 4 months after the last dose of capivasertib\u002F GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy in a partner.\n* Sexually abstinent men (i.e., refraining from heterosexual intercourse during the entire study duration) must continue for 4 months after the last dose of capivasertib\u002F GNRH and for 2 years after the last dose of fulvestrant to prevent pregnancy in a partner.\n* Male patients who intend to be sexually active with a woman of childbearing potential, must use a condom plus spermicide upon entering the study and until 4 months after the last dose of capivasertib and for 2 years after the last dose of fulvestrant to prevent pregnancy in a partner.\n* Highly effective methods of contraception should be considered in female partners of men taking capivasertib plus fulvestrant who are of childbearing potential.\n\n  9\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration over the previous 2 weeks and life expectancy of ≥12 weeks\n\n  \\*A list of eligible alterations and test procedures is provided in the protocol.\n\nExclusion Criteria:\n\n* Patients eligible for inclusion in this study must not meet any of the following criteria:\n\n  1. Absence of an alteration in the PIK3CA\u002FAKT1\u002FPTEN biomarkers\n  2. Previous enrolment in the present study\n  3. Participation in another clinical study with any investigational medicinal product and still on IMP treatment or have participated in an interventional study that remains blinded\n  4. A disease burden that makes the patient ineligible for endocrine-based therapy per the investigator's best judgement (e.g., symptomatic visceral disease that is potentially life threatening in the short-term)\n  5. Known history of drug or alcohol abuse within 1 year of screening\n  6. Except for alopecia, any unresolved toxicities from prior therapy CTCAE Grade ≥2 at the time of starting study treatment\n  7. Leptomeningeal metastases\n  8. Spinal cord compression or brain metastases unless asymptomatic, treated and stable, and not requiring steroids within 4 weeks prior to study treatment initiation\n  9. Clinically significant abnormalities of glucose metabolism as defined by any of the following:\n\n     a. HbA1c ≥8.0% (63.9 mmol\u002Fmol) at screening. Note: for any patient with evidence of impaired glucose control or insulin resistance refer to the Capivasertib Toxicity Management Guidelines.\n  10. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:\n\n      1. Absolute neutrophil count \\\u003C1.5 × 109\u002FL\n      2. Platelet count \\\u003C100 × 109\u002FL\n      3. Haemoglobin \\\u003C9 g\u002FdL (\\\u003C5.59 mmol\u002FL). \\[NOTE: any blood transfusion must be \\>14 days prior to the determination of a haemoglobin ≥9 g\u002FdL (≥5.59 mmol\u002FL)\\]\n      4. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \\>2.5 times upper limit of normal (ULN) if no demonstrable liver metastases or \\>5 × ULN in the presence of liver metastases\n      5. Total bilirubin \\>1.5 × ULN (Patients with confirmed Gilbert's syndrome may be included in the study)\n      6. Creatinine \\>1.5 × ULN concurrent with creatinine clearance \\\u003C50 mL\u002Fmin (measured or calculated by Cockcroft and Gault equation); creatinine clearance is only required when creatinine is \\>1.5 × ULN\n  11. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, or active infection including tuberculosis, hepatitis B, hepatitis C, and human immunodeficiency virus (HIV), including those who have confirmed COVID 19 and any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent. Screening for chronic conditions is not required.\n\n      Note: Known active hepatitis B or C infection, positive hepatitis C antibody, positive hepatitis B virus surface antigen. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Patients receiving antiretroviral therapies which are strong inhibitors or inducers of CYP3A4 will be excluded due to the potential for drug-drug interaction with capivasertib\n  12. Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of fulvestrant or subcutaneous injections of GNRH agonist (if applicable)\n  13. Refractory nausea and vomiting, malabsorption syndrome, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection, or other condition that would preclude adequate absorption of capivasertib\n  14. Previous allogenic bone marrow or solid organ transplant\n  15. History of another primary malignancy\n  16. Known immunodeficiency syndrome\n  17. Mean resting corrected QT interval \\>470 ms, obtained from triplicate ECGs performed at screening. History of QT prolongation associated with other medications that required discontinuation of that medication \\[Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.\\]\n  18. Medical history significant for arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted to enter the study based on the Investigator judgement with cardiologist consultation recommended.\n  19. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, hypokalaemia of Grade \\>1, potential for Torsades de Pointes, congenital long QT syndrome\n  20. Experience of any of the following procedures or conditions in the preceding 3 months: coronary artery bypass graft, angioplasty, myocardial infarction, unstable angina pectoris. Congestive heart failure New York Heart Association (NYHA) ≥grade 2.\n  21. History of hypersensitivity to active or inactive excipients of capivasertib, fulvestrant and GNRH agonists (if applicable, i.e., concomitant GNRH agonist required in this study) or drugs with a similar chemical structure or class to capivasertib, fulvestrant or GNRH agonists (if applicable)\n  22. Radiotherapy within 14 days prior to first dose of capivasertib\n  23. Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.\n  24. Evidence of dementia altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent\n  25. Pregnancy or breastfeeding\n  26. Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded\n  27. More than 2 lines of endocrine-based therapy for inoperable locally advanced or mBC\n  28. More than 1 line of chemotherapy for inoperable locally advanced or mBC. Adjuvant and neoadjuvant chemotherapy are not classed as lines of chemotherapy for mBC\n  29. Prior treatment with any of the following:\n\n      1. AKT, PIK3 and mTOR inhibitors\n      2. ngSERD (Note: prior treatment with fulvestrant (=SERD) is allowed!)\n      3. Nitrosourea or mitomycin C within 6 weeks prior to study treatment initiation\n      4. Any other chemotherapy, immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks prior to study treatment initiation. A longer washout period may be required for drugs with a long half-life (e.g., biologics) as agreed by the sponsor\n      5. Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort) or drugs that are sensitive to CYP3A4 inhibition within 1 week prior to study treatment initiation.\n      6. Any concomitant medication that may interfere with capivasertib or fulvestrant safety and efficacy based on the Investigator´s Brochure of capivasertib and the prescribing information of fulvestrant and local clinical guidelines, e.g., that are known to be associated with Torsade de Pointes or potent inducers of cytochrome P450 3A4 (CYP3A4).",{"count":108,"type":21},250,[24],"This is a multicentre phase-III-trial to evaluate the use of capivasertib in patients with HR+\u002FHER2- advanced breast cancer and progression on prior endocrine-based treatment.\n\nThe goal of this study is\n\n1. To evaluate benefit of capivasertib regarding time to next treatment (TTNT1) - i.e., time \"on treatment\" with capivasertib.\n2. To evaluate the benefits of patient reported outcome(PRO)-adherence regarding the deterioration of quality of life (DQoL)-free interval.\n\nThere is no active comparison group but a historical control group consisting of data of patients treated within the CAPItello-291-study..\n\nParticipants will take capivasertib accompanied by standard of care endocrine treatment and are asked to document ther quality of life on standardised questionnaires. Optionally, patients can use eHealth support via their own smart phones.",[27,112,113,114,115],"HR-positive Breast Cancer","Advanced Breast Cancer","Metastatic Breast Cancer","HER2-negative Breast Cancer",[117,118,119,120,121,122,123,124,125],"breast cancer","advanced, metastatic","metastatic","progression","HR+","HER2-","capivasertib","eHealth","ePRO","2026-02-24",{"date":128,"type":33},"2026-02-27",{"date":130,"type":33},"2025-11-27",{"date":132,"type":21},"2030-03",{"name":39,"class":40},7,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":143,"enrollmentInfo":144,"targetDuration":146,"studyType":147,"phases":4,"briefSummary":148,"conditions":149,"keywords":151,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},"100500122","proofs-registry---premenopausal-women-with-breast-cancer-optimally-treated-with-ofs-100500122","NCT05792150","PROOFS-Registry - Premenopausal Women With Breast Cancer Optimally Treated With OFS","Real World Data and Long-term FU of Pre-\u002FPerimenopausal Women With Luminal EBC With Intermediate to High Clinical and Low Genomic Recurrence-risk Measured by MammaPrint®, Treated by SOC ET+OFS or SOC Chemotherapy Treatment Followed by ET","PROOFS","Inclusion Criteria:\n\nPatients are eligible for participation in the registry only if they meet all the following criteria:\n\n* Female breast cancer patients\n* Pre- or perimenopausal at registry entry (age \\\u003C60 years and state after hysterectomy or amenorrhea for \\\u003C12 months; confirmation by blood hormone levels (FSH and estradiol in premenopausal range as per local normal range) recommended)\n* Primary tumor diagnosis not older than three months prior to inclusion (primary diagnosis defined as date of initial tumor biopsy)\n* Estrogen- and\u002For progesterone-receptor-positive\u002FHER2 negative early breast cancer without any clinical signs of metastases\n* Adequate risk for recurrence:\n* intermediate clinical risk for recurrence, defined as (clinical in case of neoadjuvant treatment):\n* c\u002FpT1 and\n* c\u002FpN0 and\n* Ki-67 15-24% or\n* G2 or\n* patients, who do not meet these criteria but are at intermediate clinical risk for recurrence at investigator decision (e.g., very young age, low expression of hormone receptors, existing co-morbidities, familial cancer burden, etc.) can be included on individual decision basis or\n* high clinical risk for recurrence, defined as either (clinical in case of neoadjuvant treatment):\n* c\u002FpT2-4 or\n* c\u002FpN1 or\n* Ki-67 ≥25% or\n* G3\n* Low genomic risk of recurrence by MammaPrint® (tested on treatment naïve tumor specimen)\n* Luminal-type by BluePrint®\n* Treatment according to standard-of-care (e.g., AGO Guidelines) planned or started (until completion of local therapy the latest (including started or completed endocrine induction therapy), started, or planned adjuvant or neoadjuvant treatment)\n* Availability of untreated tumor material (core biopsy if preoperative endocrine therapy performed or neoadjuvant treatment intended or surgery specimen)\n* Capability to give written informed consent\n* Nodal positive patients will be accepted to the registry up to 25% of the genomic low\u002Fultralow-risk population (n=441).\n\nExclusion Criteria:\n\nPatients will not be eligible for the registry for any of the following reasons:\n\n* Any other genomic testing, besides MammaPrint®, has been performed on the tumor material\n* Medical or psychological conditions that would not permit the patient to sign informed consent\n* Legal incapacity or limited legal capacity\n* Current participation in any interventional clinical trial which tests anticancer drugs, immunotherapeutics, or antibody treatment for any type of neoplasm\n* Non-compliance of the patient","60 Years",{"count":145,"type":21},1470,"10 Years","OBSERVATIONAL","There is only limited data for premenopausal patients in general, as well as for differences in the use of OFS in the subgroups of pre- and perimenopausal patients, respectively. The WSG ADAPT trial data on the impact of postmenopausal status and\u002For use of OFS within 3-4 weeks endocrine induction therapy show relevant impact of OFS\u002Fpostmenopausal status on Ki-67 response; also, secondary amenorrhea after (neo-)adjuvant chemotherapy was a positive predictor of outcome due to OFS \\[8, 9\\].\n\nThis registry will give insights in the real-world use of OFS and the effect of secondary amenorrhea in female pre- and perimenopausal patients with or without previous use of chemotherapy and with different endocrine treatments (ET +\u002F- GnRH).\n\nAs adherence over time (5-10 years) plays a major role in the endocrine treatment, the registry will follow patients' treatments for up to 10 years and include QoL information.\n\nResults of MammaPrint® (MammaPrint® Index) as indicating factor for chemotherapy use and risk classification, thus, choice of adjuvant treatment (chemotherapy, OFS combined with endocrine therapy, or endocrine therapy alone) will be correlated to outcome under real-world conditions.\n\nBaseline, treatment, and relapse data shall be collected to gain further insight in the treatment paths, treatment adherence, and outcome of such patients.",[150],"Female Breast Cancer",[121,122,152,153,154,155,156,157],"EBC","early breast cancer","female","OFS","ET","chemotherapy","2026-01-22",{"date":160,"type":33},"2026-01-26",{"date":162,"type":33},"2022-12-07",{"date":164,"type":21},"2035-06",{"name":39,"class":40},71,{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},"100522332","phase-3-neoadj-therapy-comparing-sacituzumab-govitecan-sg-vs-sgpembrolizumab-in-low-risk-triple-neg-ebc-adapt-tn-iii-100522332","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.",{"count":176,"type":21},348,[24],"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.",[180],"Triple Negative Breast Cancer",[182,183,184,185,157,186],"TNBC","Early breast cancer","Sacituzumab govitecan","pembrolizumab","low recurrence risk","2025-11-18",{"date":189,"type":33},"2025-11-19",{"date":191,"type":33},"2024-10-10",{"date":193,"type":21},"2029-09",{"name":39,"class":40},42,""]