[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundacao Champalimaud\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":171},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,73,97,116,144],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100365237","single-dose-image-guided-radiotherapy-with-urethral-sparing-and-dil-boost-for-intermediate-risk-prostate-cancer-prosint-ii-100365237",false,"NCT04035642","Single-Dose Image-Guided Radiotherapy With Urethral Sparing and DIL Boost for Intermediate-Risk Prostate Cancer (PROSINT II)","Phase II Study of Single-Dose Image-Guided Radiotherapy (SDRT) With Urethral Sparing and Dose-Escalated Dominant Intraprostatic Lesion Simultaneous Integrated Boost for Intermediate-Risk Prostate Cancer (PROSINT II)","PROSINT II","Inclusion criteria\n\nParticipants must meet all of the following criteria:\n\nSigned study-specific informed consent form Histologic confirmation of adenocarcinoma of the prostate by biopsy Biopsy ISUP grade 1-3 Biopsy-proven localized intermediate-risk prostate cancer according to NCCN criteria No previous hormonal therapy PSA ≤20 ng\u002FmL Staging multiparametric MRI confirmation of AJCC cT1c-cT2c disease, with no radiographic evidence of cT3, cT4, or N1 disease No direct evidence of regional or distant metastases after appropriate staging studies Age ≥18 years Performance status 0-2 IPSS score ≤15; alpha-blockers allowed CT- or ultrasound-based prostate gland volume estimate ≤100 grams\n\nExclusion criteria\n\nParticipants with any of the following are ineligible:\n\nPositive lymph nodes or metastatic disease from prostate cancer on imaging studies MRI evidence of radiographic T3, T4, or N1 disease Biopsy ISUP grade ≥4 Previous pelvic radiotherapy Previous surgery for prostate cancer Previous transurethral resection of the prostate within 3 months Contraindication to protocol-required Foley catheter placement, rectal-balloon placement, MRI, PSMA PET\u002FCT where required, or treatment immobilization\u002Ftracking procedures Active urinary tract infection, unresolved acute prostatitis, or other acute condition judged by the investigator to make simulation or SDRT unsafe until resolved Previous hormonal therapy History of Crohn's disease or ulcerative colitis Previous significant obstructive symptoms Significant psychiatric illness CT- or ultrasound-estimated prostate volume \\>100 grams Severe active comorbidity judged by the investigator to preclude protocol treatment","MALE","18 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","This prospective single-arm phase II study evaluates the safety, feasibility, quality-of-life effects, PSA kinetics, imaging response, and clinical outcomes of definitive ultra-high dose single-fraction external beam radiation therapy in patients with biopsy-proven NCCN intermediate-risk localized adenocarcinoma of the prostate.\n\nAll eligible patients receive image-guided volumetric modulated arc radiotherapy with urethral sparing and organ-motion mitigation. Treatment consists of 24 Gy in one fraction to the whole prostate gland and proximal seminal vesicles. Patients with NCCN unfavorable intermediate-risk disease and an imaging-defined dominant intraprostatic lesion may receive a PSMA PET\u002FCT-guided simultaneous integrated boost to the dominant intraprostatic lesion in sequential dose-escalation cohorts, up to 30 Gy, while maintaining protocol-defined organ-at-risk constraints.\n\nA rectal balloon with air filling is used for prostate target immobilization and anatomical reproducibility, and a urethral catheter loaded with beacon transponders is used to identify the urethra, support urethral sparing, and enable online target tracking. Toxicity is assessed using CTCAE v4.0, and patient-reported outcomes are assessed using EPIC-26, IPSS, and IIEF questionnaires. PSA is measured at protocol-defined follow-up visits. Multiparametric MRI is performed at baseline and at 12 and 24 months after treatment. Participants are followed for a minimum of 5 years.",[27],"Prostate Cancer",[29,30,31,32],"prostate cancer","PSMA PET\u002Fscan","dose escalation","simultaneous integrated boost","RECRUITING","2026-05-07",{"date":36,"type":37},"2026-05-08","ACTUAL",{"date":39,"type":37},"2019-06-01",{"date":41,"type":21},"2030-12-31",{"name":43,"class":44},"Fundacao Champalimaud","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":45},"100473213","in-vivo-cortical-excitability-modulation-in-major-depressive-disorder-100473213","NCT05441969","In Vivo Cortical Excitability Modulation in Major Depressive Disorder","PDM-TMS","Inclusion criteria (clinical groups):\n\n1\\. Diagnosis of major depressive episode or disorder as provided in the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) (American Psychiatric Association. 2013).\n\nExclusion criteria (clinical groups):\n\n1. Moderate to severe suicide risk;\n2. Known personal history of bipolar disorder or psychotic disorder;\n3. Alcohol or other substance abuse and\u002For dependence;\n4. Developmental disorder;\n5. Dementia;\n6. Presence of uncontrolled active medical illness;\n7. Known structural lesion of the central nervous system;\n8. Electrical or metallic brain implants;\n9. Cardiac implants;\n10. Epilepsy;\n11. Active use of medication known to cause seizures;\n12. Pregnancy;\n13. Breastfeeding.\n\nFor the healthy control group, participants will also be recruited at the Champalimaud Clinical Center, by advertisement in places of public circulation. The recruitment of this population will be done in order to generate a pairing with both clinical groups in terms of age and sex. The same exclusion criteria will be applied, as well as the presence of any history of neuropsychiatric disease. The total number of participants for this study will be approximately 90 volunteers. Exclusion criteria will be assessed through self-report and\u002For MINI.",true,"ALL","65 Years",{"count":57,"type":21},90,"OBSERVATIONAL","The pathophysiology of Major Depression Disorder (MDD) is unclear, with several theories for its neurobiological mechanisms. One possible explanation is the presence of altered neuroplasticity, which can be studied by Transcranial Magnetic Stimulation (TMS). Using TMS to study these mechanisms is performed by applying electromagnetic stimuli to the motor cortex, to obtain measures of temporary cortical excitability modulation. It is known that depressed patients with higher cortical modulation are more responsive to a TMS treatment course. However, it is unknown if there are differences in cortical modulation between depressed patients and healthy subjects. Our goal is to answer this question and contribute towards clarification of the neuroplasticity mechanisms underlying MDD. Accordingly, the investigators will access cortical excitability modulation measures in both depressed patients and healthy volunteers and compare their results. The investigators will also re-assess these measures after 6 weeks of antidepressant treatment. Finally, the investigators will study the association between cortical excitability measures and cognitive processes using an innovative cognitive task.",[61],"Major Depressive Disorder",[61,63,64],"Cortical Excitability Modulation","Transcranial Magnetic Stimulation","2025-02-24",{"date":67,"type":37},"2025-02-26",{"date":69,"type":37},"2020-05-19",{"date":71,"type":21},"2025-12-31",{"name":43,"class":44},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":45},"100553813","improving-obsessive-compulsive-disorder-treatments-from-lesions-to-neuromodulation-targets-100553813","NCT06490965","Improving Obsessive-compulsive Disorder Treatments: from Lesions to Neuromodulation Targets","ON-TARGET","Inclusion Criteria:\n\n* Age between 18 and 75 years;\n* Established diagnosis of Obsessive-Compulsive Disorder according to Diagnostic and statistical manual of mental disorders 5 (DSM5) criteria;\n* Capacity to give consent;\n* Fluent in Portuguese and\u002For English;\n* If potential for pregnancy, agrees to use an effective method of contraception throughout the study period.\n\nExclusion Criteria:\n\n* Obsessive-compulsive symptoms severity assessed at baseline visit with the instrument Yale-Brown Obsessive Compulsive Scale - II (YBOCS-II) ≤ 24;\n* Presence of uncontrolled active medical illness;\n* Known structural lesion of the central nervous system;\n* Electric or metallic implants in the body not compatible with electromagnetic radiation;\n* Electric or metallic brain implants;\n* Cardiac implants;\n* Epilepsy;\n* Pregnant, breastfeeding, or planning pregnancy women;\n* Alcohol or substance abuse and\u002For dependence;\n* Major Neurocognitive Disorder;\n* Developmental disorders with low intelligence quotient or any other form of cognitive deficit;\n* Active neurological disease;\n* Individuals presenting with any psychotic or mood disorder requiring hospitalization at the time of eligibility criteria assessment;\n* Contraindication for performing MRI;\n* Individuals who have already been treated for OCD with TMS;\n* Any other reason that renders the individual unable to provide informed consent.","75 Years",{"count":82,"type":21},32,[24],"While in most cases of obsessive-compulsive disorder (OCD) a cause cannot be identified, this syndrome may develop as a consequence of focal brain lesions. Neuropsychiatric disorders secondary to brain insults are open windows to understand their underlying neurobiology. Different neuroimaging analysis methods, including pooled lesion topography and lesion network mapping, can be used to study lesional neuropsychiatric syndromes, including OCD. If successful, these strategies can also reveal new neuromodulation treatment targets, including for transcranial magnetic stimulation (TMS). Indeed, TMS targets to treat depression evolved from evidence extracted from lesional studies that were then refined and validated. For OCD treatment with TMS, already approved by the FDA and European Commission, targets were defined using a distinct approach, not involving causal brain lesions, which may contribute to lower than desirable remission rates. Lesional OCD is characterized by specific dysfunctional brain circuits. These circuits may be effectively targeted by TMS, which may optimize treatment of OCD. To address these hypotheses, we will test the therapeutic benefits of optimizing brain targets for the currently used TMS treatment of OCD, using information from the lesional-OCD brain network namely refining the target in the medial orbitofrontal cortex, bilaterally. Specifically, we will conduct a randomized clinical interventional study, using TMS to treat patients with OCD with inadequate response to other treatments, comparing, within the approved protocol for OCD treatment, the most frequently used stimulation site with a new target, adjusted according to the connectivity of lesions associated with the occurrence of OCD. If successful, our results may have immediate clinical implications in OCD treatment, as it will contribute to refine current therapeutic TMS strategies for OCD and defining new clinical research strategies in this domain.",[86],"Obsessive-Compulsive Disorder",[88],"OCD","2024-11-15",{"date":91,"type":37},"2024-11-18",{"date":93,"type":37},"2024-11-07",{"date":95,"type":21},"2026-12-31",{"name":43,"class":44},{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":53,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":104,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":115,"locationsCount":45},"100559642","reinforcement-learning-and-obsessive-compulsive-disorder-exploring-the-role-of-the-orbitofrontal-cortex-100559642","NCT06566781","Reinforcement Learning and Obsessive-compulsive Disorder: Exploring the Role of the Orbitofrontal Cortex","NEUROCOMP","Inclusion Criteria:\n\n* Exclusively for the OCD group: established diagnosis of Obsessive-Compulsive Disorder according to DSM-5 criteria;\n* Exclusively for the control group: does not meet DSM criteria for any of the psychiatric diagnoses screened by the Mini International Neuropsychiatric Interview;\n* Age between 18 and 65 years-old;\n* Fluent Portuguese or English speaker.\n\nExclusion Criteria:\n\n* Any acute medical illness;\n* Substance abuse or dependence;\n* Pregnancy;\n* Dementia;\n* Developmental disorders with low intelligence quotient or any other form of cognitive impairment;\n* Active neurological disease;\n* Previously known structural lesion of the central nervous system;\n* Illiteracy or otherwise not understanding the study's instructions;\n* Inability to give informed consent;\n* Individuals presenting with any psychotic or mood disorder condition requiring hospitalization at that moment;\n* For experiment 2, these exclusion criteria will be expanded by additional factors that specifically preclude TMS use.",{"count":105,"type":21},230,"Obsessive-compulsive disorder (OCD) is a neuropsychiatric condition affecting 1-3% of the population. Typically, symptoms start in adolescence or early adulthood, are time-consuming, and have a significant impact on quality of life. However, first-line approved treatments, based on a combination of pharmacotherapy and psychotherapy, are ineffective in at least 50% of cases. Since the pathophysiology of OCD remains largely unknown, it is expected that a better understanding of the biological mechanisms of OCD would contribute to improved strategies for treatment of the disorder.\n\nCurrent neurobiological models for OCD highlight the role of corticostriatal dysfunction and hyperactivity of the orbitofrontal cortex (OFC), a part of the prefrontal cortex. Indeed, the lateral OFC plays a crucial role in controlling transitions between automatic, repetitive stimulus-response driven behaviors, and behaviors that reflect the acquisition, by the agent, of a predictive model of the consequences of each action. Previous studies have suggested that the ability to operate this transition is compromised in OCD and may be objectively measured using specifically designed Reinforcement Learning (RL) tasks. Furthermore, growing evidence has suggested that OCD may be associated with systemic immune dysfunction, as has been shown in other common neuropsychiatric conditions, such as depressive disorders. Indeed, there is evidence to support OCD-like symptoms occurring acutely in children after streptococcal infection. These findings have raised the hypothesis that vulnerable individuals exposed to pro-inflammatory early-life environmental risk factors, such as infections and childhood adversity, may suffer neuroinflammatory-induced dysfunction in corticostriatal pathways, increasing the risk of OCD psychopathology.\n\nIn this case-control study, the investigators propose an integrative approach to address how structural, functional, and metabolic brain changes involving the corticostriatal circuit correlate with performance in an RL task, as well as with peripheral blood markers of immune dysfunction and associated environmental risk factors such as infection and childhood trauma. Furthermore, since neuromodulation of the prefrontal cortex, using repetitive transcranial magnetic stimulation (rTMS), has recently received FDA clearance for adjunctive treatment in patients with OCD, these associations will be further explored in patients treated with this method. Indeed, in patients with OCD enrolled in the study upon referral to the rTMS Programme for OCD at the Champalimaud Clinical Centre, a follow-up visit will be conducted after the end of treatment (30 sessions of excitatory rTMS over the medial prefrontal cortex). In this subgroup of participants with longitudinal assessment, we will measure change in study parameters and the associations between such change and the clinical effects of treatment, as well as prediction of treatment effects according to baseline assessments.",[86],[86,64],"2024-08-20",{"date":111,"type":37},"2024-08-22",{"date":113,"type":37},"2019-10-01",{"date":95,"type":21},{"name":43,"class":44},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":124,"minAge":18,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":45},"100546389","vibe---virtual-image-guided-brachytherapy-emulation-for-locally-advanced-cervical-cancer-lacc-100546389","NCT06394297","VIBE - Virtual Image Guided Brachytherapy Emulation for Locally Advanced Cervical Cancer (LACC)","A Phase I\u002FII Study for Image Guided Stereotactic Body Radiation Therapy Boost for Definitive Treatment of Locally Advanced Cervical Cancer (LACC)","VIBE","Inclusion Criteria:\n\n* Cancer of the uterine cervix suitable for curative treatment with definitive radio-chemotherapy\n* Biopsy proven showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell carcinoma of the uterine cervix.\n* Pelvic MRI.\n* MRI and Positron emission tomography (PET-CT) of the retroperitoneal space and abdomen at diagnosis is performed.\n* Stage IIB to IVA according to International Federation of Gynecological and Obstetrics (FIGO) and TNM guidelines.\n* Planning MRI with the applicator in place for the SBRT boost.\n* Para-aortic metastatic nodes below L1-L2 are allowed.\n* Study specific signed patient informed consent.\n\nExclusion Criteria:\n\n* Other primary malignancies except carcinoma in situ of the cervix and basal cell carcinoma of the skin.\n* Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix.\n* Metastatic disease above and beyond the retroperitoneal paraaortic L1-L2 interspace.\n* Previous pelvic or abdominal radiotherapy.\n* Previous total or partial hysterectomy.\n* Contra-indications to MRI.\n* Severe psychiatric condition.\n* Severe, active co-morbidity.","FEMALE",{"count":126,"type":21},30,[24],"This study will evaluate the role of SBRT with the aim to reproduce high dose rate brachytherapy (HDR BT) dose distribution by means of external beam radiotherapy in the radical treatment in patients with LACC. The study will employ devices to accurately reproduce pelvic anatomy and mitigate target motion and will make use of real-time online tracking.",[130],"Cervical Cancer",[132,133,134,135],"cervical cancer","Stereotactic body radiotherapy (SBRT)","Stereotactic ablative body radiotherapy (SABR)","Brachytherapy","2024-04-30",{"date":138,"type":37},"2024-05-01",{"date":140,"type":37},"2023-08-04",{"date":142,"type":21},"2026-08-04",{"name":43,"class":44},{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":54,"minAge":18,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},"100544662","phase-2-trial-for-treatment-of-high-risk-bc-with-two-sequences-of-neoadjuvant-chemotherapy-with-pembrolizumab-100544662","NCT06371807","Trial for Treatment of High Risk BC With Two Sequences of Neoadjuvant Chemotherapy With Pembrolizumab","Immunogenicity Profile of Neoadjuvant Keytruda in Combination With Anthracycline Versus Carboplatin\u002FPAclitaxel Containing Chemotherapy Regimen for The Treatment of Early-stage, TILs-Positive, Triple-Negative Breast CanceR","KEYPARTNER","Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply:\n\n1. Be willing and able to provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.\n2. Be a female or male participant who is at least 18 years of age on the day of signing informed consent.\n3. Have locally histologically confirmed diagnosis of invasive carcinoma of the breast that is classified as TNBC, as defined by the most recent ASCO\u002FCAP guidelines.\n4. Has locally confirmed tumor infiltrating lymphocytes (stromal) (sTILs) equal to or above 10%, as defined by the most recent International Guidelines on TIL Assessment in Breast Cancer.\n5. Have previously untreated non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per current AJCC staging criteria for breast cancer staging criteria as assessed by the investigator based on radiological and\u002For clinical assessment:\n\n   1. T1c, N1-N2\n   2. T2, N0-N2\n   3. T3, N0-N2\n   4. T4a-d, N0-N2 Note: bilateral tumors (ie, synchronous cancers in both breasts) and\u002For multi-focal (ie, 2, separate lesions in the same quadrant)\u002Fmulti-centric (ie, 2 separate lesions in different quadrants) tumors are allowed, as well as inflammatory breast cancer, and the tumor with the most advanced T stage should be used to assess the eligibility. If the subject has either bilateral or multi-focal\u002Fmulti-centric disease, TNBC needs to be confirmed in at least 2 lesions\u002Fbreast\u002Ffocus. Beyond this rule, the extent of tumor biopsy confirmation is based on the best clinical judgment by local investigators.\n6. Provide a core needle biopsy consisting of at least 3 separate tumor cores from the primary tumor at screening to the designated central biobank (or responsible laboratories) and is willing to provide a second biopsy at the end of the first cycle of treatment.\n\n   Note: Detailed instructions on sample collection, processing, storage and shipment to the central biobank are provided in the Laboratory Manual.\n7. Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of treatment initiation.\n8. Have left ventricular ejection fraction (LVEF) of ≥50% or ≥ institution lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening.\n9. Have adequate organ function as defined in the following table (Table 2). Specimens must be collected within 28 days prior to the start of study intervention.\n10. Male participants:\n\nA male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 12 months after the last dose of cyclophosphamide or 6 months after last chemotherapy (whichever occurs last) and refrain from donating sperm during this period.\n\nFemale participants:\n\nA female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:\n\na. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 12 months after the last dose of cyclophosphamide or 6 months after last chemotherapy (whichever occurs last).\n\n\\-\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.\n2. Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.\n3. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).\n4. Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 4 weeks of the first dose of treatment in this current trial.\n\n   Note: subject should be excluded if he\u002Fshe received an investigational agent with anticancer or anti-proliferative intent within the last 12 months.\n5. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n7. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n8. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n9. Has significant cardiovascular disease, such as:\n\n   1. History of myocardial infarction, acute coronary syndrome or coronary angioplasty\u002Fstenting\u002Fbypass grafting within the last 6 months\n   2. Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA class III or IV\n10. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n11. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n12. Has a known history of active TB (Bacillus Tuberculosis).\n13. Has an active infection requiring systemic therapy.\n14. If surgery was performed prior to screening, has persistent adverse events or incomplete wound healing considered clinically relevant by the treating investigator.\n15. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n16. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n17. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through at least 12 months after the last dose of cyclophosphamide or 6 months after last chemotherapy (whichever occurs last).\n18. Has had an allogenic tissue\u002Fsolid organ transplant.\n19. Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical trial and to consent","100 Years",{"count":154,"type":21},20,[156],"PHASE2","Phase II, randomized, Active-controlled open label trial for treatment of high risk, HR-\u002FHER2- (triple negative) breast cancer, with two sequences of neoadjuvant chemotherapy on a background of pembrolizumab",[159,160],"Early Breast Cancer","Triple Negative Breast Cancer","NOT_YET_RECRUITING","2024-04-15",{"date":164,"type":37},"2024-04-17",{"date":166,"type":21},"2024-07",{"date":168,"type":21},"2026-12",{"name":43,"class":44},3,""]