[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SOLTI Breast Cancer Research Group\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":157},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,74,104,131],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100514714","phase-2-elacestrant-withwithout-triptorelin-in-premenopausal-women-with-luminal-breast-cancer-100514714",false,"NCT05982093","Elacestrant With\u002FWithout Triptorelin in Premenopausal Women With Luminal Breast Cancer","A Phase 2 Randomized Pre-operative,Window of Opportunity Trial Investigating the Effect of Elacestrant With\u002FWithout Triptorelin in Premenopausal Patients With HR+\u002FHER2- Breast Cancer - SOLTI-2104-PremiÈRe Trial.","SOLTI-2104","Inclusion Criteria:\n\n1. Signed informed consent must be obtained prior to any trial-specific procedure.\n2. Female patients who are at least 35 years of age on the day of signing informed consent.\n3. Patient is premenopausal at the time of study entry\n\n   Premenopausal status is defined as either:\n   * Patient had last menstrual period within the last 6 months. OR\n   * Plasma estradiol and FSH in the premenopausal range, according to local laboratory definition.\n\n   Note: Patients who have undergone bilateral oophorectomy are not eligible.\n4. Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast untreated and recently diagnosed, with all the following characteristics:\n\n   * Stage I to stage IIB operable breast cancer (7th Edition of the AJCC). Note: Axillary lymph node status must be assessed by fine needle biopsy or core biopsy. This procedure at screening will be omitted if there is no suspicion for positive axillary lymph node(s) radiographically or if a pathological report of suspicious lymph nodes of the results of a fine needle biopsy or core biopsy is available prior to the screening period.\n   * Absence of distant metastasis (i.e., M0) as determined by institutional practice.\n   * At least 1 lesion that can be accurately and serially measured in at least 1 dimension and for which the longest diameter is ≥ 10 mm as measured by magnetic resonance imaging (MRI) or ultrasound (US).\n   * In the case of a multifocal tumor, the largest lesion must be ≥ 10 mm and designated the \"target\" lesion for all subsequent tumor evaluations. All biopsied tumors had to be ER+HER2-negative\n5. ER-positive with expression higher than 10% and HER2-negative tumor\n\n   * HER2 negativity is defined as either of the following: Immunohistochemistry (IHC) 0, IHC 1+ or IHC2+\u002Fin situ hybridization (ISH) negative as per most recent American Society of Clinical Oncology (ASCO)-College of American Pathologists Guideline (CAP) guideline according to the local laboratory as determined on the most recently analyzed tissue sample.\n   * Documentation of ER positive tumor with ≥ 10% staining by immunohistochemistry of cells as per most recent ASCO-CAP guideline according to the local laboratory determined on the most recently analyzed tissue sample, with or without progesterone receptor positivity.\n6. Ki67 expression ≥ 10% and ≤ 35% by local assessment\n7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n8. Breast cancer eligible for primary surgery.\n9. Availability of pre-treatment tumor tissue sample of FFPE tumor block from primary tumor for biomarker analysis. The tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for quality prior to enrollment. Archival tumor tissue or ex professo biopsy are acceptable.\n10. Adequate hematologic and organ function within 14 days before the first study treatment on Day 1, defined by the following:\n\n    1. Neutrophils (ANC ≥1.000\u002FμL).\n    2. Hemoglobin ≥ 9.0 g\u002FdL (with no need for transfusions).\n    3. Platelet count ≥ 75. 000\u002FμL.\n    4. Serum creatinine ≤1.5 mg\u002FdL or calculated creatinine clearance ≥30 mL\u002Fmin (Cockcroft-Gault Equation)\n    5. International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) within therapeutic range.\n\n       Note: Subjects who are receiving anticoagulation treatment which is monitored by INR (eg, warfarin) may be allowed to participate if they have a stable INR (ie, within therapeutic range) for at least 28 days prior to the first dose of study drug, in the absence of any exclusionary medical conditions, and provided that elacestrant would be appropriate therapy for the subject\n    6. Potassium, total Calcium (corrected for serum albumin), and sodium NCI CTCAE v5.0 Grade ≤ 1.\n    7. Alanine aminotransferase (ALT) ≤ 3x upper limit of normal (ULN)\n    8. Aspartate aminotransferase (AST) ≤ 3x ULN\n    9. Total bilirubin ≤ ULN or total bilirubin ≤ 1.5x ULN with direct bilirubin ≤ ULN of the laboratory in subjects with documented Gilbert's Syndrome\n11. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.\n12. Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant, must have confirmed negative serum pregnancy test within 7 days prior to randomization.\n13. Female subjects must not donate, or retrieve for their own use, oocytes from the time of screening and throughout the study treatment period, and for at least 120 days after the time of final study drug administration.\n14. Women of CBP must be willing to use highly effective methods of contraception. Contraception must continue during the trial treatment and after stopping the treatment received according to protocol. Highly effective contraception methods include:\n\n    * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n    * Placement of a non-hormonal intrauterine device (IUD). Notes: Use of oral (estrogen and progesterone), transdermal, injected, implanted, hormone containing intrauterine system, or any other hormonal methods of contraception is not allowed in this trial. Women are considered of CBP unless: they have had ≥ 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e., age-appropriate history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least four weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment, she will be considered not of CBP. After the end of trial treatment, patients should use effective contraception at least until 28 days after therapy discontinuation.\n15. Patients must have the ability to swallow oral medication.\n\nExclusion Criteria:\n\n1. Inoperable locally advanced or inflammatory breast cancer (any stage III).\n2. Metastatic (Stage IV) breast cancer.\n3. Synchronous invasive bilateral or multicentric breast cancer.\n4. Patients requiring immediate neoadjuvant chemotherapy or immediate surgical intervention.\n5. Patients who have undergone sentinel lymph node biopsy or tumor excisional biopsy prior to study treatment.\n6. Prior malignancy within 3 years prior to randomization, except curatively treated non-melanoma skin cancer, in situ cancer or adequately and curatively treated Stage I or II cancer from which the patient is currently in complete remission.\n7. Patients currently on following medications, which cannot be interrupted 7 days prior treatment start:\n\n   * Any prohibited medication as per decapeptyl (triptorelin) label\n   * Strong inhibitors of CYP3A4, including grapefruit, grapefruit hybrids, pummelos, starfruit and Seville oranges\n   * Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 (Refer to http:\u002F\u002Fmedicine.iupui.edu\u002Fclinpharm\u002Fddis\u002F) within 5 half-life of the drug prior to initiating trial therapy\n   * Herbal preparations\u002Fmedications. These include, but are not limited to, St. John's wort, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 5 half-life of the drug prior to initiating trial therapy\n   * Vaccination, including but not limited to vaccination against COVID-19, during the 7 days prior to randomization.\n8. Any treatment, local or systemic, including prior chemotherapy, ET, targeted therapy, and\u002For radiation therapy for the currently diagnosed BC prior to enrollment.\n9. Major surgical procedure or significant traumatic injury within 28 days prior to randomization.\n10. Assessment by the investigator to be unable or unwilling to comply with the requirements of the protocol.\n11. Any of the following within 6 months before enrollment: myocardial infarction, severe\u002Funstable angina, ongoing cardiac dysrhythmias of NCI CTCAE v5.0 Grade ≥ 2, prolonged QTcF ≥ Grade 2 (i.e., \\> 480 msec), uncontrolled atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass graft, heart failure ≥ Class II as defined by the New York Heart Association guidelines, or cerebrovascular accident including transient ischemic attack.\n12. Child-Pugh Score greater than Class A (i.e., score \\>6)\n13. Coagulopathy or any history of coagulopathy within the past 6 months, including history of deep vein thrombosis or pulmonary embolism. However, subjects with the following conditions will be allowed to participate:\n\n    1. Adequately treated catheter-related venous thrombosis occurring \\>28 days prior to the first dose of study drug\n    2. Treatment with an anticoagulant, e.g., warfarin or heparin, for a thrombotic event occurring \\> 6 months before enrollment, or for an otherwise stable and allowed medical condition (eg, well controlled atrial fibrillation), provided dose and coagulation parameters (as defined by local standard of care) are in therapeutic range prior to the first dose of study drug and provided that an AI would be an appropriate therapy for the subject\n14. Known hypersensitivity to any of the study drugs, including excipients.\n15. Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction\u002Fmotility disorder, malabsorption syndrome, or prior gastric bypass.\n16. History of or clinical evidence of significant co-morbidities that, in the judgment of the investigator, may interfere with the conduction of the study, the evaluation of response, or with informed consent.\n17. Previous hormonal treatments for other indications such as osteoporosis, breast cancer prevention, hormonal substitutive therapy, such as raloxifene, tamoxifen, estrogen, progestins must have ended at least 12 months prior to trial registration. If a patient is on natural products known to contain progestins, they must be stopped 14 days prior to beginning study treatment.\n18. Used any prescription medication during the prior 1 month that the investigator judge is likely to interfere with the study or to pose an additional risk to the patient in participating.\n19. Female subject who is pregnant or breastfeeding or intends to become pregnant during the study.","FEMALE","35 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","PREMIERE parallel, non-comparative, two-arm, randomized 1:1, open-label, multicenter, exploratory window of opportunity study in premenopausal women with primary operable HR+\u002FHER2-negative breast cancer with aiming at evaluating the biological effects of elacestrant with or without triptorelin.",[27,28,29,30],"Breast Cancer","HER2-negative Breast Cancer","Hormone Receptor Positive Tumor","Premenopausal Breast Cancer","RECRUITING","2026-04-21",{"date":34,"type":35},"2026-04-24","ACTUAL",{"date":37,"type":35},"2023-02-03",{"date":39,"type":21},"2026-12",{"name":41,"class":42},"SOLTI Breast Cancer Research Group","OTHER",15,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100621512","phase-2-trastuzumab-deruxtecan-in-first-line-her2-positive-metastatic-breast-cancer-with-proactive-toxicity-management-100621512","NCT07371585","Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management","Patient-Centered Study of Trastuzumab Deruxtecan (T-DXd) in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management Reflecting Real-World Clinical Practice","TOP-REAL","Inclusion Criteria:\n\n1. Able to understand the nature of the study and to voluntarily provide written informed consent prior to any trial-specific screening procedures and has sufficient cognitive capacity to comply with study requirements, including the use of digital health tools and devices.\n2. Male\u002Ffemale patients who are at least 18 years of age on the day of signing informed consent.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n4. Histologically or cytologically locally confirmed HR+\u002FHER2+ or HR-\u002FHER2+ BC with evidence of locally advanced disease, not amenable to resection or radiation therapy with curative intent, or metastatic disease:\n\n   1. HER2-positivity confirmed in a tumor sample obtained in the metastatic setting, defined as either IHC 3+ or in situ hybridization positive (ISH+) by local laboratory assessment as per the most recent American Society of Clinical Oncology (ASCO)-College of American Pathologists Guideline (CAP) guideline. The most recent test result prior screening period will be used to confirm eligibility.\n   2. Documented HR (ER and\u002For PR) positivity or negativity, confirmed by local laboratory assessment in a tumor sample obtained in the metastatic setting. ER and\u002For PR positivity is defined as \\>1% of cells expressing HR via IHC analysis as per most recent ASCO-CAP guideline. The most recent test result prior screening period will be used to confirm eligibility.\n5. No prior chemotherapy or HER2-targeted therapy for advanced or mBC (1 prior line of endocrine therapy is allowed for mBC). Participants who have received chemotherapy or HER2-targeted therapy in the neoadjuvant or adjuvant setting at any time are eligible.\n\n   Note: Patients that received an antibody-drug conjugate containing an exatecan derivative (topoisomerase I inhibitor) in the adjuvant setting, must have a disease-free interval of ≥12 months since the last dose.\n6. Evaluable disease as defined by RECIST v1.1.\n\n   Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.\n7. Adequate FFPE tumor tissue sample available from the metastatic setting (preferably) for retrospective HER2 central analysis confirmed by central laboratory. An adequate sample of tumor tissue must be provided from either a newly acquired biopsy from a region that has not been previously irradiated or the most recent archival sample.\n8. Patients with Brain Metastases (BM): Eligible if either previously untreated or previously treated BM, provided there is no clinical indication for immediate local therapy. For untreated BM, lesions must be ≤2.0 cm in largest diameter; lesions \\>2.0 cm require discussion with and approval from the Medical Monitor. Patients must not require \\>3 mg\u002Fday of dexamethasone (or equivalent corticosteroid) for symptom control. If receiving anticonvulsants, the regimen must be stable for ≥14 days prior to first dose. A washout period prior enrollment of ≥3 weeks since stereotactic radiosurgery or gamma knife, whole-brain radiotherapy, or radiotherapy or surgery for spinal cord compression is required.\n\n   Note: Patients with leptomeningeal disease may be eligible after discussion with the Medical Monitor.\n9. Adequate hematologic and end-organ function, defined by the following laboratory results (see protocol)\n10. LVEF ≥ 50% within 28 days before Cycle 1 Day 1.\n11. Life expectancy of ≥ 12 weeks at screening.\n12. Adequate treatment washout period before first dose of study intervention, defined as (see protocol)\n13. Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified highly effective method of contraception.\n14. Access to a smartphone with internet connection that allows them to carry out the required assessments at the specified timepoints and with the following characteristics:\n\n    * Resilience PRO: Android 8.0 (or newer) OR iOS 15.0 (or newer)\n    * Cankado PRO-React: Android 13.0 (or newer) OR iOS 17.0 (or newer)\n15. Only applicable in France: patients affiliated to the social security system.\n\nExclusion Criteria:\n\n1. Patients with HER2-negative disease.\n2. Subjects who, in the opinion of the investigator, are unable to comply with the protocol requirements or who have any comorbidity or condition that may hinder study follow-up, response evaluation, or the informed consent process, including inability to read and understand the local language of the study site sufficiently to interact effectively with study materials and tools (including digital applications).\n\n   Note: Other languages for app-based questionnaires may be provided upon patient request and based on availability of such questionnaires and tools.\n3. History of other primary malignancy unless treated with curative intent with no evidence of active disease within 3 years before the first dose of study treatment and of low potential risk for recurrence. Exceptions include: basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative therapy, adequately resected non-melanoma skin cancer, in situ cancer of the cervix, curatively treated ductal carcinoma in situ (DCIS), contralateral breast cancer, Stage 1, grade 1 endometrial carcinoma or other solid malignant tumors with an expected curative outcome after Medical Monitor approval.\n4. Persistent toxicities that the investigator deems related to previous anti-cancer therapy (excluding alopecia), not yet resolved to grade ≤ 1 or baseline. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study treatment may be included (e.g., hearing loss). Participants with stable Grade 2 toxicities (defined as no worsening to \\>Grade 2 for at least 3 months prior to enrollment and managed with standard of care treatment) may be eligible per the discretion of the investigator (e.g., Grade 2 chemotherapy-induced neuropathy).\n5. Untreated spinal cord compression\n6. History of significant cardiovascular disease, defined as:\n\n   * New York Heart Association Class III or greater congestive heart failure or known left ventricular ejection fraction of \\\u003C 50%.\n   * Participants with a medical history of myocardial infarction within 6 months before enrollment or symptomatic CHF (NYHA Class II to IV). Participants with troponin levels above upper limit of normal (ULN) at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrollment to rule out myocardial infarction.\n   * History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation (Mean resting corrected QTcF interval \\>470ms (females) or \\>450msec (males)). Note: Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted upon discussion with the Medical Monitor.\n7. History of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening. Patients with a history of grade 1 drug-induced ILD\u002Fpneumonitis, who are now fully recovered, must be discussed with the Medical Monitor for approval.\n8. Meets one of the following lung criteria:\n\n   * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of study enrollment, prior pneumonectomy (complete), severe asthma, severe chronic obstructive pulmonary disorder (COPD), restrictive lung disease, pleural effusion, post COVID-19 pulmonary fibrosis, etc,).\n   * Any autoimmune, connective tissue or inflammatory disorders (eg, rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the electronic Case Report Form (eCRF) for participants who are included in the study.\n9. Received a live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of study treatment.\n\n   Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of study treatment.\n10. Active serious infection requiring IV antibiotics, antivirals, or antifungals.\n11. Active HIV, HBV (defined as having a positive HbsAg test) or HCV.\n\n    1. Participants with a known history of human immunodeficiency virus (HIV) are eligible, if viral load is undetectable for ≥ 6 months prior to enrollment, and subjects are receiving effective anti-retroviral HIV therapy, if indicated. HIV testing is not required for subjects without a known history of HIV, unless mandated by a local health authority.\n    2. For patients with a known history of HBV infection, a hepatitis B core antibody test should be conducted at screening. If positive, hepatitis B DNA testing will be performed and if active HBV infection is ruled out, the patient may be eligible.\n    3. Patients who are HCV antibody positive with polymerase chain reaction negative for HCV RNA may be eligible\n12. Other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n13. Received prior chemotherapy or HER2-targeted therapy for advanced or mBC.\n14. Prior exposure in the adjuvant setting to an antibody-drug conjugate containing an exatecan derivative (topoisomerase I inhibitor), with a disease-free interval of less than 12 months since the last dose\n15. Requirement for ongoing therapy with or prior use of any prohibited medications.\n16. Participation in other studies involving investigational drug(s) within 30 days prior to enrollment or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial. If the patient is enrolled or planned to be enrolled in another study that does not involve an investigational drug, the agreement of the Medical Monitor is required to establish eligibility.\n17. Known hypersensitivity or allergy to T-DXd, their metabolites, formulation excipient, or other monoclonal antibodies.\n18. Positive serum pregnancy test or women who are lactating.\n19. Only applicable in France: patients deprived of their liberty or under protective custody or guardianship.","ALL","18 Years",{"count":55,"type":21},300,[24],"This is an open-label, single arm, non-randomized, multicenter, phase 2 study assessing the efficacy and safety of T-DXd as first-line treatment in HER2-positive advanced\u002Fmetastatic BC patients (N=300). The study integrates digital health tools for proactive toxicity management and potentially facilitate early detection of ILD\u002Fpneumonitis.",[59],"Breast Cancer Stage IV",[61,62,63,64],"Trastuzumab deruxtecan","digital health tools","first line","proactive toxicity management","2026-03-26",{"date":67,"type":35},"2026-03-27",{"date":69,"type":35},"2026-02-18",{"date":71,"type":21},"2030-07-01",{"name":41,"class":42},27,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":82,"minAge":53,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100507255","feasibility-and-impact-of-liquid-biopsy-genomic-profiling-on-treatment-patients-with-metastatic-prostate-cancer-in-spain-solti-2102-100507255","NCT05885009","Feasibility and Impact of Liquid Biopsy Genomic Profiling on Treatment Patients With Metastatic Prostate Cancer in Spain (SOLTI-2102)","Real World Clinical Practice Study to Assess the Feasibility and Impact of Liquid Biopsy-based Genomic Profiling on Treatment Decision Making for Patients With Metastatic Prostate Cancer in Spain (SOLTI-2102)","HOPE-PROSTATE","Inclusion Criteria:\n\n1. Male patients living in Spain.\n2. Age ≥18 years.\n3. Signed informed consent before any screening procedure.\n4. Metastatic PC of any subtype confirmed both pathologically and radiologically (stage IV disease).\n5. The subjects must be about to receive, or receiving, or will have completed treatment for their metastatic disease with any line of treatment in either a clinical trial or the standard of care healthcare setting.\n6. Eastern Cooperative Oncology Group (ECOG) 0-1.\n\nExclusion Criteria:\n\n1. Inability to consent or conform to the processes involved in a clinical study.\n2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.","MALE",{"count":84,"type":21},240,"OBSERVATIONAL","HOPE Prostate is an observational study that aims at promoting research against metastatic prostate cancer by means of collective research led by patients (patient-centric trial). Patients with metastatic prostate cancer living in Spain will voluntarily register and fulfil their journey in the study through the study's digital tool. Mainly they are prompted to answer questionnaires about their disease, and to provide a blood sample and an archival tumor biopsy. In HOPE Prostate these samples will be genomically analyzed and every patient case will be presented in a multidisciplinary molecular advisory board (MAB). The MAB will issue a plain report explaining the significance of the results and will try to enumerate future therapeutic options that match patient history and his genomic profile. Finally, patients will have to answer short follow-up questionnaires twice a year for 3 years.\n\nThe study data will allow us to advance implementing precision medicine to improve the management of current and specially future metastatic prostate cancer patients.",[88],"Metastatic Prostate Cancer",[90,91,92,93,94],"molecular advisory board","molecular tumor board","genomic data","targeted therapy","patient-centric trials","2025-08-01",{"date":97,"type":35},"2025-08-06",{"date":99,"type":35},"2023-03-28",{"date":101,"type":21},"2028-03-28",{"name":41,"class":42},1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":103},"100592324","patient-centric-study-to-assess-the-impact-of-genomic-profiling-on-the-treatment-of-patients-with-metastatic-breast-cancer-in-spain-100592324","NCT06991946","Patient-Centric Study to Assess the Impact of Genomic Profiling on the Treatment of Patients With Metastatic Breast Cancer in Spain","Real-world Patient-centric Study to Assess the Feasibility of a Molecular Diagnosis on Treatment Decision Making for Patients With Metastatic Breast Cancer in Spain (HOPE-Focus)","HOPE-Focus","Inclusion Criteria:\n\n1. Female or male patients residing in Spain.\n2. Age ≥ 18 years.\n3. Signed informed consent prior to any study-related procedures, except for registration.\n4. Self-reported Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n5. Patients with metastatic breast cancer in at least one of these situations:\n\n   1. Patients recently diagnosed with ER+\u002FHER2- metastatic breast cancer as a recurrence during adjuvant treatment and prior to initiating any treatment in the metastatic setting.\n   2. Patients with metastatic breast cancer of any subtype that have progressed after at least one line of treatment in the metastatic setting.\n\nExclusion Criteria:\n\n1. Presence of a condition or abnormality that, in the opinion of the investigators, would compromise the safety of the patient or the quality of the data.\n2. Inability or refusal to commit with the procedures of the study at the moment of inclusion.\n3. More than 3 prior systemic chemotherapy or antibody-drug conjugate (ADC) regimens for metastatic disease. Note: treatments for bone metastases (eg, bisphosphonates, denosumab, etc.), targeted therapies (eg, PARP inhibitors, CDK 4\u002F6 inhibitors, immunotherapy etc.) and hormonal therapy are not considered as prior systemic chemotherapy treatments for advanced disease.",{"count":55,"type":21},"HOPE Focus is an observational study that aims at promoting research against metastatic breast cancer by means of collective research led by patients (patient-centric trial). Patients with metastatic breast cancer living in Spain will voluntarily register and fulfil their journey in the study through the study's digital tool. Mainly they are prompted to answer questionnaires about their disease and expectations, and to provide a blood sample and an archival tumor biopsy. In HOPE Focus these samples will be genomically analyzed and every patient case will be presented in a multidisciplinary molecular advisory board (MAB). The MAB will issue a plain report explaining the significance of the results and will enumerate future therapeutic options that match patient history and his genomic profile, when feasible. Finally, patients will have to answer short follow-up questionnaires twice a year for 3 years.\n\nThe study data will allow us to advance implementing precision medicine to improve the management of current and specially future metastatic breast cancer patients.",[115],"Metastatic Breast Cancer",[90,91,92,93,117,118,119,120,121,122],"patient-centric trial","observational trial","Molecular data","genomic analysis","liquid biopsy","tumor block","2025-05-19",{"date":125,"type":35},"2025-05-28",{"date":127,"type":35},"2025-05-20",{"date":129,"type":21},"2030-05-20",{"name":41,"class":42},{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},"100534241","phase-2-hrher2--advanced-or-metastatic-breast-cancer-patients-treated-with-sacituzumab-govitecan-100534241","NCT06236269","HR+\u002FHER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan","Prospective Biomarker Analysis in HR+\u002FHER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan","ACROSS-TROP2","Inclusion Criteria:\n\n1. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n2. Patients must be male or female (pre\u002Fperi or postmenopausal) ≥ 18 years of age.\n3. ECOG performance status of 0 or 1(see Appendix 1).\n4. Histologically or cytologically confirmed breast cancer with evidence of locally advanced disease, not amenable to resection or radiation therapy with curative intent or metastatic disease.\n5. HR+\u002FHER2- BC by local testing, not amenable to surgical therapy will be enrolled in this study.\n\n   1. HER2 negativity is defined as either of the following by local laboratory assessment: IHC 0, IHC 1+ or IHC2+\u002Fin situ hybridization (ISH) negative as per the most recent American Society of Clinical Oncology (ASCO)-College of American Pathologists Guideline (CAP) guideline. If a patient has had multiple HER2 results after metastatic disease, the most recent test result prior screening period will be used to confirm eligibility.\n   2. ER and\u002For PR positivity are defined as \\>1% of cells expressing HR via IHC analysis as per most recent ASCO-CAP guideline. If a patient has had multiple ER\u002FPgR results after metastatic disease, the most recent test result prior screening period will be used to confirm eligibility.\n6. Disease refractory to CDK4\u002F6 inhibitors, defined as recurrence during or within 12 months after the end of adjuvant treatment or progression during or within 6 months after the end of treatment for advanced\u002Fmetastatic disease.\n7. No more than 1 prior systemic chemotherapy or antibody-drug conjugate (ADC) regimens for metastatic disease. Adjuvant or neoadjuvant therapy for early-stage disease will qualify as one of the required prior chemotherapy regimens if the development of unresectable, locally advanced, or metastatic disease occurred within a 12-month period of time of the therapy. Note: treatments for bone metastases (eg, bisphosphonates, denosumab, etc.), targeted therapies (eg, PARP inhibitors, CDK 4\u002F6 inhibitors, immunotherapy etc.) and hormonal therapy are not considered as prior systemic chemotherapy treatments for advanced disease.\n8. Radiologic or objective evidence of disease progression on or after the last systemic therapy prior to starting study treatment\n9. Measurable or non-measurable disease but evaluable (identification of target and\u002For non-target lesions by RECIST Vs1.1).\n10. Patients must have a site of disease amenable to safely perform a biopsy, as per Investigator's assessment, and be a candidate for tumor biopsy according to the treating institution's guidelines.\n11. Possibility of performing a biopsy prior to the start of treatment and its repetition after 2 weeks (14-21 days) and at End of Treatment (EOT) on the same location. It will be provided formalin-fixed paraffin-embedded (FFPE) tumor block. The tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for quality prior to enrollment. Patients whose tumor tissue is not evaluable for central testing are not eligible. It is recommended to send the biopsy directly to the central lab after confirming the existence of a tumor, so as not to delay the inclusion, without the need to carry out IHC studies in the same sample.\n\n    * Acceptable samples include core needle biopsies for deep tumor tissue or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, bone or mucosal lesions or biopsies from bone metastases. Lymph node biopsies are also permitted.\n    * Fine needle aspiration, brushing, cell pellet from pleural effusion and lavage samples are not acceptable.\n12. Patients must have normal organ and bone marrow function measured within 35 days prior to administration of study treatment as defined below:\n\n    * Haemoglobin ≥ 9.0 g\u002FdL \\*\n    * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL\\*\n    * Platelet count ≥ 100 x 109\u002FL\\*\n    * Total bilirubin (TBL) ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia).\n    * AST (SGOT) \u002F ALT (SGPT) ≤ 2.5 x ULN unless liver metastases are present in which case, they must be ≤ 5x ULN\n    * Creatinine ≤ 1.5 x ULN or Creatinine clearance estimated of ≥30mL\u002Fmin using the Cockcroft-Gault equation.\n    * Serum albumin \\>3 g\u002FdL\n    * International normalized ratio (INR) or prothrombin time (PT) and either partial thromboplastin or activated partial thromboplastin time (aPTT) ≤ 1.5 ×ULN \\*Without transfusional or growth factor support within 1 week of study treatment initiation.\n13. Patients must have a life expectancy ≥ 16 weeks.\n14. Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 2.\n15. Willing and able to comply with the requirements and restrictions in this protocol.\n\nExclusion Criteria:\n\n1. Patients with HER2-positive or TNBC disease.\n2. Other malignancy unless curatively treated with no evidence of disease for ≥3 years except: non-melanoma skin cancer, in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma or other malignant tumors with an expected curative outcome after medical monitor approval.\n3. Has unresolved toxicities from previous anticancer therapy (≥ CTCAE version 5.0 grade 1) caused by previous cancer therapy, excluding alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion. Note: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to ≥Grade 2 for at least 2 months prior to enrollment and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, such as: Chemotherapy-induced neuropathy, Fatigue, Residual toxicities from prior IO treatment Grade 1 or Grade 2 endocrinopathies. Note: if patients received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n4. Patients may not be participating in a study with an investigational agent or investigational device within 2 weeks or 5 half-lives, whichever is longer, prior to allocation. Patients participating in observational studies are eligible.\n5. Patients with symptomatic uncontrolled brain metastases. Participants with a history of treated Central Nervous System (CNS) metastases are eligible, provided they meet all of the following criteria:\n\n   * Biopsiable disease outside the CNS is present.\n   * No evidence of interim CNS progression between the completion of CNS directed therapy and the screening radiographic study.\n   * Metastases are limited solely to cerebellar and supratentorial lesions.\n   * Stable requirement for corticosteroids (≤ 20 mg oral prednisone or equivalent) or anticonvulsants during \\>4 weeks as therapy for CNS disease.\n   * No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to enrolment.\n   * No evidence of progression or haemorrhage after completion of CNS directed therapy.\n   * Patients with spinal cord compression are excluded unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.\n6. History of significant cardiovascular disease, defined as:\n\n   * New York Heart Association Class III or greater congestive heart failure or known left ventricular ejection fraction of \\\u003C 40%.\n   * Unstable angina or myocardial infarction within 6 months before enrolment.\n   * History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.\n7. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment.\n8. Have active serious infection requiring requiring IV antibiotics, antivirals, or antifungals.\n9. Have a known history of Human Immunodeficiency Virus (HIV).\n10. Have active HBV (defined as having a positive HbsAg test) or HCV.\n\n    1. For patients with a history of HBV infection, a hepatitis B core antibody test should be conducted at screening. If positive, hepatitis B DNA testing will be performed and if active HBV infection is ruled out, the patient may be eligible.\n    2. Patients who are HCV antibody positive with polymerase chain reaction negative for HCV RNA may be eligible.\n11. Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n12. Has received a live vaccine within 30 days prior to randomization.\n13. Prior treatment with Sacituzumab-govitecan.\n14. Known or severe (≥ Grade 3) hypersensitivity or allergy to sacituzumab govitecan, their metabolites, or formulation excipient.\n15. Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 7.5.\n16. Positive serum pregnancy test or women who are lactating (see Appendix 2).",{"count":140,"type":21},50,[24],"This is an open-label, single arm, non-randomized, multicenter phase II study for the identification of predictive biomarkers of sacituzumab govitecan benefit and the understanding of key resistance mechanisms in HR+\u002FHER2- advanced\u002Fmetastatic breast cancer patients",[59],[145,146,147],"sacituzumab govitecan","breast cancer","CelTIL","2024-07-18",{"date":150,"type":35},"2024-07-19",{"date":152,"type":35},"2024-03-15",{"date":154,"type":21},"2027-02-20",{"name":41,"class":42},10,""]