[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cancer-of-the-breast\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cancer-of-the-breast":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,47,59,87,116,142,162,189,227,247,273,300,328,351,387],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100054018","collection-of-csf-samples-from-participants-with-metastatic-triple-negative-breast-cancer-tnbc-and-her2-breast-cancer-with-no-prior-history-nor-active-radiographically-detectable-brain-metastases-100054018",false,"NCT07619534","Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases","Sample Collection Study to Analyze Cerebral Spinal Fluid as a Biomarker for Brain Metastasis in Metastatic Breast Cancer","* INCLUSION CRITERIA:\n* Pathology documentation of histologically confirmed HER2+ BC or TNBC with a history of metastatic disease.\n* Participants must be able to undergo lumbar puncture (LP) and brain MRI.\n* Women age \\>= 18 years\n* Adequate organ function as defined below:\n\n  * Creatinine \\\u003C=1.5 x institutional upper limit of normal (ULN)\n\nOR\n\n--Calculated Creatinine clearance \\>=40 mL\u002Fmin\u002F1.73 m2 for individuals with creatinine levels above institutional ULN (using either Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n\n\\- Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Prior history or current MRI-detected brain metastasis or leptomeningeal disease\n* Previous history of any invasive malignancies, except for surgically resected local cutaneous malignancies.\n* Pregnancy","ALL","18 Years","120 Years",{"count":20,"type":21},139,"ESTIMATED","OBSERVATIONAL","Background:\n\nBreast cancer is the most common cancer among women. It can often spread to the liver, lungs, bones, or brain. Breast cancer that spreads to the brain is often fatal. Researchers want to know if tumor DNA found in spinal fluid, blood, or tumor tissue can help predict when the cancer will spread to the brain. They want to collect these fluid and tissue samples for research.\n\nObjective:\n\nTo collect spinal fluid and other samples from people with breast cancer that has spread to other parts of the body.\n\nEligibility:\n\nPeople aged 18 years and older with HER2-positive or triple negative breast cancer. The cancer must have spread to other parts of the body but not to the brain.\n\nDesign:\n\nParticipants will be screened. They will have blood tests to assess kidney function. They will have an imaging scan of the brain.\n\nParticipants will come to the NIH clinic to have their samples collected:\n\n* Spinal fluid. A thin needle will be inserted into the lower back to draw out a sample of fluid from the space around the spinal cord. A physical exam and blood tests will be done to make sure it is safe for participants to have this procedure.\n* Blood.\n* Saliva or cheek swabs. They will rub a cotton swab inside of their mouth.\n* Tumor samples. If participants have had samples of tumor tissue (biopsies) collected in the past, leftover tissue may be used for this study.\n\nParticipants will be contacted for follow-up every 6 months for 3 years. They may return once a year to provide further samples....",[25,26,27,28],"Breast Cancer","Breast Carcinoma","Cancer of the Breast","Malignant Neoplasm of Breast",[30,31,32,33],"Triple Negative Breast Cancer (TNBC)","HER2-Postitive","Metastatic Breast Cancer","Cerebral Spinal Fluid Collection","NOT_YET_RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":21},"2026-07-16",{"date":42,"type":21},"2034-07-01",{"name":44,"class":45},"National Cancer Institute (NCI)","NIH",1,{"id":48,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":50,"keywords":51,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":58,"locationsCount":46},"100638410",{"count":20,"type":21},[25,26,27,28],[30,31,32,33],"2026-07-01",{"date":54,"type":38},"2026-07-02",{"date":56,"type":21},"2026-07-07",{"date":42,"type":21},{"name":44,"class":45},{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":72,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":46},"100591498","chatgpt--surgeon-synergy-redefining-breast-reconstruction-consultations-for-enhanced-patient-engagement-and-satisfaction-100591498","NCT06981208","ChatGPT & Surgeon Synergy: Redefining Breast Reconstruction Consultations for Enhanced Patient Engagement and Satisfaction","Patient Eligibility Criteria:\n\n* Scheduled for initial preoperative breast reconstruction consultation following therapeutic or prophylactic mastectomy with a surgeon at Washington University School of Medicine.\n* At least 18 years of age.\n* Can speak and understand English.\n\nSurgeon Eligibility Criteria:\n\n* Routinely performs breast reconstruction surgery at Washington University School of Medicine.\n* At least 18 years of age.\n* Can speak and understand English.\n* Surgeon must not be a resident or fellow at time of enrollment.",{"count":66,"type":21},410,"INTERVENTIONAL",[69],"NA","In this study, patients who are scheduled for breast reconstruction consultation will be randomized into the intervention group (ChatGPT-generated patient education regarding possible reconstruction options) or the control group (usual patient education). All patients will complete a survey following their in-person consultation to assess their experience and overall satisfaction with the consultation process. Additionally, participating surgeons will complete a separate survey to evaluate their consultation experience, satisfaction, and to assess the accuracy and clinical utility of the ChatGPT-generated patient education materials. The surveys are designed to gather information on patient characteristics, organizational health literacy according to Brega et al. Other survey questions have been designed to meet the outcomes of this study and have not been based on previously published surveys.",[25,27],[73,74,75],"Patient education","ChatGPT","Breast reconstruction","RECRUITING","2026-06-08",{"date":79,"type":38},"2026-06-10",{"date":81,"type":38},"2025-06-03",{"date":83,"type":21},"2028-06-30",{"name":85,"class":86},"Washington University School of Medicine","OTHER",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":95,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":67,"phases":99,"briefSummary":100,"conditions":101,"keywords":102,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":46},"100635165","overcoming-racial-disparities-in-screening-mammography-100635165","NCT07549139","Overcoming Racial Disparities in Screening Mammography","A Personalized Approach to Promote Health Equity by Overcoming Racial Disparities in Screening Mammography","Inclusion Criteria:\n\n* Woman\n* At least 40 years old\n* Self-identify as Black\n* English-speaking\n* Scheduled for a screening mammogram within 8 weeks of study entry\n* Able to understand and willing to sign an IRB approved written informed consent document.\n\nExclusion Criteria:\n\n* A previous history of breast cancer\n* Scheduled for a diagnostic mammogram\n* Has a documented or uncorrectable cognitive, hearing, or visual impairment.\n* Too ill to participate (diagnosed with or suffering from a condition that, in the judgment of the investigator, may limit participation in the study).",true,"FEMALE","40 Years",{"count":98,"type":21},176,[69],"The purpose of this study is to increase screening mammography among Black women by implementing and evaluating a culturally tailored patient-centric program designed to address barriers to screening. By performing a randomized clinical trial, this study aims to develop effective strategies to improve adherence to screening mammography and contribute to reducing health disparities in breast cancer outcomes.",[25,27],[103,104,105,106,107],"Breast cancer screening","Mammography","Black women","Disparities","No-show rates","2026-05-28",{"date":110,"type":38},"2026-06-01",{"date":112,"type":21},"2026-06-30",{"date":114,"type":21},"2027-12-31",{"name":85,"class":86},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":94,"sex":95,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":67,"phases":128,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":139,"leadSponsor":141,"locationsCount":46},"100614295","precision-supplemental-imaging-in-women-with-dense-breasts-100614295","NCT07277738","Precision Supplemental Imaging in Women With Dense Breasts","Precision Supplemental Imaging in Women With Dense Breasts (PSID Trial)","PSID","Inclusion Criteria:\n\n* Normal screening mammogram within 90 days prior to enrollment.\n* Dense breasts, either:\n\n  * Class C density (\"the breasts are heterogeneously dense, which may obscure small masses\")\n  * Class D density (\"the breasts are extremely dense, which lowers the sensitivity of mammography\")\n* MRS risk estimate at \\> 3% 5-year risk of breast cancer.\n* Female.\n* Between 25 and 55 years of age (inclusive).\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n\nExclusion Criteria:\n\n* More than 1 prior mammogram\n* Contraindication to MRI with contrast (e.g. claustrophobia, metal objects in the body, known sensitivity\u002Fallergy to gadolinium).\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the study intervention (breast cancer or LCIS). Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.\n* Prior MRI screening of the breast.\n* Known to be BRCA 1\u002F2 positive or presence of any other known high penetrance genetic marker.\n* Is receiving any chemoprevention.\n* Has breast implants.\n* Is breastfeeding.","25 Years","55 Years",{"count":127,"type":21},78,[69],"Recent research has shown that, among women with extremely dense breasts and normal results on mammogram, magnetic resonance imaging (MRI) use has significantly reduced the occurrence of breast cancer that is diagnosed during the time between two regular screening mammograms (also known as interval cancers).\n\nThe investigators have developed and validated an approach to use the whole mammogram image, develop a mammogram risk score (MRS), and calibrate this to the SEER breast cancer incidence rates for US women. This model (Prognosia Breast) generates an absolute 5-year risk of breast cancer and classifies approximately 5.7% of the population as high risk using the ASCO 3% cut point as used for endocrine therapy to reduce risk. Follow-up generates an incidence of 25.2 cases per 1,000 women per year.",[25,27],[132,133,134],"Dense breasts","Abbreviated MRI","Risk assessment","2026-05-18",{"date":137,"type":38},"2026-05-20",{"date":112,"type":21},{"date":140,"type":21},"2029-06-30",{"name":85,"class":86},{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":151,"studyType":22,"phases":4,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":46},"100513966","cool-it-pro-cryoablation-of-breast-cancer-in-non-surgical-patients-100513966","NCT05972343","COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients","COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry","Eligibility Criteria:\n\n* Diagnosis of breast cancer.\n* Mass must be visible on ultrasound and \\> 5 mm from skin.\n* Not undergoing surgery, because:\n\n  * Patient has a medical condition that would not allow sedation or general anesthesia\n  * Surgery is not clinically indicated due to unresectable and\u002For metastatic disease\n  * Surgery is not clinically indicated for another reason\n  * Patient declines surgery\n* At least 18 years old.\n* Able to understand and willing to sign an IRB-approved written informed consent document.",{"count":150,"type":21},100,"3 Years","This is a subject registry study of patients who undergo cryoablation for their breast cancer after being determined not to be surgical candidates. Data collected as part of this registry will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this population as well as provide long-term follow-up of subjects who received cryoablation.",[25,27],"2026-05-04",{"date":156,"type":38},"2026-05-07",{"date":158,"type":38},"2023-07-26",{"date":160,"type":21},"2031-07-31",{"name":85,"class":86},{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":95,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":67,"phases":171,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":46},"100503607","phase-2-neotailor-abiomarker-directed-approach-to-guide-neoadjuvant-therapy-for-patients-with-stage-iiiii-er-positive-her2-negative-breast-cancer-100503607","NCT05837455","NeoTAILOR: ABiomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II\u002FIII ER-positive, HER2-negative Breast Cancer","NeoTAILOR: A Phase II Biomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II\u002FIII ER-positive, HER2-negative Breast Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed newly diagnosed clinical stage II or III (by AJCC 8th edition - at least T2, any N, M0 or if N1+ then any T) ER-positive (ER \\> 10%), any PR, and HER2-negative breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal.\n\n  * HER2 negative must be assessed by FISH or IHC staining 0 or 1+ according to ASCO\u002FCAP guidelines.\n* A palpable mass is not required; however, tumor size must be either:\n\n  * ≥2 cm in one dimension by clinical or radiographic examination (WHO criteria), if clinically axillary lymph node negative OR\n  * Measureable (≥10 mm) by modified RECIST v1.1 for breast MRI (see Section 9.0), if histologically confirmed resectable locoregional nodal involvement.\n* ECOG performance status 0 or 1.\n* Eligible to receive neoadjuvant aromatase inhibitor, as per treating physician.\n* Eligible to receive neoadjuvant standard of care anthracycline- and\u002For taxane-based chemotherapy regimen, as per treating physician.\n* Able to tolerate breast MRI with intravenous contrast administration. Must be able to complete the applicable MRI screening evaluation form.\n* Adequate bone marrow and organ function, as determined by the treating physician.\n* Known history of hepatitis C virus (HCV) infection is permissible provided the patient has been treated and cured.\n* At least 18 years of age.\n* Postmenopausal status, defined as one of the following:\n\n  * Age ≥ 60 years\n  * Age \\\u003C 60 with intact uterus and amenorrhea for 12 consecutive months or more\n  * Status post bilateral oophorectomy, total hysterectomy\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable), and willing and able to comply with scheduled visits and treatment schedule.\n\nExclusion Criteria:\n\n* Inflammatory breast cancer (cT4d disease as per AJCC 8th edition).\n* Locally recurrent or metastatic disease (cM1 disease as per AJCC 8th edition).\n* Bilateral breast cancer.\n* Prior systemic therapy for the indexed breast cancer.\n* Pre-existing Grade ≥2 neuropathy.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements.\n* A history of other malignancy ≤5 years prior to the indexed breast cancer diagnosis with the following exceptions:\n\n  * Basal cell or squamous cell carcinoma of the skin which were treated with local resection only\n  * Adequately treated carcinoma in situ of the cervix.\n  * Prior or concurrent malignancy whose natural history or treatment will not interfere with the safety or efficacy assessments of the indexed breast cancer. In this event, review and approval by the study PI is required.\n* Concurrent participation in any investigational therapeutic trial for treatment of breast cancer.\n* Known HIV positivity that in the judgement of the treating physician would impact safety of chemotherapy receipt.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to anastrozole, taxanes (paclitaxel or nab-paclitaxel), anthracyclines (doxorubicin or epirubicin) or cyclophosphamide.\n* Evidence of uncontrolled ongoing or active infection, requiring parenteral anti-bacterial, anti-viral, or anti-fungal therapy ≤ 7 days prior to administration of study treatment. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible.\n* Any uncontrolled medical condition that in the opinion of the Investigator would pose a risk to participant safety or interfere with study participation or interpretation of individual participant results.",{"count":170,"type":21},81,[172],"PHASE2","This study aims to utilize a novel biomarker-driven approach to guide neoadjuvant treatment selection. It is the hypothesis that this will improve clinical response for postmenopausal women with clinical stage II\u002FIII ER-positive, HER2-negative breast cancer and identify those who may not require neoadjuvant chemotherapy, with a primary focus on outcomes in Black patients.",[25,27],[176,177,178,179,180],"breast cancer","postmenopausal women","Ki67","PAM50 subtype","breast cancer disparities","2026-04-07",{"date":183,"type":38},"2026-04-13",{"date":185,"type":38},"2024-05-30",{"date":187,"type":21},"2027-11-30",{"name":85,"class":86},{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":67,"phases":199,"briefSummary":200,"conditions":201,"keywords":212,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":226},"100598533","phase-2-psilocybin-assisted-psychotherapy-in-cancer-patients-with-adjustment-disorder-100598533","NCT07072728","Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder","A Phase 2b Double-blind, Randomized, Low-dose Comparator-controlled Clinical Trial to Assess the Efficacy and Safety of NPX-5 in Psilocybin-assisted Psychotherapy for the Treatment of Adjustment Disorder Associated With Cancer.","Inclusion Criteria:\n\nTo be eligible for study entry participants must satisfy all of the following criteria:\n\n1. Screening AjD diagnosis (ICD-11), as defined by an ADNM-20 score ≥ 47.5, a score of ≥ 4 on the Distress Thermometer.\n2. Screening HAM-A Score ≥18 (moderate anxiety).\n3. Adults aged 18 to 80 years (inclusive) at screening.\n4. Diagnosed with cancer (exempting those cancers listed in the exclusion criteria) and a minimum life-expectancy of 6 months in the opinion of the treating physician, with performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale performed at screening.\n5. Agrees not to commence any new psychiatric medications or psychotherapies from Screening to Week 10.\n6. Able to communicate well and follow study procedures, judged as sufficiently competent with the English language by the investigator, able to build adequate rapport with study staff.\n7. Judged to be of low suicide risk based on Sheehan-Suicide Tracking Scale (S-STS) and the opinion of a research team psychiatrist.\n8. Be medically suitable in the opinion of the investigator as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and blood tests.\n9. Have access to a device that is compatible to use the digital technology, i.e smart-phone device or tablet.\n10. Agree not to take any sedating medications for a minimum of 12 hours before the dosing session including benzodiazepines, zopiclone, eszopiclone, zaleplon and zolpidem. Medications for cancer-related pain are permitted.\n11. Must be willing and able to refrain from smoking throughout the duration of the dosing session. Nicotine replacement therapies may be permitted with the agreement of the medical monitor.\n12. Agree that for 1 week before the psilocybin dosing session, participants will refrain from taking any illegal drugs or non-prescription medication (including cannabis, or CBD or THC containing products), nutritional supplement, or herbal supplement except when approved by the study investigators. Additionally, agree not to take any form of psilocybin outside of the study, including microdosing, from baseline through Day 70\u002FWeek 10 (Visit 11).\n13. Participants taking any other medication that is not explicitly detailed as an excluded medication will be discussed with the investigator and medical monitor as appropriate. Decisions on inclusion will be based on clinical judgement and with sufficient justification provided.\n\nExclusion Criteria\n\nParticipants will be excluded from the study if one or more of the following criteria are applicable:\n\nPsychiatric Exclusion Criteria:\n\n1. Current Major Depressive Disorder MDD (or within 12 months of Screening) deemed independent from the cancer diagnosis, current or past diagnosis of schizophrenia, psychotic disorder, unless this was resulting from a medical condition (e.g. lupus or malaria etc.), bipolar disorder I and II, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anti-social personality disorder or judged to be incompatible with establishment of rapport or safe exposure to psilocybin, as determined using clinical judgement of past and present medical and psychiatric history by any specialist psychiatrist or registered medical professional under the authorized delegation of a specialist psychiatrist.\n2. First-degree relative with a diagnosed psychotic disorder.\n3. Scores from the screening psychiatrist (or registered medical professional under the authorized delegation of a specialist psychiatrist) and baseline (S-STS) that indicate that the participant is of clinically significant risk of suicide. A decision will be formed based on S-STS scores and used in combination with other clinically significant data at screening. Sites should refer to the medical monitor if required.\n4. Has attempted suicide in the twelve months preceding the screening visit.\n5. Current (\\\u003C 1 year) alcohol or drug misuse as identified as moderate or severe during screening in accordance with Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, using the MINI 7.0.2, not able or willing to abstain from alcohol consumption in the period 12 hours prior to the dosing session.\n6. Any other reason that might prevent a participant from engaging in therapeutic preparation and integration sessions.\n7. Anyone who has taken a microdose of psilocybin within 5 days of baseline, taken a higher dose of psilocybin (e.g., dried mushrooms or capsules) within 30 days of baseline and experienced euphoria, hallucinations, or altered mental status, or used any classic psychedelics (LSD, ibogaine, ayahuasca, DMT, mescaline) within 3 months prior to baseline.\n\nMedical Exclusion Criteria:\n\n1. Diagnosed with brain metastases, glioblastoma, phaeochromocytoma, bowel obstruction or intestinal failure, active carcinoid syndrome, uncontrolled hypercalcaemia, or uncontrolled diabetes mellitus or insipidus.\n2. Currently taking or planning to take any of the following: any typical or atypical antipsychotic and monoamine-oxidase inhibitors. Participants with prior use of these medications must be willing to discontinue their use for at least 2 weeks prior to the baseline visit and to Day 28.\n3. Currently taking or planning to take any anticonvulsant or mood stabilizer, including carbamazepine, lithium, phenytoin, and valproate. Participants with prior use of these medications must be willing to discontinue their use for at least 1 week prior to the baseline visit and to Day 28.\n4. Any form of fungal allergy.\n5. Positive pregnancy test at screening, women who are breastfeeding or of childbearing potential who are unwilling or unable to use an effective form of contraception (or abstinence) for the study period and for 1 month post NPX-5 dose will be excluded. Women will be required to conduct a serum pregnancy test at the in-person screening visit and urine test prior to dosing session. Male participants who do not agree to use contraception for the study period and for 90 days post NPX-5 dose to mitigate the risk of pregnancy will also be excluded. Note: Refer to Section 4.3.2.1 for further details about contraception.\n6. A diagnosis of epilepsy or at significant risk of seizures based on medical history.\n7. Cardiovascular conditions including stroke and\u002For myocardial infarction (less than one year before providing informed consent), uncontrolled hypertension (blood pressure \\> 140\u002F90 mmHg) or clinically significant arrhythmia at screening. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to administration of psilocybin, following discretion of the investigator.\n8. Anyone who, at screening, has clinically significant findings on physical examination, including resting vital signs (HR below 40 or above 120 bpm, blood pressure below 90\u002F60 or above 140\u002F90), ECG (QTcF \\> 450 msec for males and \\>470 for females), and positive alcohol breath test. Note: Inclusion of individuals with any out-of-range values, including blood pressure, is at the discretion of the Investigator.\n9. Liver dysfunction at screening as defined by AST and\u002For ALT \\> 1.5 times the upper level of normal or upper reference range. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to the administration of psilocybin, following discretion of the investigator.\n10. Renal Function: estimated glomerular filtration rate \\\u003C60 mL\u002Fmin (calculated using Chronic Kidney Disease Epidemiology Collaboration) unless this is a direct result of the cancer diagnosis and does not present a risk to the administration of psilocybin, following the discretion of the investigator.\n11. Any clinically significant laboratory abnormality(s) that in the opinion of the investigator would present a risk to the administration of psilocybin.\n12. Any clinically significant renal, pulmonary, gastrointestinal, hepatic, or other illness that could affect the interpretation of results or be a potential health risk for the person if they were to be included in the study. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to administration of psilocybin, following discretion of the investigator.\n13. Below 18 or above 32kg\u002Fm2 Body Mass Index (BMI) score at Screening.\n14. Anyone with organic brain injury or diagnosed with any cognitive impairment.\n15. Positive urine drug test for non-prescribed psychoactive substances at the dosing session visit. Positive urine drug test for psychoactive substances at the in-person screening should be referred to the medical monitor. Note: Testing may be repeated once at the discretion of the Investigator.\n16. Anyone on a research study of an investigational drug or who has been on a clinical trial within 3 months of enrolment.","80 Years",{"count":198,"type":21},87,[172],"This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis.\n\nWho is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called adjustment disorder.\n\nStudy details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg NPX-5 dose group, a 10 mg NPX-5 dose group or a 1mg NPX-5 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with NPX-5 administered at Day 14 (dosing day).\n\nAt Week 10, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg NPX-5). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3 months post Week 10 (of the final cycle) to assess safety and tolerability of NPX-5.\n\nIt is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis.",[202,203,204,205,206,207,208,27,209,210,211],"Adjustment Disorder","Adjustment Disorder With Anxious Mood","Cancer","Cancer Cachexia","Cancer of Endometrium","Cancer of Kidney","Cancer of Prostate","Cancer of Stomach","Cancer Melanoma Skin","Cancer Pancreas",[204,202,213,214,215],"Existential Distress","Psilocybin","Psilocin","2026-03-01",{"date":218,"type":38},"2026-03-03",{"date":220,"type":38},"2025-10-01",{"date":222,"type":21},"2027-07-30",{"name":224,"class":225},"Psyence Australia Pty Ltd","INDUSTRY",3,{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":67,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":46},"100436876","treatment-monitoring-of-patients-receiving-cdk-46-inhibitors-for-hormone-receptor-hr-positive-her2-negative-metastatic-breast-cancer-mbc-with-or-without-the-addition-of-divitum-serum-thymidine-kinase-1-tk1-activity-testing-100436876","NCT04968964","Treatment Monitoring of Patients Receiving CDK 4\u002F6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing","TK IMPACT: Treatment Monitoring of Patients Receiving CDK 4\u002F6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing: Physician Decision Impact Study","Inclusion Criteria - Patients:\n\n* Diagnosis of metastatic or advanced resectable invasive breast cancer that is hormone receptor-positive (HR+) and HER2-negative. Tumor assessment by radiographic imaging will be performed within 4 weeks of baseline study visit.\n* Cohort 1 only: Scheduled to initiate standard of care first-line combination therapy with any FDA-approved endocrine therapy plus any FDA-approved CDK 4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib) for the stated diagnosis at the time of study enrollment. Type of endocrine therapy and CDK 4\u002F6 inhibitor will be documented. Patients may also be eligible if:\n\n  * Patients were treated with and progressed on prior endocrine therapy monotherapy in the metastatic setting, OR\n  * Patients initiated endocrine therapy alone with ultimate intention to add CDK 4\u002F6 inhibitor therapy, OR\n  * Patients recurred on adjuvant endocrine therapy monotherapy and are scheduled to receive next line endocrine therapy combined with CDK 4\u002F6 inhibitor. Patients may have also received CDK 4\u002F6 inhibitor therapy in the adjuvant setting provided therapy completion occurred greater than 12 months prior to study enrollment.\n* Cohort 2 only: Currently receiving first-line combination therapy with any FDA-approved endocrine therapy plus any FDA-approved CDK 4\u002F6 inhibitor (palbociclib, ribociclib, or abemaciclib). Changes in endocrine therapy or CDK 4\u002F6 inhibitor agent during first-line combination therapy are permitted as long as change was not performed due to progressive disease. CDK 4\u002F6 inhibitor must have been initiated within 24 months of study enrollment, and patient must have at least stable disease (no progression) on such therapy for a minimum of 12 weeks prior to enrollment as determined by radiographic studies as deemed appropriate by the treating physician. Type of endocrine therapy and CDK 4\u002F6 inhibitor will be documented. Patients may also be eligible if they are receiving next line endocrine therapy plus CDK 4\u002F6 inhibitor therapy following:\n\n  * Progression on prior endocrine therapy monotherapy in the metastatic setting, OR\n  * Recurrence on adjuvant endocrine therapy monotherapy. Patients may have also received CDK 4\u002F6 inhibitor therapy in the adjuvant setting provided therapy completion occurred greater than 12 months prior to study enrollment.\n* Any prior therapy for early stage breast cancer is allowed, including endocrine therapy and chemotherapy.\n* At least 18 years of age.\n* Life expectancy \\> 6 months.\n* Post-menopausal status, defined as one of the following:\n\n  * Age ≥ 60 years\n  * Age \\\u003C 60 with intact uterus and amenorrhea for 12 consecutive months or more\n  * Status post bilateral oophorectomy, total hysterectomy\n  * Pre- or peri-menopausal with suppressed ovarian function by use of GnRH agonist\u002Fantagonist or surgical bilateral oophorectomy\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n* Currently being treated at Siteman Cancer Center by a medical oncologist participating in this trial.\n\nExclusion Criteria - Patients:\n\n* Receipt of any prior cytotoxic chemotherapy line for metastatic disease. There will be no limited to chemotherapy use in the neoadjuvant or adjuvant setting.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the protocol assessments or analyses are eligible for this trial as determined by treating physician and with agreement by Principal Investigator\n* Concurrent participation in any investigational therapeutic trial for treatment of metastatic breast cancer.\n\nEligibility Criteria - Physicians:\n\n* Medical Oncologist at Siteman Cancer Center\n* Treating patients with metastatic or advanced unresectable invasive breast cancer\n* Willing to complete Study Care Plans on a serial basis during participation",{"count":235,"type":21},55,[69],"Historically, serial testing of patients with metastatic breast cancer has included a combination of physical exam, symptom evaluation, laboratory testing, and imaging. Circulating tumor biomarkers are sometimes also incorporated. Frequent testing with numerous diagnostics at each time point is a significant burden to patients and to healthcare systems.\n\nThe DiviTum® TKa assay measures TK1 activity. Numerous studies have illustrated the prognostic nature of plasma or serum TK1 activity level in metastatic cancer. The investigators hypothesize that the incorporation of data from DiviTum® TKa measurement into the treatment monitoring schema will be associated with physician desire to change the near-term usage and\u002For timing of other routine restaging tests, including either standard tumor imaging or tumor marker testing. Given the relatively low rate of disease progression in this first-line population, it is expected that most of this change will be an intended reduction in scheduling of routine treatment surveillance testing with increase in intervals of subsequent tumor restaging imaging by at least 4 weeks. Secondarily, the consequences of rescheduling of routine surveillance testing may ultimately result in an absolute reduction in the number of some tests used during the time period examined.",[25,27],"2026-01-06",{"date":241,"type":38},"2026-01-07",{"date":243,"type":38},"2022-03-07",{"date":245,"type":21},"2029-09-30",{"name":85,"class":86},{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":95,"minAge":96,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":67,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":272},"100582759","breast-re-irradiation-after-second-ipsilateral-lumpectomy-100582759","NCT06867484","Breast Re-irradiation After Second Ipsilateral Lumpectomy","Breast Re-irradiation After Second Ipsilateral Lumpectomy (BRASIL Trial)","BRASIL","Inclusion Criteria:\n\n* Diagnosed with ER+HER2- breast cancer\n* Provision of signed and dated ICF\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Age ≥ 40 years\n* Oncotype \\\u003C 26 (postmenopausal) \\\u003C16 (premenopausal), Low, or Ultra-Low index.\n* Minimum interval of 18 months from last breast radiotherapy session.\n* Prior radiation therapy in the form of brachytherapy, external beam MV photons, protons or intraoperative radiation are allowed with an upper total dose limit of 68 Gy (EQD2) for those patients with prior records available.\n* Ipsilateral recurrence, unifocal \\\u003C 3 cm with negative margins, N0, Tis and invasive (pathological staging)\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Planning target volume: whole breast (PTV: WB) ratio \\\u003C 1\u002F2\n* Life expectancy \\> 12 months\n* Individuals able to become pregnant: agreement to use highly effective contraception starting at screening through treatment, and for 1 year after the end of PBI. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately.\n\nA person able to become pregnant is any person assigned female at birth (regardless of gender identity, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n1. Has not undergone a hysterectomy or bilateral oophorectomy; or\n2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time during the preceding 12 consecutive months)\n\nExclusion Criteria:\n\n* BRCA1\u002F2 mutation or any other receptor subtypes\n* Individuals assigned male at birth with breast cancer\n* Pregnancy or breastfeeding\n* Skin involvement\n* Distant metastasis\n* Patients with initial high-risk triple negative or HER-2 enriched breast cancer will be excluded from the trial. However, if the initial subtype is not known, patients will still be allowed to enroll, and the initial primary tumor information will be recorded as missing on the clinical forms.\n* Other malignancies (except skin)\n* Connective tissue disorder (e.g., scleroderma, lupus)\n* Any other condition that may put a participant at higher risk, at the discretion of the investigator.",{"count":256,"type":21},114,[69],"The purpose of this research study is to test the safety and possible harms of treating breast cancer with reirradiation, after breast surgery. The researchers want to find out what effects (good and bad) reirradiation has on people who have already received radiation before surgery.",[25,204,27,260,261,262],"HER2-negative Breast Cancer","ER+ Breast Cancer","Estrogen-receptor-positive Breast Cancer","2025-11-12",{"date":265,"type":38},"2025-11-13",{"date":267,"type":38},"2025-10-27",{"date":269,"type":21},"2033-05",{"name":271,"class":86},"Youssef Zeidan",2,{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":96,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":67,"phases":283,"briefSummary":284,"conditions":285,"keywords":287,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":272},"100573663","phase-2-daance-for-chemotherapy-induced-neuropathy-100573663","NCT06749210","DAANCE FOR CHEMOTHERAPY-INDUCED NEUROPATHY","DANCE-BASED AVENUES TO ADVANCE NONPHARMACOLOGIC TREATMENT OF CHEMOTHERAPY EFFECTS (DAANCE): A MULTICENTER TRIAL","DAANCE","Inclusion Criteria:\n\n* Breast Cancer (BC) diagnosis of Stage I-IV including metastatic disease\n* completed taxane-based chemotherapy for BC at least 3 months ago (no limit on how long ago)\n* symptomatic for chemotherapy-induced neuropathy (self-report)\n* postural control score that indicates potential fall-risk\n* able to understand and comply with directions associated with testing and study treatments\n\nExclusion Criteria:\n\n* pre-existing vestibular dysfunction\n* poorly controlled diabetes (hgA1C\\>=8)\n* non-ambulatory (assistive and prosthetic devices allowed)\n* hearing impairment resulting in less than 10% hearing bilaterally\n* contraindication to participate in the experimental physical activity per the treating oncologist due to additional condition (e.g., herniated disc, unstable bone metastases)\n* currently in activity-based therapy (e.g., physical therapy, occupational therapy). May enroll if still meet eligibility criteria once activity-based therapy is complete.",{"count":282,"type":21},140,[172],"Up to 80% of breast cancer survivors experience chemotherapy-induced neuropathy that impairs quality of life and increases fall risk long into survivorship, yet treatment options for neuropathy remain limited. The successful treatment will target neurophysiologic mechanisms for restoring function while addressing patient-reported symptoms and participation in treatment. Toward this end, the investigators propose to study a noninvasive, social sensorimotor intervention - Adapted Argentine Tango - which targets motor control restoration, symptom alleviation, and treatment participation in concert.",[27,286],"Chemotherapy-induced Neuropathy",[288,289,290],"survivorship","music","dance","2025-11-03",{"date":293,"type":38},"2025-11-05",{"date":295,"type":38},"2025-02-19",{"date":297,"type":21},"2029-08-15",{"name":299,"class":86},"Ohio State University Comprehensive Cancer Center",{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":95,"minAge":306,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":67,"phases":309,"briefSummary":310,"conditions":311,"keywords":314,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":327},"100191324","phase-2-phase-ii-protocol-of-proton-therapy-for-partial-breast-irradiation-in-early-stage-breast-cancer-100191324","NCT01766297","Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer","Inclusion Criteria:\n\n* Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial.\n* Must be female.\n* Must be \\> = 50 years of age.\n* Must have a life expectancy of at least 5 years based on age and co-morbidities.\n* Must have pathology proven invasive ductal carcinoma (lobular is not allowed) and\u002For ductal carcinoma in situ (DCIS).\n* One of the following criteria must be met: (a) Tumors that are microscopically multifocal must be 3.0 cm or less in total aggregate size and encompassed within a single scar (b) Patient does not have microscopically multifocal tumor.\n* For tumors that are invasive, if in the presence of extensive intraductal component (EIC), the entire pathologic tumor size (including both the intraductal and invasive component) must be 3.0 cm or less.\n* Must be Stage 0, I, II (Tis, T1, or T2, N0, M0 per AJCC criteria 7th and\u002For 8th Ed.). If stage II, the tumor size must be \\\u003C = 3.0 cm. A patient with invasive histology must have nodal stage pN0 by H\\&E stains on sentinel node biopsy or axillary lymph node dissection.\n* Must have ER positive disease with ER\u002FPR report available.\n* For tumors that are invasive, HER2 must be performed (positive or negative is acceptable).\n* Must have a lumpectomy performed, with documented negative surgical margins by 0.2 cm or more. If re-excision results in negative surgical margins 0.2 cm or more, patient is eligible.\n* If image guidance with daily cone beam CT with direct physician visual assessment is used for treatment positioning, the presence of markers or clips in the surgical bed is recommended but not required. If cone beam CT imaging will NOT be used for image guidance, then the patient must be prepared to have 2 fiducial markers minimum, 3 preferred, placed prior to treatment (if not previously done).\n\n  * If markers or clips were placed at the time of surgery, patient must be able to start treatment within 12 weeks after lumpectomy or re-excision for adequate margins.\n  * If markers were not placed at the time of surgery and are needed, patient must have markers placed within 6 weeks after surgery.\n  * If systemic chemotherapy was given, patient must have had clips or markers placed at the time of surgery (if they are needed) and patient must have simulation scans within 6 weeks of the completion of the chemotherapy.\n* Must be able to start treatment within 12 weeks of surgery or 8 weeks of finalization of chemotherapy.\n\nExclusion Criteria:\n\n* Previous history of ipsilateral invasive breast cancer or DCIS.\n* Any clinical or radiographically suspicious nodes, unless biopsy proven benign.\n* Non-epithelial malignancies such as sarcoma or lymphoma.\n* Suspicious residual microcalcifications on mammography of either breast, unless negative for malignancy on pathology.\n* Multicentric or bilateral disease unless biopsy of the clinical abnormalities are performed and result is negative.\n* Lymphovascular space invasion (LVSI) on pathology specimen.\n* Any previously treated breast carcinoma or synchronous breast carcinoma in ipsilateral breast.\n* Prior radiation therapy to the ipsilateral breast or thorax.\n* Paget's disease of the nipple.\n* Histologic examination showing invasive lobular histology.\n* Skin involvement.\n* Breasts technically unsatisfactory for radiation treatment upon the discretion of the treating physician.\n* Significant infection or other co-existing medical condition that would preclude protocol therapy such as pregnancy, HIV\u002FAIDS or collagen vascular diseases specifically systemic lupus erythematosus, scleroderma, or dermatomyositis.\n* Known BRCA 1 or BRCA 2 mutation.\n* Pregnant or lactating.","50 Years",{"count":308,"type":21},132,[172],"The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy.\n\nThis study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary to compare the results (good or bad) of proton radiation therapy.",[25,312,313,27],"Breast Neoplasm","Breast Tumor",[25,315,316],"Proton","Radiation","2025-09-02",{"date":319,"type":38},"2025-09-09",{"date":321,"type":4},"2013-02",{"date":323,"type":21},"2035-01",{"name":325,"class":326},"Proton Collaborative Group","NETWORK",9,{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":95,"minAge":335,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":67,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":46},"100245694","phase-2-endocrine-treatment-alone-for-elderly-patients-with-estrogen-receptor-positive-operable-breast-cancer-and-low-recurrence-score-100245694","NCT02476786","Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score","Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score","Inclusion Criteria:\n\n* Newly diagnosed histologically or cytologically confirmed operable invasive breast cancer defined as cT1 or T2, N0-1, and M0.\n* Disease must be ER+ and HER2-.\n* Ki67 score\u002Fproliferative index ≤ 30% or low to intermediate mitotic index\n* Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) by ultrasound or mammogram.\n* 70 years of age or older.\n* ECOG performance status ≤ 3\n* Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* Prior surgery for this cancer\n* A history of other malignancy ≤ 5 years previous which would preclude endocrine treatment of their cancer.\n* Currently receiving any other investigational agents.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.\n* Uncontrolled intercurrent illness as determined by their treating physician which would limit compliance with study requirements.\n* Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with endocrine therapies. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.","70 Years",{"count":337,"type":21},50,[172],"Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. A new standard of care needs to be defined for elderly women with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. The investigators hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast cancer and low Ki67 scores.",[25,341,342,27],"Cancer of Breast","Breast Neoplasms","2025-07-23",{"date":345,"type":38},"2025-07-28",{"date":347,"type":38},"2017-01-17",{"date":349,"type":21},"2032-07-31",{"name":85,"class":86},{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":94,"sex":16,"minAge":17,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":362,"conditions":363,"keywords":368,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":46},"100570799","vocorder-device-validation-in-clinical-settings---continuous-monitoring-of-individuals-vocorder-clinical-validation-vcv-100570799","NCT06711939","Vocorder Device Validation in Clinical Settings - Continuous Monitoring of Individuals (Vocorder Clinical Validation-VCV)","Vocorder Device Validation in Clinical Settings - Continuous Monitoring of Individuals (Vocorder Clinical Validation-VCV). This Clinical Study Will Explore the Correlation Analysis Between Volatile Organic Compounds (VOC) Profiles in Breath As Detected by the VOCORDER Breath Analyser and Electronic Medical Data As Collected by Medical Professionals. the Obtained Results Are Expected to Be Significant in Refining the Technology of Breath Analysis in the VOCORDER Breath Analyser for the Early Detection of Diseases of Interest.","VCV","Inclusion Criteria:\n\n* Patients aged 18-75 years of both genders, selected according to the following inclusion criteria:\n\n  1. Patients\\>18 years of age of both genders\n  2. They must be able to communicate and understand the information given to them by the MITERA staff.\n  3. Suffer from the disease under investigation.\n  4. The disease must be at the earliest possible stage, i.e., the patients must not yet have started treatment.\n  5. Patients should have no other serious comorbidities that affect the derived measurements. Patients will be selected in collaboration with the clinicians responsible for the treatment and\u002For hospitalisation of patients with the diseases under investigation.\n\n     Criteria 1, 2, and 3 are mandatory for enrollment in the study. For the enrollment of the patients in the study specific documentation of the disease should be available to the project team as following:\n* Healthy controls of both sexes, aged between 20 and 75 years, who do not suffer from the diseases under investigation will be selected for participation in the study at the same time as the patients.\n\nExclusion Criteria:\n\n* Lack of signed consent\n* Lack of co-operation due to any reason\n* Failure to follow the recommendations on the requirements prior to the breath sampling procedure\n* Inability to provide a reliable breath sample\n* Any treatment, specific diet, surgery, or other intervention having been initiated between obtaining samples for breath VOCs.","75 Years",{"count":361,"type":21},515,"This is performed under Vocorder project that is Co-Funded by the European Union. (Grant Agreement 101115442 VOCORDER HORIZON EIC-2022-PATHFINDERCHALLENGE-01). The projects has 9 work packages (one dedicated to the clinical study) and 12 partners (collaborators). MITERA Hospital serves as the project Coordinator as well as the leader of the clinical study.\n\nVOCORDER aims to create a paradigm shift in healthcare monitoring by developing a portable device for continuous assessment of health through breath analysis.\n\nOur mission is to make health monitoring seamless and non-intrusive, empowering individuals and healthcare professionals with real-time data and proactive health management.\n\nOur vision is to make continuous health monitoring a part of everyday life, helping in early disease detection and management. We are on a mission to create accessible, easy-to-use technology that integrates seamlessly into daily routines.\n\nOur objective is to create a tool designed for the discreet and continuous monitoring of human health. This involves the development and implementation of a system that can consistently assess, process, and analyze human breath. The key aim is to detect early indicators of diseases, thereby facilitating timely and proactive healthcare interventions.\n\nStrategic objectives\n\n1. Provide a solution for easy-to-use breath analysis able to monitor the health of any individual at any setting.\n2. Develop and demonstrate the beyond state-of-the-art technologies needed to implement the VOCORDER breath analysis apparatus.\n3. Develop a health monitoring apparatus people can easily integrate into their everyday life.\n\nScientific and technological Objectives\n\n1. Demonstration of QCLs and ICLs monolithically integrated arrays.\n2. Integrate QCLs\u002FICLs arrays with MPLC components for beam combing and providing high quality beam profile.\n3. Implement a detector-less sensing scheme.\n4. Enable AI-based breath analysis for the identification of health conditions.\n5. Implement clinical studies of VOCORDER.",[27,209,364,365,366,367],"Colon Cancer","Lung Cancers","Kidney Insufficiency","Pneumonia",[369,370,371,372,373,374,375,376,377],"VOC","breath analysis","organ insufficiency","infections","Lung cancer","Gastric and colon cancer","Breast cancer","Kidney insufficiency","Infections - Pneumonia","2024-11-27",{"date":380,"type":38},"2024-12-02",{"date":382,"type":21},"2024-12-09",{"date":384,"type":21},"2026-12-31",{"name":386,"class":86},"Mitera Hospital",{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":67,"phases":395,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":46},"100552329","phase-1-a-study-of-bria-ots-cellular-immunotherapy-in-metastatic-recurrent-breast-cancer-100552329","NCT06471673","A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer","Key Inclusion Criteria:\n\n1. Histological confirmed recurrent metastatic breast cancer which has failed prior\n\n   therapy defined as:\n   1. Human epidermal growth factor 2 (EGFR2, HER2) positive tumors must have failed therapy with at least 2 anti-HER2 agents\n   2. HER2 negative and either ER or PR positive tumors: must be refractory to hormonal therapy and previously treated with at least 2 hormone based targeted therapy containing regimens.\n   3. Triple-negative and inflammatory tumors must have exhausted other curative intent therapies including prior treatment with a taxane and platinum-based agent\n   4. All other MBC types must have exhausted other curative intent therapies including any genomic or germline directed targeted therapy having available approved drug(s)\n   5. Patients with new or progressive breast cancer metastatic to the brain will be eligible, provided:\n\n   i. The brain metastases must be clinically stable (without evidence of progressive disease by imaging) for at least 4 weeks, prior to first dose.\n\n   ii. There is no need for steroids and patients have not had steroids for at least 2 weeks prior to the first dose.\n2. Be 18 years of age or older.\n3. Have expected survival of at least 4 months.\n4. Have adequate performance status (up to and including ECOG 2)\n5. Patients must be stable with all known or expected toxicities from previous treatment including:\n\n   1. Prior immune related toxicity must not have exceeded Grade 2 with exception of stable endocrinopathy (endocrinopathy if well-managed, is not exclusionary).\n   2. Toxicity of prior therapy that has not recovered to ≤ grade 1 or baseline (with the exception of any grade of alopecia, adequately treated endocrinopathy, and anemia not requiring transfusion support).\n\nExclusion Criteria:\n\n1. Concurrent anti-cancer treatment.\n2. Recent chemotherapy, radiotherapy, or other anti-cancer treatment within 3 weeks of first protocol treatment.\n3. Participant has not recovered adequately from toxicities and\u002For complications from surgical intervention before starting study drug.\n4. History of clinical hypersensitivity to the designated therapy, as specified in the protocol or to any components used in the preparation of any cell line in this study.\n5. History of clinical hypersensitivity to any protocol specified therapy.\n6. BUN \\>30 in conjunction with a creatinine \\>2, or calculated creatinine clearance (CrCl) \\\u003C30 mL\u002Fmin (GFR can be used in place of creatinine or CrCl).\n7. Absolute granulocyte count \\\u003C 1000; platelets \\\u003C50,000.\n8. Bilirubin \\>2.0; alkaline phosphatase \\>4x upper limit of normal (ULN); ALT\u002FAST \\>2x ULN. For patients with hepatic metastases, ALT\u002FAST \\>5x ULN is exclusionary.\n9. Proteinuria \\>1+ on urinalysis or \\>1 gm\u002F24hr.\n10. New York Heart Association stage 3 or 4 cardiac disease.\n11. A pleural or pericardial effusion of moderate severity or worse.\n12. Any woman of childbearing potential (i.e., has had a menstrual cycle within the past year and has not been surgically sterilized), unless she: agrees to take appropriate precautions to avoid becoming pregnant during the study and has a negative serum pregnancy test within 7 days prior to starting treatment.\n13. Men who are fertile\u002Freproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study.\n14. Women who are pregnant or nursing.\n15. Patients with concurrent second malignancy.\n16. Persons with previous malignancies requiring treatment within the past 24 months.\n17. Patients who have clinical or laboratory features indicative of AIDS and are HIV positive (by self-report).\n18. Have a diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent), or any other form of immunosuppressive therapy within 21 days prior to first dose of study treatment.\n19. Patients who are on treatment for an autoimmune disease, unless specifically approved by the Investigator and the Sponsor.\n20. Patients with severe psychiatric (e.g., schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator and Sponsor.\n21. Patients may not be on a concurrent clinical trial, unless approved by Investigator and Sponsor.",{"count":394,"type":21},18,[396,172],"PHASE1","This is an open-label Phase 1\u002F2a study. Once the safety of the BC1 cell line alone has been demonstrated in Phase 1, in Phase 2, patients will be treated with the Bria-OTS regimen (see below) and a clinically available check point inhibitor (CPI).\n\nDuring the monotherapy phase of Phase 1, one patient will be treated intradermally every 2 weeks for 6 weeks (4 doses) with an initial dose of the BC1 cell line. If this dose is tolerated, the next patient will receive an increased dose of BC1. If once again tolerated, the third patient will receive a further dose increase of the BC1. Once at least 3 patients have been safely treated with the BC1 cell line, with no dose-limiting toxicity (DLT), the combinational phase of the study will commence.\n\nFollowing the monotherapy phase, patients will be treated with BC1 and the Bria-OTS regimen (see below) every 3 weeks, plus a CPI at the FDA approved labelled dose and schedule. There will be at least a 2-week spacing between enrollment of each of the first three subjects in the study in order to assess for any early unanticipated risk(s).\n\nDuring the Phase 1 combination and Phase 2 expansion phases, all patients will be treated with BC1 cells as part of the Bria-OTS regimen, which includes cyclophosphamide 300 mg\u002Fm2 2-3 days prior to BC1 cell inoculation, and peginterferon alpha-2a administered on the same day, following BC1 cell inoculation.",[25,313,341,27,399,400],"Malignant Tumor of Breast","Tumors, Breast","2024-08-23",{"date":403,"type":38},"2024-08-26",{"date":405,"type":38},"2024-05-29",{"date":407,"type":21},"2025-10-30",{"name":409,"class":225},"BriaCell Therapeutics Corporation"]