[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"invasive-breast-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:invasive-breast-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,42,75,162,186,199,209,233,256,276,296,319,349,388,410,439,465,495,524,550,573,595,632,654],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100054011","phase-2-testing-the-addition-of-an-individualized-vaccine-to-durvalumab-and-tremelimumab-and-chemotherapy-in-patients-with-metastatic-triple-negative-breast-cancer-100054011",false,"NCT03606967","Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer","Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer","Inclusion Criteria:\n\n* Patients must have a histologically confirmed diagnosis of metastatic invasive triple negative breast cancer. Patients with clinical and\u002For radiologic suspicion of metastatic TNBC can be consented prior to this confirmation.\n* Estrogen receptor (ER) and progesterone receptor (PR) less than Allred score of 3 OR less than 1% positive staining cells in the invasive component of the tumor.\n* HER2 negative by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) staining 0 or 1+.\n* PD-L1 negative by a Clinical Laboratory Improvement Act (CLIA) approved laboratory using compatible assays appropriate for treatment decisions.\n* Patients may have measurable or evaluable disease.\n* Patients must be willing to undergo biopsy and have accessible lesions for a new biopsy, or they must have sufficient tissue available from a biopsy performed for standard of care (specifications below). If patient does not have enough archived tissue available, a new biopsy is required. A tumor specimen obtained from relapsed primary, metastatic, or locally advanced sites of disease (if applicable) must be submitted. Acceptable samples include core needle biopsies for deep tumor tissue (minimum 4 cores) or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, or mucosal lesions. Formalin-fixed, paraffin-embedded (FFPE) tumor specimens in paraffin blocks are preferred; FFPE tumor tissue sections on slides may be provided if sufficient material (15 x 10μ, unstained) is available. Fine-needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable.\n* No prior therapy for metastatic TNBC. Patients who have received taxane-based adjuvant therapy are required to have a disease-free interval of at least 12 months after completion of taxane therapy.\n* Age \\>= 18 years. Because no dosing or adverse event data are currently available on the use of durvalumab (MEDI4736) and tremelimumab in combination with neoantigen vaccine in patients \\\u003C 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 1 (Karnofsky \\>= 60%).\n* Body weight \\> 30 kg.\n* Must have a life expectancy of at least 12 weeks.\n* Absolute neutrophil count \\>= 1,500\u002FmcL.\n* Platelets \\>= 100,000\u002FmcL.\n* Hemoglobin \\>= 9.0 g\u002FdL.\n* Serum bilirubin =\\\u003C 1.5 x institutional upper limit of normal.\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be =\\\u003C 5 x institutional upper limit of normal.\n* Calculated creatinine clearance \\> 40 mL\u002Fmin by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance.\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women \\>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\> 1 year ago, had chemotherapy-induced menopause with last menses \\> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n* The effects of durvalumab (MEDI4736) and tremelimumab and neoantigen vaccine on the developing human fetus are unknown. For this reason and because these agents may be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 180 days after completion of durvalumab (MEDI4736) and tremelimumab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n* Human immunodeficiency virus (HIV)-positive patients are eligible provided they have a negative viral load, CD4 count \\> 250, and are on a stable antiretroviral regimen.\n* Ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity who have a close caregiver or legal guardian are also eligible with the consent of the caregiver\u002Fguardian.\n\nExclusion Criteria:\n\n* Patients who are not considered to be candidates for carboplatin + gemcitabine for first line therapy of their metastatic triple negative breast cancer are not eligible.\n* Patients who have had chemotherapy, radiotherapy (to more than 30% of the bone marrow), or biologic therapy within 30 days (42 days for nitrosoureas or mitomycin C) prior to entering the study.\n* Patients who have received prior immunotherapy for metastatic disease.\n* Patients who have not recovered from grade \\>= 2 adverse events due to prior anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.\n\n  * Patients with grade \\>= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician.\n* Patients with grade \\>= 2 endocrinological adverse events (AEs), (e.g., hypothyroidism, adrenal insufficiency, hypopituitarism, or diabetes mellitus), must have been on a stable dose of supplemental therapy for at least 2 weeks before screening to be eligible for this study, and the endocrinological AE must be stable in the opinion of the treating physician.\n* Patients who are receiving any other investigational agents or who have received an investigational agent within the last 30 days.\n* Receipt of live attenuated vaccination within 6 months prior to study entry or within 30 days of receiving durvalumab (MEDI4736) and tremelimumab.\n\n  * Note: Patients, if enrolled, should not receive live vaccine whilst receiving study treatment and up to 30 days after the last dose of study treatment.\n* Major surgical procedure within 28 days prior to the first dose of durvalumab (MEDI4736) and tremelimumab. Local surgery of isolated lesions for palliative intent is acceptable.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab (MEDI4736) or tremelimumab. The following are exceptions to this criterion:\n\n  * Intranasal, inhaled, topical steroids or local steroid injections (e.g. intra-articular injection)\n  * Systemic corticosteroids at physiological doses which are not to exceed 10 mg\u002Fday of prednisone or an equivalent corticosteroid\n  * Steroids as premedication for hypersensitivity reactions (e.g. CT scan premedication)\n  * Steroids for symptoms from brain metastases as defined.\n* Spinal cord compression or active brain metastases and\u002For carcinomatous meningitis. Subjects who have had brain metastases resected or have received radiation therapy ending at least 4 weeks prior to registration are eligible if they meet all of the following criteria:\n\n  * Residual neurological symptoms have resolved to grade =\\\u003C 2\n  * On stable doses of dexamethasone, if applicable and if acceptable in the opinion of the treating physician\n  * Follow-up MRI performed after surgery or completion of radiation therapy and prior to registration shows no new lesions.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab (MEDI4736) and tremelimumab. Known allergy, or history of serious adverse reaction to vaccines, such as anaphylaxis, hives or respiratory difficulty.\n* Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) \\>= 470 ms calculated from 3 electrocardiograms (ECGs) (within 15 minutes at 5 \\[+\u002F- 3\\] minutes apart).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, evidence of any acute or chronic viral illness or disease, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because durvalumab (MEDI4736) and tremelimumab has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with durvalumab (MEDI4736) and tremelimumab, breastfeeding should be discontinued if the mother is treated with durvalumab (MEDI4736) and tremelimumab. These potential risks may also apply to other agents used in this study. A negative serum pregnancy test is required no more than 7 days before study entry.\n* Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* History of pneumonitis or interstitial lung disease.\n* History of active primary immunodeficiency.\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and tuberculosis \\[TB\\] testing in line with local practice), hepatitis B (known positive hepatitis B virus \\[HBV\\] surface antigen \\[HBsAg\\] result), or hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).\n* The patient with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided the following criteria are met:\n\n  * Patient has undergone potentially curative therapy for all prior malignancies.\n  * Patients have been considered disease free for at least 1 year (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix).\n* Patients with a strong likelihood of non-adherence (such as difficulties in adhering to follow-up schedule due to geographic distance from the treatment facility) should not be knowingly registered.\n* History of allogeneic organ transplantation.","ALL","18 Years",{"count":19,"type":20},86,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple negative breast cancer.",[26,27,28],"Anatomic Stage IV Breast Cancer AJCC v8","Invasive Breast Carcinoma","Metastatic Triple-Negative Breast Carcinoma","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2021-04-13",{"date":37,"type":20},"2026-12-30",{"name":39,"class":40},"National Cancer Institute (NCI)","NIH",30,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100053568","phase-1-testing-the-safety-of-the-combination-of-anti-cancer-drugs-cx-5461-pidnarulex-and-trastuzumab-deruxtecan-t-dxd-for-human-epidermal-growth-factor-receptor-2-her2-positive-solid-tumors-and-breast-cancer-100053568","NCT07137416","Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer","Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing Solid Tumors","Inclusion Criteria:\n\n* DOSE ESCALATION PHASE ONLY: Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective\n* DOSE EXPANSION PHASE ONLY: Participants must have histologically or cytologically confirmed invasive breast cancer, with either locally advanced or metastatic disease\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of CX-5461 (pidnarulex) in combination with T-DXd in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL\n\n  * No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 1 week prior to screening assessment\n* Platelets ≥ 100,000\u002FmcL\n\n  * No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) (or ≤ 2 × institutional ULN in patients with documented Gilbert's syndrome)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 × institutional ULN (or ≤ 5 × ULN in patients with liver metastases)\n* International normalized ratio (INR)\u002Fprothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n* Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 (using the Cockcroft-Gault equation for participants with creatinine levels above institutional ULN)\n* Patients must have had at least one prior line of cytotoxic chemotherapy. Patients can have received an unlimited number of additional lines of chemotherapy, targeted therapy, biologic therapy, or hormonal therapy. Patients must not have progressed on a prior anthracycline in the metastatic setting. Receipt of anthracycline in the (neo)adjuvant setting is allowed, provided that disease recurrence occurred later than 6 months after the completion of treatment\n* Prior poly (ADP-ribose) polymerase (PARP) inhibition is allowed\n* No specific germline mutation is required\n* DOSE ESCALATION PHASE ONLY:\n\n  * HER2-positive (IHC 3+) solid cancers,\n  * HR+ HER2 positive\u002Flow\u002Fultralow breast cancer or triple negative breast cancer (TNBC) HER2-low breast cancer, with HER2 positive defined by the current American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines,\n  * HER2-low, with HER2-low defined as IHC 2+\u002Fin situ hybridization (ISH)-, IHC 1+\u002FISH-, or IHC 1+\u002FISH untested\n* DOSE EXPANSION PHASE ONLY:\n\n  * Either the primary invasive tumor and\u002For the metastasis must be:\n\n    * HER2-low, with HER2-low defined as IHC 2+\u002FISH-, IHC 1+\u002FISH-, or IHC 1+\u002FISH untested. Any estrogen receptor (ER) and progesterone receptor (PR) expression is permitted but must be known, or\n    * HR+ HER2-ultralow defined as IHC 0 with membrane staining\n* Participants must have at least one lesion that is not within a previously radiated field that is measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Bone lesions are not considered measurable by definition. Biopsy of the lesion that will be used for disease evaluation (measurable disease) is not allowed in the dose expansion portion of this study\n* Peripheral neuropathy grade ≤ 1\n* Patients must have left ventricular ejection fraction (LVEF) ≥ 50% by either an echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within 28 days before randomization\u002Fenrollment\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* The effects of CX-5461 (pidnarulex) and T-DXd on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) 14 days prior to study entry and for the duration of study participation and for at least 7 months (women of childbearing potential \\[WOCBP\\] only) after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women should not breastfeed while taking CX-5461 (pidnarulex) and T-DXd and for 7 months after cessation of treatment. Men treated or enrolled on this protocol must also agree to use adequate contraception 14 days prior to the study, for the duration of study participation, and 6 months after completion of CX-5461 (pidnarulex) and T-DXd administration\n* Women of non-child-bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone \\[FSH\\] \\> 40 mIU\u002FmL and estradiol \\\u003C 40 pg\u002FmL \\[\\\u003C 147 pmol\u002FL\\] is confirmatory) or on ovarian suppression are eligible. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method\n* Male patients must not freeze or donate sperm starting at screening and throughout the study period, and at least 6 months after the final study drug administration. Preservation of sperm should be considered prior to enrollment in this study\n* Female patients must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives (LAR) may sign and give informed consent on behalf of study participants\n* Patients who have had chest radiation therapy within 4 weeks (2 weeks for palliative stereotactic radiation therapy). These patients will be excluded because T-DXd is known to increase the risk of developing pneumonitis\n\nExclusion Criteria:\n\n* Patients with a history of (non-infectious) interstitial lung disease (ILD) that required steroids, have current ILD, or where there is suspected ILD that cannot be ruled out by imaging at screening. These patients will be excluded because T-DXd is known to increase the risk of developing ILD and pneumonitis\n* Patients with clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (i.e., Rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior pneumonectomy at the time of screening. These patients will be excluded because T-DXd is known to increase the risk of developing ILD and pneumonitis\n* Patients who have had chemotherapy (including antibody drug therapy, retinoid therapy, hormonal therapy for cancer) within 3 weeks (2 weeks or five half-lives, whichever is longer for small-molecule targeted agents such as 5-fluorouracil-based agents, folinate agents), weekly paclitaxel; 6 weeks for nitrosoureas or mitomycin C. These patients will be excluded to allow for recovery of toxicities related to chemotherapy and minimize risk of drug interactions\n* Patients who have had cancer immunotherapy including monoclonal antibody therapy within 4 weeks\n* Patients who have had a major surgery within 4 weeks\n* Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade ≤ 1 or baseline. Patients with chronic grade 2 toxicities may be eligible (e.g., grade 2 chemotherapy-induced neuropathy). Patients should no longer be symptomatic nor require treatment with corticosteroids or anticonvulsants and must have recovered from the acute toxic effect of radiotherapy\n* Eligibility of subjects receiving any medications or substances known to affect or with the potential to affect the activity of CX-5461 (pidnarulex) will be determined based on their potential to interact with the CYP3A4 isozyme. Specifically, subjects taking strong CYP3A4 inhibitors or strong CYP3A4 inducers will be excluded from participation in the trial. A list of agents that interact with CYP450 isoenzymes is provided\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CX-5461 (pidnarulex), T-DXd, or the inactive ingredients in the drug products, including patients who have a history of severe hypersensitivity reactions to other monoclonal antibodies\n* Patients with a corrected QT interval (QTc) prolongation to \\> 470 ms (females) or \\> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)\n* Patients with clinically significant corneal disease, cicatricial conjunctivitis or active ocular surface disease in the opinion of the investigator\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because CX-5461 (pidnarulex) and T-DXd are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with CX-5461 (pidnarulex) and T-DXd, breastfeeding should be discontinued if the mother is treated with CX-5461 (pidnarulex) and T-DXd and avoided for 7 months after the last dose",{"count":50,"type":20},36,[52],"PHASE1","This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein called HER2 and that has spread from where it first started (primary site) to other places in the body (metastatic), that cannot be removed by surgery (unresectable), or that has spread to nearby tissue or lymph nodes (locally advanced). Pidnarulex is an enzyme inhibitor that causes cell death and prevents tumor cell growth. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Giving pidnarulex in combination with trastuzumab deruxtecan may be safe, tolerable and\u002For effective in treating patients with metastatic, unresectable, or locally advanced HER2-expressing breast cancer or other solid tumors.",[55,26,27,56,57,58,59,60,61,28,62,63,64,65,66,67],"Anatomic Stage III Breast Cancer AJCC v8","Locally Advanced Breast Carcinoma","Metastatic Breast Carcinoma","Metastatic HER2-Low Breast Carcinoma","Metastatic HER2-Positive Breast Carcinoma","Metastatic Hormone Receptor-Positive Breast Carcinoma","Metastatic Malignant Solid Neoplasm","Unresectable Breast Carcinoma","Unresectable HER2-Low Breast Carcinoma","Unresectable HER2-Positive Breast Carcinoma","Unresectable Hormone Receptor-Positive Breast Carcinoma","Unresectable Malignant Solid Neoplasm","Unresectable Triple-Negative Breast Carcinoma",{"date":32,"type":33},{"date":70,"type":20},"2026-10-05",{"date":72,"type":20},"2028-01-10",{"name":39,"class":40},2,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":16,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":161},"100464928","collecting-blood-samples-from-patients-with-and-without-cancer-to-evaluate-tests-for-early-cancer-detection-100464928","NCT05334069","Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection","Blinded Reference Set for Multicancer Early Detection Blood Tests","Inclusion Criteria:\n\n* Participants with a cancer diagnosis: Documentation of disease:\n\n  * Histologic documentation: Histologically confirmed diagnosis of invasive cancer\n  * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma\n\n    * For leukemia: Type (chronic lymphocytic leukemia \\[CLL\\], chronic myeloid leukemia \\[CML\\], acute lymphoblastic lymphoma \\[ALL\\], acute myeloid leukemia \\[AML\\])\n    * For lymphoma: Stage I-IV based on Ann Arbor staging\n    * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)\n  * One of the following tumor types:\n\n    * Colorectal\n    * Bladder\n    * Head and neck\n    * Hepatobiliary\n    * Lung\n    * Lymphoma\n    * Leukemia\n    * Ovary \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Pancreas \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Multiple myeloma\n    * Gastric, esophageal or gastroesophageal\n    * Breast\n    * Thyroid\n    * Kidney\n\n      * For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Endometrium\n    * Prostate\n    * Melanoma\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Sarcoma\n* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention\n* Participants with a cancer diagnosis: Age \\>= 40 and =\\\u003C 75\n* Participants with a cancer diagnosis: No known current pregnancy by self-report\n* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a cancer diagnosis: Willingness to provide blood samples for research use\n* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a cancer diagnosis: No history of organ transplantation\n* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants without a cancer diagnosis and without suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report\n* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)\n* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use\n* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation\n* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and\u002For radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw\n\n  \\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma\n* Participants with a high suspicion of cancer: Central review of radiology reports and\u002For clinical documentation conducted by study chairs\n* Participants with a high suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants with a high suspicion of cancer: No known current pregnancy by self-report\n* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use\n* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a high suspicion of cancer: No history or organ transplantation\n* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \\* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages",true,"40 Years","75 Years",{"count":86,"type":20},2000,"OBSERVATIONAL","This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.",[90,91,92,93,94,95,96,97,98,99,100,27,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Ann Arbor Stage I Lymphoma","Ann Arbor Stage II Lymphoma","Ann Arbor Stage III Lymphoma","Ann Arbor Stage IV Lymphoma","Chronic Lymphocytic Leukemia","Chronic Myeloid Leukemia","Gastroesophageal Junction Adenocarcinoma","Head and Neck Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Kidney Carcinoma","Malignant Hepatobiliary Neoplasm","Malignant Solid Neoplasm","Melanoma","Muscle-Invasive Bladder Carcinoma","RISS Stage I Plasma Cell Myeloma","RISS Stage II Plasma Cell Myeloma","RISS Stage III Plasma Cell Myeloma","Sarcoma","Stage I Bladder Cancer AJCC v6 and v7","Stage I Breast Cancer AJCC v7","Stage I Colorectal Cancer AJCC v6 and v7","Stage I Esophageal Cancer AJCC V7","Stage I Gastric Cancer AJCC V7","Stage I Lung Cancer AJCC v7","Stage I Ovarian Cancer AJCC v6 and v7","Stage I Pancreatic Cancer AJCC v6 and v7","Stage I Prostate Cancer AJCC v7","Stage I Uterine Corpus Cancer AJCC v7","Stage II Bladder Cancer AJCC v6 and v7","Stage II Breast Cancer AJCC v6 and v7","Stage II Colorectal Cancer AJCC v7","Stage II Esophageal Cancer AJCC v7","Stage II Gastric Cancer AJCC v7","Stage II Lung Cancer AJCC v7","Stage II Ovarian Cancer AJCC v6 and v7","Stage II Pancreatic Cancer AJCC v6 and v7","Stage II Prostate Cancer AJCC v7","Stage II Uterine Corpus Cancer AJCC v7","Stage III Bladder Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage III Colorectal Cancer AJCC v7","Stage III Esophageal Cancer AJCC v7","Stage III Gastric Cancer AJCC v7","Stage III Lung Cancer AJCC v7","Stage III Ovarian Cancer AJCC v6 and v7","Stage III Pancreatic Cancer AJCC v6 and v7","Stage III Prostate Cancer AJCC v7","Stage III Uterine Corpus Cancer AJCC v7","Stage IV Bladder Cancer AJCC v7","Stage IV Breast Cancer AJCC v6 and v7","Stage IV Colorectal Cancer AJCC v7","Stage IV Esophageal Cancer AJCC v7","Stage IV Gastric Cancer AJCC v7","Stage IV Lung Cancer AJCC v7","Stage IV Ovarian Cancer AJCC v6 and v7","Stage IV Pancreatic Cancer AJCC v6 and v7","Stage IV Prostate Cancer AJCC v7","Stage IV Uterine Corpus Cancer AJCC v7","Thyroid Gland Carcinoma","2026-07-01",{"date":153,"type":33},"2026-07-02",{"date":155,"type":33},"2022-08-18",{"date":157,"type":20},"2027-02-28",{"name":159,"class":160},"Alliance for Clinical Trials in Oncology","OTHER",745,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100402553","phase-1-a-vaccine-mv-s-nap-for-the-treatment-of-patients-with-invasive-metastatic-breast-cancer-100402553","NCT04521764","A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Breast Cancer","Phase I Trial of Intratumoral Administration of a Measles Virus Derivative Expressing the Helicobacter Pylori Neutrophil-Activating Protein (NAP) (MV-s-NAP) in Patients With Metastatic Breast Cancer","Inclusion Criteria:\n\n* Age \\>= 18 years\n* COHORT 1 ONLY: Pathologically confirmed invasive breast adenocarcinoma with documented estrogen receptor (ER)\u002Fprogesterone receptor (PR) \u002FHER2 status and radiographic evidence of distant metastatic disease\n* COHORTS 2 \\& 3 ONLY: Pathologically confirmed invasive breast adenocarcinoma with documented ER\u002FPR\u002FHER2 status and radiographic evidence of distant metastatic or recurrent disease\n* COHORT 1 ONLY: Radiographic evidence of distant metastatic disease (using 7th edition American Joint Committee on Cancer \\[AJCC\\] criteria) with two discrete sites of measurable disease\n* COHORTS 2 \\& 3 ONLY: Radiographic evidence of distant metastatic or recurrent disease (using 8th edition AJCC criteria) with at least one site of measurable disease\n* Prior therapies:\n\n  * Patients with ER\u002FPR positive, HER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease and no longer be candidates for standard endocrine therapy or combination of endocrine therapy with other agents such as CDK4\u002F6 inhibitors\n  * Patients with HER2 positive breast cancer irrespective of ER\u002FPR status must have received or no longer be candidates for HER2 directed therapy with trastuzumab or pertuzumab\n  * Patients with ER\u002FPR\u002FHER2 negative breast cancer must have progressed through at least one prior cytotoxic regimen for advanced disease\n* COHORT 1: At least one site of recurrent\u002Fmetastatic disease that measures \\> 1 cm in greatest dimension (\\> 2 cm for lung lesions) and is amenable to safe percutaneous intratumoral administration of MV-s-NAP as determined by an interventional radiologist\n* COHORTS 2 \\& 3 ONLY: At least 1 site of recurrent\u002Fmetastatic disease measuring \\> 1 cm in greatest dimension \\[\\> 2 cm for lung lesions\\] (Note that if the lesion injected in cycle 1 is not amenable to re-injection, another lesion could be selected for injection\n* Absolute neutrophil count (ANC) \\>= 1500\u002FuL (=\\\u003C 7 days prior to registration)\n* Platelets (PLT \\>= 100,000\u002FuL) (=\\\u003C 7 days prior to registration)\n* Total bilirubin =\\\u003C institutional upper limit of normal (=\\\u003C 7 days prior to registration)\n* Aspartate aminotransferase (AST) =\\\u003C 2 x upper limit of normal (ULN) (=\\\u003C 7 days prior to registration)\n* Creatinine =\\\u003C 1.5 x ULN (=\\\u003C 7 days prior to registration)\n* Hemoglobin \\>= 9.0 g\u002FdL (=\\\u003C 7 days prior to registration)\n* Negative pregnancy test done =\\\u003C 7 days prior to registration (for women of childbearing potential only)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Ability to provide informed written consent\n* Willingness to return to the Mayo Clinic enrolling institution for follow-up\n* Willingness to provide biologic samples for correlative research purposes\n* Life expectancy \\>= 12 weeks\n* Concomitant administration of a bone modifying agent (e.g., zoledronic acid or denosumab) is permitted for the prevention or management of skeletal related events in patients with bone metastases and documentation of tolerability with prior exposures\n\nExclusion Criteria:\n\n* Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy\n* Clinical or radiographic suspicion of impending visceral crisis due to invasion or compression by tumor\n* Active infection =\\\u003C 5 days prior to registration\n* History of other malignancy =\\\u003C 5 years except for non-melanoma skin cancer or carcinoma in situ of the cervix\n* Any of the following prior therapies:\n\n  * Chemotherapy =\\\u003C 3 weeks prior to registration\n  * Immunotherapy =\\\u003C 4 weeks prior to registration\n  * HER2 directed therapy =\\\u003C 3 weeks prior to registration\n  * Targeted therapy =\\\u003C 2 weeks prior to registration (e.g., CDK4\u002F6 inhibitors, everolimus)\n  * Investigational agent =\\\u003C 4 weeks prior to registration\n  * Any viral or gene therapy prior to registration\n* Failure to fully recover from acute, reversible effects of prior systemic therapy regardless of interval since last treatment\n* New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia \\[SVT\\])\n* Untreated or progressive central nervous system (CNS) metastases\n\n  * NOTE: Patients with a history of treated brain metastases (surgical resection, whole brain radiation, and\u002For stereotactic radiosurgery) are eligible only if they are asymptomatic and have stable MRI scans for 3 consecutive months, including \\\u003C 28 days of study entry\n* Standing requirement for blood product support\n* Human immunodeficiency virus (HIV) positive test result or history of other immunodeficiency\n* History of organ transplantation\n* History of chronic hepatitis B or C\n* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \\[FDA\\]-approved indication and in the context of a research investigation)\n* Any concurrent medications that the principal investigator determines could interfere with the trial\n* Treatment with oral\u002Fsystemic corticosteroids, with the exception of topical or inhaled steroids\n* Exposure to household contacts =\\\u003C 15 months old or household contact with known immunodeficiency\n* Allergy to measles vaccine or history of severe reaction to prior measles vaccination\n* History of receiving the measles vaccination with the \"killed vaccine\" between 1963-1967 without subsequent re-immunization (2 doses) with the active, live vaccination.\"",{"count":170,"type":20},54,[52],"This phase I trial investigates the side effects and best dose of using a modified measles virus, MV-s-NAP, in treating patients with invasive breast cancer that has spread to other places in the body (metastatic). Both the unmodified vaccination measles virus (MV-Edm) and this modified virus (MV-s-NAP) have been shown to multiply in and destroy breast cancer cells in the test tube and in research mice. MV-s-NAP has been altered by having an extra gene (piece of deoxyribonucleic acid \\[DNA\\]) so that virus can make a protein called helicobacter pylori neutrophil activating protein (NAP) which is normally expressed in inflammatory reactions. Monitoring blood, urine, tissue, and throat swab samples, and using imaging tests may help to determine whether MV-s-NAP has any impact on the amount of disease present in metastatic breast cancer patients.",[26,27,174,175,141],"Metastatic Breast Adenocarcinoma","Recurrent Breast Carcinoma","2026-06-16",{"date":178,"type":33},"2026-06-17",{"date":180,"type":33},"2020-09-23",{"date":182,"type":20},"2027-08-15",{"name":184,"class":160},"Mayo Clinic",1,{"id":187,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":188,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":21,"phases":191,"briefSummary":24,"conditions":192,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":197,"leadSponsor":198,"locationsCount":41},"100332337","Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine Vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer",{"count":190,"type":20},70,[23],[26,27,28],"2026-06-11",{"date":195,"type":33},"2026-06-12",{"date":35,"type":33},{"date":37,"type":20},{"name":39,"class":40},{"id":200,"slug":4,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":202,"briefSummary":53,"conditions":203,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":207,"leadSponsor":208,"locationsCount":74},"100603507",{"count":50,"type":20},[52],[55,26,27,56,57,58,59,60,61,28,62,63,64,65,66,67],"2026-06-10",{"date":193,"type":33},{"date":70,"type":20},{"date":72,"type":20},{"name":39,"class":40},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":216,"minAge":17,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"100574749","phase-3-metformin-for-the-treatment-of-insulin-resistance-in-women-with-stage-i-iii-breast-cancer-completing-chemotherapy-100574749","NCT06763328","Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy","Metformin (Dimethylbiguanide) and Insulin Resistance in Women Completing Neoadjuvant and\u002For Adjuvant Cytotoxic Treatment of Stage I-III Breast Cancer","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Agreement to allow lab draw of approximately 26 mL of blood (less than 2 tablespoons)\n\n  * To check blood counts, organ function and disease at baseline and 12 months\n  * Review of clinical charts at pre-registration\\* (refer to Study Calendar), baseline, 3 months, 6 months,12 months, and 24 months\n  * Research labs at baseline, 6 months,12 months, and 24 months\n* Age: ≥ 18 years\n* Female sex assigned at birth\n* Ability to read and understand English or Spanish for questionnaires\n* Diagnosis of invasive breast cancer stages I-III\n* Completed adjuvant treatment for Stage 1-3 breast cancer within 5 years and are disease free.\n* Women who receive drugs for weight loss - e.g. semaglutide - prior to diagnosis are eligible for this protocol and can continue the drug during the intervention.\n\nExclusion Criteria:\n\n* Currently taking metformin or any other oral antidiabetic medications. Weight loss medications are permitted - e.g. semaglutide\n* Taking tamoxifen or aromatase inhibitor\n* Contraindication to metformin prevention such as acute hypersensitivity or allergic reaction to metformin\n* Participants with acute or chronic renal insufficiency (a glomerular filtration rate \\[GFR\\] \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2) or those with acute renal insufficiency of any severity due to hepato-renal syndrome or in the peri-operative liver transplantation period\n* Bilirubin of \\>2.5 mg\u002FdL (normal range 0.1-1.2 mg\u002FdL).\n* Previously diagnosed type 1 or type 2 diabetes\n* Patients pregnant or within 1 year of pregnancy and completion of lactation (to be determined at randomization).\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* An employee who is under the direct\u002Findirect supervision of the principal investigator (PI)\u002Fa co-investigator\u002Fthe study manager and\u002For a direct study team member\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","FEMALE",{"count":218,"type":20},80,[220],"PHASE3","This phase III trial evaluates how often women develop insulin resistance and type-2 diabetes and compares metformin with usual care to usual care alone in treating insulin resistance in women with stage I-III breast cancer after chemotherapy. Insulin resistance occurs when cells stop responding to insulin and is a risk factor for developing diabetes and heart disease. Higher levels of insulin have been shown to be associated with aggressive breast cancer. Metformin hydrochloride decreases the amount of glucose (a type of sugar) released into the bloodstream from the liver and increases the body's use of the glucose. Metformin as well as standard of care diet and exercise education is known to lower blood sugar. However, chemotherapy may accelerate metabolic disorders, such as high blood sugar, and the impact of metformin in these breast cancer survivors is not known. Giving metformin with usual care may be more effective than usual care alone in preventing or reversing insulin resistance in women with stage I-III breast cancer after chemotherapy.",[223,224,55,27],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8",{"date":195,"type":33},{"date":227,"type":33},"2024-12-16",{"date":229,"type":20},"2029-06-16",{"name":231,"class":160},"City of Hope Medical Center",3,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":216,"minAge":17,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":243,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":74},"100572852","application-of-single-port-robot-assisted-breast-conserving-surgery-via-axillary-approach-for-breast-cancer-100572852","NCT06738654","Application of Single-Port Robot-Assisted Breast-Conserving Surgery Via Axillary Approach for Breast Cancer.","单孔机器人-SPR","Inclusion Criteria:\n\n1. The patient himself has very high requirements for beauty, and requires no scar on the chest;\n2. No chest surgery and radiotherapy.\n3. No contraindications to surgery and anesthesia.\n4. Clinical I, stage of early breast cancer and the breast has an appropriate volume, can maintain a good breast shape after surgery.\n5. Patients in the clinical period who meet the standard of breast conservation surgery after preoperative treatment.\n6. Age: 18 and 65 years old.\n\nExclusion Criteria:\n\n1. Inflammatory breast cancer.\n2. The tumor is extensive and it's difficult to achieve negative margins or an ideal breast - conserving appearance.\n3. Diffusely distributed malignant - characteristic calcifications.\n4. The margin is positive after local extensive tumor resection, and a negative margin in pathological examination still can't be ensured after re - resection.\n5. The patient refuses.","65 Years",{"count":242,"type":20},64,[244],"NA","Evaluate the safety,feasibility and quality of life(QoL)of single-port robotic surgery in breast-conserving surgery, compare and analyze the advantages and disadvantages of single-port robotic surgery and open surgery in terms of complications, postoperative complications, perioperative recovery effects, and safety in breast cancer breast-conserving surgery, in order to select a more effective and safe surgical method. Subjects who meet the inclusion criteria will enter the research process, with surgery including SPr-breast-conserving surgery or open-breast-conserving surgery, and the choice of the two surgical methods is based on the patient's financial situation and the availability of equipment;",[27],"2026-05-30",{"date":249,"type":33},"2026-06-02",{"date":251,"type":33},"2024-12-31",{"date":253,"type":20},"2027-12-31",{"name":255,"class":160},"Xu Yan",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":216,"minAge":17,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":185},"100499700","breast-cancer-survivorship-biorepository-100499700","NCT05786664","Breast Cancer Survivorship Biorepository","A Comprehensive Breast Cancer Survivorship Biorepository","Inclusion Criteria:\n\n* Women of all racial and ethnic groups 18 years of age or older\n* Women with a diagnosis of invasive breast cancer (stages I-III) within the past 7 years\n* Women who have completed active treatment for breast cancer (surgery, chemotherapy, HER2-directed therapy and radiation)\n* Prior participation on clinical trials is allowed\n\nExclusion Criteria:\n\n* Current receipt of interventional clinical trial participation\n* Stage IV (metastatic) cancer\n* Prior history of recurrence (except recurrence following ductal carcinoma in situ)\n* Inability to give informed consent\n* Unable to speak English, Spanish, Chinese, or Korean",{"count":264,"type":20},1300,"This study collects blood samples as well as clinical and self-report data from stage I-III breast cancer survivors to create a biorepository for future use. The creation of this biorepository will allow for future research into links between individual, molecular, and genomic signatures and cancer outcomes.",[223,224,55,27],"2026-05-26",{"date":269,"type":33},"2026-05-28",{"date":271,"type":33},"2022-04-11",{"date":273,"type":20},"2028-04-11",{"name":275,"class":160},"University of Southern California",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":185},"100470467","temporal-immunologic-changes-with-hypofractionated-radiation-induced-dna-damage-in-breast-cancer-100470467","NCT05406232","Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer","Breast Radiation-induced Immunologic Genomic Hypofractionated Temporal Radiation Alterations DNA Damage (BRIGHT-RAD) Study.","Inclusion Criteria:\n\n* Patients \\>= 18 years of age with biopsy proven invasive breast cancer\n* Breast cancer that appears to be superficially accessible to a tumor punch biopsy\n* Patients thought to derive clinical benefit from palliative RT to the breast\u002Fchestwall\n* In discussions with the medical oncologist, if clinically reasonable, systemic therapy will be held during RT\n\nExclusion Criteria:\n\n* A history of prior radiation to the area requiring radiation for which the attending physician believes reirradiation could not be safely delivered\n* Pregnancy\n* Active usage of anticoagulant medications that are considered to pose an increased risk of tumor punch biopsies\n* Receipt of immunotherapy or chemotherapy 7 days prior to start of RT",{"count":50,"type":20},"This study assesses changes to the immune cells following hypofractionated radiation-induced DNA damage in breast cancer patients. Radiation therapy may cause immune cells to enter tumors and target cancer cells. The goal of this study is to measure the change in the level of immune cells in the tumor before and after radiation therapy.",[286,27],"Breast Carcinoma","2026-04-30",{"date":289,"type":33},"2026-05-06",{"date":291,"type":33},"2023-09-15",{"date":293,"type":20},"2026-12-31",{"name":295,"class":160},"M.D. Anderson Cancer Center",{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":216,"minAge":17,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},"100375518","impact-of-covid-19-pandemic-on-out-of-pocket-costs-lost-wages-and-unemployment-in-patients-with-breast-cancer-undergoing-breast-surgery-100375518","NCT04169542","Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery","Potential Impact of the COVID -19 Pandemic on Financial Toxicity in Breast Cancer Surgical Patients: The Impact on Out of Pocket Costs, Lost Wages and Economic Strain","Inclusion Criteria:\n\n* Have an indication for surgical treatment of invasive breast cancer or ductal breast carcinoma in situ (DCIS) or prophylaxis in the setting of genetic mutations or strong family history\n* English-speaking\n* Able to complete consent\n* Able to fill out computer survey material\n\nExclusion Criteria:\n\n* Non-English-speaking\n* Those with recurrent or metastatic disease or concurrent primary cancers\n* Patients undergoing breast conservation therapy will also be excluded from the study",{"count":304,"type":20},600,"This study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). The goal of this study is to collect information about financial costs patients may have as a result of surgical treatment for cancer with or without breast reconstruction and to learn if COVID-19 affects patient costs of breast reconstruction. This may help researchers demonstrate the financial consequences of undergoing breast surgery.",[307,308,309,27],"Breast Ductal Carcinoma In Situ","COVID-19 Infection","Hereditary Breast Carcinoma","2026-04-28",{"date":312,"type":33},"2026-05-04",{"date":314,"type":33},"2019-05-21",{"date":316,"type":20},"2028-03-31",{"name":295,"class":160},4,{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":216,"minAge":17,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":21,"phases":329,"briefSummary":330,"conditions":331,"keywords":334,"overallStatus":339,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":185},"100634780","areola-preservation-in-nsm-with-nipple-involvement-100634780","NCT07544134","Areola Preservation in NSM With Nipple Involvement","Oncologic Safety and Aesthetic Outcomes of Areola Preservation With Simultaneous Nipple Reconstruction in Nipple-Sparing Mastectomy With Intraoperative Nipple Involvement: A Single-Center, Prospective, Exploratory Study","APRESERVE-1","Inclusion Criteria:\n\n1. Female, age ≥ 18 years.\n2. Pathologically confirmed primary invasive breast carcinoma or ductal carcinoma in situ (DCIS).\n3. Clinical tumor stage cTis-2, N0-2, M0 (AJCC 8th Edition).\n4. Planned for therapeutic nipple-sparing mastectomy (NSM) with immediate reconstruction.\n5. Intraoperative frozen section confirms involvement of the nipple core tissue by invasive carcinoma or DCIS.\n6. ECOG performance status 0-1.\n7. Willing and voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n1. Clinical or radiological suspicion of areola or skin involvement.\n2. Inflammatory breast cancer.\n3. Pregnancy or lactation.\n4. Any severe medical or psychiatric condition that, in the investigator's judgment, would preclude safe participation or compliance.\n5. Severe uncontrolled comorbidities with a life expectancy of less than 5 years.",{"count":328,"type":20},40,[244],"Background:\n\nDuring nipple-sparing mastectomy (a surgery that removes breast tissue but keeps the nipple and areola), doctors test the tissue behind the nipple right away. If cancer cells are found in this nipple tissue, current guidelines say the entire nipple and areola must be removed. However, research suggests that when the nipple is involved, the surrounding pigmented skin (the areola) is very rarely affected by cancer. Removing it might be unnecessary and leads to a worse cosmetic outcome, which can impact a woman's self-image and quality of life. Currently, there is no prospective study to guide whether the areola can be safely preserved in this specific situation.\n\nPurpose:\n\nThis is a pilot study that aims to explore the feasibility, safety, and early outcomes of a new surgical procedure: preserving the areola and performing immediate nipple reconstruction when cancer is found in the nipple during surgery.\n\nStudy Plan:\n\nThis is a single-arm, single-center, prospective, exploratory study. Women with early-stage breast cancer who are scheduled for a nipple-sparing mastectomy will be invited. Only if cancer is confirmed in the nipple during their surgery will they be enrolled into the single test group. In this group:\n\nThe nipple is removed.\n\nA small ring of tissue from under the areola is tested immediately (second frozen section). If this ring shows no cancer, the areola skin is preserved.\n\nA new nipple is created during the same operation using a local skin flap technique (purse-string suture).\n\nAll patients will have immediate breast reconstruction.\n\nWe plan to include about 40-60 patients at one hospital. Patients will be closely followed for 3 years with regular check-ups and scans to monitor for any cancer recurrence or complications.\n\nWhat We Will Measure (Exploratory Endpoints):\n\nSafety \\& Feasibility: The success rate of areola preservation (based on negative second frozen section), surgical complication rates (e.g., infection, tissue necrosis).\n\nEarly Effectiveness: The rate of cancer returning in the breast\u002Fchest wall area within 3 years (local recurrence).\n\nPatient-Reported Outcomes: Patient satisfaction with their breasts and well-being, measured by the BREAST-Q questionnaire before and after surgery.\n\nWhy This Study is Important:\n\nThis is the first prospective study to systematically evaluate this new surgical approach. The results will provide crucial preliminary data on safety and early outcomes. If the findings are promising, they will form the foundation for designing a larger, controlled trial in the future. Ultimately, this research could lead to a new option that offers women better cosmetic results and improved quality of life after mastectomy.",[332,333,27],"Breast Cancer","Ductal Carcinoma In Situ, DCIS",[332,335,336,337,338],"Nipple Sparing Mastectomy","NSM","Nipple Areola Complex","Nipple Reconstruction","NOT_YET_RECRUITING","2026-04-19",{"date":342,"type":33},"2026-04-22",{"date":344,"type":20},"2026-05-01",{"date":346,"type":20},"2030-01-15",{"name":348,"class":160},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":216,"minAge":17,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":21,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":185},"100279522","decision-making-tool-in-supporting-decision-making-in-contralateral-prophylactic-mastectomy-in-patients-with-newly-diagnosed-breast-cancer-100279522","NCT02918474","Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer","Decision Making Tool for Contralateral Prophylactic Mastectomy","Inclusion Criteria:\n\n* Newly diagnosed ductal breast carcinoma in situ (DCIS) or stage I-III sporadic unilateral invasive breast cancer\n* Able to speak read or write English\n\nExclusion Criteria:\n\n* Patients with previous breast cancer\n* Prior history of bilateral prophylactic mastectomy\n* Known to have a germline mutation that predisposes them to an increased risk of breast cancer (e.g. BRCA1\u002F2) and\u002For they are considered at high risk for contralateral breast cancer on the basis of a strong family history of cancer",{"count":357,"type":20},15,[244],"This trial studies the acceptability and how well decision making tool works in supporting decision making in contralateral prophylactic mastectomy in patients with newly diagnosed breast cancer. Decision making tool may help patients with early stage breast cancer make decisions regarding their surgical options.",[223,361,362,224,363,364,55,365,366,367,368,27,369,370,371,372,373,374,375,376,377,378,379],"Anatomic Stage IA Breast Cancer AJCC v8","Anatomic Stage IB Breast Cancer AJCC v8","Anatomic Stage IIA Breast Cancer AJCC v8","Anatomic Stage IIB Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Ductal Breast Carcinoma In Situ","Prognostic Stage I Breast Cancer AJCC v8","Prognostic Stage IA Breast Cancer AJCC v8","Prognostic Stage IB Breast Cancer AJCC v8","Prognostic Stage II Breast Cancer AJCC v8","Prognostic Stage IIA Breast Cancer AJCC v8","Prognostic Stage IIB Breast Cancer AJCC v8","Prognostic Stage III Breast Cancer AJCC v8","Prognostic Stage IIIA Breast Cancer AJCC v8","Prognostic Stage IIIB Breast Cancer AJCC v8","Prognostic Stage IIIC Breast Cancer AJCC v8","Sporadic Breast Carcinoma","2026-04-13",{"date":382,"type":33},"2026-04-16",{"date":384,"type":33},"2017-04-28",{"date":386,"type":20},"2026-09-30",{"name":295,"class":160},{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":409},"100093472","biospecimen-and-medical-data-collection-and-tumor-biopsy-in-creating-research-tissue-registry-in-patients-with-inflammatory-or-invasive-breast-cancer-100093472","NCT00477100","Biospecimen and Medical Data Collection and Tumor Biopsy in Creating Research Tissue Registry in Patients With Inflammatory or Invasive Breast Cancer","Inflammatory Breast Cancer (IBC) Registry","Inclusion Criteria:\n\n* Patients with clinical diagnosis of primary inflammatory breast cancer (IBC), second primary IBC, or highly suspicious for IBC (MD Anderson patients only).\n* Histological diagnosis of invasive breast cancer, or highly suspicious for IBC (MD Anderson patients only) but pending breast cancer diagnosis.\n* Be either newly diagnosed, or highly suspicious for IBC (MD Anderson patients only) \\[Cohort I\\] or have paraffin blocks or up to 20 unstained slides of each representative block(s) from the time of initial diagnosis of IBC(i.e. core biopsy and punch biopsy) and\u002For from mastectomy (Cohort II-MD Anderson patients only)\n* Age \\> 18 years\n* Able to provide informed consent\n\nExclusion Criteria:",{"count":396,"type":20},1200,"This trial studies the biospecimen and medical data collection in creating a research tissue registry in patients with inflammatory or invasive breast cancer. Collecting medical data and storing samples of blood, tissue, and stool from patients with inflammatory breast cancer to study in the laboratory may help doctors find better ways to treat and study inflammatory breast cancer in the future.",[399,27,400],"Inflammatory Breast Carcinoma","Second Primary Malignant Neoplasm","2026-04-10",{"date":403,"type":33},"2026-04-15",{"date":405,"type":33},"2007-04-17",{"date":407,"type":20},"2030-04-30",{"name":295,"class":160},10,{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":216,"minAge":17,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":419,"conditions":420,"keywords":424,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":185},"100615182","circulating-micrornas-and-response-to-neoadjuvant-chemotherapy-in-breast-cancer-100615182","NCT07289282","Circulating microRNAs and Response to Neoadjuvant Chemotherapy in Breast Cancer","The Relationship Between microRNAs in Breast Cancer Subtypes and Response to Neoadjuvant Chemotherapy and Pathological Response","miRNA-NAC","Inclusion Criteria:\n\n* Histologically confirmed breast cancer\n* Planned to receive neoadjuvant chemotherapy\n* Biologically female\n* Age ≥ 18 years\n* Ability to provide informed consent\n* Adequate organ function to receive standard NAC (based on routine clinical evaluation)\n\nExclusion Criteria:\n\n* Presence of metastatic disease at diagnosis\n* Prior systemic chemotherapy for breast cancer\n* Pregnancy or breastfeeding\n* Active infection or uncontrolled comorbid conditions interfering with study participation\n* Any condition preventing collection of blood samples",{"count":218,"type":20},"This prospective observational study aims to investigate subtype-specific circulating microRNAs (miRNAs) and their association with response to neoadjuvant chemotherapy (NAC) in patients with breast cancer. Serum samples will be collected before NAC and prior to surgery, and changes in miRNA expression levels will be evaluated. Pathological complete response (pCR) and Miller-Payne scoring will be used to assess treatment response after NAC. The study also explores whether changes in circulating miRNA profiles can predict treatment response across different breast cancer subtypes. The findings may help identify biomarkers that support treatment planning and personalized therapy strategies.",[332,421,422,27,423],"Neoadjuvant Therapy","Pathological Response","MicroRNAs",[425,426,427,428,429],"microRNA","Circulating microRNAs","Neoadjuvant Chemotherapy","Pathological Complete Response","Predictive Biomarkers","2026-03-30",{"date":432,"type":33},"2026-03-31",{"date":434,"type":33},"2025-12-15",{"date":436,"type":20},"2026-12",{"name":438,"class":160},"Atlas University",{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":82,"sex":216,"minAge":17,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":449,"conditions":450,"keywords":453,"overallStatus":339,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":4},"100631396","tissue--and-serum-derived-exosomal-micrornas-as-predictors-of-neoadjuvant-chemotherapy-response-in-breast-cancer-100631396","NCT07500129","Tissue- and Serum-Derived Exosomal microRNAs as Predictors of Neoadjuvant Chemotherapy Response in Breast Cancer","Clinical and Mechanistic Validation of a Tumor-Derived Extracellular Vesicle-Associated miRNA Signature Predicting Response to Neoadjuvant Chemotherapy in Breast Cancer","ExoTSS-BC","Inclusion Criteria:\n\n* Female patients aged 18 years or older\n* Histologically confirmed locally advanced breast cancer scheduled to receive neoadjuvant chemotherapy\n* Availability of residual tumor tissue and\u002For serum samples obtained during routine clinical care\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Male sex\n* Age under 18 years\n* Prior systemic chemotherapy or radiotherapy administered for the current breast disease before enrollment.\n* Evidence of metastatic disease at diagnosis (for breast cancer cohort)\n* Pregnancy or breastfeeding\n* Any condition that precludes the availability or adequate quality of tissue or blood samples for research purposes",{"count":448,"type":20},60,"This prospective observational study aims to evaluate whether exosomal microRNA profiles derived from tumor tissue and blood serum are associated with pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) in patients with breast cancer.\n\nBreast cancer patients with similar clinical and pathological features may respond differently to treatment, underscoring the need for reliable biomarkers that can help predict therapeutic outcomes. Exosomes are small extracellular vesicles released by tumor cells that carry molecular signals, including microRNAs, which may reflect tumor behavior and treatment sensitivity.\n\nIn this study, patients with breast cancer receiving standard NAC as part of routine clinical care will be followed prospectively. Exosomal microRNA profiles obtained from tumor tissue and blood samples collected during routine diagnostic and treatment procedures will be analyzed and compared with pathological complete response (pCR) assessed after completion of neoadjuvant chemotherapy.\n\nA group of patients with benign breast disease will be included as a reference control for comparative analyses.\n\nThe results of this study may contribute to the identification of minimally invasive biomarkers that support personalized treatment strategies in breast cancer.",[332,27,451,452,428],"Exosomal microRNA","Neoadjuvant Chemotherapy Response",[332,454,451,455,456,457,428],"Breast Cancer Biomarkers","Circulating microRNA","Tissue-derived exosomes","Serum-derived exosomes","2026-03-24",{"date":430,"type":33},{"date":461,"type":20},"2026-04-12",{"date":463,"type":20},"2027-04-22",{"name":438,"class":160},{"id":466,"slug":467,"hasResults":11,"nctId":468,"briefTitle":469,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":11,"sex":216,"minAge":471,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":21,"phases":474,"briefSummary":475,"conditions":476,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":494},"100281599","multicenter-trial-for-eliminating-breast-cancer-surgery-or-radiotherapy-in-exceptional-responders-to-neoadjuvant-systemic-therapy-100281599","NCT02945579","Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy","Inclusion Criteria:\n\n* Cohort A1 and A2\n\n  • Conditions for patient eligibility: Patients on this portion of the study can receive radiation treatment at any MD Anderson Cancer Center or any outside hospital and may be enrolled prior to, during, or following neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below:\n  1. Pathologically confirmed unicentric invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0 or N1 (≤ 4 abnormal axillary nodes on initial ultrasound), clinical stage M0.\n  2. HER2 positive (IHC 3+ and or FISH amplified) or triple receptor negative (TN, ER\u002FPR\\< 10% HER2 negative (IHC 1+ or 2+ FISH non-amplified) receiving any standard routine clinical NST regimen.\n  3. Patient desires breast conserving therapy.\n  4. Age 40 years or older. This age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences \\[124, 125\\].\n  5. Female sex.\n  6. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer.\n  7. Patient must have an initial nodal ultrasound that does not demonstrate more than four suspicious lymph nodes, any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present.\n  8. Patient understands that the breast lesion size on final breast imaging must be less than or equal to 2 cm prior to the biopsy procedure being performed on study and if the biopsy shows residual carcinoma the patient will be taken off study.\n* Cohort B1 and B2\n\n  • Conditions for patient eligibility: Patients on this portion of the study will be limited to receive radiation treatment at MD Anderson Cancer Center or other approved locations and must be enrolled prior to any neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below:\n  1. ER and\u002For PR positive, HER2 negative\n  2. Clinical stage T1N0M0, unicentric non-lobular breast cancer, no lymphovascular space invasion,\n  3. At least 40 years of age.\n  4. Oncotype ≤ 25 if age ≥ 50 years\n  5. Oncotype 0-20 and tumor size ≤ 1.5cm if age 40-49 years.\n  6. Patient agrees to take anti-estrogen therapy and is interested in breast conservation\n  7. Female sex.\n  8. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer.\n  9. No history of prior radiation to the area of the breast that would require protocol-mandated treatment\n* Cohort C\n\n  • Conditions for patient eligibility: Patients on this portion of the study can receive surgical treatment at any MD Anderson Cancer Center or any outside hospital and may be enrolled prior to or following neoadjuvant systemic therapy provided they meet the following eligibility and ineligibility requirements noted below:\n  1. Pathologically confirmed invasive breast cancer defined as radiologic clinical stage T1 or T2 (≤ 5 cm), N0, clinical stage M0 and HER2 positive (IHC 3+ and or FISH amplified) receiving any standard routine clinical NST regimen containing her-2 directed therapy OR Pathologically confirmed invasive breast cancer defined as radiologic clinical stage T1 (≤ 2 cm), N0, clinical stage M0 and triple negative, receiving any standard routine clinical NST regimen.\n  2. For cohort C patients participating in the optional pretreatment biopsy, the patient should be able undergo biopsy or surgery of the primary tumor site of suspected or proven invasive breast cancer and should be planned to receive neoadjuvant systemic therapy.\n  3. Patient desires breast conserving therapy.\n  4. Age 30 years or older if HER2 positive. Age 50 or older if HER2 negative (triple negative).\n  5. Female sex.\n  6. If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer.\n  7. Patient must have an initial nodal ultrasound that does not demonstrate suspicious lymph nodes; any suspicious lymph nodes should be biopsied to determine if nodal metastatic disease present.\n  8. Patient must have no evidence of residual invasive tumor or DCIS on pathologic review of the lumpectomy surgical specimen\n  9. Patient must have no evidence of metastatic disease or isolated tumor cells involving the lymph nodes on pathologic review of the lymph node surgical specimen. If treatment effect in the nodes is noted on the pathology report, the investigators would generally discourage enrollment on this protocol.\n  10. Unifocal disease or limited multifocal disease that can be excised in a single lumpectomy specimen\n* Cohort D (MD Anderson Houston patients only)\n\n  * Conditions for patient eligibility: Patients on this portion of the study meet all eligibility requirements for cohort C, but have not enrolled onto the study to omit radiation. Patients in Cohort D can be identified at the time of diagnosis or prior to lumpectomy. They are not required to participate in one of the treatment arms of the study, but can ultimately choose to move to an omission Cohort at a later time point.\n\n3.5.1 Patients with triple negative or her-2 positive tumor who are amenable to breast conserving treatment and have received or are planned for neoadjuvant systemic therapy prior to surgery are eligible for Cohort D.\n\n3.5.2 Eligible patients in cohort D who have undergone optional ARTIDIS biopsies of the primary breast tumor at the time of diagnosis, prior to starting neoadjuvant therapy, or following completion of systemic therapy, at the time of surgery, may later move to Cohort A or C if they meet all eligibility requirements and ultimately desire surgery or radiation omission\n\nExclusion Criteria:\n\n1. Radiologic evidence for a stage T3 or clinical stage T4 breast cancer in Cohort A1\u002FA2\u002FC; radiologic evidence for a stage T2-T3 or clinical stage T4 breast cancer in Cohort B1\u002FB2.\n2. Clinical or pathologic evidence for distant metastases.\n3. Prior diagnosis of invasive or ductal carcinoma in situ breast cancer in the ipsilateral breast.\n4. Clinical evidence of progression of disease \\>20% in the breast or new evidence of nodal metastases.\n5. Patient is known to be pregnant.\n6. Patient is participating in a NST protocol in which surgical excision of the breast and or lymph nodes are required in Cohort A1\u002FA2\u002FB1\u002FB2.","30 Years",{"count":473,"type":20},120,[244],"This clinical trial studies eliminating surgery and\u002For radiation therapy in treating breast cancer patients. In HER2 positive and triple negative breast cancers, after systemic therapy, when image-guided biopsy shows no residual cancer, patients then receive standard breast radiotherapy with no surgery. In ER positive\u002FHER2 negative breast cancers, after endocrine therapy and ablative radiotherapy, when image-guided biopsy shows no residual cancer, patients then receive standard endocrine therapy with no surgery. For patients who have HER2 positive and triple negative breast cancers and standard surgery, after systemic therapy, breast radiotherapy is being eliminated when the pathology from surgery shows no residual cancer.",[477,478,479,27,480,111,481,482,121,483,484,485],"Estrogen Receptor Negative","HER2 Positive Breast Carcinoma","HER2\u002FNeu Negative","Progesterone Receptor Negative","Stage IA Breast Cancer AJCC v7","Stage IB Breast Cancer AJCC v7","Stage IIA Breast Cancer AJCC v6 and v7","Stage IIB Breast Cancer AJCC v6 and v7","Triple-Negative Breast Carcinoma","2026-03-05",{"date":488,"type":33},"2026-03-09",{"date":490,"type":33},"2017-01-20",{"date":492,"type":20},"2028-01-31",{"name":295,"class":160},8,{"id":496,"slug":497,"hasResults":11,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":11,"sex":216,"minAge":17,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":21,"phases":503,"briefSummary":504,"conditions":505,"keywords":509,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":185},"100573298","nearwave-optical-molecular-monitoring-100573298","NCT06744465","NearWave Optical Molecular Monitoring","NearWave Optical Molecular Monitoring for Predicting Complete Pathological Response (pCR) to Neoadjuvant Chemotherapy (NAC) in Breast Cancer Patients","Inclusion Criteria:\n\n1. Women ≥ 18 years old at the time of informed consent\n2. Ability to provide written informed consent and HIPAA authorization\n3. Patients who:\n\n   1. have been diagnosed with invasive breast cancer by tissue biopsy and have not yet started any therapy for the disease; a) Subtype HER2 positive (IHC 3+ or if IHC 2+, then positive by FISH), with any ER status, OR b) Subtype TNBC, defined by: HER2 negative and ER\u002FPR negative or low (ER and PR ≤ 9%, weak staining)\n   2. with ≥2 cm tumor size in the largest dimension as measured by ultrasound, MRI, or mammography. If multifocal disease, at least one tumor must measure ≥2 cm\n   3. are planned to receive neoadjuvant chemotherapy followed by surgery\n   4. Will be at least two weeks out from biopsy of the primary lesion at the time of baseline visit\n   5. Have a palpable breast mass as determined by a treating physician\n\nExclusion Criteria:\n\n1. Patients with significant bruising or hematoma from diagnostic breast biopsy, as determined by clinical judgement (mild ecchymosis okay)\n2. Inflammatory breast cancer\n3. Prior breast cancer requiring surgery or radiation in either breast\n4. Pregnant or nursing due to changes in breast architecture\n5. Patients with a BMI of ≥ 40, unless the lesion is near the surface (\\\u003C3 cm from the skin surface), based on diagnostic scan measurements\n6. Patients with any tattoos on their breasts",{"count":357,"type":20},[244],"The purpose of this study is to assess the feasibility of the NearWave optical molecular monitoring system for monitoring therapy progression and predicting pathologic complete response (pCR) of breast cancer patients undergoing neoadjuvant chemotherapy (NAC).",[332,506,507,508,27],"HER2-positive Breast Cancer","TNBC - Triple-Negative Breast Cancer","HER2-negative Breast Cancer",[510,511,512,513,514],"neoadjuvant chemotherapy","breast cancer","imaging","NearWave","invasive breast cancer","2026-02-12",{"date":517,"type":33},"2026-02-17",{"date":519,"type":33},"2025-03-07",{"date":521,"type":20},"2027-01",{"name":523,"class":160},"Indiana University",{"id":525,"slug":526,"hasResults":11,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":21,"phases":532,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":185},"100436149","pre-operative-sabr-with-and-without-caloric-restriction-for-early-stage-breast-cancer-100436149","NCT04959474","Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer","SABR-CaRe: A Phase II Randomized Trial of Pre-Operative Stereotactic Ablative Radiation Therapy (SABR) With and Without Caloric Restriction for Early Stage Breast Cancer","Inclusion Criteria:\n\n* • Patients with pathologically proven DCIS or invasive breast cancer histologies\n* Willing and able to provide informed consent\n* Willing and able to comply with study treatments including dietary intervention\n* Body mass index (BMI) \\>= 21 at time of enrollment\n* Age \\>= 40 years at time of consent\n\n  \\* Patients with triple negative breast cancer (TNBC) must be \\>= 50 years of age at time of consent\n* Karnofsky performance status (KPS) score 70 - 100\n* Tumor size =\\\u003C 3.0 cm\n* Gross disease within the breast must be unifocal\n\n  \\* Gross disease may be multifocal as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension =\\\u003C 3 cm\n* Patients with invasive disease are required to have clinical axillary staging including axillary ultrasound (US) that proves patient is clinically node negative or can be done by physical examination if the patient is over 70\n* Patient is not being considered for preoperative chemotherapy\n* Must be English or Spanish speaking\n\nExclusion Criteria:\n\n* Patient is clinically node positive: clinically suspicious axillary lymph node(s) by axillary US or exam unless biopsied and found to be negative\n* Patient has stage IV metastatic disease\n\n  \\* Patients with oligo-metastatic disease who are being treated with curative intent per the treating physician will not be excluded if all other eligibility criteria are met\n* Breast tumor size is \\> 3.0 cm\n* Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor\n* Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign\n* Paget's disease of the nipple\n* Previous breast radiation on ipsilateral side\n* Any prior treatment with radiation therapy or chemotherapy for the current breast cancer diagnosis prior to registration\n* Patients with significant psychiatric illness that would preclude them from adhering to the protocol in the judgement of the treating clinician\n* BMI \\\u003C 21 at the time of study enrollment",{"count":218,"type":20},[244],"This phase II trial studies the effect of calorie reduction while undergoing stereotactic ablative radiation therapy in treating patients with breast cancer. Stereotactic ablative radiation therapy (sABR) is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organ. Giving SABR before surgery may make the tumor smaller. Adding dietary restrictions in combination with radiation therapy may help increase local control and decrease the spread of the cancer to other places in the body. The purpose of this trial is to identify if there is a decrease in tumor tissue in patients undergoing caloric restriction during pre-operative SABR, compared to patients undergoing pre-operative SABR alone.",[535,536,537,538,539,27,540],"Anatomic Stage 0 Breast Cancer AJCC v8","Anatomic Stage 1 Breast Cancer AJCC v8","Anatomic Stage 2 Breast Cancer AJCC v8","Anatomic Stage 3 Breast Cancer AJCC v8","Breast Ductal Carcinoma in Situ","Triple Negative Breast Carcinoma","2026-01-21",{"date":543,"type":33},"2026-01-23",{"date":545,"type":33},"2021-08-23",{"date":547,"type":20},"2028-11-01",{"name":549,"class":160},"Thomas Jefferson University",{"id":551,"slug":552,"hasResults":11,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":11,"sex":216,"minAge":17,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":21,"phases":560,"briefSummary":561,"conditions":562,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":185},"100599165","sentinel-lymph-node-biopsy-after-neoadjuvant-chemotherapy-in-ibc-100599165","NCT07080944","Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in IBC","Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy in Inflammatory Breast Cancer: a Prospective Trial","SYMPHONY","Inclusion Criteria:\n\n* Female patients over 18 years of age with clinically and biopsy-proven stage IIIB cT4d cN0-2 M0 breast cancer as assessed by clinical exam and imaging\n* Patients receiving NACT and having a nodal complete clinical response (ycN0) as assessed by physical exam and imaging (ultrasound and PET)\n* Ability to understand and willingness to sign informed consent document and comply with study procedures\n\nExclusion Criteria:\n\n* Patients with cN3 stage at diagnosis\n* Participants with stage IV (metastatic) breast cancer\n* Participants with positive contralateral axillary nodes identified on standard imaging studies (mammograpy, MRI, ultrasound) and cito-histologically ascertained\n* Patients with a prior history of ipsilateral breast cancer\n* Pregnant patients\n* Patients after NACT with persistent palpable axillary nodes, as assessed by physical exam, or with persistent pathological axillary nodes, as assessed by imaging\n* Patients not consenting to ALND",{"count":559,"type":20},75,[244],"This study will prospectively determine the feasibility and oncological safety of sentinel lymph node biopsy (SLNB) after neoadjuvant chemotherapy (NACT) in inflammatory breast cancer patients traditionally considered ineligible for SLNB due to locally advanced cancer with skin\u002Fchest wall involvement (cT4d) and heavy nodal burden at presentation (cN1\u002FN2). This study will also assess the identification rate of sentinel lymph-node (SLN) (using single tracer mapping) after NACT in this patient population. Finally, the study will determine the long-term outcome of such cohort.",[27,563,427],"Sentinel Lymph Node Biopsy (SLNB)","2026-01-02",{"date":566,"type":33},"2026-01-06",{"date":568,"type":33},"2025-12-12",{"date":570,"type":20},"2030-08",{"name":572,"class":160},"European Institute of Oncology",{"id":574,"slug":575,"hasResults":11,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":21,"phases":582,"briefSummary":583,"conditions":584,"keywords":4,"overallStatus":339,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":591,"leadSponsor":593,"locationsCount":185},"100607681","phase-2-imlunestrant-and-abemaciclib-for-the-treatment-of-estrogen-receptor-positive-breast-cancer-in-patients-with-minimal-residual-disease-miri-trial-100607681","NCT07191717","Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial","Phase II Minimal Residual Disease Study of Selective Estrogen Receptor Degrader Imlunestrant With Cyclin-Dependent Kinase (CDK) 4\u002F6 Inhibitor Abemaciclib in Patients With ER+ Breast Cancer (MIRI)","Inclusion Criteria:\n\n* Participants must have localized ER+ (≥ 10% on surgical pathology), HER2 negative, any grade, invasive breast cancer. Pathological stage (from time of surgery, including patients who received neoadjuvant therapy) I - III by American Joint Committee on Cancer (AJCC) 8th edition staging\n\n  * Note: Invasive breast cancer must be ER+ in ≥ 10% of the cells and HER2 negative (immunohistochemistry \\[IHC\\] 0 or 1+ and\u002For fluorescence in situ hybridization \\[FISH\\] negative with a ratio \\\u003C 2) by American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines. For Immunohistochemistry (IHC) 2+, the tumor must be FISH negative with a ratio \\\u003C 2. ER, progesterone receptor (PR) and HER2 measurements should be performed according to institutional (local) guidelines, in a Clinical Laboratory Improvement Act (CLIA)-approved setting\n* Detectable ctDNA in a CLIA-certified lab (separate pre-screening consent available) within the past six months. Participants must have no clinical or radiographic evidence of recurrence as determined by the treating investigator\n* Confirmation of adequate archival tissue (either initial biopsy or surgical specimen) (15-20 unstained slides cut at 5 µm or 1 block) required before study entry. If adequate surgical tissue is available, this is preferred. Otherwise tissue from diagnostic biopsy is acceptable. If adequate tissue not available, principal investigator (PI) approval is required prior to study entry\n* No prior history of other malignancies within past 5 years (besides breast cancer as per inclusion #1). Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin. No concurrent malignancy or other serious medical condition as deemed by the investigator\n* Participants may or may not have received (neo)adjuvant chemotherapy and\u002For biological therapy at the time of screening, with no more than grade 1 residual toxicity (except ≤ grade 2 neuropathy or ≤ grade 2 alopecia)\n* Participants may or may not have received adjuvant radiotherapy, with no more than grade 1 residual toxicity\n* Pre- and postmenopausal women and men are eligible. Premenopausal women must have a negative serum pregnancy test at time of screening\n\n  * Pregnancy testing does not need to be pursued in female patients who are:\n\n    * Age ≥ 60 years; OR\n    * Age \\\u003C 60 with intact uterus AND amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range\n    * OR status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\n* Must be ≥ 18 years of age\n* History of CDK 4\u002F6 inhibitor is permitted provided the last dose was more than 6 months ago (from consent date)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky ≥ 70%)\n* Patients must currently be on endocrine therapy in the adjuvant setting and must have received (neo) adjuvant endocrine therapy for at least 24 months (cumulative duration)\n* Ability to understand and the willingness to sign a written informed consent document. Patient must sign the informed consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements\n* Participants must currently be receiving adjuvant endocrine therapy and have been on adjuvant endocrine therapy for at least 2 years. Adjuvant endocrine therapy can be either tamoxifen or aromatase inhibitor (AI), i.e prior use of any AI, including letrozole, anastrozole or exemestane, or tamoxifen is allowed. Concurrent gonadotrophin releasing hormone (GNRH) agonist is required with AI in pre - and\u002For peri-menopausal patients and men\n* Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL\n* Platelets ≥ 100 × 10\\^9\u002FL\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Serum creatinine \\\u003C 1.5 mg\u002FdL OR creatinine clearance ≥ 50 mL\u002Fmin\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 2.5 x institutional upper limit of normal (ULN)\n* Total bilirubin \\\u003C institutional 1.5 times ULN; or total bilirubin ≤ 3.0 x institutional ULN. Patients with Gilbert's Syndrome with a total bilirubin ≤ 2.0 times ULN and direct bilirubin within normal limits are permitted\n* The patient is able to swallow oral medications\n\nExclusion Criteria:\n\n* Participants with metastatic disease (including contralateral axillary lymph nodes) or inflammatory breast cancer. Of note, if a patient had locally advanced breast cancer leading to inflammation, this would not exclude the patient on the grounds of inflammatory carcinoma\n* Participants who have had CDK 4\u002F6 inhibitor therapy within the past 6 months. Use of prior CDK 4\u002F6 inhibitor with last dose more than 6 months ago is permitted\n* Participants who are receiving any other anti-cancer investigational agents. Participation in other observational studies is permitted\n* History of other malignancies within past 5 years, except ductal carcinoma in situ of the breast, cervical cancer in situ, melanoma in situ, and basal cell or squamous cell carcinoma of the skin. No concurrent malignancy or other serious medical condition as deemed by the investigator\n* Herbal products and supplements will generally not be allowed, but specific supplements (such as cannabidiol \\[CBD\\] oil) can be considered on a case-by-case basis by Overall PI\n* Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment (e.g. estimated creatinine clearance \\\u003C 30ml\u002Fmin), unstable angina pectoris, cardiac arrhythmia, a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, stomach resection, or small bowel resection) are ineligible. Patient with active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]). Screening for HIV and hepatitis is not required for enrollment\n* The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* A history of venous thromboembolism (VTE): deep vein thrombus or pulmonary embolism. An exception can be made for patients with a history of an uncomplicated venous catheter-related occlusion. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* History of hypersensitivity to imlunestrant, abemaciclib or any of the components in either medication\n* HIV-positive participants not on antiretroviral therapy are at increased risk of lethal infections when treated with marrow-suppressive therapy and should not be enrolled until their HIV is managed. If the HIV is well controlled, participants may participate in this study\n* Pregnant women are excluded from this study because embryo-fetal toxicity is a potential side effect of abemaciclib and imlunestrant. For this reason, women of child-bearing potential (WOCBP) and men must agree to use highly effective contraception prior to study entry, for the duration of treatment, and for at least 3 months after the completion of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential. All WOCBP must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of the investigational agent(s). Registration may occur prior to this pregnancy test. If the pregnancy test is positive, the patient must not receive protocol treatment and must not continue in the study. WOCBP is defined as follows:\n\n  * Any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or a bilateral oophorectomy) OR\n  * Any female who is not postmenopausal defined as:\n\n    * Age ≥ 60 years; OR\n    * Age \\\u003C 60 with intact uterus AND amenorrhea for 12 consecutive months or more AND estrogen (estradiol) levels within postmenopausal range; OR\n    * Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 12 weeks after study drug discontinuation. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential. 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  * Female sterilization (surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment\n  * Use of non-estrogen oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example hormone vaginal ring or transdermal hormone contraception\n  * Use of luteinizing hormone-releasing hormone (LHRH) agonist with estrogen level in post-menopausal range and one form of barrier method contraception\n* Women who are lactating. Advise lactating women to not breastfeed during treatment and for 1 week after last dose",{"count":581,"type":20},42,[23],"This phase II trial studies how well imlunestrant and abemaciclib work in treating patients with estrogen receptor positive (ER+) breast cancer who have tumor remaining in the blood following treatment (minimal residual disease). Estrogen can cause the growth of breast cancer cells. Imlunestrant lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Imlunestrant and abemaciclib may be effective in treating patients with ER+ breast cancer who have minimal residual disease.",[223,224,55,27,585,586],"Localized Estrogen Receptor-Positive Breast Carcinoma","Localized Human Epidermal Growth Factor Receptor (HER2)-Negative Breast Carcinoma","2025-11-06",{"date":589,"type":33},"2025-11-10",{"date":287,"type":20},{"date":592,"type":20},"2031-04-30",{"name":594,"class":160},"Jonsson Comprehensive Cancer Center",{"id":596,"slug":597,"hasResults":11,"nctId":598,"briefTitle":599,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":87,"phases":4,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":631},"100443825","oracle-observation-of-residual-cancer-with-liquid-biopsy-evaluation-100443825","NCT05059444","ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation","ORACLE","Inclusion Criteria:\n\n* Age \\> 18 years old AND\n* Initial treatment is given with curative\u002Fradical intent AND\n* Are planning to undergo regular follow-up and monitoring for cancer recurrence per standard of care at the enrolling site AND\n* Provided written informed consent to participate in the study AND\n* Are willing to have de-identified clinical data shared with investigators at regular intervals as outlined in the study protocol and informed consent AND\n* Are willing to provide blood samples at enrollment and at subsequent clinical visits coinciding with standard of care follow-up, for up to 5 years as outlined in the study protocol and informed consent AND\n* Have at least one Landmark blood sample\n\nHave a histologically confirmed Index Cancer that qualifies for inclusion, defined as:\n\nPrimary Study Cohorts\n\n* Cohort 1: Cohort 1: Muscle invasive carcinoma of the bladder, ureter, or renal pelvis (stage II-III),\n* Cohort 2: Cohort 2: Non-small cell lung cancer (stage IB-III):\n\nCohort 2A: Resectable OR Cohort 2B: Unresectable,\n\n* Cohort 3: Invasive breast carcinoma with hormone receptor (e.g. estrogen receptor (ER) and progesterone receptor (PR) expression) and human epidermal growth factor receptor 2 (HER2) status known and one the following:\n\nCohort 3A: High-risk2 HER2+ breast cancer (any ER, PR status allowed) OR Cohort 3B: High-risk2 triple negative breast cancer (TNBC) OR Cohort 3C: High-risk3 HR-positive\u002FHER2-negative invasive breast carcinoma,\n\n* Cohort 4: Stage IIB-III cutaneous melanoma or limited (resectable) stage IV melanoma treated with curative intent,\n* Cohort 5: Esophageal or gastroesophageal junction carcinoma (stage II-III),\n* Cohort 6: Gastric adenocarcinoma (stage II-III),\n* Cohort 7: Pancreatic adenocarcinoma that is has been surgically resected or is eligible for surgical resection,\n* Cohort 8: Invasive squamous cell carcinoma of the head and neck (Includes stage I-IVB oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, nasal cavity, and paranasal sinus cancers),\n* Cohort 9: High-risk epithelial ovarian or Fallopian tube carcinoma (Defined as FIGO stage IC-III or stage IA-IB that has high grade or clear cell histology),\n* Cohort 10: High-risk endometrial carcinoma (Defined as 2023 FIGO Stage II-III),\n* Cohort 11: High-risk renal cell carcinoma (Defined as high grade (grade 3-4) stage II, stage III or limited (resectable) stage IV treated with curative intent)\n\nExploratory Cohort\n\n* Cohort 12: Pathologically confirmed adenocarcinoma of the rectum (located up to 15 cm from the anal verge) that is undergoing or underwent a preoperative chemotherapy- or immunotherapy- containing regimen\n\nExclusion Criteria:\n\n* History of allogeneic organ or tissue transplant\n* Index cancer has predominantly neuroendocrine histology\n* History of another primary cancer diagnosed within 3 years of enrollment, with the exception that in situ cancers, non-melanoma skin carcinomas, localized low- or intermediate risk prostate cancers, and stage I papillary thyroid carcinoma, and participants with bilateral\u002Fmultifocal tumors within the same organ (for example, bilateral breast cancer) are allowed if diagnosed within 3 years of enrollment\n* Known distant metastasis at time of enrollment (with the exception of participants with limited\u002Fresectable stage IV cutaneous melanoma or RCC)",{"count":603,"type":20},2020,"The purpose of ORACLE is to demonstrate the ability of a novel ctDNA assay developed by Guardant Health to detect recurrence in individuals treated for early-stage solid tumors. It is necessary that ctDNA test results are linked to clinical outcomes in order to demonstrate clinical validity for recurrence detection and explore its value in a healthcare environment subject to cost containment.",[606,607,608,609,27,610,611,612,613,614,615,616,617,618,619,620],"Bladder Carcinoma","Ureter Carcinoma","Renal Pelvis Carcinoma","Non-small Cell Lung Cancer","Cutaneous Melanoma","Esophageal Carcinoma","Gastroesophageal Junction Carcinoma","Gastric Adenocarcinoma","Pancreatic Adenocarcinoma","Squamous Cell Carcinoma of the Head and Neck","Epithelial Ovarian Carcinoma","Fallopian Tube Carcinoma","Endometrial Carcinoma","Renal Cell Carcinoma","Rectal Adenocarcinoma","2025-08-18",{"date":623,"type":33},"2025-08-22",{"date":625,"type":33},"2021-09-07",{"date":627,"type":20},"2029-08",{"name":629,"class":630},"Guardant Health, Inc.","INDUSTRY",57,{"id":633,"slug":634,"hasResults":11,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":639,"targetDuration":4,"studyType":21,"phases":641,"briefSummary":642,"conditions":643,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":185},"100464431","neoadjuvant-breast-cancer-time-restricted-eating-100464431","NCT05327608","Neoadjuvant Breast Cancer Time Restricted Eating","Time Restricted Eating for Patients With HER2- Negative Breast Cancer Receiving Neoadjuvant Chemotherapy","Inclusion Criterion\n\nIndividuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:\n\n1. Patient must be ≥ 18 years of age at time of consent and must be able to understand and provide informed consent.\n2. BMI 25-40 at time of enrollment.\n3. Patients must have an ECOG performance status of 0 or 1.\n4. Patient must have a recent diagnosis of histologically confirmed primary invasive breast carcinoma.\n\n   1. Multifocal or contralateral DCIS or invasive breast cancers are allowed if the breast cancers meet the same eligibility criteria for ER\u002FPR and HER2.\n   2. Oligometastatic disease is allowed if treating physician recommends standard neoadjuvant chemotherapy.\n5. Tumor status must be HER2 negative per ASCO\u002FCAP guidelines (determined by local testing).\n6. Patients must have clinical stage I-III (utilizing TNM criterion) at diagnosis.\n7. Clinical T size must be ≥ 1.5cm if there is no radiographic or clinical evidence of axillary lymph node involvement. Any size tumor is allowed if axillary lymph nodes appear to be involved.\n8. Patient must be willing and able (have no contraindication) to receive recommended standard neoadjuvant therapy consisting of at least 16 weeks of planned neoadjuvant chemotherapy.\n\n   a. Acceptable regimen includes doxorubicin and cytoxan followed by a taxane The schedule will be determined by treating physician. Carboplatin and pembrolizumab can also be added to the neoadjuvant chemotherapy regimen if determined to be appropriate by treating physician.\n9. Patients must have organ and marrow function adequate for initiating neoadjuvant chemotherapy as determined by their treating physician.\n10. Patient must be willing and able (have no contraindication) to participate in TRE consisting of 16 weeks\n11. Women of childbearing potential and sexually active males must use accepted and effective method(s) of contraception or abstain from sexual intercourse for the duration of their participation in the study and for 6 months after the last study intervention.\n12. Patient must have a personal email address, an internet-capable device, and the ability\u002F willingness to read and reply to email every day for the duration of the study.\n\nExclusion Criteria\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Clinical T4 and\u002For N3 disease, including inflammatory breast cancer.\n2. Any prior treatment for the current breast cancer diagnosis, including surgery, chemotherapy, radiation, or experimental therapy.\n3. Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive from the time of registration, while on study treatment, and until at least 6 months after the last study intervention.\n4. Patients with type 1 diabetes, or type 2 diabetes treated with insulin.\n5. Patients with a history of eating disorder or taking weight loss medications\n6. Patients who actively smoke\n7. Patients who work night shifts or on a rotating shift schedule.\n8. Patients must not have impaired decision-making capacity.\n9. Patients who are not English speaking as study staff is only able to provide the study intervention measurement tool.\n10. Patients that are \\>2 weeks into starting neoadjuvant chemotherapy regimen.",{"count":640,"type":20},55,[244],"A phase II study to evaluate an innovative approach of following time restricted eating (TRE) in patients with HER2- negative breast cancer who will start neoadjuvant chemotherapy (NCT) for a new diagnosis of stage I-III breast cancer. Participants at baseline will have a body mass index (BMI) of (25-40) and engage in a TRE 16:8 schedule which includes 16 hours of fasting and 8 hours of eating. Patients will continue TRE for 16 weeks while receiving NCT. For patients who report at the time of the 2-3 week clinic visit that they are finding it challenging to adhere to the 16:8 TRE, instructions will be provided about alternative measures such as changing the time of the day they fast, dietary modifications and finally changing to a 14:10 schedule if other measures fail. For patients requiring NCT for longer than 16 weeks, they will be encouraged to continue TRE. Adherence calculation for the primary endpoint will include data for the first 16 weeks, and then monitored separately for any additional optional fasting beyond the first 16 weeks. Adherence to TRE will be self-reported by patients daily through electronic surveys through RedCap and approximately every 2-3 weeks (+\u002F- 5 days) by the research team during their clinic visit.",[223,224,55,539,644,645,27],"HER2 Negative Breast Carcinoma","Hormone Receptor Positive Breast Carcinoma","2025-07-30",{"date":648,"type":33},"2025-08-01",{"date":650,"type":33},"2022-07-28",{"date":652,"type":20},"2027-05-01",{"name":549,"class":160},{"id":655,"slug":656,"hasResults":11,"nctId":657,"briefTitle":658,"officialTitle":659,"acronym":4,"eligibilityCriteria":660,"healthyVolunteers":11,"sex":216,"minAge":17,"maxAge":4,"enrollmentInfo":661,"targetDuration":4,"studyType":21,"phases":662,"briefSummary":664,"conditions":665,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":668,"lastUpdatePostDateStruct":669,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":675,"locationsCount":318},"100474969","early-phase-1-letrozole-with-and-without-simvastatin-for-the-treatment-of-stage-i-iii-hormone-receptor-positive-her2-negative-breast-cancer-100474969","NCT05464810","Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer","A Randomized Window of Opportunity Study of Preoperative Letrozole and Simvastatin Versus Letrozole Alone in Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Biopsy proven hormone receptor positive, HER2 negative stage I-III invasive breast cancer\n\n  * Estrogen receptor (ER) and\u002For progesterone receptor (PR) positivity are defined as \\>= 10% of cells expressing hormonal receptors via IHC analysis\n  * HER2 negativity is defined as either of the following by local laboratory assessment\n\n    * IHC 0, 1+, or 2+ and in situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 \\\u003C 2.0 or single probe average HER2 gene copy number \\\u003C 4 signals\u002Fcell)\n* Minimum primary tumor size 5 mm on any breast imaging (mammogram, ultrasound, magnetic resonance imaging \\[MRI\\])\n* Baseline Ki-67 IHC expression on tumor tissue \\>= 10%\n* Post-menopausal women\n\n  * Prior bilateral oophorectomy\n  * Age \\>= 55 years\n  * Age \\\u003C 55 and amenorrheic for 12 months or more in the absence of chemotherapy, endocrine therapy, or ovarian suppression and follicle stimulating hormone (FSH), luteinizing hormone (LH), and estradiol in the postmenopausal range\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Prior treatment:\n\n  * No systemic therapy (chemotherapy, immunotherapy, endocrine therapy, and\u002For investigational therapy) within 3 months of trial enrollment\n* No statins, fibrates, or ezetimibe within 3 months of trial enrollment\n* No active liver disease\n* Hemoglobin \\>= 9.0 g\u002Fdl (Note: the use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 9.0 g\u002Fdl is acceptable) (within 14 days prior to initiation of study treatment)\n* Absolute neutrophil count (ANC) \\>= 1,500\u002FmcL (after at least 7 days without growth factor support or transfusion) (within 14 days prior to initiation of study treatment)\n* Platelets \\>= 100,000\u002FmcL (within 14 days prior to initiation of study treatment)\n* Total bilirubin =\\\u003C 2 institutional upper limit of normal (ULN) (within 14 days prior to initiation of study treatment)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3 institutional ULN (within 14 days prior to initiation of study treatment)\n* Serum creatinine =\\\u003C 2 mg\u002FdL (or glomerular filtration rate \\>= 40 mL\u002Fmin) (within 14 days prior to initiation of study treatment)\n* Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions\n* Be willing and able to provide written informed consent for the trial\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents or an investigational device within 3 months before administration of first dose of study drugs\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to simvastatin and\u002For letrozole\n* Concomitant use of strong CYP3A4 inhibitors (i.e. clarithromycin, erythromycin, itraconazole, ketroconazole, nefazodone, Posaconazole, voriconazole, protease inhibitors \\[including boceprevir and telaprevir\\], telithromycin, cobicistat-containing products), cyclosporine, danazol, and gemfibrozil\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, substance abuse disorders, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Significant cardiovascular disease (e.g., myocardial infarction, arterial thromboembolism, cerebrovascular thromboembolism) within 3 months prior to start of study therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association class 3 or 4 congestive heart failure; or uncontrolled grade \\>= 3 hypertension (diastolic blood pressure \\>= 100 mmHg or systolic blood pressure \\>= 160 mmHg) despite antihypertensive therapy\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy",{"count":328,"type":20},[663],"EARLY_PHASE1","This early phase I trial tests whether letrozole with simvastatin works better than letrozole alone to stop tumor cell proliferation in patients with stage I-III hormone receptor positive, HER2 negative invasive breast cancer. Letrozole and simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The addition of simvastatin to letrozole may be more effective at stopping the growth of cancer cells than letrozole alone.",[223,224,55,666,667,27],"HER2-Negative Breast Carcinoma","Hormone Receptor-Positive Breast Carcinoma","2025-05-20",{"date":670,"type":33},"2025-05-23",{"date":672,"type":33},"2022-09-02",{"date":674,"type":20},"2027-04-15",{"name":676,"class":160},"Emory University"]