[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prognostic-stage-iv-breast-cancer-ajcc-v8\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prognostic-stage-iv-breast-cancer-ajcc-v8":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,68,93,118,146,187,209,235,315],{"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":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100421724","phase-2-avapritinib-for-the-treatment-of-ckit-or-pdgfra-mutation-positive-locally-advanced-or-metastatic-malignant-solid-tumors-100421724",false,"NCT04771520","Avapritinib for the Treatment of CKIT or PDGFRA Mutation-Positive Locally Advanced or Metastatic Malignant Solid Tumors","Phase 2 Study of Avapritinib in Patients With CKIT or PDGFRA Mutation-Positive Malignant Solid Tumors","Inclusion Criteria:\n\n1. The patient (or legally acceptable representative if applicable) provides written informed consent for the study.\n2. Male or female ≥18 years of age on the day of informed consent signing. Adolescent patients aged 12 years and older are allowed with signed assent and parental consent according to institutional guidelines and requirements.\n3. Cohorts 1 and 2: Patient has a locally advanced or metastatic solid tumor and has progressed on appropriate standard therapy, has not shown clinically meaningful benefit to appropriate standard therapy, has no available standard therapy, or has declined appropriate standard therapy.\n\n   • NOTE: Specific solid tumor types include but are not limited to melanoma, breast cancer, lung cancer, gastroesophageal cancer, colorectal cancer, sarcoma, solid tumors NOS, and primary CNS tumors. Patients with any other recurrent solid tumor type with the exception of gastrointestinal stromal tumor (GIST) will be eligible.\n4. Cohort 3: Patient has newly diagnosed IDH wild-type, MGMT-unmethylated glioblastoma. Patients must have received prior treatment with radiation and concurrent temozolomide per standard of care.27 Patients must have completed radiation and concurrent temozolomide 3-8 weeks prior to study treatment initiation.\n5. Measurable disease per the RECIST v1.1 or RANO criteria, as appropriate, for Cohorts 1 and 2. Patients in Cohort 3 can have measurable or non-measurable disease per the RANO criteria.\n\n6 Documented pathogenic CKIT activating mutation (Cohort 1) OR pathogenic PDGFRA activating mutation (Cohort 2) based on Clinical Laboratory Improvement Amendments-certified next-generation sequencing diagnostic test. Cohort 3 should have pathogenic CKIT or PDGFRA activating mutation\u002Famplification based on CLIA-certified NGS diagnostic test. CKIT and PDGFRA mutation pathogenicity will be verified by the MD Anderson Cancer Center's Precision Oncology Decision Support team. Acceptable CKIT\u002FPDGFRA mutations for study eligibility are listed in Appendix E.\n\n7\\. Has available archival tissue for CKIT\u002FPDGFRA mutation (amplification \\[Cohort 3 only\\]) retrospective testing.\n\n8\\. Adequate organ and marrow function as defined below within 7 days of study treatment initiation:\n\n* White blood cell count \\>2,500\u002FµL and \\\u003C15,000\u002FµL\n* Absolute neutrophil count ≥1.5 × 109\u002FL (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility)\n* Platelet count ≥75 × 109\u002FL (without transfusion within 2 weeks of laboratory test used to determine eligibility)\n* Hemoglobin ≥9.0 g\u002FdL (without blood transfusion within 7 days of laboratory test used to determine eligibility)\n* Total bilirubin ≤1.5 × upper limit of normal (ULN); if hepatic metastases are present, ≤3.0 × ULN\n* Aspartate transaminase and alanine transaminase ≤2.5 × ULN; if hepatic metastases are present, ≤5.0 × ULN\n* Serum creatinine ≤2.0 × ULN or creatinine clearance ≥45 mL\u002Fmin. 9. Cardiac ejection fraction \\>45% per screening echocardiogram or multigated acquisition scan.\n\n  10\\. Eastern Cooperative Oncology Group performance status of 0-2.\n\n  11\\. Life expectancy ≥3 months.\n\n  12\\. Willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations.\n\n  13\\. Willing to undergo biopsy as required by the study.\n\n  14\\. Females must be postmenopausal (defined as ≥45 years of age with at least 12 months of spontaneous amenorrhea) or premenopausal with documented surgical sterilization (tubal ligation, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or evidence of non-childbearing status for women of childbearing potential (negative serum beta-human chorionic gonadotropin pregnancy test) within 3 days of study treatment initiation.\n\n  15\\. Females of childbearing potential must either abstain from heterosexual intercourse or use a highly effective method of contraception for the course of the study and for 6 weeks after the last dose of study treatment.\n\n  16\\. Males with female partners of reproductive potential must either abstain from sexual intercourse or they and their partners must use a highly effective method of contraception when engaging in sexual intercourse for the course of the study through 30 days after the last dose of study treatment.\n\nExclusion Criteria:\n\nPatients eligible for this study must not meet any of the following criteria:\n\n1. Patients who have GIST.\n2. Patients with tyrosine kinase inhibitor-resistant CKIT mutation V654A or T670I.\n3. Patients with meningeal carcinomatosis, leptomeningeal carcinomatosis, spinal cord compression, or symptomatic or unstable brain metastases. Note: Patients with stable brain metastases (defined as asymptomatic or no requirement for high-dose or increasing dose of systemic corticosteroids) and without imminent need of radiation therapy) are eligible (including those with untreated brain metastases). If applicable, patients must have completed brain radiation therapy and recovered adequately from any associated toxicity and\u002For complications prior to eligibility assessment. For patients who have received prior radiation therapy, post-treatment magnetic resonance imaging scan should show no increase in brain lesion size\u002Fvolume.\n4. History of documented congestive heart failure (New York Heart Association functional classification III-IV) or serious cardiac arrhythmias requiring treatment.\n5. QT interval corrected using Fridericia's formula of \\>470 msec.\n6. Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 2 weeks prior to study treatment initiation.\n7. Prior anticancer chemotherapy, hormone therapy, immunotherapy, targeted therapy, radiation therapy, or surgery within 2 weeks prior to study treatment initiation.\n\n   * NOTE: Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline (except alopecia). Patients with ≤ Grade 2 neuropathy are eligible.\n   * NOTE: If patient received major surgery, she\u002Fhe must have recovered adequately from the toxicity and\u002For complications from the intervention prior to study treatment initiation.\n   * NOTE: Patients in Cohort 3 must have completed radiation and concurrent temozolomide 3-8 weeks prior to study treatment initiation.\n8. Symptomatic non-healing wound, ulcer, gastrointestinal perforation, or bone fracture.\n9. History of psychotic or depressive disorder. Patients whose disorder is well controlled on a stable antipsychotic or antidepressant medication for at least 12 months prior to study entry will be eligible.\n10. Concomitant use of a known strong cytochrome P450 (CYP)3A4 inhibitor or strong CYP3A4 inducer. The required washout period prior to study treatment initiation is 2 weeks or 5 half-lives, whichever is shortest.\n11. Females who are pregnant or breastfeeding.\n12. Unable to swallow and retain oral medications.\n13. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study treatment (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n14. Known additional malignancy that is progressing or requires active treatment. NOTE: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical cancer in situ that have undergone potentially curative therapy are not excluded.\n15. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the investigator.\n16. Prior treatment with an intracerebral agent or bevacizumab (Cohort 3 only).\n17. Prior treatment including radiation, chemotherapy, or immunotherapy for low-grade glioma (Cohort 3 only).","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies the effect of avapritinib in treating malignant solid tumors that have a genetic change (mutation) in CKIT or PDGFRA and have spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Avapritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Avapritinib may help to control the growth of malignant solid tumors.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54],"Anatomic Stage IV Breast Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Locally Advanced Malignant Solid Neoplasm","Locally Advanced Melanoma","Locally Advanced Primary Malignant Central Nervous System Neoplasm","Locally Advanced Sarcoma","Metastatic Malignant Solid Neoplasm","Metastatic Melanoma","Metastatic Primary Malignant Central Nervous System Neoplasm","Metastatic Sarcoma","Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8","Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8","Prognostic Stage IIIC Breast Cancer AJCC v8","Prognostic Stage IV Breast Cancer AJCC v8","Stage IIIC Colorectal Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Stage IV Colorectal Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IVA Colorectal Cancer AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVB Colorectal Cancer AJCC v8","Stage IVB Lung Cancer AJCC v8","Stage IVC Colorectal Cancer AJCC v8","RECRUITING","2026-06-09",{"date":58,"type":59},"2026-06-11","ACTUAL",{"date":61,"type":59},"2021-01-20",{"date":63,"type":20},"2026-12-31",{"name":65,"class":66},"M.D. Anderson Cancer Center","OTHER",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":75,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100389274","phase-2-dendritic-cell-vaccines-against-her2her3-and-pembrolizumab-for-the-treatment-of-brain-metastasis-from-triple-negative-breast-cancer-or-her2-breast-cancer-100389274","NCT04348747","Dendritic Cell Vaccines Against Her2\u002FHer3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer","A Phase IIa Study of Dendritic Cell Vaccines Against Her2\u002FHer3 and Pembrolizumab in Patients With Asymptomatic Brain Metastasis From Triple Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC) or Hormone Receptor Positive (HR+) Breast Cancer.","Inclusion Criteria:\n\n* female participant is eligible to participate if she is not pregnant,not breastfeeding, and at least one of the following conditions applies:\n\n  * Not a woman of childbearing potential (WOCBP)\n  * A WOCBP who agrees to follow contraceptive guidance\n* WOCBP must agree to use acceptable birth control methods for the duration of the study and until persistence of the study drug is no longer detected in the peripheral blood:this may be a period of several years. Methods for acceptable birth control include: condoms, diaphragm or cervical cap with spermicide, intrauterine device, and hormonal contraception; it is recommended that a combination of two methods be used. NOTE: If the risk of conception exists, patients must agree to use highly effective contraception throughout the study and for at least two years following the last study treatment administration\n* Negative serum and highly sensitive urine pregnancy test(s):\n* At initial screening prior to eligibility confirmation\n* within 72 hours prior to leukapheresis if \\>72 hours have passed between screening test and the Leukapheresis visit\n* Pregnancy testing will be performed for WOCBP and interpreted prior to every cycle of pembrolizumab (Initial Treatment Phase);\n* at the End of Treatment (EOT) Assessment; and\n* whenever pregnancy is otherwise suspected. Note: In the event that 72 hours have elapsed between the screening pregnancy test and leukapheresis, another pregnancy test must be performed and must be negative in order for subject to undergo leukapheresis\n* Histologically or cytologically confirmed diagnosis of triple negative breast cancer (TNBC) (estrogen receptor \\[ER\\] =\\\u003C 1%, progesterone receptor \\[PR\\] =\\\u003C 1% HER2 negative) or HR+ breast cancer\n\n  * HER2 testing should be performed on the invasive component using a validated immunohistochemistry (IHC) or in situ hybridization (ISH) assay\n  * IHC staining is defined as:\n\n    * IHC 3+ if there is complete and intense circumferential membrane staining within \\> 10 percent of tumor cells. All IHC 3+ tumors are considered HER2 positive\n    * IHC 2+ if there is incomplete and\u002For weak\u002Fmoderate, circumferential membrane staining within \\> 10 percent of tumor cells. All IHC 2+ tumors are reported as HER2 equivocal\n    * IHC 1+ if there is faint or barely perceptible, incomplete membrane staining within \\> 10 percent of tumor cells. All IHC 1+ tumors are reported as HER2 negative\n    * IHC 0 if (1) no staining is observed, or (2) there is faint or barely perceptible, incomplete membrane staining within \\\u003C 10 percent of tumor cells. All IHC 0 tumors are reported as HER2 negative\n    * Equivocal HER2 testing should trigger reflex HER2 testing using ISH on the same specimen or a new test (using a different specimen with either IHC or ISH)\n  * Results from ISH are defined as the ratio of gene amplification of HER2 and the chromosome 17 enumeration probe (CEP17). Results are reported as:\n\n    * ISH positive if the HER2\u002FCEP17 ratio is \\>= 2.0, and the HER2 copy number signals\u002Fcell is \\>= 4\n    * Definitive diagnosis will be rendered pending further workup in the following instances:\n\n      * If the HER2\u002FCEP17 ratio is \\>= 2.0 and an average HER2 copy number is \\\u003C 4.0 signals\u002Fcell - negative if confirmed on retesting\n      * If the HER2\u002FCEP17 ratio is \\\u003C 2.0 and the average HER2 copy number is \\>= 6.0 signals\u002Fcell positive - if confirmed on retesting\n      * If the HER2\u002FCEP17 ratio is \\\u003C 2.0 and an average HER2 copy number is between \\>= 4.0 and \\\u003C 6.0 signals\u002Fcell negative - if confirmed on retesting\n    * ISH negative if the HER2\u002FCEP17 ratio is \\\u003C 2.0 and average HER2 copy number is \\\u003C 4.0 signals\u002Fcell\n* Measurable brain disease as per RANO-BM criteria modified to include the cut off point of 0.5 cm or higher. Have at least one untreated (includes irradiation) brain metastasis approved by a research team that meets the following size requirements:\n\n  * \\>= 0.5 cm AND twice the magnetic resonance imaging (MRI) slice thickness; and\n  * \\\u003C 3.0 cm, that is asymptomatic and does not require local therapy at the time of enrollment (i.e. target lesion\\[s\\])\n  * Of note, lesions \\>= 0.5 cm and \\\u003C 3 cm may be determined ineligible by the research team because of location or symptoms. An untreated brain metastasis is defined as a lesion not present at the time of whole brain radiation therapy or not included in a stereotactic radiotherapy field (or within 0.5 cm of a treated lesion), or any lesion that is new or unequivocally progressing since prior radiation therapy or prior surgery.\n* Any brain metastasis \\>= 3.0 cm or causing symptoms must have previously been treated with local therapy (i.e. radiation or surgical resection, as clinically appropriate) prior to study enrollment. Any lesion present at the time of whole brain radiation therapy (WBRT) or included in the stereotactic radiotherapy field (or within 5 mm of the treated lesion) will NOT be considered evaluable unless it is new or documented to have progressed since treatment\n* Stereotactic radiosurgery (SRS) and\u002For prior radiotherapy is permitted \\>=2 weeks prior to initial Dendritic Cell (DC) vaccine dose (leaving one or more lesions which are not radiated and will be used as target lesions) but a follow up brain MRI should be obtained prior to dendritic cell (DC) vaccine to determine stability of the lesions. An interval of at least 4 weeks after the end of whole brain radiation or for any surgical resection of brain lesions is permitted ; an interval of at least 4 weeks or 5 half-lives (whichever is sorter) after the last cytotoxic, targeted, immunotherapeutic or investigational agent is permitted (prior to the start of DC vaccine)\n\n  * Previous whole brain radiation is allowed if patient has been diagnosed with recurrent, progressive brain metastasis. Previously irradiated lesions would be considered non-target lesions\n  * Previously resected lesions or those treated with SRS would be considered nontarget lesions. There is no limitation on prior local therapies to other lesions.\n* If subject received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Toxicity that has not recovered to \\\u003C=Grade 1 is allowed if it meets the inclusion requirments for lab parameters (Participants with \\\u003C= Grade 2 neuropathy may be eligible)\n* Patients must have adequate organ and marrow function as defined below (specimens must be collected within 10 days prior to the start of study treatment):\n* Hemoglobin \\>= 9 g\u002FdL or \\>= 5.6 mmol\u002FL\n* Leukocytes: \\>= 3 x 10\\^9\u002FL\n* Absolute neutrophil count: \\>= 1.5 x 10\\^9\u002FL\n* Platelets: \\>= 100 x 10\\^9\u002FL\n* Total bilirubin: =\\\u003C 1.5 x upper limit of normal (ULN) OR direct bilirubin =\\\u003C ULN for participants with total bilirubin levels \\> 1.5 x ULN\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]): =\\\u003C 2.5 x institutional upper limit of normal (=\\\u003C 5 x ULN for participants with liver metastases)\n* Creatinine OR Measured or calculated creatinine clearance (Glomerular Filtration Rate (GFR) can also be used in place of creatinine or CrCl): ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n* International normalized ratio (INR) OR prothrombin time (PT) activated partial thromboplastin time (APTT) =\\\u003C 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* No evidence of leptomeningeal disease\n* If patient is on steroids, they must be on a steroid dose less than or = to an equivalent prednisone dose of 10 mg daily\n* Life expectancy of \\> 3 months\n* Prior checkpoint inhibitors permitted 3 weeks prior to enrollment\n* If the disease has progressed on current treatment in the CNS, prior to consent, patients may continue Her 2 directed antibody treatment (trastuzumab and pertuzumab); aromatase inhibitor or tamoxifen while on the study; patients with triple negative breast cancer may continue capecitabine, eribulin or paclitaxel while on study per PI discretion\n* Patients with systemic disease will be managed as detailed in Section 10.1 - Patients who develop systemic disease progression on the protocol will be managed as detailed in Section 10.4.2\n\nExclusion Criteria:\n\n* Any condition which might confound the results of the study, interfere with the subject's participation for full participation (for the full duration of the study) or in the Investigator's opinion deems the participant an unsuitable candidate for the study\n* Symptomatic brain metastases. Any neurologic symptoms present must have resolved with local therapy by the time of administration of study drugs\n* May not be receiving any other investigational agents and may not have participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of DC vaccine treatment\n* Has had prior chemotherapy or targeted small molecule therapy (except treatment mentioned in inclusion criteria 17) within 4 weeks or 5 half-lives (whichever is sooner) prior to start of treatment (first DC vaccine) or who has not recovered (i.e., =\\\u003C grade 1 or at baseline) from adverse events due to a previously administered agent. Previous radiation to extracranial sites may be completed at any time prior to initiation of study drugs (first DC vaccine) with a 2-week washout is required.\n* Rapidly progressing systemic disease which might interfere with completion of all the vaccine doses\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 and is allowed\n* History of allogenic tissue\u002Fsolid organ transplantation\n* Has an active infection requiring systemic therapy which in the investigator's opinion will increase risk to the patient\n* Has known active hepatitis B or hepatitis C infection (Testing is not mandatory)\n* Has known immunosuppressive disease (e.g. human immunodeficiency virus \\[HIV\\], acquired immunodeficiency syndrome \\[AIDS\\] or other immune depressing disease). Testing is not mandatory\n* Has received a blood transfusion in the two weeks prior to leukapheresis\n* Pregnant or actively nursing (females who agree to stop nursing would be eligible) participants\n* Unwilling or unable to follow protocol requirements\n* Brain lesion size with significant midline shift or obstructive hydrocephalus\n* The use of corticosteroids to control cerebral edema or treat neurologic symptoms will not be allowed unless at a low dose, not to exceed 10 mg of prednisone (or equivalent) per day\n* History of stroke or transient ischemic attack within 6 months prior to study enrollment\n* History of (non-infectious) pneumonitis \u002Finterstitial lung disease that required steroids, or has current pneumonitis\u002F interstitial lung disease\n* Presence of leptomeningeal disease\n* Any contraindication to MRI (i.e., patients with pacemakers or other metal implanted medical devices). An MRI safety questionnaire is required prior to MR imaging\n* Has received prior radiotherapy within 2 weeks of start of study treatment with dendritic cell (DC) vaccine and\u002For has received SRS \\\u003C2. weeks prior to the administration of the first DC vaccine dose. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=\\\u003C 2 weeks of radiotherapy) to non-CNS disease\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Seasonal influenza vaccines for injection are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed. Administration of killed vaccines is allowed.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug (DC vaccine)\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* A WOCBP who has a positive urine or blood pregnancy test at screening and within 72 hrs prior to leukapheresis\n\n  \\*Note: in the event that 72 hrs have elapsed between the initial screening pregnancy test and leukapheresis, another pregnancy test (urine or serum) must be performed and must be negative in order for subject to undergo leukapheresis\n* Known active carcinomatous meningitis\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.","FEMALE",{"count":77,"type":20},23,[23],"This phase IIa trial studies how well dendritic cell vaccines against Her2\u002FHer3 and pembrolizumab work for the treatment of triple negative breast cancer or HER2+ breast cancer or HER+ Breast cancer that has spread to the brain (brain metastasis). Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the cancer cells. . Pembrolizumab is an \"immune checkpoint inhibitor\" which is designed to either \"unleash\" or \"enhance\" the cancer immune responses that already exist by either blocking inhibitory molecules\" or by activating stimulatory molecules. Giving dendritic cell vaccines and pembrolizumab may shrink the cancer.",[26,81,82,45],"Metastatic Malignant Neoplasm in the Brain","Metastatic Triple-Negative Breast Carcinoma","2026-05-07",{"date":85,"type":59},"2026-05-11",{"date":87,"type":59},"2022-12-19",{"date":89,"type":20},"2027-12-15",{"name":91,"class":66},"Roswell Park Cancer Institute",3,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":100,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100385985","phase-2-abemaciclib-and-endocrine-therapy-in-older-patients-with-breast-cancer-100385985","NCT04305834","Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.","A Phase IIA Trial Assessing the Tolerability of Abemaciclib in Combination With Endocrine Therapy in Patients Age 70 and Older With Hormone Receptor Positive Metastatic Breast Cancer Who Have Progressed on or After Prior CDK 4\u002F6 Inhibition","Inclusion Criteria:\n\n* Documented informed consent of the participant\n* Age \\>= 70 years\n* Life expectancy \\> 6 months\n* Ability to read and understand English or Spanish\n* Measurable or non-measurable disease\n* Histologically or cytologically confirmed diagnosis of:\n\n  * Estrogen-receptor positive and\u002For progesterone receptor positive breast cancer determined by immunohistochemistry (IHC) methods according to the local institution standard protocol\n  * HER2-negative breast cancer defined as negative if the IHC status is 0 or 1+, or if IHC is 2+ and in situ hybridization assay is negative per American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines\n* Radiographically confirmed metastatic breast cancer\n* Progressed on prior endocrine therapy or palbociclib or ribociclib or chemotherapy\n* Patients who received chemotherapy recovered from the acute side effects to prior cancer therapy (except alopecia or residual grade 2 peripheral neuropathy) to =\\\u003C grade 1 or baseline. A washout period of at least 21 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy)\n* Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization\n* Absence of central nervous system (CNS) involvement unless they meet ONE of the following criteria:\n\n  * Untreated brain metastases (e.g., lesions \\\u003C 1 cm) not needing immediate local therapy\n  * Previously treated brain metastases not needing immediate local therapy\n\n    * At least 4 weeks from the last date of prior therapy completion (including radiation and\u002For surgery) to starting the study treatment\n    * Clinically stable CNS tumor at the time of screening and not receiving steroids and\u002For enzyme-inducing anti-epileptic medications for brain metastases\n* Absence of interstitial lung disease\u002Fpneumonitis\n* Absolute neutrophil count (ANC) \\>= 1.5 X 10\\^9\u002FL\n* Platelets \\>= 100 x 10\\^9\u002FL\n* Hemoglobin \\>= 8 g\u002FdL\n\n  * (Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion)\n* In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 3.0 x upper limit of normal (ULN)\n\n  * If the patient has liver metastases, ALT and AST \\\u003C 5 x ULN\n* In patients without Gilbert's syndrome, total bilirubin =\\\u003C 1.5 x ULN; In patients with Gilbert's syndrome, total bilirubin =\\\u003C 2.0 x ULN or direct bilirubin within normal limits (WLN)\n* Creatinine clearance of \\>= 30 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula\n\nExclusion Criteria:\n\n* Major surgery within 14 days prior to receiving study drug or has not recovered from major side effect\n* Patient is currently receiving any of the prohibited medications detailed below and cannot be discontinued 7 days prior to starting study drug\n\n  * Other investigational therapy should be given to participants\n  * Anticancer agents other than the study medications administered as part of this study protocol should be given to participants. If such agents are required for a participant then the participant must first be withdrawn from the study\n  * Co-medication that may interfere with study results; e.g. immune-suppressive agents other than corticosteroids, such as systemic cyclosporine and tacrolimus are prohibited during the treatment phase of the study, unless discussed with principal investigator felt to be of low clinical risk to the participant\n  * Use of herbal medications may have unknown interactions with the metabolism of the study agents, and therefore are prohibited from use during the treatment phase of the trial\n* Known hypersensitivity to any of the excipients of abemaciclib\n* 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 is not required for enrollment\n* Impairment of gastrointestinal (GI) function or GI disease that in the investigator's opinion may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)\n* 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* Patient has any other concurrent severe or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis)\n* Inability to swallow oral medications\n* Serious or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C 30 ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)\n* History of non-compliance to medical regimen\n* Patients with a prior malignancy diagnosed within 2 years and with evidence of disease (except adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer","70 Years",{"count":102,"type":20},43,[23],"This phase IIa trial studies the side effects of abemaciclib monotherapy in treating patients age 70 years and older with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body.",[26,106,107,45],"Hormone Receptor Positive Breast Carcinoma","Metastatic Breast Carcinoma","2026-04-30",{"date":110,"type":59},"2026-05-04",{"date":112,"type":59},"2020-03-25",{"date":114,"type":20},"2026-08-21",{"name":116,"class":66},"City of Hope Medical Center",6,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":145},"100341312","s1703-serum-tumor-marker-directed-disease-monitoring-in-patients-with-hormone-receptor-positive-her2-negative-metastatic-breast-cancer-100341312","NCT03723928","S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer","Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored With Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients With Metastatic Hormone Receptor Positive Breast Cancer","Inclusion Criteria:\n\n* STEP 1 REGISTRATION\n* Patients must have a diagnosis of hormone receptor positive (estrogen receptor positive \\[ER+\\] and\u002For progesterone receptor positive \\[PR+\\]), HER-2 negative, metastatic (M1) breast cancer and must be receiving or plan to receive first-line systemic treatment for metastatic disease. (Systemic treatment is any treatment meant to treat the whole body such as endocrine therapy +\u002F- targeted therapy +\u002F- chemotherapy).\n\n  * NOTE: Participants are eligible if they have either de-novo metastatic breast cancer and\u002For recurrent breast cancer from an earlier stage that is now metastatic\n* Patients must be registered to step 1 between 14 days prior to and 60 days after start of first-line systemic treatment for metastatic disease\n* Patients must have been tested for the following breast cancer specific STMs after diagnosis of metastatic disease and within +\u002F-14 days of initiation of first-line systemic treatment for metastatic disease:\n\n  * CEA (must be tested)\n  * CA 15-3 or CA 27.29 (at least one of these must be tested)\n  * At least one of the tested STMs must have been \\>= 1.5 x the institutional upper limit of normal at this time.\n\nTesting all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring.\n\n* Patients must have systemic radiographic imaging prior to initiation of systemic therapy or within 30 days of initiation of treatment for metastatic breast cancer and prior to step 1 registration. Modality of imaging is at the discretion of the treating physician.\n\n  * Note: the treating physician can order additional imaging tests at any point prior to randomization at their discretion\n* Patients must be willing to obtain disease monitoring (imaging and\u002For serum tumor markers) from a consistent facility in which the registering site has access to the results for the duration of the study intervention (312 weeks after step 2 randomization). Imaging and STMs do not need to be completed at the same facility.\n* Patients with known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia are not eligible as these could cause falsely elevated STM levels\n* Patients with known brain leptomeningeal metastases are not eligible as they may require regular radiographic monitoring to assess treatment response\n* Patients must not be currently enrolled or plan to participate in a first-line treatment trial for metastatic breast cancer with a defined monitoring schedule\n* Patients who are able to complete questionnaires in English or Spanish must participate in patient-reported outcome (PRO) assessments\n* Patients must not be pregnant due to the potential harm to the fetus from radiation exposure from radiographic imaging\n* Except for breast cancer (and previous history of breast cancer), no other prior malignancy is allowed with the following exceptions:\n\n  * Adequately treated basal (or squamous cell) skin cancer\n  * Any cancer from which the patient has been disease free for five years\n  * Prior Stage 0 or pre-cancerous lesions that have been removed with clear margins\n* Patients must not have received prior systemic therapy for metastatic breast cancer, except for their current line of therapy.\n* Patients must have decision making capacity and be able to provide informed consent\n* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; use of legally-authorized representative is not permissible for this study. Remote consent is allowed with adequate documentation.\n* As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* STEP 2 RANDOMIZATION\n* Patients must be tested for the breast cancer specific STMs that were tested prior to STEP 1 Registration between 56 and 140 days after initiation of first-line systemic therapy for metastatic disease:\n\n  * CEA (must be tested)\n  * CA 15-3 or CA 27.29 (whichever was tested prior to Step 1)\n\nTesting all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring.\n\n* At least one of the STMs that was previously elevated must have decreased from the assessment at step 1 by \\>= 10% at this time.\n* Patients must not have known progression since registration to step 1\n* Patients must be registered to step 2 randomization between 56 days and 140 days after the initiation of first-line systemic therapy for metastatic disease; This window is inclusive; patients may be registered to Step 2 on day 56 or Day 140. Patients must have been eligible for Step 1 in order to be eligible for Step 2 Randomization\n* Baseline questionnaires must be completed within 28 days prior to step 2 randomization; (Note: Those patients who cannot complete the PRO questionnaires in English or Spanish can be registered to step 2 without contributing to PRO research)",{"count":126,"type":20},739,[128],"NA","This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.",[26,131,132,133,45,134],"Estrogen Receptor Positive","HER2\u002FNeu Negative","Progesterone Receptor Positive","Elevated CA15-3 or CEA or CA27-29","2026-04-01",{"date":137,"type":59},"2026-04-02",{"date":139,"type":59},"2018-09-17",{"date":141,"type":20},"2036-12-01",{"name":143,"class":144},"SWOG Cancer Research Network","NETWORK",723,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":75,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":67},"100471317","early-phase-1-topical-or-oral-minoxidil-for-the-treatment-of-endocrine-therapy-induced-alopecia-in-patients-with-stage-i-iv-breast-cancer-100471317","NCT05417308","Topical or Oral Minoxidil for the Treatment of Endocrine Therapy-Induced Alopecia in Patients With Stage I-IV Breast Cancer","A Pilot Trial of Topical vs Oral Minoxidil for Treatment of Endocrine Therapy-Induced Alopecia in Breast Cancer Patients","Inclusion Criteria:\n\n* Women \\>= 18 years of age\n* Established diagnosis of breast cancer stages I-IV\n* On endocrine therapy including tamoxifen or aromatase inhibitors with or without concurrent use of ovarian function suppression\n* Self-reporting hair loss since starting endocrine therapy\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* Current chemotherapy use or prior chemotherapy use within the last 2 years\n* History of scarring\u002Fcicatricial alopecia or alopecia areata\n* Prior use of oral or topical minoxidil\n* Prior or ongoing use of spironolactone\n* Known sensitivity to minoxidil\n* Untreated hypothyroidism or iron deficiency as determined by thyroid stimulating hormone (TSH) with reflex free T4 and ferritin level \\> 40 to be checked at the time of enrolling if not completed in the 12 months prior",{"count":19,"type":20},[155],"EARLY_PHASE1","This early phase I trial studies the possible benefits and\u002For side effects of topical or oral minoxidil in treating endocrine therapy-induced hair loss (alopecia) in patients with stage I-IV breast cancer. Endocrine therapy-induced alopecia (EIA) is a distressing side effect that leads to reduced quality of life and early cessation of therapy in women undergoing treatment for breast cancer. Patients on endocrine therapy commonly report hair loss or thinning. Minoxidil is a drug that may promote hair growth and reduce hair loss. Oral minoxidil may increase hair density in women with EIA, and work the same as topical minoxidil in treating EIA in patients with breast cancer.",[158,159,160,161,162,163,164,165,166,167,26,168,169,170,171,172,173,174,175,176,177,44,45],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage IA Breast Cancer AJCC v8","Anatomic Stage IB Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage IIA Breast Cancer AJCC v8","Anatomic Stage IIB Breast Cancer AJCC v8","Anatomic Stage III 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","Endocrine Therapy-Induced Alopecia","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","2026-03-06",{"date":180,"type":59},"2026-03-10",{"date":182,"type":59},"2023-03-01",{"date":184,"type":20},"2027-12-31",{"name":186,"class":66},"Ohio State University Comprehensive Cancer Center",{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":75,"minAge":17,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":21,"phases":196,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":208,"locationsCount":67},"100369455","phase-2-olaparib-with-cediranib-or-azd6738-for-the-treatment-of-advanced-or-metastatic-germline-brca-mutated-breast-cancer-100369455","NCT04090567","Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer","Overcoming PARP Inhibitor Resistance in BRCA Germline Mutation Positive Advanced Breast Cancer","Inclusion Criteria:\n\n1. Provision of informed consent prior to any study specific procedures\n2. Women age greater than 18 years with advanced\u002Fmetastatic HER2 negative, BRCA germline positive breast cancer. Estrogen receptor positive (ER+) patients must have progressed on a prior endocrine therapy or are considered inappropriate for any FDA approved endocrine therapies for ER+ breast cancer.\n3. Eligible patients must agree to a mandatory fresh biopsy (excluding bone) at screening. In addition, if available, an archival tissue sample will also be collected at screening.\n4. Patients must have normal organ and bone marrow function measured within 28 days (baseline screening) as defined below:\n\n   * Hemoglobin (Hgb) \\>\u002F= 10.0 g\u002FdL with no blood transfusion in the past 28 days prior to the administration\n   * Absolute neutrophil count (ANC) \\>\u002F= 1.5 x 109\u002FL with no GCSF administration within 28 days prior to administration of study treatment\n   * Platelet count \\>\u002F= 100 x 109\u002FL\n   * Total bilirubin \\\u003C\u002F= 1.5 x institutional upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST) \u002F Alanine aminotransferase (ALT) \\\u003C\u002F=3.0 x institutional upper limit of normal unless liver metastases are present in which case they must be \\\u003C\u002F=5x ULN\n\n4\\) Eastern Cooperative Oncology Group (ECOG) performance status 0-1 5) Patients must have life expectancy \\>\u002F= 16 weeks. 6) Negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on Cycle 1 day 1 and during the study for child bearing potential women.\n\n• Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: ≥ 60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry and be using highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female subjects if the risk of conception exists (Note: The effects of the trial treatment on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use highly effective contraception, defined in Appendix E or as stipulated in national or local guidelines). Highly effective contraception must be used 30 days prior to first trial treatment administration, for the duration of trial treatment, and at least for 1 month after stopping trial treatment.\n\n7\\) Patients is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations. 8) Patient has measurable disease, per RECIST v 1.1. At least one lesion, not previously irradiated or biopsied for this study that can be accurately measured at baseline as \\>\u002F= 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI).\n\n9\\) Willingness to undergo baseline biopsy of metastatic lesion (repeat biopsy at progression\u002For end of the study is optional) 10) Willingness to have research blood draw at baseline and at progression\u002Fend of the study 11) Patient should have previously treated with any PARP inhibitor ((neo)adjuvant or metastatic) setting) and must have remained on treatment for \\>\u002F= 2 months prior to progression of disease.\n\n12\\) Able to swallow and retain oral medications and without gastrointestinal (GI) illnesses that would preclude absorption of Olaparib or ceralasertib.\n\n13\\) Non-english speaking subject can be enrolled\n\nExclusion Criteria:\n\n1. Patients who have had chemotherapy or RT within 3 weeks ( or less than 1 week if on weekly chemotherapy) prior to start of the study agents. or persisting \\>\u002F= Grade 2 CTCAE toxicity (except alopecia and Grade 2 peripheral neuropathy) from previous anti-cancer treatment(s), or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier. No washout time period is needed for PARP inhibitors.\n2. Patients received any other investigational agents within the past 4 weeks.\n3. Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on computed tomography (CT) or magnetic resonance imaging (MRI) scans should be excluded from this clinical trial. Patient with known and treated brain metastases is allowed in this study if they fulfil the following criteria: The lesions have improved or remained stable radiographically and clinically for at least 6 weeks after completion of brain irradiation or stereotactic brain radiosurgery. Patients can be on steroids not more than 10 mg\u002Fday if started 4 weeks prior to initiation of study drug).\n4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Olaparib or ceralasertib.\n5. Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 (See Appendix A) are ineligible, unless discontinues within the washout period (2 weeks for CYP3A4 inhibitors and 4weeks for CYP3A4 inducers) as described in Appendix A. Dihydropyridine calcium-channel blockers are permitted for management of hypertension. Other medications described in Appendix A should be discontinued within the washout period prior to the initiation of study drugs. In addition, patients enrolled in Olaparib+ ceralasertib arm, co-administration of study drug with substrates of OATP1B1 and Pgp (P-glycoprotein) inhibitor or inducer is prohibited.\n6. Current use of natural herbal products (see Appendix A) or other complementary alternative medications (CAM) or \"folk remedies\" should be discontinued 7 days prior to the initiation of study drugs.\n\n8\\) Patients with concomitant or prior invasive malignancies within the past 5 years. Subjects with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible.\n\n9\\) Uncontrolled inter-current illness including, but not limited to, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan, ongoing or active infection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n\n10\\) History of myocardial infarction, stroke or transient ischemic attack within 6-12 months. Current condition requiring concurrent use of drugs or biologics with anti-arrhythmic or proarrhythmic potential 11) History of hypertensive crisis or hypertensive encephalopathy within 3 years.\n\n12\\) Clinically significant peripheral vascular disease or vascular disease (abdominal aortic aneurysm (\\>5cm) or aortic dissection). If known history of abdominal aortic aneurysmwith\n\n* 4cm in diameter, all the following criteria must be met:\n\n  * An ultrasound (US) within the last 6 months will be required to document that it is \\\u003C\u002F= 5cm\n  * Patient must be asymptomatic from the aneurysm.\n\n    13\\) A major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting study drug (percutaneous\u002Fendobronchial biopsies are allowed). The patient must have recovered from any effects of any major surgery and surgical wound should have healed prior to starting treatment.\n\n    14\\) Patients may not have current signs and\u002For symptoms of bowel obstruction within 3 months prior to starting study drugs, except if it was a temporary incident (improved within \\\u003C 24hrs with medical management).\n\n    15)History of haemoptysis or any significant bleeding within the last 1 month prior to enrolment. 16) Presence of cavitation of central pulmonary lesion 17) Intra-abdominal abscess within the 3 months prior to enrolment. Patient with history of GI perforation. History of abdominal fistula will be considered eligible, if the fistula was surgically repaired, there has been no evidence of fistula for at least 6 months prior to starting treatment, and patient is deemed to be at low risk of recurrent fistula.\n\n    18\\) Patients may have current dependency on IV hydration or total parenteral nutrition (TPN).\n\n    19\\) Patients may have features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated. 20) As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, active bleeding diatheses, renal transplant, or active infection including any patient known to have hepatitis B, hepatitis C and human immunodeficiency virus (HIV).\n\nScreening for chronic conditions is not required 21) Any condition that, in the opinion of the treating investigator would interfere with evaluation of the investigational product or interpretation of subject safety or study results.\n\n22\\) Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n\n23\\) Prior exposure to Ceralasertib 24) Patients with uncontrolled seizure 25) Any of the following cardiac criteria:\n\n* Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \\>450 milli-second, or patients with congenital long QT syndrome or family history of unexplained sudden death under 40 years of age\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block).\n\n  26\\) Patients at risk of brain perfusion problems, e.g., carotid stenosis 27) Patients with relative hypotension (\\\u003C 100\u002F60 mm Hg) or clinically relevant orthostatic hypotension (\\>\u002F= 20 beats per minute change in pulse including a fall in blood pressure of\n\n  \\>\u002F=20mm Hg associated with dizziness, syncope, and blurred vision, from lying down or sitting to standing). Uncontrolled hypertension requiring clinical intervention.\n\n  28\\) Breast feeding\u002Flactating\u002Fpregnant women. 29) Prior allogeneic bone marrow transplant or double umbilical cord blood transplantation.\n\n  30\\) A diagnosis of ataxia telangiectasia 31) Major surgery within 3 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.",{"count":195,"type":20},60,[23],"This phase II trial studies how well olaparib with cediranib or AZD6738 works in treating patients with germline BRCA mutated breast cancer that has spread to other places in the body (advanced or metastatic). Olaparib, cediranib, and AZD6738 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.",[199,164,165,166,167,26,200,201,132,107,175,176,177,44,45],"Advanced Breast Carcinoma","Germline BRCA1 Gene Mutation","Germline BRCA2 Gene Mutation","2026-03-03",{"date":204,"type":59},"2026-03-05",{"date":206,"type":59},"2020-07-28",{"date":184,"type":20},{"name":65,"class":66},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":21,"phases":218,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":232,"locationsCount":234},"100541006","phase-1-personalized-vaccine-immunotherapy-in-combination-with-checkpoint-inhibitor-for-treatment-of-triple-negative-breast-cancer-100541006","NCT06324240","Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer","Clinical Evaluation of a Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Triple Negative Breast Cancer (TNBC)","Inclusion Criteria:\n\n* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\n* Must be age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 14 days prior to tissue consent\n* Absolute neutrophil count \\> 1500\u002FmcL (obtained within 14 days prior to vaccine administration)\n* Absolute lymphocyte count \\>= 600 cells\u002Fµl (obtained within 14 days prior to vaccine administration)\n* Platelets \\> 100,000 mm (obtained within 14 days prior to vaccine administration)\n* Hemoglobin \\> 9.0 g\u002FdL (obtained within 14 days prior to vaccine administration) (NOTE: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\> 9.0g\u002Fdl is acceptable)\n* Serum creatinine =\\\u003C 1.5 x upper limit of normal (ULN) or calculated creatinine clearance \\>= 60 mL\u002Fmin using Cockcroft-Gault equation for patients with creatinine levels \\> 1.5 x institutional ULN (obtained within 14 days prior to vaccine administration)\n* Total bilirubin =\\\u003C 1.5 x ULN OR direct bilirubin =\\\u003C 1 x ULN (obtained within 14 days prior to vaccine administration)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN unless liver metastases are present, in which case they must be =\\\u003C 5 x ULN (obtained within 14 days prior to vaccine administration)\n* Bilirubin =\\\u003C 1.5 X ULN (except in participants with documented Gilbert's disease, who must have a total bilirubin =\\\u003C 3.0 mg\u002FdL) (obtained within 14 days prior to vaccine administration)\n* International normalized ratio (INR) or prothrombin time (PT) =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (obtained within 14 days prior to vaccine administration)\n* Activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (obtained within 14 days prior to vaccine administration)\n* TNBC as defined by estrogen receptor (ER)\u002Fprogesterone receptor (PR) =\\\u003C 10% if Allred =\\\u003C 3; Her2\u002Fneu negative as defined by scores of 0 or 1+ by immunohistochemistry (IHC) or 2+ by IHC associated with a fluorescence in situ hybridization (FISH) ratio of \\\u003C 2.0 or \\\u003C 6 Her2 copies per cell\n* Patients with metastatic or inoperable locally advanced disease: Metastatic or inoperable locally advanced disease is defined as either histologically confirmed metastatic breast cancer by biopsy; or locally advanced breast cancer that, in the opinion of the treating physician, is not amenable to curative intent surgical resection; or, radiological or clinical evidence suggestive and supportive of metastatic disease\n\n  * Documented metastatic biopsy is not required provided the patient has a prior diagnosis of TNBC that otherwise meets the eligibility criteria\n  * Eligible patients must have =\\\u003C 3 lines of chemotherapy in the metastatic\u002Fadvanced disease setting. For patients who have relapsed within 6 months of systemic therapy given within curative intent, that therapy will count as a line of metastatic therapy. Last cycle of cytotoxic therapy must be \\>= 21 days prior to cycle (C)1 day (D)1 of vaccine. Last cycle of checkpoint inhibitor therapy be \\>= 28 days prior to C1D1 of vaccine. Last dose of radiotherapy must be \\>= 14 days prior to C1D1 of vaccine\n  * Prior checkpoint inhibitor is permitted. Patients who are known to have PD-L1 positive with combined positive score (CPS) \\>= 10 will be required to have had pembrolizumab therapy prior to enrollment\n  * Patients who are metastatic or inoperable, locally advanced will only be eligible for the Phase 1b combination cohort. They will not be eligible for the Phase 1a dose escalation cohort. Patients who have received prior anti-CTLA-4 antibody will preferentially be enrolled to cohort B (combination of TMV vaccine with pembrolizumab). Patients who have received prior PD-L1 or PD-1 antibody therapy will preferentially be enrolled to cohort C (combination of TMV vaccine with ipilimumab). Patients with metastatic disease who have received no prior immune checkpoint inhibitor therapy will be assigned to a treatment arm based on available slots and discretion of treating physician\n* Patients with early stage TNBC: Early stage TNBC is defined as clinical or pathologic Stage I-III TNBC\n\n  * After resection of disease in the breast and axilla, early stage patients are eligible for either the Phase 1a dose escalation of TMV vaccine monotherapy Cohort A or the Phase 1b combination arm of the vaccine with immune checkpoint inhibitor (ICI)\n  * Patients will be required to have completed adjuvant radiotherapy (if indicated) \\>= 14 days prior to initiation of vaccine on trial\n  * Patients who have residual disease after completion neoadjuvant therapy that proceed with adjuvant capecitabine can enroll \\>= 28 days after completion of final dose of capecitabine. Patients electing to enroll onto the Phase 1a Cohort A monotherapy arm can enroll prior to initiation of capecitabine, however must not initiate capecitabine prior to the Week 12 blood draw (measurement of immune biomarkers) on study\n  * Patients who have a germline BRCA 1\u002F2 mutation that meet the Food and Drug Administration (FDA) indication for use of adjuvant Olaparib can enroll \\>= 28 days after completion of final dose of olaparib. Patients electing to enroll onto the Phase 1a Cohort A monotherapy arm can enroll prior to initiation of olaparib, however must not initiate olaparib prior to the Week 12 blood draw (measurement of immune biomarkers) on study\n  * Patients who undergo upfront surgery: Patients may initiate injection of vaccine \\>= 28 days after completion of final cycle of adjuvant chemotherapy\n  * Patients who have early stage breast cancer that have residual disease after completing neoadjuvant chemotherapy with the KEYNOTE 522 regimen (pembrolizumab at a dose of 200 mg every 3 weeks plus weekly paclitaxel and carboplatin for 4 cycles followed by pembrolizumab-doxorubicin-cyclophosphamide or of pembrolizumab-epirubicin-cyclophosphamide every 3 weeks for 4 cycles):\n\n    * Patient enrolling onto Phase 1a Cohort A will initiate injection of vaccine \\>= 28 days after completion of final cycle of standard of care adjuvant pembrolizumab\n    * Patient enrolling onto Phase 1b Cohort B or C will initiate injection of vaccine \\>= 28 days surgical resection. Patients who have received pembrolizumab as part of the preoperative KEYNOTE 522 regimen will preferentially be enrolled to cohort B (combination of TMV vaccine with pembrolizumab) and will receive up to 9 cycles of adjuvant pembrolizumab every 3 weeks as per standard of care. Vaccine will be administered every 2 weeks for 3 doses prior to the first three ICI cycles\n  * Patients who have early stage breast cancer that have that have residual disease after completing neoadjuvant chemotherapy with either dose-dense doxorubicin-cyclophosphamide followed by paclitaxel or docetaxel-cyclophosphamide:\n\n    * Patient enrolling onto Phase 1a Cohort A will initiate injection of vaccine \\>= 28 days surgical resection\n    * Patient enrolling onto Phase 1b Cohort B or C will initiate injection of vaccine \\>= 28 days surgical resection. Patients will be assigned to receive either pembrolizumab (Cohort B) every 3 weeks for 6 cycles or ipilimumab (Cohort C) every 3 weeks for 4 cycles in combination with TMV vaccine based on available slots in each arm and discretion of treating physician. Vaccine will be administered every 2 weeks for 3 doses; the TMV vaccine will be administered prior to the ICI cycle if ICI is due.\n* Weight of tumor tissue for production of vaccine must be at least 1 gram. In metastatic patients, preferentially, invasive tumor in breast or lymph node tissue will be retrieved by excisional biopsy to ensure sufficient yield. In metastatic patients who undergo initiation of first-line standard of care systemic therapy off study (i.e. pembrolizumab and chemotherapy in a PD-L1 positive patient), then ideally collection of tumor tissue will occur prior to treatment initiation of standard of care therapy to maximize cellularity. Metastatic patients who have undergone mastectomy during curative treatment initially or have no invasive disease in the breast, chest wall, or accessible regional lymph nodes, will be evaluated for image-guided core biopsies of liver metastasis or video-assisted thorascopic wedge resection of lung metastasis\n\n  * In patients with early stage TNBC undergoing upfront surgery, the tumor tissue will be retrieved during lumpectomy\u002Fmastectomy. In early stage patients who are identified as high risk of having residual disease after neoadjuvant chemotherapy or undergo upfront resection, tissue will be retrieved during planned lumpectomy or mastectomy\n* Measurable disease is not required in metastatic patients but patients must have sufficient tumor to yield 1g on biopsy to enable production of personalized TMV vaccine product\n* Patients will undergo germline testing to assess for a BRCA1\u002FBRCA2 deleterious mutation. Knowledge of germline status is not required to enroll on the study\n* Able and willing to complete the entire study according to the study schedule\n* Patients must give written informed consent. A copy of the signed informed consent form will be retained in the patient's chart\n\nExclusion Criteria:\n\n* Weight of the tumor tissue is less 1 gram\n* Clinically significant comorbid conditions such as cardiovascular disease or significant peripheral vascular (e.g., uncontrolled hypertension, myocardial infarction, unstable angina) within 6 months of study entry, serious cardiac arrhythmia requiring medication, and uncontrolled infection\n* No second malignancy except prior breast cancer or except non-melanomatous skin cancer within the past 5 years\n* Ongoing or planned systemic anti-cancer therapy or radiation therapy. Last cycle of cytotoxic therapy must be \\>= 21 days prior to C1D1 of vaccine. Last cycle of checkpoint inhibitor therapy be \\>= 28 days prior to C1D1 of vaccine. Last dose of radiotherapy must be \\>= 14 days prior to C1D1 of vaccine\n* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 120 days after the last dose of study treatment\n* Has a known history of active tuberculosis (Bacillus Tuberculosis)\n* History of allogeneic organ transplant\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for management of brain metastases for at least 7 days prior to study treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability\n* Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid\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) is not considered a form of systemic treatment\n* Known history of non-infectious pneumonitis that required steroids or any evidence of active pneumonitis\n* Failure to recover from grade 3 or 4 toxicity from previous treatment\n* For the combination cohort: prior grade 4 immune-related adverse events due to previous ICI. Patients who experienced grade 2 or 3 toxicity with prior ICI therapy may enroll if toxicity reverted to =\\\u003C grade 1",{"count":217,"type":20},18,[219],"PHASE1","This phase I trial tests the safety, side effects, and best dose of a personalized vaccine (tumor membrane vesicle or TMV vaccine) by itself and in combination with checkpoint inhibitor (pembrolizumab or ipilimumab) in treating patients with triple negative breast cancer. This vaccine is made by taking a piece of patient's triple negative breast cancer to design a vaccine to stimulate the immune system's memory. Patients are treated with the personalized vaccine immunotherapy with or without monoclonal antibodies, such as pembrolizumab and ipilimumab. This approach may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving personalized TMV vaccine with pembrolizumab or ipilimumab may help the immune system attack cancer better and reduce the risk of this breast cancer coming back or growing.",[158,159,160,161,162,163,164,165,166,167,26,222,223,82,169,170,171,172,173,174,175,176,177,44,45,224,225],"Early Stage Triple-Negative Breast Carcinoma","Locally Advanced Triple-Negative Breast Carcinoma","Recurrent Breast Carcinoma","Unresectable Triple-Negative Breast Carcinoma","2026-01-23",{"date":228,"type":59},"2026-01-26",{"date":230,"type":59},"2025-12-02",{"date":63,"type":20},{"name":233,"class":66},"Emory University",4,{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":21,"phases":242,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":67},"100446356","phase-1-phase-i-study-of-tumor-treating-fields-ttf-in-combination-with-cabozantinib-or-with-pembrolizumab-and-nab-paclitaxel-in-patients-with-advanced-solid-tumors-involving-the-abdomen-or-thorax-100446356","NCT05092373","Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib or With Pembrolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax","Inclusion Criteria:\n\n* Participants must have pathologically confirmed advanced\u002Fmetastatic solid cancer (hepatocellular carcinoma, renal cell carcinoma, breast cancer, ovarian\u002Ffallopian, or endometrial\u002Fprimary peritoneal tumors) involving the abdomen or thorax, cannot tolerate standard therapy or have experienced tumor progression on standard therapy.\n* Age: ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Life expectancy \\>3 months.\n* Normal bone marrow function, defined as absolute neutrophil count ≥1,000\u002FµL; platelets ≥75,000\u002FµL; hemoglobin ≥8 g\u002FdL.\n* Adequate hepatic function as defined by a total bilirubin level ≤1.5 x the upper limit of normal (ULN), unless the patient has known Gilbert's syndrome, and alanine aminotransferase (ALT)\u002F serum glutamic pyruvic transaminase levels (SGPT) ≤2.5 x ULN (unless the patient has liver metastases: ALT)\u002F serum glutamic pyruvic transaminase levels (SGPT) ≤5 x ULN).\n* Participants with HCC must have a Child Pugh status A, no clinically significant ascites (requiring pharmacological or interventional treatment), and no history (or increased risk) of esophageal\u002Fgastric bleeding, impaired wound healing, perforation or fistula.\n* Serum creatinine clearance ≥50 mL\u002Fmin by the Cockcroft-Gault formula.\n* Measurable disease by RECIST or evaluable disease.\n* Contraception: Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months and who have not had a tubal ligation, hysterectomy, or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. Male participants must agree to use effective contraception or abstinence while on study.\n* Able to operate the TTF device independently or with the help of a caregiver.\n\nExclusion Criteria:\n\n* Participants must not receive prior anticancer therapy or radiation therapy within 2 weeks and must not undergo major surgery within 4 weeks prior to initiation of treatment on protocol. Participants who are already on cabozantinib and have progressive disease are allowed to transition to treatment with tumor treating fields and cabozantinib. Participants in both cohorts who already started treatments as standard of care (Cohort 1: Cabozantinib and Cohort 2: nab-paclitaxel and Pembrolizumab) are allowed to start on protocol within the first 2-3 weeks of treatment initiation. Palliative radiation therapy is allowed.\n* Participants must have recovered to Grade 0-1 toxicity from prior therapy.\n* Active brain metastasis or leptomeningeal disease. Patients with treated brain metastasis must have stable disease, evidenced by brain imaging for at least 4 weeks and the patient must have been off steroids for at least 2 weeks.\n* The patient has cardiac conditions as follows: uncontrolled: hypertension (blood pressure \\[BP\\] \\> 160\u002F100) despite optimal therapy, uncontrolled angina, ventricular arrhythmias, congestive heart failure (New York Heart Association Class II or above), prior or current cardiomyopathy, uncontrolled atrial fibrillation with heart rate \\> 100 beats per minute (bpm), unstable ischemic heart disease (myocardial infarction within 6 months prior to starting treatment or angina requiring use of nitrates more than once weekly).\n* The patient has concurrent severe and\u002For uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease).\n* Concurrent malignancies are permitted if (A) they were previously treated, and all treatment of that malignancy was completed at least 2 years before enrollment and no evidence of disease exists, or (B) with agreement from the Principal Investigator (PI), participants who have a concurrent malignancy that is clinically stable and does not require tumor-directed treatment are eligible to participate if the risk of the prior malignancy interfering with either safety or efficacy endpoints is very low, or (C) with agreement from the PI, other malignancies may be permitted if the risk of the prior malignancy interfering with either safety or efficacy end points is very low. Adequately treated basal or squamous cell carcinoma or carcinoma in situ is allowed.\n* The patient is pregnant or breastfeeding.\n* History of hypersensitivity or contraindication to TTF.\n* Implanted pacemaker, defibrillator or other electrical medical devices.\n* The participant has a previously-identified allergy or hypersensitivity to cabozantinib, nab-paclitaxel, or pembrolizumab, medical adhesives or hydrogel or the patient has received prior cabozantinib and discontinued therapy due to unacceptable toxicity.\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.\n* The patient is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.\n* CABOZANTINIB COHORT ONLY: The patient has experienced clinically-significant hematemesis or hemoptysis of \\> 0.5 teaspoon of red blood, or other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment.\n* CABOZANTINIB COHORT ONLY: The patient has a cavitating pulmonary lesion(s) or a pulmonary lesion abutting or encasing a major blood vessel.\n* CABOZANTINIB COHORT ONLY: The patient has received drugs used to control loss of bone mass within 4 weeks prior to the first dose of study treatment.\n* CABOZANTINIB COHORT ONLY: The patient has prothrombin time\u002Finternational normalized ratio (PT\u002FINR) or partial thromboplastin time (PTT) test results that are above (1.3X) the laboratory upper limit of normal.\n* CABOZANTINIB COHORT ONLY: The subject has a corrected QT interval (QTcF) \\> 450 ms for men or \\> 470 ms for women.\n* CABOZANTINIB COHORT ONLY: The patient requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or Coumadin-related agents, heparin, thrombin or FXa inhibitors, and antiplatelet agents. Low-dose aspirin (≤ 81 mg\u002Fday), low dose warfarin (≤ 1mg\u002Fday), and prophylactic low molecular weight heparin (LMWH) are permitted.\n* CABOZANTINIB COHORT ONLY: Patients with encasement of a major artery or bowel by tumor are excluded.\n* CABOZANTINIB COHORT ONLY: The patient is unable to swallow capsules.\n* CABOZANTINIB COHORT ONLY: History of hypersensitivity or contraindication to cabozantinib.\n* ATEZOLIZUMAB-CONTAINING COHORT: Participants who have received prior immunotherapy, including prior anti-PD-1 or anti-PD-L1 therapies may participate: (A) only if their prior anti-PD-1 or anti-PDL1 monotherapy or combination therapy were NOT the last treatment prior to participation on this study. (B) Participants who had prior immunotherapies and experienced Grade 1-2 immune-related adverse event (irAE) must have documentation that their irAEs are Grade 1 or 0 using current Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0) and participants must be off steroid therapy and\u002For other immunosuppressive therapy, as treatment for irAEs, for \\>= 14 days from Cycle 1, Day 1. (C) Participants who experienced Grade 3 irAEs consisting of laboratory abnormalities that were asymptomatic and have now resolved to Grade 1 or 0 and participants who have been off steroid and\u002For other immunosuppressive therapy, as treatment for irAEs, for \\>= 30 days from Cycle 1, Day 1. Participants with prior irAE pneumonitis (\\>= Grade 2) should not be given atezolizumab.\n* ATEZOLIZUMAB-CONTAINING COHORT: Human immunodeficiency virus (HIV) infection, active Hepatitis B or C infection, or active infections requiring oral or intravenous antibiotics.\n* ATEZOLIZUMAB-CONTAINING COHORT: Has received a live vaccine within 30 days prior to first dose.\n* ATEZOLIZUMAB-CONTAINING COHORT: Active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis or other known risk factors for bowel perforation.\n* ATEZOLIZUMAB-CONTAINING COHORT: Serious autoimmune disease at the discretion of the treating attending: Patients with a history of active serious inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g. Wegener's Granulomatosis) are excluded from this study.\n* ATEZOLIZUMAB-CONTAINING COHORT: History of\u002For current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician.",{"count":102,"type":20},[219],"This phase Ib trial tests the safety, side effects, and best dose of tumor treating fields therapy in combination with either cabozantinib or nab-paclitaxel and atezolizumab in treating patients with solid tumors involving the abdomen or thorax that have spread to other parts of the body (advanced). Tumor treating fields therapy on this study utilizes NovoTTF systems that are wearable devices that use electrical fields at different frequencies that may help stop the growth of tumor cells by interrupting cancer cells' ability to divide. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. 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 atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tumor treating fields therapy in combination with either cabozantinib, or with nab-paclitaxel and atezolizumab may help control advanced solid tumors involving the abdomen or thorax.",[199,245,246,247,248,249,250,251,252,253,164,165,166,167,26,254,255,107,256,257,258,259,260,261,262,263,264,175,176,177,44,45,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291,292,293,294,295,296,297,298,299,300,301,302,303,304,305,306],"Advanced Endometrial Carcinoma","Advanced Fallopian Tube Carcinoma","Advanced Hepatocellular Carcinoma","Advanced Malignant Abdominal Neoplasm","Advanced Malignant Female Reproductive System Neoplasm","Advanced Malignant Thoracic Neoplasm","Advanced Ovarian Carcinoma","Advanced Primary Peritoneal Carcinoma","Advanced Renal Cell Carcinoma","Malignant Abdominal Neoplasm","Malignant Solid Neoplasm","Metastatic Endometrial Carcinoma","Metastatic Fallopian Tube Carcinoma","Metastatic Hepatocellular Carcinoma","Metastatic Malignant Abdominal Neoplasm","Metastatic Malignant Female Reproductive System Neoplasm","Metastatic Malignant Thoracic Neoplasm","Metastatic Ovarian Carcinoma","Metastatic Primary Peritoneal Carcinoma","Metastatic Renal Cell Carcinoma","Stage III Fallopian Tube Cancer AJCC v8","Stage III Hepatocellular Carcinoma AJCC v8","Stage III Ovarian Cancer AJCC v8","Stage III Primary Peritoneal Cancer AJCC v8","Stage III Renal Cell Cancer AJCC v8","Stage III Uterine Corpus Cancer AJCC v8","Stage IIIA Fallopian Tube Cancer AJCC v8","Stage IIIA Hepatocellular Carcinoma AJCC v8","Stage IIIA Ovarian Cancer AJCC v8","Stage IIIA Primary Peritoneal Cancer AJCC v8","Stage IIIA Uterine Corpus Cancer AJCC v8","Stage IIIA1 Fallopian Tube Cancer AJCC v8","Stage IIIA1 Ovarian Cancer AJCC v8","Stage IIIA2 Fallopian Tube Cancer AJCC v8","Stage IIIA2 Ovarian Cancer AJCC v8","Stage IIIB Fallopian Tube Cancer AJCC v8","Stage IIIB Hepatocellular Carcinoma AJCC v8","Stage IIIB Ovarian Cancer AJCC v8","Stage IIIB Primary Peritoneal Cancer AJCC v8","Stage IIIB Uterine Corpus Cancer AJCC v8","Stage IIIC Fallopian Tube Cancer AJCC v8","Stage IIIC Ovarian Cancer AJCC v8","Stage IIIC Primary Peritoneal Cancer AJCC v8","Stage IIIC Uterine Corpus Cancer AJCC v8","Stage IIIC1 Uterine Corpus Cancer AJCC v8","Stage IIIC2 Uterine Corpus Cancer AJCC v8","Stage IV Fallopian Tube Cancer AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Primary Peritoneal Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IV Uterine Corpus Cancer AJCC v8","Stage IVA Fallopian Tube Cancer AJCC v8","Stage IVA Hepatocellular Carcinoma AJCC v8","Stage IVA Ovarian Cancer AJCC v8","Stage IVA Primary Peritoneal Cancer AJCC v8","Stage IVA Uterine Corpus Cancer AJCC v8","Stage IVB Fallopian Tube Cancer AJCC v8","Stage IVB Hepatocellular Carcinoma AJCC v8","Stage IVB Ovarian Cancer AJCC v8","Stage IVB Primary Peritoneal Cancer AJCC v8","Stage IVB Uterine Corpus Cancer AJCC v8","2026-01-13",{"date":309,"type":59},"2026-01-14",{"date":311,"type":59},"2022-04-29",{"date":313,"type":20},"2026-09-01",{"name":65,"class":66},{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":324,"phases":4,"briefSummary":325,"conditions":326,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":67},"100402922","biomarkers-and-clinical-features-of-metastatic-breast-cancer-in-patients-treated-with-cdk46-inhibitors-100402922","NCT04526587","Biomarkers and Clinical Features of Metastatic Breast Cancer in Patients Treated With CDK4\u002F6 Inhibitors","The Roswell Park Ciclib Study: A Prospective Study of Biomarkers and Clinical Features of Advanced\u002FMetastatic Breast Cancer Treated With CDK4\u002F6 Inhibitors","Inclusion Criteria:\n\n* All adult patients with ER+\u002FHER2- metastatic breast cancer or HR+\u002FHER2-node positive, high risk early breast cancer who are being or have been treated with ciclib-based therapies are eligible for inclusion in this study\n\n  * This includes patients receiving standard of care therapy for ER+\u002FHER2- metastatic breast cancer, as well as those who would be eligible to participate in a non-interventional study while on a clinical study open at Roswell Park or St. Vincent's Hospital\n  * Screening will occur in breast oncology clinic, by review of patient medical records for the pending, ongoing, or past treatment with ciclib-based therapy\n* Participant must understand the prospective nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form\n\nExclusion Criteria:\n\n* Pregnant of nursing female subjects\n* Unwilling or unable to follow protocol requirements",{"count":323,"type":20},700,"OBSERVATIONAL","This study investigates the clinical course of CDK4\u002F6 inhibitor treated patients in the real-world setting among patients with breast cancer. CDK4\u002F6 inhibitors may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Studying samples of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy, from patients with breast cancer that has spread to the other places in the body (metastatic) may help doctors learn more about cancer and the development of drug resistance in patients, and predict how well patients will respond to treatment.",[26,107,45],"2025-11-11",{"date":329,"type":59},"2025-11-13",{"date":331,"type":59},"2020-07-03",{"date":333,"type":20},"2035-07-03",{"name":91,"class":66}]