[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-breast-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-breast-carcinoma":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,70,97,119,150,170,215,242],{"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":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100404756","phase-2-measuring-the-effects-of-talazoparib-in-patients-with-advanced-cancer-and-dna-repair-variations-100404756",false,"NCT04550494","Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations","A Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response","Inclusion Criteria:\n\n* Adult patients with solid tumors and documented germline or somatic aberrations in genes involved in DNA damage response (DDR) and whose disease has progressed following at least one standard therapy or who have no acceptable standard treatment options. Molecular testing performed at an National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) (NCT02465060) study-designated Clinical Laboratory Improvement Act (CLIA) laboratory or at Myriad Genetics, GeneDx, Invitae, or the Frederick National Laboratory for Cancer Research (FNLCR) Molecular Characterization Laboratory (MoCha) will be acceptable for determination of eligibility\n* Patients with the following germline or somatic genetic aberrations will be eligible based on compelling preclinical and\u002For clinical data suggesting that these deleterious mutations confer sensitivity to PARP inhibitors; no more than 6 patients (across both cohorts) with an eligibility mutation in any one gene will be enrolled\n\n  * Deleterious BRCA1 or BRCA2 mutations\n  * Loss of function mutations (including novel loss of function frameshift or nonsense mutations) in the following Fanconi anemia genes: FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM, FANCN\n  * A known functional mutation (including novel loss of function frameshift or nonsense mutations) in any of the following DDR genes: ARID1A, ATM, ATR, BACH1 (BRIP1), BAP1, BARD1, CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L\n* Age \\>= 18 years of age\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Life expectancy of greater than 3 months\n* Leukocytes \\>= 3,000\u002FmcL\n* Absolute neutrophil count \\>= 1,500\u002FmcL\n* Platelets \\>= 100,000\u002FmcL\n* Hemoglobin \\>= 10 g\u002FdL\n* Total bilirubin =\\\u003C 1.5 x institutional upper limit of normal (=\\\u003C 3 x upper limit of normal in the presence of documented Gilbert's syndrome or liver metastases at baseline)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) \u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 x institutional upper limit of normal\n* Creatinine =\\\u003C 1.5 x institutional upper limit of normal OR Creatinine clearance (CrCl) \\>= 60 mL\u002Fmin\u002F1.73m\\^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL\u002Fmin\u002F1.73m\\^2\n* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \\>= 20 mm (\\>= 2 cm) by chest x-ray or as \\>= 10 mm (\\>= 1 cm) with CT scan, MRI, or calipers by clinical exam\n* Patients must have a tumor site amenable to biopsy. If avoidable, the lesion for biopsy should not be selected as a target lesion for RECIST measurements\n* The effects of talazoparib on the developing human fetus are unknown. For this reason and because PARP inhibitors are known to be teratogenic, women of child-bearing potential must agree to use a highly effective method of contraception for the duration of study participation and for at least 7 months after completing study treatment. 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. Male patients with female partners of reproductive potential and pregnant partners who are treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and for at least 4 months after completion of talazoparib administration\n* Patients must be able to swallow whole tablets or capsules. Nasogastric or gastric-tube (G-tube) administration is not allowed. Any gastrointestinal disease which would impair ability to swallow, retain, or absorb drug is not allowed\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients must have recurrent, locally advanced or metastatic disease\n* Patients must have progressed on or after at least one line of standard-of-care (SOC) intervention, except for those patients without SOC or for whom talazoparib is SOC\n* PATIENTS WITH OVARIAN CANCER:\n* All patients with ovarian cancer should have one prior platinum-based therapy\n* Patients with ovarian cancer with platinum-sensitive disease are eligible. Patients with platinum-refractory disease are not eligible\n* Patients with gBRCAm ovarian cancer must also have progressed on a PARP inhibitor. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented\n* PATIENTS WITH PANCREATIC CANCER:\n* All patients with pancreatic cancer should have received prior platinum-containing therapy in the metastatic setting\n* PATIENTS WITH BREAST CANCER:\n* Patients with HER2+ breast cancer should have had 2 prior systemic lines of therapy in the metastatic setting, including anti-HER2 therapy\n* Patients with breast cancer who are eligible for a PARP inhibitor by Food and Drug Association (FDA) approvals must have had prior PARP inhibitor as per FDA indication. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented\n* PATIENTS WITH GASTRIC CANCER:\n* Patients with HER2+ gastric cancer should have had received anti-HER2 therapy in the metastatic setting\n* PATIENTS WITH PROSTATE CANCER:\n* Patients with prostate cancer who are eligible for a PARP inhibitor by FDA approvals must have had prior PARP inhibitor for eligibility. The time and treatment between the prior PARP inhibitor and protocol initiation must be documented\n* All patients with prostate cancer can continue to receive treatment with gonadotropin-releasing hormone (GnRH) agonists while on study, as long as there is evidence of disease progression on prior therapy\n* Patients with castration resistant prostate cancer must have castrate levels of testosterone (\\\u003C 50 ng\u002FdL \\[1.74 nmol\u002FL\\])\n* Patients with metastatic hormone receptor (HR) prostate cancer and mutations in either BRCA1, BRCA2, or ATM should continue to receive anti-androgen receptor (anti-AR) therapy\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 4 weeks or 5 half-lives, whichever is shorter (6 weeks for nitrosoureas or mitomycin C). Patients must be \\>= 2 weeks since any prior administration of a study drug in a phase 0 or equivalent study and be \\>= 1 week from palliative radiation therapy. Patients must have recovered to eligibility levels from prior toxicity or adverse events\n* Patients who have had prior treatment with talazoparib are ineligible\n* Patients who have had prior monoclonal antibody therapy must have completed that therapy \\>= 6 weeks (or 3 half-lives of the antibody, whichever is shorter) prior to enrollment on protocol (minimum of 1 week between prior therapy and study enrollment) except for monoclonal antibody therapies that have been proven to be safe when combined with PARP inhibitor (PARPi) treatment (such as anti-PD-1\u002FPD-L1 and anti-HER2), which must be completed \\>= 4 weeks prior to enrollment\n* Patients who are receiving any other investigational agents\n* Patients with active brain metastases or carcinomatous meningitis are excluded from this clinical trial. Patients with treated brain metastases, whose brain metastatic disease has remained stable for \\>= 1 month without requiring steroid and anti-seizure medication are eligible to participate\n* Eligibility of subjects receiving any medications or substances with the potential to affect the activity or pharmacokinetics of talazoparib will be determined following review by the principal investigator\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women are excluded from this study because the effects of the study drugs on the developing fetus are unknown\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* Patients who require use of coumarin-derivative anticoagulants such as warfarin are excluded. Low-dose warfarin (=\\\u003C 1 mg\u002Fday) is permitted\n* Women who are currently lactating\n* History of prior malignancies within the past 3 years other than non-melanomatous skin cancers that have been controlled","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial studies if talazoparib works in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and has mutation(s) in deoxyribonucleic acid (DNA) damage response genes who have or have not already been treated with another PARP inhibitor. Talazoparib is an inhibitor of PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. All patients who take part on this study must have a gene aberration that changes how their tumors are able to repair DNA. This trial may help scientists learn whether some patients might benefit from taking different PARP inhibitors \"one after the other\" and learn how talazoparib works in treating patients with advanced cancer who have aberration in DNA repair genes.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56],"Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Castration-Resistant Prostate Carcinoma","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","HER2-Positive Breast Carcinoma","Locally Advanced Breast Carcinoma","Locally Advanced Gastric Carcinoma","Locally Advanced Malignant Solid Neoplasm","Locally Advanced Ovarian Carcinoma","Locally Advanced Pancreatic Carcinoma","Locally Advanced Prostate Carcinoma","Metastatic Breast Carcinoma","Metastatic Gastric Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Ovarian Carcinoma","Metastatic Pancreatic Carcinoma","Metastatic Prostate Carcinoma","Platinum-Sensitive Ovarian Carcinoma","Recurrent Breast Carcinoma","Recurrent Gastric Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Pancreatic Carcinoma","Recurrent Prostate Carcinoma","Stage II Pancreatic Cancer AJCC v8","Stage III Ovarian Cancer AJCC v8","Stage III Pancreatic Cancer AJCC v8","Stage III Prostate Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","Stage IV Prostate Cancer AJCC v8","RECRUITING","2026-06-18",{"date":60,"type":61},"2026-06-22","ACTUAL",{"date":63,"type":61},"2021-04-26",{"date":65,"type":20},"2026-12-01",{"name":67,"class":68},"National Cancer Institute (NCI)","NIH",4,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"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":78,"type":20},54,[80],"PHASE1","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.",[27,83,84,45,85],"Invasive Breast Carcinoma","Metastatic Breast Adenocarcinoma","Stage IV Breast Cancer AJCC v6 and v7","2026-06-16",{"date":88,"type":61},"2026-06-17",{"date":90,"type":61},"2020-09-23",{"date":92,"type":20},"2027-08-15",{"name":94,"class":95},"Mayo Clinic","OTHER",1,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":96},"100403111","phase-2-177lu-dotatate-for-the-treatment-of-stage-iv-or-recurrent-breast-cancer-100403111","NCT04529044","177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancer","A Phase II Pilot Study of (Lutetium (177Lu)-DOTATATE in Patients With Metastatic Breast Cancer","Inclusion Criteria:\n\n* Life expectancy of \\> 6 months, as determined by the investigator\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients aged \\>= 18-100 years old at time of informed consent\n* Histologically or cytologically confirmed metastatic breast carcinoma\n* Stage IV or recurrent disease with distant metastases\n* Female and male patients with breast cancer will be included in the study\n* Participants must have experienced disease progression after at least two lines of standard treatment modalities and\u002For one prior line of cytotoxic chemotherapy (not just endocrine therapy). Specifically, patients must have received or declined the following therapies: a) Hormone receptor positive (HR+)\u002FHER2: endocrine therapy and CDK4\u002F6 inhibitor (i); b) HER2+: trastuzumab, pertuzumab, T-DM1 and tucatinib; c) Triple negative breast cancer (TNBC): chemotherapy, immunotherapy (in PD-L1+ tumors). Patients can be consented if they are foregoing treatments known to confer survival advantage\n* Participants must have at least one measurable site of disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v1).1 that is amendable to biopsy\n* Confirmed presence of SSTR based on \\> 50% of lesions with DOTATATE uptake of 68Ga DOTATATE equivalent to the liver\n* Participants must have fully recovered from the acute toxic effects of all prior treatment to grade 1 or less, except alopecia and =\\\u003C grade 2 neuropathy which are allowed\n* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Participant must consent to undergo a pre-treatment screening biopsy for enrollment\n* Hemoglobin \\>= 8.0 g\u002FdL with no blood transfusion in the past 28 days (measured within 28 days prior to administration of study treatment)\n* Absolute neutrophil count (ANC) \\>= 2.0 x 10\\^9\u002FL (measured within 28 days prior to administration of study treatment)\n* Platelet count \\>= 75 x 10\\^9\u002FL (measured within 28 days prior to administration of study treatment)\n* Total bilirubin =\\\u003C 3 x institutional upper limit of normal (ULN) (measured within 28 days prior to administration of study treatment)\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 2.5 x institutional upper limit of normal (unless liver metastases are present in which case they must be =\\\u003C 5 x ULN) (measured within 28 days prior to administration of study treatment)\n* Serum albumin \\>= 3.0 g\u002FL, unless prothrombin time or international normalized ratio (INR) value is within the normal range (measured within 28 days prior to administration of study treatment)\n* Participants must have serum creatinine =\\\u003C 1.7 mg\u002FdL, or creatinine clearance estimated of \\>= 51 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test (measured within 28 days prior to administration of study treatment)\n* Female participants of childbearing potential (FOCBP) must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* FOCBP agree to use a highly-effective method of contraception starting with the first dose of study therapy up to 7 months after the last dose of study therapy\n\n  * FOCBP are those who are not proven postmenopausal. Postmenopausal is defined as:\n\n    * Amenorrheic for \\> 24 consecutive months following cessation of exogenous hormonal treatments\n    * Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50 years of age\n    * Radiation-induced oophorectomy with last menses \\> 1 year ago\n    * Chemotherapy-induced menopause with \\> 1 year interval since last menses\n    * Surgical sterilization (bilateral oophorectomy or hysterectomy or tubal ligation)\n\nExclusion Criteria:\n\n* Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of first dose of 177Lu- DOTATATE treatment\n\n  * Individuals in the follow-up phase of a prior investigational study may participate as long as it has been 4 weeks since last dose of the previous investigational agent or device\n* Prior external beam radiation therapy to more than 25% of the bone marrow\n* Other malignancy unless curatively treated with no evidence of disease for \\>= 5 years except: adequately treated non-melanoma skin cancer or curatively treated in situ cancer of the cervix\n* Known brain metastases, unless these metastases have been treated and stabilized\n* Peptide receptor radionuclide therapy at any time prior to study enrollment\n* Known hypersensitivity to somatostatin analogues or any component of the 68Ga- DOTATATE or 177Lu- DOTATATE formulations\n* Patients with uncontrolled infection will not be enrolled until infection is treated per provider discretion\n* Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction within 6 months prior to enrollment, New York Heart Association (NYHA) class III or IV heart failure\n* Uncontrolled diabetes mellitus as defined by a fasting blood glucose \\> 2x ULN\n* Any patient receiving treatment with short-acting somatostatin analogs, which cannot be interrupted for both 24 hours before and after the administration of 177Lu, or any patient receiving treatment with long-acting release somatostatin analogs that cannot be interrupted for at least 4 weeks before the administration of 177Lu- DOTATATE\n* Any surgery or radiofrequency ablation within 12 weeks prior to enrollment in the study; or prior radioembolization; chemoembolization; or external beam radiation therapy (EBRT) to \\> 25% of bone marrow, at any time\n* Any chemotherapy or targeted therapy within 4 weeks prior to enrollment in the study\n* Current spontaneous urinary incontinence making impossible the safe administration of the radioactive study agent\n* Any psychiatric illness that prevents patient from informed consent process\n* Any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol\n* Participant is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment","100 Years",{"count":106,"type":20},10,[23],"This phase II trial investigates how well 177Lu-DOTATATE works in treating patients with breast cancer that is stage IV or has come back (recurrent). 177Lu-DOTATATE may shrink or destroy the tumor or circulating breast cancer stem cells if they show evidence of the SSTR2. 177Lu-DOTATATE is a targeted therapy that uses DOTATATE, linked to a radioactive agent called 177Lu. DOTATATE attaches to tumor cells with SSTR2 and delivers 177Lu to kill them. Giving 177Lu-DOTATATE may help decrease the number and size of tumors and the number of circulating cancer stem cells in patient's blood for the treatment of patients with breast cancer positive for SSTR2.",[27,38,45],"2026-06-03",{"date":112,"type":61},"2026-06-05",{"date":114,"type":20},"2026-06-30",{"date":116,"type":20},"2027-12-20",{"name":118,"class":95},"OHSU Knight Cancer Institute",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":126,"minAge":127,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":130,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":149},"100570239","study-on-recurrent-breast-cancer-and-repeated-radiation-therapy-100570239","NCT06704659","Study on Recurrent Breast Cancer and Repeated Radiation Therapy","RAY-no-BAN","Inclusion Criteria:\n\n* The patient has a diagnosed breast cancer or tumor area in the breast with a maximum diameter of 3 cm, where a previous breast-conserving surgery has been performed (either invasive breast cancer or carcinoma in situ, DCIS).\n\nThe patient has only a local recurrence, and imaging studies show no suspicion of metastases outside the breast (preoperative staging N0M0).\n\nAt least 3 years have passed since the completion of prior radiation therapy. The new breast cancer can be technically treated with another breast-conserving surgery using a technique that does not require tissue transfer from areas opposite the removed tumor to restore the shape of the breast.\n\nThe patient is at least 55 years old at the time of surgery. The patient is willing to participate in the study. The patient is capable of providing informed consent.\n\nExclusion Criteria:\n\n* A booster dose, also known as a \"boost,\" was administered during prior radiation therapy.\n\nPreoperative assessments suggest multifocal breast cancer, with the tumor area to be removed exceeding 3 cm.\n\nThe planned radiation therapy per the study protocol cannot be administered due to factors such as shoulder joint stiffness, a pacemaker located in the radiation field, or a skin condition (e.g., scleroderma).\n\nThe patient is unable to provide informed consent or is unwilling to participate in the study.\n\nMetastases outside the breast (e.g., axillary or distant metastases) are present.","FEMALE","55 Years",{"count":129,"type":20},60,[131],"NA","This study explores whether recurrent breast cancer can be safely treated with breast-conserving surgery and repeated radiation therapy in cases where patients have previously undergone radiation. Traditionally, recurrent breast cancer has been treated by removing the entire breast. However, recent research has shown that in certain situations, it may be possible to preserve the breast.\n\nThe study will collect data on the safety of this treatment approach and its effects on patients. The treatment follows standard breast cancer care practices, involving 30 patients from Helsinki and Turku University Hospitals. Patients are carefully selected based on specific criteria, such as tumor size, localization, and prior treatment history. Special attention is given to the planning of radiation therapy and surgical techniques.\n\nThe goal is to develop new treatment strategies that allow breast preservation even in cases of recurrent breast cancer, providing patients with high-quality and individualized care.",[45],[135,136,137,138],"Breast cancer","Recurrence","Repeat radiation therapy","Radiation therapy","2026-03-06",{"date":141,"type":61},"2026-03-09",{"date":143,"type":61},"2024-12-01",{"date":145,"type":20},"2030-12-31",{"name":147,"class":148},"Turku University Hospital","OTHER_GOV",2,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":96},"100532827","collection-of-specimens-and-clinical-data-for-patients-with-recurrent-or-metastatic-breast-cancer-or-male-breast-cancer-100532827","NCT06217874","Collection of Specimens and Clinical Data for Patients With Recurrent or Metastatic Breast Cancer or Male Breast Cancer","Inclusion Criteria:\n\n* Female participants must have histologically or cytologically confirmed invasive breast cancer.\n* Male participants must have biopsy proven breast cancer.\n* Age must be \\>= 18 years, and all must be able to understand and willing to sign an informed consent document.\n\nExclusion Criteria:\n\n* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent; a history of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine).\n* Any other condition, which in the opinion of the patient's treating oncologist, or the physician performing the biopsy procedure, would make participation in this protocol unreasonably hazardous for the patient.",{"count":157,"type":20},2000,"OBSERVATIONAL","This study is being done to create a resource of samples and information that can be used to improve our understanding of the development, progression and treatment of recurrent or metastatic breast cancer or male breast cancer.",[161,38,45],"Breast Carcinoma","2026-02-23",{"date":164,"type":61},"2026-02-25",{"date":166,"type":61},"2014-06-05",{"date":168,"type":20},"2034-06-30",{"name":94,"class":95},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":69},"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":178,"type":20},18,[80],"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.",[182,183,184,185,186,187,26,188,189,190,27,191,192,193,194,195,196,197,198,199,200,201,202,203,204,45,205],"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 IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Early Stage Triple-Negative Breast Carcinoma","Locally Advanced Triple-Negative Breast Carcinoma","Metastatic Triple-Negative Breast Carcinoma","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","Prognostic Stage IV Breast Cancer AJCC v8","Unresectable Triple-Negative Breast Carcinoma","2026-01-23",{"date":208,"type":61},"2026-01-26",{"date":210,"type":61},"2025-12-02",{"date":212,"type":20},"2026-12-31",{"name":214,"class":95},"Emory University",{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":21,"phases":224,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":241},"100317923","phase-3-s1501-dual-observational-and-randomized-cohort-study-of-patients-with-metastatic-her-2-breast-cancer-at-risk-of-cardiac-toxicity-100317923","NCT03418961","S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity","Prospective Observational Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity","Inclusion Criteria:\n\n* STEP 1 REGISTRATION\n\nPatients must:\n\n1. Have metastatic breast cancer, AND\n2. Be initiating within 11 calendar days of Step 1 Registration OR be continuing trastuzumab-based HER-2 targeted therapy without concurrent anthracyclines, AND\n3. Be receiving the trastuzumab-based HER-2 targeted therapy for metastatic disease in first, second, third-, or fourth-line setting. Patients may have brain metastasis. There is no limit for number of doses of HER-2 targeted therapy prior to registration.\n\nExamples of eligible HER-2 targeted therapy:\n\n* Trastuzumab or a trastuzumab biosimilar\n* Trastuzumab + chemotherapy or hormonal therapy\n* Trastuzumab + other HER-2 targeted agent with or without chemotherapy (such as pertuzumab, lapatinib, and tucatinib)\n* Ado-trastuzumab (Kadcyla®)\n* Fam-trastuzumab deruxtecan (Enhertu) NOTE: Patients on lapatinib without trastuzumab are not eligible. Planned treatment with concurrent HER-2 targeted therapy and anthracyclines is not permitted.\n\n  * Patients must be at increased risk for cardiotoxicity defined by at least one of the following:\n\n    1. Previous anthracycline exposure OR\n    2. 1 or more of the following risk factors for heart disease:\n\n       * LVEF 50-54% by local ECHO read\\*\n       * Age ≥ 65\n       * BMI ≥ 30 kg\u002Fm2\n       * Current or prior anti-hypertensive therapy\n       * Diagnosis of coronary artery disease (CAD)\n       * Diagnosis of diabetes mellitus\n       * Diagnosis of atrial fibrillation\u002Fflutter Note: ECHO can be performed at any time prior to registration with the most recent being sent.\n  * Patients must not have taken within 21 days prior to Step 1 Registration, be currently taking at the time of Step 1 Registration or planning to take once registered to Step 1 a beta blocker, ARB, or ACE inhibitor, in order to be randomized (Arms 1 and 2).\n\nPatients enrolling in the observational cohort (Arm 3) must be currently taking a beta blocker, ARB, or ACE inhibitor at the time of Step 1 Registration.\n\n* Patients must have a Zubrod Performance status of 0-2\n* Patients must have a complete physical examination and medical history within 28 days prior to registration\n* Patients must have LVEF \\>= 50% echocardiogram (2D or 3D) within 28 days prior to registration. The echocardiogram must be obtained from a S1501 validated ECHO laboratory (lab) and submitted for central review by the S1501 ECHO core lab.\n\nIf a 3D echocardiogram is performed at baseline, sites must ensure that standard 2D images, including 40chamber and 2-chamber views, are also obtained and submitted at subsequent timepoints.\n\nAll follow-up echocardiograms (every 12 weeks) must be performed using 2D imaging to allow for standardized assessments. Follow-up scans must be completed at a site that can provide 2D images per protocol requirements. The echocardiograms cannot be submitted for central read until after Step 1 registration is complete.\n\n* Patients must have adequate hepatic function as evidenced by all of the following within 28 days prior to registration:\n\n  * Serum bilirubin \\\u003C 3.0 x institutional upper limit of normal (IULN)\n  * Serum glutamic oxaloacetic transaminase (SGOT)\u002Faspartate aminotransferase (AST) and serum glutamic pyruvic transaminase (SGPT)\u002Falanine aminotransferase (ALT) \\\u003C 5.0 x IULN\n* Patients must not be dialysis dependent\n* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, prostate cancer on active surveillance, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years\n* Patients must not be pregnant or nursing due to potential fetal or nursing infant harm; women\u002Fmen of reproductive potential must have agreed to use an effective contraceptive method, a woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\u002Fshe is responsible for beginning contraceptive measures\n* Patients must be willing to submit blood specimens\n* Sites must seek additional patient consent for the future use of specimens\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\n* For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and CIRB regulations.\n* As a part of the 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 REGISTRATION (Randomization)\n* Patients must not be registered to step 2 until confirming via RAVE EDC that the patient's LVEF by echocardiogram was \\>= 50% by central review. Patients must be registered within 21 calendar days of submission of the ECHO study\u002F\n* Site must verify that there is no known change in the step 1 eligibility since initial registration",{"count":223,"type":20},491,[225],"PHASE3","This trial has two cohorts of patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. All patients must be receiving trastuzumab-based treatment. Both cohorts are being observed for cardiac toxicity. The largest cohort (currently open to accrual) is observational, and contains patients who are taking a beta blocker, ACE inhibitor, or ARB as well as their trastuzumab-based treatment. The goal is to understand how common cardiac problems are in this group of patients at high risk. The smaller cohort (currently closed to accrual) is randomized. Patients in this second cohort are randomized to either carvedilol or no treatment, with the goal of seeing whether carvedilol (used to treat heart failure and high blood pressure) may prevent the heart from side effects of chemotherapy.",[228,229,230,45,85],"Cardiotoxicity","HER2\u002FNeu Positive","Metastatic Malignant Neoplasm in the Brain","2025-10-03",{"date":233,"type":61},"2025-10-08",{"date":235,"type":61},"2017-11-01",{"date":237,"type":20},"2027-09-15",{"name":239,"class":240},"SWOG Cancer Research Network","NETWORK",590,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":126,"minAge":250,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":21,"phases":253,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":96},"100565338","phase-2-preoperative-partial-breast-reirradiation-and-repeat-breast-conserving-surgery-in-patients-with-recurrent-breast-cancer-the-repeat-trial-100565338","NCT06640881","Preoperative Partial Breast Reirradiation and Repeat Breast-conserving Surgery in Patients With Recurrent Breast Cancer: the REPEAT Trial","Preoperative Partial Breast Reirradiation and Repeat Breast-conserving Surgery in Patients With Recurrent Breast Cancer: the REPEAT Trial - a Study Protocol","REPEAT","Inclusion Criteria:\n\n* Female ≥ 50 years with an ipsilateral invasive recurrent breast cancer event after previous breast-conserving surgery and postoperative whole breast irradiation\n* World Health Organization performance status 0-2\n* Tumor size ≤ 2 cm and unifocal on MRI\n* Tumor histology as assessed on biopsy:\n\nBloom-Richardson grade 1 or 2 Non-lobular invasive histological type carcinoma Estrogen receptor positive HER2 receptor negative No lymphovascular invasion\n\n* No extensive DCIS (outside tumor size of 2 cm) on mammography or tumor biopsy, including non-mass enhancement on MRI\n* Clinical node negative on 18-F FDG PET-CT, ultrasound and MRI\n* No distant metastasis\n* No or mild late toxicity (no grade 2 or higher) from previous breast-conserving therapy\n* Adequate understanding of the Dutch language\n\nExclusion Criteria:\n\n* Ipsilateral invasive breast cancer event less than two years after first breast-conserving therapy for breast cancer\n* Other malignancy within 5 years before ipsilateral breast recurrence diagnosis. For carcinoma in situ no specific time span to ipsilateral breast recurrence diagnosis is required for inclusion\n* Known breast cancer mutation gene carrier\n* Collagen synthesis disease (e.g. osteogenesis imperfect, Ehlers-Danlos syndrome, systemic sclerosis)\n* Previous ipsilateral mastectomy\n* Invasive lobular carcinoma, DCIS without invasive cancer\n* MRI absolute contraindications\n* Indication for treatment with neoadjuvant chemotherapy\n* Legal incapacity","50 Years",{"count":252,"type":20},25,[23],"Over the past decades, interest in second breast-conserving therapy (BCT) has increased due to, among others, advancements in radiotherapy techniques. Preoperative partial breast irradiation (PBI) is an experimental treatment for patients with low-risk primary breast cancer. This approach can downstage the tumor, and may possibly reduce toxicity and improve cosmetic outcomes compared to postoperative radiotherapy. This study aims to evaluate the feasibility of single-dose preoperative PBI and second breast-conserving surgery (BCS) for patients with an ipsilateral recurrent breast event (IRBE) after previous BCT.\n\nThe REPEAT trial is a multicenter, prospective, single-arm trial investigating ablative single-dose preoperative PBI in patients with an IRBE. Eligible patients are ≥ 50 years, have a unifocal non-lobular invasive breast cancer ≤ 2 cm, Bloom-Richardson grade 1 or 2, estrogen receptor-positive, HER2-negative and clinically negative axillary lymph nodes. The study plans to enroll 25 patients. Radiotherapy planning will involve the use of CT and MRI in the treatment position. Single-dose PBI of 20 Gy to the tumor and 15 Gy to the surrounding 2 cm of breast tissue will be delivered using a conventional or MR-guided linear accelerator. Tumor response will be monitored preoperatively using MRI and liquid biopsies to identify biomarkers for evaluating radiosensitivity. BCS will be performed 3 weeks post-PBI. The primary endpoint is the incidence of grade 2 or higher treatment-associated acute toxicity within 90 days. Secondary endpoints include the evaluation of acute (grade 1) and late toxicity, radiologic and pathologic response, mastectomy rate, patient-reported outcomes, cosmetic outcome, local, regional and distant recurrence rates, survival outcome, and biomarkers in liquid biopsies and tumor tissue. Patients will be followed up to 5 years after PBI.\n\nThis trial will evaluate the feasibility of single-dose preoperative PBI and BCS for patients with IRBE. This treatment approach is expected to minimize the irradiated volume, reduce toxicity, and improve cosmetic outcomes compared to postoperative PBI after second BCS. Identifying biomarkers for radiosensitivity will help in selection patients and tailoring treatment.",[45,256],"Ipsilateral Recurrence",[258,259,260,261,262],"single-dose preoperative radiotherapy","pathologic response","radiologic response","cosmetic outcome","partial breast irradiation","2025-09-30",{"date":265,"type":61},"2025-10-01",{"date":267,"type":61},"2025-01-01",{"date":269,"type":20},"2026-12",{"name":271,"class":95},"Amsterdam UMC, location VUmc"]