[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-triple-negative\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-triple-negative":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,72,99],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100506705","evaluating-and-monitoring-immune-and-clinical-responses-in-early-stage-triple-negative-breast-cancer-undergoing-neoadjuvant-chemo-immunotherapy-with-pembrolizumab-100506705",false,"NCT05877859","Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab","Inclusion Criteria:\n\n* Newly diagnosed, previously untreated, non-metastatic Stage II-III invasive breast cancer\n* Estrogen receptor IHC expression ≤10%; progesterone receptor IHC expression ≤ 10%; HER2 negative\n* HER2 negativity is defined as either of the following by local laboratory assessment:\n* IHC 0, 1+, or 2+ and In situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 \\\u003C2.0 or single probe average HER2 gene copy number \\\u003C4 signals\u002Fcell)\n* No prior chemotherapy, endocrine therapy, or immunotherapy\n* Willingness and ability of the subject to comply with scheduled visits, standard of care drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.\n* Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study\n* Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs.\n* Patients on steroid medications (i.e. prednisone, dexamethasone, etc.) that are not part of the standard pre-medications and\u002For take home medications that are included as a part of medication regimen for the pre-operative chemo-immunotherapy described in the study.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study.\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* HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with study agents. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.",true,"FEMALE","18 Years",{"count":19,"type":20},10,"ESTIMATED","OBSERVATIONAL","This research study is a prospective, single arm, pilot study, designed to evaluate the correlation between the immune and clinical responses of subjects with untreated Stage II-III triple negative breast cancer (TNBC) undergoing standard of care neoadjuvant chemo- immunotherapy.",[24,25,26,27],"Breast Cancer Triple Negative","Breast Cancer Stage II","Breast Cancer Stage III","Breast Cancer Invasive","RECRUITING","2026-05-05",{"date":31,"type":32},"2026-05-07","ACTUAL",{"date":34,"type":32},"2023-05-30",{"date":36,"type":20},"2028-02-20",{"name":38,"class":39},"Emory University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100607414","phase-2-neoadjuvant-sbrt-with-intratumoural-pembrolizumab-followed-by-neoadjuvant-chemotherapy-in-breast-cancer-100607414","NCT07188246","Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer","A Trial of Neoadjuvant, Hypofractionated Radiation, With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy, in Stage 3 or High-risk Stage 2 Breast Cancer","BRINK","Inclusion Criteria:\n\n1. Invasive ductal carcinoma of any subtype (including invasive mammary carcinoma with lobular features), excluding sarcomatous, signet or metaplastic subtypes.\n2. Invasive mammary carcinoma of stages IIB - III (excluding inflammatory breast cancer). Stage IIA is eligible for triple negative and HER2+ breast cancers.\n\n   a. Clinical staging based on AJCC 8th edition.\n3. Lesion palpable by treating physician.\n4. Plan to be treated with neoadjuvant chemotherapy.\n5. Able to tolerate core needle biopsies and pembrolizumab injection.\n6. 18 years of age or older.\n7. Able to provide informed consent.\n\nExclusion Criteria:\n\n1. Any serious medical comorbidities or other contraindications to radiotherapy, chemotherapy, or surgery (e.g., uncontrolled diabetes, serious heart condition, etc).\n2. Prior treatment for current breast cancer.\n3. Previous radiation therapy to the same breast.\n4. Inflammatory breast carcinoma.\n5. Invasive mammary carcinoma with sarcomatous, signet cell or metaplastic subtypes.\n6. Recurrent breast cancer.\n7. Clinical or radiologic evidence or suspicion of distant metastatic disease (metastatic workup that requires additional imaging to follow-up on suspicious findings will exclude patients).\n8. Any collagen vascular disease precluding radiotherapy at the discretion of the treating radiation oncologist (particularly lupus, scleroderma, dermatomyositis, psoriatic arthritis).\n9. No prior stem cell transplantation.\n10. Any poorly controlled autoimmune conditions.\n11. Current use of corticosteroids or immunosuppressants.\n12. Any other malignancy at any site (except non-melanomatous skin cancer) \\\u003C5 years prior to study enrollment. Synchronous bilateral breast cancers are acceptable.\n13. Inability to tolerate core needle biopsies or pembrolizumab injection.\n14. Pregnant or lactating.\n15. Under 18 years of age.\n16. Inability or unwillingness to provide informed consent.\n17. Inability or unwillingness to complete study assessments\u002Finterventions and follow-up assessments.","ALL",{"count":51,"type":20},40,"INTERVENTIONAL",[54],"PHASE2","This study will evaluate the immune-priming effects of stereotactic body radiation therapy (SBRT) regimen coupled with two injections of pembrolizumab in high-risk primary breast carcinoma prior to neoadjuvant chemotherapy. Preliminary results from the investigators' local TRIO Trial suggest that SBRT prior to neoadjuvant chemotherapy (NAC) may result in improved response rates due to the combined effect of radiation therapy (RT) and chemotherapy. The investigators aim to augment this effect with the addition of pembrolizumab, a monoclonal antibody that binds to and blocks programmed cell death protein 1 (PD-1).",[57,25,26,27,24],"Breast Cancer",[59,60,61],"Immunotherapy","Pembrolizumab","Breast SBRT","2026-02-09",{"date":64,"type":32},"2026-02-11",{"date":66,"type":32},"2026-01-19",{"date":68,"type":20},"2029-02",{"name":70,"class":39},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":52,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":40},"100449150","phase-2-temozolomide-monotherapy-or-in-combination-with-olaparib-in-patients-with-triple-negative-breast-cancer-tnbc-100449150","NCT05128734","Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC)","A Randomized Phase II Study of Temozolomide Monotherapy or in Combination With Olaparib in Patients With METHYLATED 06-Methylguanine-DNA Methyltransferase (MGMT) Pre-Treated Triple Negative Breast Cancer (TNBC)","Inclusion Criteria:\n\n* Female or male patients with triple negative breast cancer confirmed by pathology of the primary tumour or metastatic biopsy sample. Estrogen receptor (ER) and progesterone receptor (PgR) must be ≤2 Allred score by Immunohistochemistry (IHC); human epidermal growth factor receptor 2 (HER2) 0 or 1+ by IHC, or 2+ with confirmed negativity by in situ hybridization (ISH) assay.\n* Available Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue. If archival tissue is not available, the participant will have the option to provide a fresh tumour tissue specimen from a newly obtained biopsy. If archival and fresh tissue are not available, the participants will be excluded.\n* MGMT promoter methylated by clinical assay.\n* Prior exposure to anthracyclines and taxanes in adjuvant\u002Fneoadjuvant and\u002For metastatic setting.\n* At least one line of chemotherapy in the context of metastatic disease.\n* ECOG performance status 0 or 1 (Appendix A).\n* Age ≥ 18 years old.\n* Measurable disease (at least one 1x1 cm or greater lesion evaluable by CT scan and\u002For clinically; i.e., includes clinically evaluable skin metastases). Patients with only metastases to the bone are not eligible (See Section 10 Measurement of Effect for the evaluation of measurable disease).\n* Adequate hematological, renal and hepatic function according to all of the following laboratory values (to be performed within 4 weeks prior to start of study treatment):\n\n  * Absolute neutrophil count \\> 1.5 x109\u002FL\n  * Platelets \\> 100 x109\u002FL\n  * Serum creatinine \\\u003C 1.5 times upper limit of laboratory normal\n  * Total serum bilirubin \\\u003C 1.5 times upper limit of laboratory normal\n  * AST or ALT ≤ 2.5 times upper limit of laboratory normal\n  * Alkaline phosphatase of ≤ 2.5 times upper limit of laboratory normal\n* Each subject must be able to sign an informed consent form prior to enrollment in the trial to document their understanding and willingness to participate.\n* Subjects must be accessible for treatment and follow-up at one of the participating centres.\n* Women\u002Fmen of childbearing potential must have agreed to use a highly effective contraceptive method from the start of treatment until 6 months after treatment discontinuation. A woman is considered to be of \"childbearing 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, or vasectomy\u002Fvasectomized partner. 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* Male patients must not donate sperm and\u002For father a child during treatment with temozolomide alone or in combination with olaparib and for at least 6 months after the final dose.\n* Women of childbearing potential will have a pregnancy test as part of the Pre-Study Evaluation within 7 calendar days prior to first study treatment.\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of radiographic and\u002For clinical progression and the patient does not require ongoing use of corticosteroids. Participants with known history of CNS involvement, should have a brain imaging (CT\u002FMRI) at screening.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients must be \\>class 2B.\n\nExclusion Criteria:\n\n* Patients who have received chemotherapy within 4 weeks or radiotherapy to a non-target site within 2 weeks prior to entering the study or who have not recovered from adverse events from prior anti-cancer therapy (residual toxicities \\> Grade 1) with the exception of alopecia.\n* Patients who are receiving any other investigational agents within 3 weeks of signing the main informed consent form.\n* Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.\n* Patients with psychiatric illness\u002Fsocial situations\u002Fsubstance abuse that would limit compliance with study requirements.\n* Pregnant, breastfeeding women, and subjects unable and\u002For unwilling to use contraception methods.\n* Patients with metastatic disease to bone only.\n* Prior treatment with Temozolomide or Olaparib.\n* Patients who are hypersensitive to any ingredients in the formulation of Olaparib, temozolomide or to dacarbazine (DTIC).\n* Known BRCA1 or BRCA2 germline mutation(s).\n* Patients with HIV, Hepatitis B, or Hepatitis C infection.\n* Inclusion of Women and Minorities: There are no exclusions based on gender, race or ethnicity in this trial. The intention, therefore, is to recruit subjects from racial\u002Fethnic groups in close approximation to the local incidence of the disease in these groups.",{"count":51,"type":20},[54],"This is a randomized phase II study to evaluate the disease control rate (DCR) of patients with metastatic or locally advanced METHYLATED 06-methylguanine-DNA methyltransferase (MGMT) with triple-negative breast cancer (TNBC) treated with Temozolomide ± Olaparib. Patients will be randomized 1:1 to Treatment Arm 1 (temozolomide treatment) or Arm 2 (temozolomide plus olaparib treatment).",[24],[84,85,86,87,88],"METHYLATED 06-methylguanine-DNA methyltransferase (MGMT)","Triple-Negative Breast Cancer","TNBC","Temozolomide","Olaparib","NOT_YET_RECRUITING","2025-12-08",{"date":92,"type":32},"2025-12-15",{"date":94,"type":20},"2026-04-01",{"date":96,"type":20},"2028-07-01",{"name":98,"class":39},"AHS Cancer Control Alberta",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":49,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":52,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":40},"100557030","phase-1-til-gean-therapy-combined-with-immunotherapy-for-advanced-or-metastatic-refractory-breast-cancer-100557030","NCT06532812","TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer","Efficacy and Safety of Autologous Tumor-Infiltrating Lymphocytes (TIL) Therapy Combined With Pembrolizumab (Keytruda) Immunotherapy in Patients With Advanced or Metastatic Refractory Breast Cancer","BAH249","Inclusion Criteria:\n\n* Age: 16 years to 90 years\n* Histologically diagnosed as primary\u002Frelapsed\u002Fmetastasized Breast Cancer\n* Expected life span more than 3 months\n* Karnofsky≥60% or ECOG score 0-2\n* Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.\n* Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated\n* At least 1 evaluable tumor lesion\n* Hematology and Chemistry（within 7 days prior to enrollment）:\n* Absolute count of white blood cells≥2.5×10\\^9\u002FL\n* Absolute count of neutropils≥1.5×10\\^9\u002FL\n* Absolute count of lymphocytes ≥0.7×109\u002FL\n* Platelet count≥100×10\\^9\n* hemoglobin≥90 g\u002FL\n* Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)\n* Serum creatinine ≤1.5mg\u002FdL(or ≤132.6μmol\u002FL), or clearance rate≥50mL\u002Fmin\n* Serum ALT\u002FAST ≤3×ULN(subjects with liver metastasis ≤3×ULN)\n* Totol bilirubin≤1.5×ULN\n* No absolute or relative contraindications to operation or biopsy\n* Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent and continue within 1 year after the completion of lymphodepletion\n* Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy, and biologics must cease 28 days before obtaining TILs\n* Be able to understand and sign the informed consent document;\n* Be able to stick to follow-up visit plan and other requirements in the agreement.\n\nExclusion Criteria:\n\n* Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment\n* Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%\n* Significant cardiovascular anomalies according to any of the following definitions:\n* New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant\n* Low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular conductive block, etc.\n* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and\u002For anti-HCV positive), syphilis infection or Treponema pallidum antibody positive.\n* Severe physical or mental diseases;\n* Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection).\n* Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy.\n* History of allergy to chemical compounds consisting of chemical and biological substances resembling cell therapy.\n* Having received immunotherapy and developed an irAE level greater than Level 3.\n* Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded).\n* Females in pregnancy or lactation. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy.\n* Researchers consider the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.","16 Years","90 Years",{"count":110,"type":20},85,[112,54],"PHASE1","This Phase I\u002FII study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory breast cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody that targets the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.",[57,115,116,24],"Breast Carcinoma","Breast Cancer Metastatic",[118,119,120,121,59,122],"Tumor Infiltrating Lymphocytes","CAR-T CELL","Biological Therapy","CAR-T","TIL","2024-11-10",{"date":125,"type":32},"2024-11-12",{"date":127,"type":32},"2024-08-22",{"date":129,"type":20},"2026-12-28",{"name":131,"class":39},"Essen Biotech"]