[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancers":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,42,69,100,135,160,189,217,239,257,274,292,358],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100600248","neoadjuvant-oral-paclitaxel-plus-subcutaneous-pertuzumabtrastuzumab-in-patients-with-her2-positive-breast-cancer-100600248",false,"NCT07095023","Neoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab\u002FTrastuzumab in Patients With HER2-positive Breast Cancer","A Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Neoadjuvant Oral Paclitaxel Plus Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Injection in Patients With HER2-positive Breast Cancer","OPTIMAL-BC","Inclusion Criteria:\n\nAged 18-75 years old. Histologically confirmed HER2-positive invasive breast cancer with clinical stages T1c-4, N0-3, and M0 (excluding T1cN0M0), according to the 8th American Joint Committee on Cancer (AJCC) edition BC staging system HER2 overexpression was defined as immunohistochemistry (IHC) 3+ or 2+ with HER2 gene amplification, determined by fluorescence in situ hybridization (FISH).\n\nBaseline left ventricular ejection fraction (LVEF) of ≥50%. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n\nThe functional level of major organs must meet the following requirements (no blood transfusion and no use of white blood cell, red blood cell and platelet-raising drugs within 2 weeks before the first dose):\n\n* Absolute neutrophil count ≥ 1,500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n* Alanine aminotransferase and aspartate aminotransferase (ALT\u002FAST) ≤1.5×ULN\n* Blood urea nitrogen and serum creatinine ≤1.5×ULN\n* Creatinine clearance (Ccr) ≥50 ml\u002Fmin (Cockcroft-Gault formula) Signature of informed consent\n\nExclusion Criteria:\n\n* History of invasive breast cancer. Bilateral breast cancer or inflammatory breast cancer . Prior excisional and\u002For incisional biopsy of the primary tumor and\u002For axillary lymph nodes.\n\nPrior systemic therapy for breast cancer. History of life-threatening hypersensitivity reactions or known hypersensitivity to any component of the investigational drug.\n\nParticipation in another clinical trial of a drug or medical device within 4 weeks prior to the first dose and\u002For receipt of investigational drug\u002Fdevice during the trial.\n\nMajor surgery within 28 days prior to the first dose or planned major surgery during the study period.\n\nHistory of other malignancies within the past 5 years, except for carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ.\n\nActive tuberculosis or other severe infectious diseases requiring systemic treatment, including but not limited to bacteremia, severe pneumonia, and other serious infections.\n\nHistory of immunodeficiency or autoimmune diseases, including but not limited to HIV infection (HIV antibody positive), systemic lupus erythematosus, rheumatoid arthritis, or history of organ transplantation.\n\nHistory of cardiovascular or cerebrovascular diseases, including:\n\n* Unstable angina;\n* Clinically significant arrhythmias requiring medication;\n* Myocardial infarction within the past 6 months;\n* Heart failure or second-degree or higher atrioventricular block;\n* Cerebral infarction (excluding lacunar infarction) or cerebral hemorrhage within the past 6 months.\n\nPoorly controlled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg despite regular medication), or history of hypertensive crisis or hypertensive encephalopathy.\n\nUnsuitability for oral administration of the investigational drug, as judged by the investigator, including:\n\n* Clinically significant or uncontrolled congenital or acquired gastrointestinal diseases;\n* Diseases that may affect drug administration, gastric entry, or absorption (e.g., intestinal obstruction, Crohn's disease, ulcerative colitis).\n\nPregnant or breastfeeding women; women of childbearing potential with a positive pregnancy test at screening; or those unwilling to use effective contraception during the study and for 6 months after the last dose.","ALL","18 Years","75 Years",{"count":21,"type":22},112,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to evaluate the efficacy and safety of oral paclitaxel plus fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in the neoadjuvant treatment of HER2+ breast cancer patients.",[28],"Breast Cancers","RECRUITING","2026-04-27",{"date":32,"type":33},"2026-04-29","ACTUAL",{"date":35,"type":33},"2025-08-15",{"date":37,"type":22},"2029-06-30",{"name":39,"class":40},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",9,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100589454","partial-breast-re-irradiation-for-breast-cancer-100589454","NCT06954623","Partial Breast Re-irradiation for Breast Cancer","Partial Breast Re-irradiation for Breast Cancer Recurrences After Repeat Breast-conserving Surgery With Proton Beam Therapy","BREAST","Inclusion Criteria:\n\n* histologically confirmed recurrent (or new primary) ipsilateral invasive breast cancer or DCIS after prior RT of the ipsilateral breast\n* indication for re-irradiation after repeat breast conserving surgery (e.g. lumpectomy, wide excision, …)\n* tumor size \\\u003C 3 cm\n* clinically node-negative (cN0)\n* negative resection margin (R0)\n* time interval: start of re-RT to prior RT ≥ 12 months\n* ECOG Performance status ≤ 2\n* ability of subject to understand character and individual consequences of the clinical trial\n* written informed consent\n* ≥18 years of age\n\nExclusion Criteria:\n\n* distant metastases\n\n  * concomitant chemotherapy (concomitant endocrine hormonal therapy is allowed; sequential chemotherapy is allowed)\n  * patients who have not recovered from acute toxicities of prior therapies\n  * known carcinoma \\\u003C 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy\n  * pregnant or lactating women\n  * participation in another competing clinical study or observation period of competing trials\n  * history of active connective tissue disorder (i.e. systemic lupus erythematosus, scleroderma, dermatomyositis, xeroderma pigmentosum, …)\n  * medical implants, which are at the time of reirradiation not eligible for particle therapy at Heidelberg Ion Beam Therapy Center","FEMALE",{"count":52,"type":22},20,[25],"Breast cancer is the most common malignancy in women. Breast-conserving surgery (BCS) with adjuvant whole-breast irradiation (WBI) is currently the standard of care in the oncological treatment of primary breast cancer and offers an equivalent alternative to mastectomy. The primary aim of adjuvant radiotherapy (RT) is to improve local control and thus improve overall survival and breast cancer-specific mortality. However, nodal-negative women have a 10-year risk for local recurrences after RT in up to 15.6%. The management of ipsilateral breast cancer recurrence depends on the extent of tumor disease and staging results at the time of recurrence and mastectomy is currently the standard of care for previously irradiated patients. The application of particle therapy using proton beam therapy (PBT) represents an innovative radiotherapeutic technique for breast cancer patients. This trial will be conducted as a prospective single-arm phase II study in 20 patients with histologically proven invasive breast cancer recurrences with negative margins after repeat BCS and with an indication for local re-irradiation. Required time interval will be 1 year after previous RT to the ipsilateral breast. Patients will receive partial breast re-RT with proton beam therapy in 15 once daily fractions up to a total dose of 40.05 GyRBE. The primary endpoint is defined as the cumulative overall occurrence of acute \u002F subacute skin toxicity grade ≥3 within 6 months after the start of re-RT.",[28],[57,58],"re-irratdiation","proton beam","2026-03-06",{"date":61,"type":33},"2026-03-10",{"date":63,"type":33},"2025-08-28",{"date":65,"type":22},"2029-10-01",{"name":67,"class":40},"University Hospital Heidelberg",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":23,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":68},"100555832","phase-2-tirzepatide-weight-loss-for-mrd-early-breast-cancer-100555832","NCT06517212","Tirzepatide Weight Loss for MRD+ Early Breast Cancer","Adjuvant Tirzepatide Plus Standard of Care Endocrine Therapy in Patients With Obesity or Overweight Who Have Hormone Receptor-positive, HER2-negative, Node-positive Early Breast Cancer, With Molecular Residual Disease (MRD), as Determined by Circulating Tumor DNA (ctDNA)","TRIM-EBC","Inclusion Criteria:\n\n1. Female or male patients ≥18 years of age\n2. Have a diagnosis of node-positive, hormone receptor-positive (ER+ \\> 10%), and HER2-negative breast cancer within the past 15 years per the American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines\n\n   1. If patients have synchronous bilateral ER+ breast cancers, tissue from both primary cancers should be submitted for next-generation sequencing (NGS) to inform ctDNA testing\n   2. Patients with multifocal\u002Fmulticentric cancers are eligible and the largest focus of cancer should be submitted for NGS evaluation. If tested, all tumor foci must meet have ER \\> 10%\n   3. For patients who received neoadjuvant therapy and have discordant hormone receptor and\u002For HER2 results between the diagnostic biopsy (pre-treatment) and the surgical pathology (post-neoadjuvant treatment), the hormone receptor status and HER2 status of the post-treatment specimen will determine eligibility\n3. Overweight or obesity defined as body mass index (BMI) \\> 27 kg\u002Fm2\n4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n5. Have received at least 1 year of or having completed standard neo\u002Fadjuvant endocrine therapy. If adjuvant cyclin dependent kinase (CDK) 4\u002F6 inhibitor therapy was prescribed, patients must have completed this therapy\n6. Positive ctDNA blood test as determined by the Haystack Oncology Haystack MRD tumor-informed ctDNA assay\n7. Patients must have formalin-fixed paraffin-embedded (FFPE) tissue from the primary tumor available for submission to Haystack Oncology to perform whole genome sequencing (WGS) to build customized mutation panel to monitor for plasma ctDNA\n8. No clinical evidence of metastatic breast cancer found on history, physical examination, complete blood count (CBC), comprehensive metabolic panel (CMP), and radiologic imaging following a finding of positive ctDNA\n9. Have adequate hematologic function, defined by:\n\n   1. Absolute neutrophil count (ANC) \\>1500\u002FµL\n   2. Platelet count ≥100,000\u002F µL\n   3. Hemoglobin ≥9 g\u002FdL or ≥5.6 mmol\u002FL\n10. Have adequate liver function, defined by:\n\n    1. Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 x the upper limit of normal (ULN)\n    2. Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels \\>1.5 × ULN\n11. Have adequate renal function, defined by:\n\n    a. Serum creatinine ≤1.5 x ULN or calculated creatinine clearance of ≥30 mL\u002Fmin\n12. Patients must be accessible for treatment and follow-up\n13. All patients must be able to understand the investigational nature of the study and give written informed consent prior to study entry\n\nExclusion Criteria:\n\n1. Prior bariatric surgery and\u002For endoscopic procedures for weight loss (e.g., intragastric balloon, sleeve gastrostomy) following diagnosis of breast cancer\n2. Treatment with a GLP-1\u002FGlucagon receptor agonist, GIP\u002FGLP-1\u002FGlucagon receptor agonist, GIP\u002FGLP receptor agonist, or any combinations with GLP-1 receptor agonist therapies within the last 3 months\n3. History of severe hypersensitivity reaction to GLP-1\u002FGlucagon receptor agonist, GIP\u002FGLP-1\u002FGlucagon receptor agonist, or any combinations with GLP-1 receptor agonist therapies\n4. Insulin-dependent diabetes\n5. Has clinical evidence of diabetic retinopathy\n6. Clinical evidence or suspicion of metastatic breast cancer\n7. Current or past invasive cancers, other than breast cancer, are not allowed except for:\n\n   1. Adequately treated basal or squamous cell carcinoma of the skin\n   2. Previously diagnosed invasive cancer treated with curative intent, with no evidence of disease recurrence for at least 5 years, and are considered low risk for future recurrence by the treating physician\n8. Patients with a second synchronous primary HER2-positive or triple negative breast cancer\n9. Has an active infection requiring systemic therapy\n10. Has a known history of human immunodeficiency virus (HIV) or active or persistent hepatitis B or hepatitis C virus\n11. Has significant cardiovascular disease, such as:\n\n    1. History of stroke, myocardial infarction, acute coronary syndrome, or coronary angioplasty\u002Fstenting\u002Fbypass grafting within the last 6 months\n    2. Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV, or history of CHF NYHA class III or IV.\n12. Has a known history of active tuberculosis\n13. Women who are pregnant or lactating. All patients of reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug\n14. Patients who have any severe and\u002For uncontrolled medical conditions or other conditions that could affect their participation such as:\n\n    1. severe impaired lung functions as defined as spirometry and diffusing capacity of lung for carbon monoxide (DLCO) that is 50% of the normal predicted value and\u002For O2 saturation that is 88% or less at rest on room air\n    2. liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh class C)\n    3. history of gastroparesis, impaired gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drug (e.g., ulcerative diseases, uncontrolled nausea vomiting and\u002For diarrhea, malabsorption syndrome, or small bowel resection)\n15. Has a history of pancreatitis or current symptoms of untreated cholelithiasis\n16. Has a family history of Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2) or medullary thyroid cancer (MTC)\n17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's full participation for the full duration of the study, or results in trial participation not being in the patient's best interest, in the opinion of the Treating Physician\n18. Has received an investigational agent within 4 weeks prior to study treatment; investigational monoclonal antibodies should have a 4-week (28 day) or 5 half-life washout period\n19. Any other investigational or anti-cancer treatments while participating in this study with the exception of standard adjuvant endocrine therapy, zoledronic acid, or denosumab",{"count":78,"type":22},48,[80],"PHASE2","This trial aims to asses if tirzepatide-induced weight loss will lead to metabolic and hormonal changes in hormone receptor-positive (HR+), human epidermal growth factor receptor-negative (HER2-), node-positive (N+) high risk early breast cancer patients with obesity or overweight, inhibiting the growth and survival of micrometastatic disease and leading to clearance of tumor-informed circulating tumor DNA (ctDNA) and freedom from the development of metastatic disease.",[83,84,28],"Breast Cancer","Breast Neoplasms",[86,87,75,88,89,90],"TRIM","TRIM EBC","tirzepatide","MRD","ctDNA","2026-02-10",{"date":93,"type":33},"2026-02-12",{"date":95,"type":33},"2024-11-26",{"date":97,"type":22},"2030-12-31",{"name":99,"class":40},"Baylor Research Institute",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":116,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100589890","sustainable-implementation-of-the-excel-exercise-oncology-program-across-canada-100589890","NCT06960291","Sustainable Implementation of the EXCEL Exercise Oncology Program Across Canada","EXCEL","Inclusion Criteria:\n\n* have or had a diagnosis of cancer;\n* be 18 years or older;\n* be able to participate in low-intensity levels of activity, at minimum;\n* be pretreatment, or receiving active cancer treatment (i.e., surgery, systemic therapy and radiation therapy), have received cancer treatment within the past 3 years, or if beyond 3 years since treatment completion, have a referral from their healthcare team indicating they have side effects from cancer treatment or the cancer itself, that could be improved or managed with exercise;\n* be able to provide informed written consent in English or French\n\nExclusion Criteria:\n\n* does not or did not have a cancer diagnosis\n* is under the age of 18\n* is unable to participate in mild exercise, at minimum\n* is not pretreatment, or receiving active cancer treatment (i.e., surgery, systemic therapy and radiation therapy), has not received cancer treatment within the past 3 years, or if beyond 3 years since treatment completion, doesn't have side effects from cancer treatment or the cancer itself, that could be improved or managed with exercise\n* unable to read\u002Fwrite in English\n* for online programs, does not have internet or computer access",{"count":108,"type":22},740,[25],"EXCEL will provide online and, where feasible, in-person exercise programs to individuals living with and beyond cancer (ILWBC). Research has shown that targeted programs that include tailored exercise prescriptions are more successful in helping individuals with chronic disease to incorporate physical activity and exercise into their daily routines. While ILWBC are advised by healthcare professionals (HCPs) to engage in exercise, there is a lack of cancer-specific exercise programs and cancer-trained exercise specialists in Canada, outside of the research setting. Considering the negative impact cancer and its treatments have on fitness and physical activity levels, community-based efforts towards improving access, uptake and maintenance of exercise programming are needed.\n\nThis study will evaluate the benefits of a community-based or online EXCEL exercise program for people living with and beyond cancer across Canada, using a streamlined intake process compared to the original EXCEL Study (HREBA.CC-20-0098, NCT04478851). This 8 to 12-week program (intervention) will be delivered in-person or over virtual platform. It includes twice weekly supervised exercise classes.",[112,113,28,114,115],"Cancer","Prostate Cancers","Colon Cancer","Lung Cancers",[117,118,119,120,121,122,123,124],"Exercise oncology","Exercise","Physical activity","community program","online exercise","cancer survivor","individual living with and beyond cancer","quality of life","2025-10-02",{"date":127,"type":33},"2025-10-07",{"date":129,"type":33},"2025-03-11",{"date":131,"type":22},"2026-11-30",{"name":133,"class":40},"University of Calgary",5,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100562712","phase-3-personalizing-the-use-of-pembrolizumab-for-patients-who-have-a-strong-response-in-early-triple-negative-breast-cancer-100562712","NCT06606730","Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer","OPTimizing Adjuvant Prescription of PEMBROlizumab in Patients With Early-stage Triple-negative Breast Cancer Achieving Pathologic Complete Response After Standard Neoadjuvant Chemotherapy and Pembrolizumab","OPT-PEMBRO","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent prior to any trial-related procedures. When the patient is physically unable to give his written consent, a trusted person of his choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent;\n2. Age ≥ 18 years;\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;\n4. Histologically documented stage II-III breast cancer according to the primary tumour-regional lymph node anatomic staging criteria of the American Joint Committee on Cancer (AJCC), 8th edition as determined by the investigator during radiologic assessment, clinical assessment or both;\n5. Estrogen receptor (ER) and Progesterone receptor (PR) ≤10%; HER2-negative as per ASCO\u002FCAP guidelines Note: In case of bilateral breast cancer, participation in the study is permitted as long as both tumours are triple negative;\n6. Patients previously treated with neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles (All systemic chemotherapy must have been completed preoperatively);\n7. Absence of residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy (Residual ductal carcinoma in situ \\[DCIS\\] is allowed);\n8. Have had an adequately excised breast cancer (surgical removal of all clinically evident disease in the breast and lymph nodes) :\n\n   1. Breast surgery: patients must have undergone either breast-conserving surgery or total mastectomy with histologically negative margins for invasive tumour and DCIS. Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection.\n   2. Lymph node surgery: patients must have had sentinel lymph node biopsy (SLNB) and\u002For axillary lymph node dissection (ALND) to evaluate the pathologic nodal status;\n9. Patients that have received adequate locoregional radiation therapy or with planned adequate locoregional radiation therapy;\n10. Adequate organ and bone marrow functions. All screening lab tests should be performed within 28 days before randomisation;\n\n    1. Absolute Neutrophil Count (ANC) ≥ 1,000 \u002FµL\n    2. Platelets ≥ 100,000 \u002FµL\n    3. Hemoglobin ≥ 9 g\u002FdL\n    4. Creatinine clearance ≥ 30 mL\u002Fmin for subject with creatinine levels \\> 1.5 x institutional upper limit of normal (ULN)\n    5. Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN (Patients with Gilbert's disease with a total bilirubin ≤ 2.5 x ULN and direct bilirubin within normal limits are permitted)\n    6. Aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤ 2.5 x ULN\n11. Randomisation must take place no more than 12 weeks after breast surgery. Adjuvant radiotherapy is authorized. If given, as per investigator discretion it can be given concurrently with pembrolizumab;\n12. Patients must not be pregnant or nursing (for women of childbearing potential only, a negative serum pregnancy test must be obtained within 7 days of Cycle 1 Day 1);\n13. Women of childbearing potential and male patients must agree to use 1 effective form of contraception and up to 4 months after the last dose of study drugs;\n14. Patients should be able and willing to comply with study visits and procedures as per protocol;\n15. Patients must be affiliated to a Social Security System (or equivalent).\n\nExclusion Criteria:\n\n1. Radiological or clinical evidence of metastatic disease (stage IV) documented by imaging or clinical examination;\n2. Evidence of recurrent disease following preoperative therapy and surgery;\n3. Any prior history of (ipsi- or contralateral) invasive breast cancer;\n4. Patients with a prior or concurrent malignancy (other than invasive breast cancer) whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of the investigational regimen;\n5. Patients for whom pembrolizumab has been permanently discontinued during the neoadjuvant phase of treatment due to pembrolizumab-related AE;\n6. History of intolerance, including Grade 3 or 4 infusion reaction or hypersensitivity to pembrolizumab or murine proteins or any component of the product;\n7. Medical conditions that require chronic systemic steroids (\\> 10 mg prednisone or equivalent) or any other form of immunosuppressive medication in the past 2 years. Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment;\n8. Known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis;\n9. HIV-infected patients on effective anti-retroviral therapy with detectable viral load within 6 months prior to enrollment;\n10. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better;\n11. Patients unwilling or unable to comply with the medical follow-up required by the trial due to geographic, familial, social, or psychological reasons;\n12. Persons deprived of their liberty or under protective custody or guardianship;\n13. Participation in another therapeutic trial within the 30 days prior to randomisation.",{"count":144,"type":22},2454,[146],"PHASE3","OPT-PEMBRO trial is a pragmatic, multicentre, international, prospective, non-inferiority, two-arms, randomised (1:1), open-label, Phase III clinical study.\n\nThe main goal of this research is to determine if patients with triple-negative breast cancer, who experience a complete response after neoadjuvant treatment, have the same chance of avoiding cancer recurrence whether they stop pembrolizumab or continue taking it for an additional 6 months.\n\nThis research will also take into account patients tolerance to treatment and quality of life.",[28,149],"Triple Negative Breast Cancer (TNBC)","2025-08-19",{"date":152,"type":33},"2025-08-26",{"date":154,"type":33},"2025-07-23",{"date":156,"type":22},"2039-06-01",{"name":158,"class":40},"UNICANCER",2,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":19,"enrollmentInfo":166,"targetDuration":4,"studyType":168,"phases":4,"briefSummary":169,"conditions":170,"keywords":174,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":68},"100594366","epcam-targeted-surface-enhanced-raman-spectroscopy-nanotags-for-rapid-evaluation-of-surgical-margins-and-sentinel-lymph-node-metastasis-status-in-breast-cancers-100594366","NCT07018505","EpCAM-Targeted Surface-Enhanced Raman Spectroscopy Nanotags for Rapid Evaluation of Surgical Margins and Sentinel Lymph Node Metastasis Status in Breast Cancers","Inclusion Criteria:\n\n* Adult patients between 18-75 years of age\n* Female\n* Patients presenting with a breast cancer to be resectable on pre-operative assessment\n* Good operative candidate\n* Subject capable of giving informed consent and participating in the process of consent\n\nExclusion Criteria:\n\n* Patients unable to participate in the consent process\n* Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc\n* Other conditions that the researcher considers inappropriate to participate in the study",{"count":167,"type":22},40,"OBSERVATIONAL","For early breast cancer patients, breast-conserving surgery and sentinel lymph node biopsy have emerged as the cornerstone of precision oncology, harmonizing oncologic efficacy with the preservation of breast cosmetics and axillary function. However, conventional margin evaluation relies on subjective experience, leading to positive margin rates of 15%-50% Additionally, sentinel lymph node biopsy faces inherent technical limitations, including prolonged procedural time and significant false-negative rates in detecting micro-metastases. To overcome these challenges, the investigators will introduce a stable \"sandwich\" EpCAM-targeted surface-enhanced Raman spectroscopy (SERS) detection system to provide rapid evaluation of surgical margins and sentinel lymph node (SLN) metastasis status. In brief, a portion of resected tissue will be immediately homogenized by grinding, and the tissue homogenate will then be analyzed using this detection system to determine its histological characteristics. Pathological confirmation will further validate the method. This approach aims to improve the accuracy and efficiency of intraoperative assessment of breast-conserving surgical margins and SLN status, thereby effectively reducing local recurrence rates and complications.",[171,28,172,173],"Sentinel Lymph Node","Metastases","Margin Assessment",[171,175,176,177,178],"Surface Enhanced Raman Spectroscopy","EpCAM","Breast cancers","Surgical margin","NOT_YET_RECRUITING","2025-06-04",{"date":182,"type":33},"2025-06-12",{"date":184,"type":22},"2025-06-15",{"date":186,"type":22},"2026-07-01",{"name":188,"class":40},"Yunnan Cancer Hospital",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":168,"phases":4,"briefSummary":198,"conditions":199,"keywords":202,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":4},"100589594","prediction-of-icg-for-skin-necrosis-in-mastectomy-with-immediate-reconstruction-100589594","NCT06956443","Prediction of ICG for Skin Necrosis in Mastectomy With Immediate Reconstruction","The Predictive Value of Quantified Indocyanine Green Fluorescent Angiography for Skin Necrosis in Mastectomy With Immediate Reconstruction","Inclusion Criteria:\n\n1. Age \\>18 years\n2. Patients undergoing mastectomy with immediate reconstruction using ICG-NIR\n3. Patients are mentally competent\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Patients with known allergy to ICG or iodinated contrast media\n2. Pregnant or lactating women\n3. Patients with dialysis-dependent renal failure and renal transplantation",{"count":197,"type":22},50,"Background Breast cancer represents 30 percent of newly diagnosed malignancies in female patients and is the leading cause of death in middle-aged women. Surgical treatment of breast cancer is performed with breast-conserving surgery or mastectomy. An increasing proportion of breast cancer patients undergo breast reconstruction after mastectomy. Reconstruction can be performed using various techniques that may involve the use of autologous tissues, implants, or a combination of both. However, mastectomy followed by immediate reconstruction can be associated with complications, including skin and fat necrosis, which occurs in 20% of cases.\n\nWhen assessing tissue perfusion during immediate reconstruction, the surgeon relies on subjective observations, including skin color, capillary refill, and the occurrence of bleeding. One possible technique to assist the surgeon in assessing tissue perfusion is near-infrared (NIR) fluorescence imaging with Indocyanine Green (ICG). ICG can visualize tissue perfusion, because once in the bloodstream it is completely and permanently fixed to plasma proteins and circulates only in the intravascular compartment. ICG was approved for clinical use of tissue perfusion as early as 1956, such as in intestinal anastomoses, for the perfusion of free flaps or parathyroid glands.\n\nICG can also help predict postoperative skin necrosis in breast reconstruction after mastectomy. In patients undergoing (reconstructive) breast surgery, the intraoperative use of ICG NIR fluorescence imaging has been shown to help surgeons assess skin viability, thereby reducing the occurrence of skin necrosis in several studies. This reduction in necrosis can be explained by the intraoperative removal of tissue with reduced fluorescence intensity, observed with ICG NIR fluorescence imaging. However, there is no consensus on which ICG-NIR perfusion parameter is most accurate for assessing tissue perfusion. Further research is needed to determine cut-off values for adequate tissue perfusion. This study focuses on quantifying perfusion parameters and determining the diagnostic accuracy of ICG-NIR in patients undergoing mastectomy with immediate reconstruction.\n\nWhat is the purpose of the study\u002Fresearch question? The purpose of this study is to determine the predictive value of quantified ICG fluorescence angiography for the occurrence of skin necrosis in patients undergoing mastectomy with immediate reconstruction with associated cut-off values.\n\nStudy design\u002Fprocedure and intervention:\n\nThis will be a prospective cohort study of patients undergoing mastectomy with immediate reconstruction using ICG-NIR (the use of ICG during these operations is not an additional procedure).\n\nThis study will include patients who have undergone surgery with ICG (mastectomy with immediate reconstruction). We will use the videos of the ICG angiography for quantitative analysis of the data. This data will be correlated with the postoperative outcome (occurrence of skin\u002Ffat necrosis).\n\nAll patients will be asked in advance for permission to use their data. This will be processed pseudo-anonymously.",[28,200,201],"Mastectomy and Breast Reconstruction","Skin Necrosis",[203,204,205,206,207],"ICG","mastectomy","breast cancer","breast reconstruction","skin necrosis","2025-04-25",{"date":210,"type":33},"2025-05-04",{"date":212,"type":22},"2025-06-01",{"date":214,"type":22},"2026-12-01",{"name":216,"class":40},"University Medical Center Groningen",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":159},"100578482","phase-1-a-phase-ii-single-arm-clinical-study-to-explore-the-efficacy-and-safety-of-hyperbaric-oxygen-in-the-neoadjuvant-treatment-of-breast-cancer-patients-100578482","NCT06811870","A Phase II Single-Arm Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Breast Cancer Patients","Inclusion Criteria:\n\n1. Understand the study process, participate in the study voluntarily, and sign the informed consent form.\n2. patients with histopathologically confirmed initial unilateral primary invasive breast cancer, occult breast cancer, Patients with histopathologically confirmed initial unilateral primary invasive breast cancer, with the exception of occult breast cancer, inflammatory breast cancer and eczema-like carcinoma\n3. aged ≥ 18 years and ≤ 60 years, female\n4. patients who meet the inclusion criteria for neoadjuvant therapy to receive neoadjuvant therapy for breast cancer (locally advanced) Patients with locally advanced breast cancer (AJCC stage III, except T3N1M0) or operable breast cancer, but without breast-conserving or axillary preservation (stage IIA-IIB and T3N1M0) or HER2 positive or TNBC with certain tumour load, or patients with clinical lymph node positivity or tumour size of 2cm and above.)\n5. ECOG performance status 0-1. 6.\n6. LVEF ≥ 55% 7.\n7. Adequate bone marrow functional reserve: white blood cell count ≥3.0 x 109\u002FL, neutrophil count ≥1.5 x 109\u002FL; and 1.5 x 109\u002FL; platelet count ≥ 100 x 109\u002FL; haemoglobin ≥ 90 g\u002FL;\n8. AST, ALT ≤ 2.5 times the upper limit of normal value, alkaline phosphatase ≤ 2.5 times the upper limit of normal value.\n\n   Total bilirubin ≤ 1.5 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value.\n9. For non-menopausal or non-surgically sterilised female patients: during treatment and at least 7 months after the last dose of study treatment.\n\nFor non-menopausal or non-surgically sterilised female patients: consent to contraception during treatment and for at least 7 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Contraindication to hyperbaric oxygen therapy: untreated pneumothorax. Concurrent use of disulfiram. concomitant administration of anti-tumour drugs such as bleomycin, cisplatin, adriamycin concomitant administration of antineoplastic drugs such as bleomycin, cisplatin, adriamycin. Premature and\u002For low body mass neonates. Lung disease (severe chronic obstructive pulmonary disease).\n\n   Diseases of the lungs (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infections, uncontrolled asthma, uncontrolled diarrhoea).\n\n   controlled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear disease (eustachian tube Dysfunction of the eustachian tube, recurrent episodes of vertigo), ocular disease (retinal detachment).\n2. previous hyperbaric oxygen therapy.\n3. distant metastases, including lymph node metastases to the contralateral breast and mediastinum.\n4. other malignant tumours within the last two years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix.\n\n   Tumour.\n5. pregnancy or lactation\n6. uncontrolled hypertension, cardiac, hepatic, renal related disease or other medical or psychiatric conditions.\n7. major surgical procedure unrelated to breast cancer within 4 weeks prior to randomisation, or the patient has not fully recovered from such procedure; or has not fully recovered from such surgical intervention.\n8. serious or uncontrolled infections that may interfere with study treatment or assessment of study results, including but not limited to Serious or uncontrolled infections that may interfere with study treatment or the evaluation of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positivity, and pulmonary infections.\n9. recent history of thromboembolism and taking full dose anticoagulant medication.\n10. any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study","60 Years",{"count":225,"type":22},161,[227,80],"PHASE1","The goal of the study is to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of breast cancer patients",[28],"2025-03-31",{"date":232,"type":33},"2025-04-01",{"date":234,"type":33},"2025-02-01",{"date":236,"type":22},"2026-12-31",{"name":238,"class":40},"Guangdong Provincial People's Hospital",{"id":240,"slug":241,"hasResults":11,"nctId":242,"briefTitle":243,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":223,"enrollmentInfo":245,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":256,"locationsCount":68},"100579567","a-phase-ii-single-arm-clinical-study-to-explore-the-efficacy-and-safety-of-hyperbaric-oxygen-in-the-neoadjuvant-treatment-of-triple-negative-and-her2-breast-cancer-patients-100579567","NCT06825975","A Phase II Single-Arm Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Triple-Negative and HER2+ Breast Cancer Patients","Inclusion Criteria:\n\n1. Understand the study process, participate in the study voluntarily, and sign the informed consent form.\n2. have an initial histopathologically confirmed diagnosis of unilateral primary invasive breast cancer, excluding occult breast cancer, inflammatory breast cancer and eczema-like carcinoma\n3. aged ≥ 18 years and ≤ 60 years, female\n4. patients who meet the inclusion criteria of neoadjuvant therapy to receive neoadjuvant therapy for breast cancer (patients with locally advanced breast cancer (AJCC Stage III, except T3N1M0) or operable but not in breast-conserving or axillary-sparing condition (Stage IIA-IIB and T3N1M0), or patients with a certain tumour load of HER2-positive or TNBC with clinical lymph node positivity, or patients with a tumour size of 2cm and above). or tumour size 2cm and above).\n5. ECOG performance status 0-1.\n6. LVEF ≥ 55%\n7. Adequate bone marrow functional reserve: white blood cell count ≥3.0 x 109\u002FL, neutrophil count ≥1.5 x 109\u002FL; platelet count ≥100 x 109\u002FL; haemoglobin ≥90 g\u002FL;\n8. AST, ALT ≤ 2.5 times the upper limit of normal value, alkaline phosphatase ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value\n9. For non-menopausal or non-surgically sterilised female patients: consent to contraception during treatment and for at least 7 months after the last dose of the study treatment\n\n   \\-\n\nExclusion Criteria:\n\n1. Contraindication to hyperbaric oxygen therapy: untreated pneumothorax. Concurrent use of disulfiram. concomitant administration of anti-tumour drugs such as bleomycin, cisplatin, adriamycin concomitant administration of antineoplastic drugs such as bleomycin, cisplatin, adriamycin. Premature and\u002For low body mass neonates. Lung disease (severe chronic obstructive pulmonary disease). Diseases of the lungs (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infections, uncontrolled asthma, uncontrolled diarrhoea). controlled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear disease (eustachian tube Dysfunction of the eustachian tube, recurrent episodes of vertigo), ocular disease (retinal detachment).\n2. previous hyperbaric oxygen therapy.\n3. distant metastases, including lymph node metastases to the contralateral breast and mediastinum.\n4. other malignant tumours within the last two years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix. Tumour.\n5. pregnancy or lactation\n6. uncontrolled hypertension, cardiac, hepatic, renal related disease or other medical or psychiatric conditions.\n7. major surgical procedure unrelated to breast cancer within 4 weeks prior to randomisation, or the patient has not fully recovered from such procedure; or has not fully recovered from such surgical intervention.\n8. serious or uncontrolled infections that may interfere with study treatment or assessment of study results, including but not limited to Serious or uncontrolled infections that may interfere with study treatment or the evaluation of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positivity, and pulmonary infections.\n9. recent history of thromboembolism and taking full dose anticoagulant medication.\n10. any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study",{"count":246,"type":22},348,[25],"The goal of the study is to explore the efficacy and safety of hyperbaric oxygen therapy in the neoadjuvant treatment of triple-negative and HER2+ breast cancer patients",[28],"2025-02-10",{"date":252,"type":33},"2025-02-13",{"date":254,"type":22},"2025-02-12",{"date":236,"type":22},{"name":238,"class":40},{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":223,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":273,"locationsCount":68},"100579565","a-clinical-study-to-explore-the-efficacy-and-safety-of-hyperbaric-oxygen-in-the-neoadjuvant-treatment-of-hormone-receptor-positive-breast-cancer-patients-100579565","NCT06825949","A Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Hormone Receptor Positive Breast Cancer Patients","A Phase II Single-Arm Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Hormone Receptor Positive Breast Cancer Patients","Inclusion Criteria:\n\n1. understood the study process, volunteered to participate in this study and signed an informed consent form\n2. Patients with histopathologically confirmed diagnosis of initial unilateral primary invasive breast cancer, occult breast cancer, Inflammatory breast cancer and eczema-like carcinoma are excluded.\n3. Female, aged ≥ 18 years and ≤ 60 years.\n4. Patients who meet the inclusion criteria of neoadjuvant therapy to receive neoadjuvant therapy for breast cancer (locally advanced breast cancer (AJCC Stage III, except T3N1M0), or operable, but do not meet the conditions of breast conservation or axillary preservation (Stage IIA-IIB and T3N1M0).\n5. Hormone receptor-positive breast cancer (Luminal\u002FHER2-low (IHC 2+\u002FFISH-negative)).\n6. ECOG performance status 0-1.\n7. LVEF ≥ 55 per cent\n8. Adequate bone marrow functional reserve: white blood cell count ≥ 3.0 x 109\u002FL, neutrophil count ≥ 1.5 x 109\u002FL; platelet count ≥ 100 x 109\u002FL; haemoglobin ≥ 90g\u002FL;\n9. AST, ALT ≤ 2.5 times the upper limit of normal value, alkaline phosphatase ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value\n10. For non-menopausal or non-surgically sterilised female patients: consent to contraception during treatment and for at least 7 months after the last dose of study treatment\n\nExclusion Criteria:\n\n1. have contraindications to hyperbaric oxygen therapy: lung disease (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infections, uncontrolled asthma, untreated pneumothorax), previous history of middle ear surgery, middle ear disease (eustachian tube dysfunction\\\\recurrent vertigo), eye disease (retinal detachment).\n2. Previous hyperbaric oxygen therapy.\n3. Distant metastases, including lymph node metastases in the contralateral breast and mediastinum.\n4. Malignancy other than radically treated basal or squamous cell carcinoma of the skin or CIS of the uterine cervix within the last two years.\n5. Pregnancy or lactation.\n6. Uncontrolled hypertension, cardiac, hepatic, renal related diseases or other medical or psychiatric disorders.\n7. Major surgical procedures unrelated to breast cancer within 4 weeks prior to randomisation, or patients who have not fully recovered from such surgical procedures.\n8. Serious or uncontrolled infections that may interfere with study treatment or assessment of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positivity, pulmonary infection, or other infections.",{"count":265,"type":22},55,[25],"The goal of this study is to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of hormone receptor positive breast cancer patients",[28],{"date":252,"type":33},{"date":271,"type":22},"2025-02-15",{"date":236,"type":22},{"name":238,"class":40},{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":223,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":179,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":68},"100579069","hyperbaric-oxygen-therapy-for-peripheral-neuropathy-due-to-paclitaxel-analogs-100579069","NCT06819501","Hyperbaric Oxygen Therapy for Peripheral Neuropathy Due to Paclitaxel Analogs","Inclusion Criteria:\n\n1. Patients with newly diagnosed breast cancer by pathology\n2. Age 18-60 years\n3. ECOG 0-2\n4. CIPN patients with NCI-CTCAE grade 1 or higher after treatment with paclitaxel-based drugs\n\nExclusion Criteria:\n\n1. Patients with contraindications to hyperbaric oxygen i. Untreated pneumothorax. ii. concomitant administration of disulfiram. iii. concomitant administration of antineoplastic drugs such as bleomycin, cisplatin, adriamycin. iv. premature and\u002For low body mass newborns.\n\n   iv. Premature and\u002For low body mass neonates.\n2. Other cancers",{"count":281,"type":22},226,[25],"The goal of this study was to explore the safety and efficacy of hyperbaric oxygen in the treatment of peripheral neuropathy due to paclitaxel analogues",[28],{"date":286,"type":33},"2025-02-11",{"date":288,"type":22},"2025-02-05",{"date":290,"type":22},"2026-09-01",{"name":238,"class":40},{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":300,"targetDuration":4,"studyType":168,"phases":4,"briefSummary":302,"conditions":303,"keywords":342,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":357},"100578016","predicting-clinical-outcomes-during-first-line-cdk46-inhibitors-plus-endocrine-therapy-in-patients-with-advanced-hormone-receptor-positive-her2-negative-breast-cancer-the-retrospective-prospective-multicenter-italian-palmares-2-study-100578016","NCT06805812","Predicting clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","Predictive Impact of Peripheral Blood Lymphocytes on clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","PALMARES-2","Inclusion Criteria:\n\n* Diagnosis of HR+\u002FHER2- advanced Breast Cancer (aBC), as defined as at least 1% estrogen receptor (ER) and\u002For progesterone receptor (PgR) positivity at IHC. HER2 negativity is defined on the basis of an IHC score of 0, 1+, or 2+ with absence of gene amplification at in situ hybridization (ISH) analyses.\n* Have received or are candidate to receive treatment with palbociclib, ribociclib or abemaciclib in combination with endocrine therapy as first-line treatment for HR+\u002FHER2- aBC.\n\nExclusion Criteria:\n\n* Less than 3 months of follow up from the CDK4\u002F6i start to the date of data cut-off;\n* Have received CDK4\u002F6i as monotherapy;\n* Have received CDK4\u002F6i as adjuvant treatment for localized disease.",{"count":301,"type":22},3500,"PALMARES-2 is a retrospective\u002Fprospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+\u002FHER2- aBC patients treated with first-line CDK4\u002F6i plus ET. The present study has the objective to collect data coming from different sources, i.e. RWD, medical images and biological samples, from patients treated with CDK4\u002F6i as first-line of therapy for HR+\u002FHER2- aBC. In consideration of the complexity of data collected and different objectives of the study, this master protocol foresees different sub-studies, which encompasses different methodologies for data collection, data extraction and analyses.",[304,305,306,307,308,84,309,83,310,28,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341],"Breast Adenocarcinoma","Breast Cancer Stage IV","Breast Cancer, Metastatic","Breast Carcinoma","Breast Diseases","Breast Neoplasms, Male","Breast Cancer With Metastatic Bone Disease","Breast Neoplasm","Breast Tumors","HR+ HER2- Men, Pre\u002FPostmenopausal Advanced Breast Cancer","HR+ Advanced or Metastatic Breast Cancer","HR+\u002FHER2- Breast Cancer","HRpos Breast Neoplasms","HR-positive, HER2-negative Advanced Breast Cancer","HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer","HR-positive Breast Cancer","Hormone Receptor-Positive Breast Cancer","Hormone Receptor Positive Breast Adenocarcinoma","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Breast Neoplasms","Hormone Receptor Positive HER-2 Negative Breast Cancer","Hormone Receptor Positive Malignant Neoplasm of Breast","Hormone Receptor Positive Metastatic Breast Cancer","Hormone Receptor Positive, HER2 Negative Breast Cancer","Hormone Receptor Negative Breast Cancer","Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer","Hormone Receptor Positive Breast Cancer","Hormone Receptor Positive (ER+\u002FPR+, and Her2-) Metastatic Breast Cancer","Hormone Receptor Positive, HER2-negative Neoplasms","Hormone Receptor Positive, HER2-low Neoplasms","Hormone Receptor Positive (HR+), HER2-negative Breast Cancer","Hormone Receptor (HR)-Positive Breast Cancer","Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer","Palbociclib","Ribociclib","Abemaciclib","CDK4\u002F6 Inhibitor","CDK4\u002F6 Inhibitors",[343,344,337,338,339,345,346,347],"HR+\u002FHER2- Advanced Breast Cancer","HR+\u002FHER2- Metastatic Breast Cancer","CDK4\u002F6i","Cyclin-Dependent Kinase 4\u002F6 inhibitors","Metastatic Breast Cancer","2025-01-28",{"date":350,"type":33},"2025-02-03",{"date":352,"type":33},"2023-05-01",{"date":354,"type":22},"2040-12-31",{"name":356,"class":40},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",24,{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":365,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":168,"phases":4,"briefSummary":368,"conditions":369,"keywords":371,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":68},"100336975","genetic-predisposition-to-breast-and-ovarian-cancer-prospective-study-of-brcax-gene-mutation-100336975","NCT03667417","Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation","GENEPSO","1. Woman or man, with or without cancer, carrying a deleterious BRCA1\u002FBRCA2 mutation, aged 18 years and over.\n\n   1. Woman with or without breast cancer or ovarian cancer at baseline.\n   2. Man with or without breast cancer at baseline.\n2. Signed consent to participation\n3. Affiliation to a social security regimen, or beneficiary of such a regimen.\n\nExclusion Criteria:\n\n1. A person of legal age subject to a legal protection measure, or unable to express consent.\n2. Impossibility to submit to the follow-up of the test for geographical, social or psychological reasons",true,{"count":367,"type":22},5000,"Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers",[28,370],"Ovarian Cancers",[372],"BRCA gene mutation","2020-06-30",{"date":375,"type":33},"2020-07-01",{"date":377,"type":33},"1999-10-15",{"date":379,"type":22},"2028-10-15",{"name":381,"class":40},"Institut Paoli-Calmettes"]