[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-breast-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,52,93,115,149,189,212,251,282,320,350,373,396,424,448,470,492,521,545,566],{"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":25,"conditions":26,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100579664","phase-1-a-clinical-study-to-find-the-optimal-dose-of-an-investigational-treatment-called-bnt323-when-used-in-combination-with-another-investigational-treatment-bnt327-and-to-test-if-that-combination-treatment-is-safe-and-beneficial-for-patients-with-advanced-breast-cancer-100579664",false,"NCT06827236","A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer","A Phase I\u002FII, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer","Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified):\n\n* Have pathologically documented BC that:\n\n  * Is locally advanced, unresectable or metastatic.\n  * Has a confirmed HER2 status as determined by the local laboratory as standard of care testing prior to study screening (Part 1, Part 2 Cohorts 2 and 4) or the central laboratory (Part 2, Cohorts 1 and 3) from the most recently collected pre-randomization tumor sample.\n  * Has a documented history of HER2 expression consistent with the subgroup definitions (i.e., HER2-low, HER2-ultralow, HER2-null, HER2-positive, or TNBC) as per current American Society of Clinical Oncology\u002FCollege of American Pathologists guidelines.\n* Have measurable disease defined by RECIST v1.1.\n* Has left ventricular ejection fraction ≥55% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization\u002Fenrollment.\n\nKey Exclusion Criteria:\n\n* Have history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP.\n* Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events.\n* Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization\u002Fenrollment.\n* Have a history of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, have current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Had prior treatment with topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I inhibitor payloads such as trastuzumab deruxtecan.\n* Have received any of the following therapies or drugs prior to the initiation of the study:\n\n  * Participants who have received prior treatment with BNT323.\n  * Participants who received prior treatment with a programmed death-ligand 1 (PD-L1) \u002F vascular endothelial growth factor (VEGF) bispecific antibody. Note: Prior treatment with programmed death 1 (PD-1)\u002FVEGF bispecific antibodies, PD-1\u002FPD-L1 inhibitors or anti-VEGF therapies are permitted.\n  * Have received other systemic immunostimulatory agents or immunosuppressive therapies (such as interferon-α, interleukin-2, or methotrexate) within 4 weeks prior to the initiation of study treatment or are within five half-lives of the treatment drug (whichever is longer). Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens).\n  * Have received systemic corticosteroids (at a dosage greater than 10 mg\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 3 weeks prior to the initiation of study treatment.\n\nNOTE: Other protocol defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years",{"count":19,"type":20},380,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a Phase I\u002FII, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-positive, HER2-low (immunohistochemistry \\[IHC\\] 1+ or IHC 2+\u002Fin situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).",[27,28,29],"Locally Advanced Breast Cancer","Unresectable Breast Carcinoma","Metastatic Breast Cancer",[31,32,33,34,35,36,37,38],"Breast Cancer (BC)","Human epidermal growth factor receptor 2 (HER2)","IHC scores 0, 1+, 2+, and 3+","Antibody drug conjugate (ADC)","Programmed Death-1 (PD-1)","Programmed Death Ligand-1 (PD-L1)","Programmed Death-1 monoclonal antibodies","Anti vascular endothelial growth factor-A (anti-VEGF-A)","RECRUITING","2026-06-22",{"date":42,"type":43},"2026-06-23","ACTUAL",{"date":45,"type":43},"2025-04-23",{"date":47,"type":20},"2029-08",{"name":49,"class":50},"BioNTech SE","INDUSTRY",56,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":21,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100599536","phase-3-palazestrant-in-combination-with-ribociclib-for-the-first-line-treatment-of-erher2--advanced-breast-cancer-100599536","NCT07085767","Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+\u002FHER2- Advanced Breast Cancer","A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02)","OPERA-02","Inclusion Criteria:\n\n* Adult female or male participants.\n* ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.\n* Evaluable disease (measurable disease per RECIST 1.1 or bone-only disease).\n* De novo advanced breast cancer or with disease recurrence occurring after 12 months of completing adjuvant endocrine therapy (with or without CDK4\u002F6 inhibitors)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, hepatic, and renal functions.\n* Female participants can be pre-, peri- or postmenopausal.\n* Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.\n\nExclusion Criteria:\n\n* Disease recurrence during adjuvant endocrine therapy\n* Currently receiving or previously received systemic anti-cancer therapy for ER+, HER2- advanced breast cancer.\n* Previously received treatment with fulvestrant, elacestrant or an investigational endocrine therapy in any setting.\n* History of allergic reactions to study treatment.\n* Any contraindications to letrozole and ribociclib.\n* Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.",{"count":61,"type":20},1000,[63],"PHASE3","This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.",[66,27,29,67,68],"Breast Cancer","ER Positive Breast Cancer","HER2 Negative Breast Carcinoma",[70,71,72,73,74,75,76,77,78,79,80,81,82],"Randomized","Multicenter","Double-Blind","Active-Controlled","Phase 3","Palazestrant","Complete Estrogen Receptor Antagonist (CERAN)","Selective Estrogen Receptor Degrader (SERD)","Ribociclib","CDK4\u002F6i","Letrozole","Aromatase inhibitors","Antineoplastic agents","2026-06-12",{"date":85,"type":43},"2026-06-16",{"date":87,"type":43},"2025-11-03",{"date":89,"type":20},"2032-01",{"name":91,"class":50},"Olema Pharmaceuticals, Inc.",150,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":103,"phases":4,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100619667","a-study-to-evaluate-the-effectiveness-and-safety-of-inavolisib-in-participants-with-endocrine-resistant-pik3ca-mutated-hormone-receptor-positive-her2-negative-locally-advanced-or-metastatic-breast-cancer-100619667","NCT07347600","A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer","A Non-interventional Study to Evaluate the Effectiveness and Safety of Inavolisib in Patients With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer (reaINAVO)","reaINAVO","Inclusion Criteria:\n\n* Participants must be diagnosed with endocrine-resistant, PIK3CA-mutated, HR+\u002FHER2- LA\u002FmBC, following recurrence on or after completing adjuvant endocrine therapy\n* Participants must receive the treatment of inavolisib for the first time\n* PIK3CA mutation status should be detected by a National Medical Products Administration (NMPA)-approved or validated assay \\[Polymerase Chain Reaction (PCR) or Next Generation Sequencing (NGS)\\] by testing of blood or tumor tissue prior to the initiation of inavolisib\n\nExclusion Criteria:\n\n* Participants for which the treatment with inavolisib is not indicated per prescribing information. If the participant starts palbociclib and fulvestrant first, and starts inavolisib after getting a PIK3CA mutation-positive test result later, the palbociclib and fulvestrant will not be deemed as a different line of therapy. However, the medical order of PIK3CA mutation test must be made before or at the same time with the prescription of palbociclib and fulvestrant\n* Participants not receiving treatment for LA\u002FmBC with inavolisib according to standard of care (SOC) and in line with the current summary of product characteristics (SPC)\u002Flocal labeling\n* At the investigator's discretion, any reason that makes the participant hard to follow up or unsuitable to participate in the study",{"count":102,"type":20},500,"OBSERVATIONAL","The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA\u002FmBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.",[27,29],"2026-06-11",{"date":83,"type":43},{"date":109,"type":43},"2026-01-21",{"date":111,"type":20},"2029-09-09",{"name":113,"class":50},"Hoffmann-La Roche",23,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":123,"minAge":17,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":148},"100484012","phase-2-fudan-university-shanghai-cancer-center-breast-cancer-precision-platform-series-study--neoadjuvant-therapy-100484012","NCT05582499","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy","Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (FASCINATE-N)","FASCINATE-N","Inclusion Criteria:\n\n* Histologically confirmed invasive breast cancer of clinical stage T1-4N1-3M0 or cT2-4N0M0;\n* Age between18-70 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n* ER, PR and HER2 status were measured by immunohistochemistry (IHC);\n* LVEF≥55%；\n* Definition of SNF subtypes: SNF subtypes confirmed by digital pathology of H\\&E slices;\n* Triple negative subtyping: On the basis of triple-negative pathological diagnosis, AR, cluster of differentiation 8 (CD8) and Forkhead Box C1 (FOXC1) were combined to define the subtyping;\n* At least one measurable lesion according to RECIST version 1.1\n* Normal organ and marrow function: Hemoglobin (HB) ≥90 g\u002FL (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 75,000\u002FμL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \\\u003C 1 x ULN, endogenous creatinine clearance \\> 50 ml\u002Fmin (Cockcroft-Gault formula);\n* Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug;\n* Ability to understand and willingness to sign a written informed consent\n\nExclusion Criteria:\n\n* Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;\n* Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II);\n* Patients with severe systemic infections or other serious diseases;\n* Patients with known allergy or intolerance to the study drug or its excipients;\n* Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;\n* Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study;\n* Participated in other trial studies within 30 days before the administration of the first dose of the study drug;\n* Patients who were judged by the investigator to be unsuitable for this study.","FEMALE","70 Years",{"count":126,"type":20},716,[24],"The purpose of this study is to establish a prospective, single-center platform research based on clinical subtypes to explore precision neoadjuvant therapy in patients with operable breast cancer who met the indications for neoadjuvant chemotherapy and by the update of basic translational research in the center, especially the refinement of typing, the discovery of new targets and the development of novel targeted drugs, verified the effectiveness of new targeted drugs in neoadjuvant therapy.",[130,66,131,132,133,134,135,136,137,27],"Breast Neoplasm","Breast Tumors","Triple-Negative Breast Cancer (TNBC)","HER2-positive Breast Cancer","HER2-negative Breast Cancer","Hormone Receptor Positive Tumor","Hormone Receptor Negative Tumor","Early-stage Breast Cancer","2026-05-22",{"date":140,"type":43},"2026-05-28",{"date":142,"type":43},"2022-11-01",{"date":144,"type":20},"2029-09",{"name":146,"class":147},"Fudan University","OTHER",1,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":159,"conditions":160,"keywords":166,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},"100535064","phase-1-a-study-of-pembrolizumab-and-cryoablation-in-people-with-breast-cancer-100535064","NCT06246968","A Study of Pembrolizumab and Cryoablation in People With Breast Cancer","Does Cryoablation Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer?","Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* Confirmed histologic diagnosis of metastatic TNBC\n* 1 site amenable cryoablation of at least 1.5 cm in size as determined by an Interventional Radiologist. Eligible cryoablation sites include (but not limited to) soft tissue, liver, lung, and bone as determined by an Interventional Radiologist to be safest and most feasible.\n* Physically fit (clinically eligible) to undergo cryoablation as per usual clinical practice\n* Per clinical guidelines, women of childbearing age should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of the drug, which will be assessed and monitored by, and the responsibility of, the patient's medical oncologist (not study investigators or research team) as pembrolizumab is standard of care. Memorial Sloan Kettering Cancer Center Pregnancy Standards will be followed prior to cryoablation. That is, female patients that are 11-50 years of age and of childbearing potential will undergo a pregnancy test within 2 weeks (15 days) before cryoablation. Pregnancy test will not be required in patients with bilateral oophorectomy, bilateral salpingectomy, bilateral salpingectomy-oophorectomy, hysterectomy, menopause (no menses ≥ 1 year prior to treatment or after completion of all treatment), or surgical sterilization (i.e. tubal ligation or blockage), with documentation of permanent exemptions in CIS (\"Pregnancy Testing Exemption\").\n* Pembrolizumab therapy (200 mg every 3 weeks) planned as part of standard of care as first, second, or third line of therapy\n\n  * Eligible for PD-1 inhibitor per the patient's medical oncologist, with planned treatment with PD-1 inhibitor per the patient's medical oncologist. Additional systemic therapy is per the patient's medical oncologist. The following systemic therapy will be accepted (the timing of the systemic therapy relative to pembrolizumab and cryoablation is not restricted):\n\n    * Capecitabine (Xeloda, available as a generic drug)\n    * Carboplatin (Paraplatin, available as a generic drug)\n    * Cisplatin (Platinol, available as a generic drug)\n    * Cyclophosphamide (Cytoxan, available as a generic drug)\n    * Docetaxel (Taxotere)\n    * Doxorubicin (Adriamycin, available as a generic drug)\n    * Pegylated liposomal doxorubicin (Doxil)\n    * Epirubicin (Ellence, available as a generic drug)\n    * Eribulin (Halaven)\n    * Fluorouracil (5-FU, Adrucil, available as a generic drug)\n    * Gemcitabine (Gemzar, available as a generic drug)\n    * Ixabepilone (Ixempra)\n    * Methotrexate (available as a general drug)\n    * Nab-paclitaxel (Abraxane)\n    * Paclitaxel (Taxol, available as a generic drug)\n    * Vinorelbine (Navelbine, available as a generic drug)\n\nExclusion Criteria:\n\n* Patient not eligible for PD-1 inhibitor per the patient's medical oncologist\n* No disease amenable for cryoablation\n* Pembrolizumab therapy not planned as part of standard of care",{"count":157,"type":20},30,[23],"Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with cryoablation OR pembrolizumab alone. Participants will be randomly assigned.",[29,66,161,162,163,164,27,165],"Breast Cancer Stage IV","Triple Negative Breast Cancer","Triple Negative Breast Neoplasms","Metastatic Triple-Negative Breast Carcinoma","Locally Advanced Triple-Negative Breast Carcinoma",[167,168,169,170,171,172,173,174,175,176,177,178,179],"metastatic TNBC","metastatic triple negative breast carcinoma","metastatic breast cancer","breast cancer","breast cancer stage IV","triple negative breast cancer","pembrolizumab","cryoablation","Memorial Sloan Kettering Cancer Center","23-390","locally advanced breast cancer","locally advanced triple negative breast carcinoma","locally advanced triple negative breast cancer","2026-05-18",{"date":182,"type":43},"2026-05-20",{"date":184,"type":43},"2024-01-29",{"date":186,"type":20},"2027-01-29",{"name":175,"class":147},7,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":123,"minAge":17,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":21,"phases":198,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":4},"100641095","phase-4-trastuzumab-rezetecan-t-dxh-in-her2-breast-cancer-with-non-pcr-after-tcbhp-100641095","NCT07589699","Trastuzumab Rezetecan (T-DXh) in HER2+ Breast Cancer With Non-pCR After TCbHP","A Single-Arm, Exploratory Study of 4 Additional Cycles of Trastuzumab Rezetecan (T-DXh) as Neoadjuvant Therapy in Patients With Early or Locally Advanced HER2-Positive Breast Cancer Who Have Non-pCR After TCbHP Neoadjuvant Therapy","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* For premenopausal and perimenopausal patients: negative pregnancy test and agreement to use reliable contraception during the treatment period.\n* Pathologically confirmed HER2-positive invasive breast cancer (IHC 3+ or IHC 2+ with FISH+).\n* Completed standard neoadjuvant TCbHP (taxane + carboplatin + trastuzumab + pertuzumab) with imaging assessment not achieving clinical complete remission (non-cCR).\n* Agree to undergo a core needle biopsy.\n* ECOG performance status 0 or 1.\n* Adequate organ function meeting the following criteria: hemoglobin ≥ 90 g\u002FL, white blood cell count ≥ 3.5 × 10\\^9\u002FL, platelet count ≥ 100 × 10\\^9\u002FL, absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL, AST\u002FALT ≤ 3 × ULN, total bilirubin ≤ 1.5 × ULN, serum creatinine ≤ 1.5 × ULN.\n* No myocardial ischemia on ECG; New York Heart Association (NYHA) functional class I; left ventricular ejection fraction (LVEF) ≥ 55% by echocardiography; cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) within normal limits.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Male breast cancer or inflammatory breast cancer.\n* Metastatic breast cancer (Stage IV).\n* Concurrent other malignancy or history of other malignancy within the past 5 years, except adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.\n* Concurrent other anti-tumor therapy or participation in another clinical trial.\n* Severe non-malignant disease that would affect compliance or place the patient at risk.\n* Major surgery within 4 weeks prior to start of study treatment or anticipated need for major surgery during the study.\n\nHistory of allergic reaction or contraindication to any component of the study drug.\n\n* Dementia, mental abnormality, or any psychiatric illness that interferes with understanding of the informed consent.\n* Any other condition assessed by the investigator as unsuitable for inclusion.",{"count":197,"type":20},59,[199],"PHASE4","This is a prospective, multi-center, single-arm, phase 2 exploratory study to evaluate the efficacy and safety of adding 4 cycles of Trastuzumab Rezetecan (T-DXh), an anti-HER2 antibody-drug conjugate, as continued neoadjuvant therapy in patients with early or locally advanced HER2-positive breast cancer who have residual invasive disease after standard 6-cycle TCbHP (taxane, carboplatin, trastuzumab, pertuzumab) neoadjuvant therapy. Patients will receive 4 cycles of T-DXh (4.8 mg\u002Fkg IV Q3W) followed by radical surgery. The primary endpoint is tpCR rate. Secondary endpoints include ORR, EFS, OS, 3-year iDFS, and safety. Simon's two-stage design (H0: pCR ≤10%, H1: pCR ≥25%, α=0.05, β=0.2) requires 43 evaluable patients; with 10% dropout, 48 patients will be enrolled.",[66,133,137,27],"NOT_YET_RECRUITING","2026-05-11",{"date":205,"type":43},"2026-05-15",{"date":207,"type":20},"2026-05-31",{"date":209,"type":20},"2031-12-31",{"name":211,"class":147},"The First Affiliated Hospital with Nanjing Medical University",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":228,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":250},"100136130","phase-2-i-spy-trial-neoadjuvant-and-personalized-adaptive-novel-agents-to-treat-breast-cancer-100136130","NCT01042379","I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer","I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)","I-SPY","Inclusion Criteria:\n\n* Histologically confirmed invasive cancer of the breast\n* Clinically or radiologically measureable disease in the breast after diagnostic biopsy, defined as longest diameter greater than or equal to 25 mm (2.5cm)\n* No prior cytotoxic regimens are allowed for this malignancy. Patients may not have had prior chemotherapy or prior radiation therapy to the ipsilateral breast for this malignancy. Prior bis-phosphonate therapy is allowed\n* Age ≥18 years\n* ECOG performance status 0-1\n* Willing to undergo core biopsy of the primary breast lesion to assess baseline biomarkers\n* Non-pregnant and non-lactating\n* No ferromagnetic prostheses. Patients who have metallic surgical implants that are not compatible with an MRI machine are not eligible.\n* Ability to understand and willingness to sign a written informed consent (I-SPY TRIAL Screening Consent)\n* Eligible tumors must meet one of the following criteria: Stage II or III, or T4, any N, M0, including clinical or pathologic inflammatory cancer or Regional Stage IV, where supraclavicular lymph nodes are the only sites metastasis\n* Any tumor ER\u002FPgR status, any HER-2\u002Fneu status as measured by local hospital pathology laboratory and meets any tumor assay profile described in protocol section 4.1.2F\n* Normal organ and marrow function: Leukocytes ≥ 3000\u002FμL, Absolute neutrophil count ≥ 1500\u002FμL, Platelets ≥ 100,000\u002FμL, Total bilirubin within normal institutional limits, unless patient has Gilbert's disease, for which bilirubin must be ≤ 2.0 x ULN, AST(SGOT)\u002FALT (SGPT) ≤ 1.5 x institutional ULN, creatinine \\\u003C 1.5 x institutional ULN\n* No uncontrolled or severe cardiac disease. Baseline ejection fraction (by nuclear imaging or echocardiography) must by ≥ 50%\n* No clinical or imaging evidence of distant metastases by PA and Lateral CXR, Radionuclide Bone scan, and LFTs including total bilirubin, ALT, AST, and alkaline phosphatase\n* Tumor assay profile must include on of the following: MammaPrint High, any ER status, any HER2 status, or MammaPrint Low, ER negative (\\\u003C5%), any HER2 status, or MammaPrint Low, ER positive, HER2\u002Fneu positive by any one of the three methods used (IHC, FISH, TargetPrint™)\n* Ability to understand and willingness to sign a written informed consent document (I-SPY 2 TRIAL Consent #2)\n\nExclusion Criteria:\n\n* Use of any other investigational agents within 30 days of starting study treatment\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications.\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",{"count":221,"type":20},5000,[24],"The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.",[225,66,131,226,227,133,134,135,136,137,27],"Breast Neoplasms","Angiosarcoma","TNBC - Triple-Negative Breast Cancer",[229,230,231,232,233,234,235,236,237,238,239,240],"Neoadjuvant","Breast","Cancer","Neoplasm","Adaptive","pCR","Pathologic Complete Response","Biomarkers signature","MRI Volume","Endocrine Therapy","Chemotherapy","Immunotherapy","2026-05-04",{"date":243,"type":43},"2026-05-06",{"date":245,"type":43},"2010-03-01",{"date":247,"type":20},"2031-12",{"name":249,"class":147},"QuantumLeap Healthcare Collaborative",42,{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":123,"minAge":17,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":21,"phases":259,"briefSummary":260,"conditions":261,"keywords":268,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":148},"100572016","phase-2-memantine-and-exercise-to-improve-cognitive-function-and-modulate-biological-pathways-of-cognitive-decline-during-chemotherapy-in-breast-cancer-100572016","NCT06727773","Memantine and Exercise to Improve Cognitive Function and Modulate Biological Pathways of Cognitive Decline During Chemotherapy in Breast Cancer","Inclusion Criteria:\n\nIn order to participate in the study a subject must meet all of the eligibility criteria outlined below.\n\n* Female\n* Age ≥ 18 years at the time of consent.\n* Stage I-III Breast Cancer\n* Recommended chemotherapy\n* Enroll prior to 3rd cycle of chemotherapy\n* English-speaking\n\nExclusion Criteria:\n\n* Allergy to memantine\n* Previous chemotherapy (prior to the current regimen),\n* Severe cognitive impairment, defined by Blessed Orientation Memory Concentration Test Score ≥11\n* Myocardial infarction in the last 6 months\n* Cardiovascular or orthopedic limitations to exercise\n* Severe mental illness (i.e., schizophrenia or bipolar affective disorder)\n* Current alcohol or drug abuse\n* Inability to swallow capsules \\\u003C\u002F= 5mL\u002Fmin\n* CrCl \\\u003C\u002F= 5mL\u002Fmin",{"count":258,"type":20},90,[24],"This randomized, placebo-controlled trial aims to assess the feasibility, acceptability, and preliminary efficacy of memantine and the University of Carolina (UNC)'s Get Real \\& Heel cancer exercise program (MEM+EX) in addressing cancer-related cognitive impairment (CRCI) and underlying CRCI biomarkers. Ninety stage I-III breast cancer patients during chemotherapy will be randomized into three groups: MEM+EX, memantine, or placebo. The study will evaluate recruitment, retention, adherence, acceptability, cognitive function, brain-derived neurotrophic factor (BDNF), inflammatory markers, and frailty at multiple time points.",[66,27,262,263,264,265,266,267],"Cognitive Impairment","Cognitive Decline","Cognitive Change","Breast Cancer Stage I","Breast Cancer Stage II","Breast Cancer Stage III",[269,270,271,272,273],"chemotherapy","memantine","placebo-controlled","exercise","Get Real & Heel cancer exercise program","2026-05-01",{"date":243,"type":43},{"date":277,"type":43},"2025-08-19",{"date":279,"type":20},"2029-06-15",{"name":281,"class":147},"UNC Lineberger Comprehensive Cancer Center",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":123,"minAge":289,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":21,"phases":293,"briefSummary":295,"conditions":296,"keywords":299,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":4},"100636798","targeting-stress-driven-inflammatory-and-angiogenic-pathways-with-brief-act-to-enhance-neoadjuvant-chemotherapy-response-in-locally-advanced-breast-cancer-100636798","NCT07570368","Targeting Stress-Driven Inflammatory and Angiogenic Pathways With Brief ACT to Enhance Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer","Effect of Brief Acceptance and Commitment Therapy on Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer Through Modulation of Inflammatory and Angiogenic Biomarkers.","Inclusion Criteria:\n\n* Female patients aged 40-65 years\n* Histologically confirmed locally advanced breast cancer\n* Planned to undergo neoadjuvant chemotherapy\n* ECOG performance status 0-2\n* Able to provide informed consent\n* Willing to participate in psychological intervention sessions\n\nExclusion Criteria:\n\n* Severe psychological distress defined as Perceived Stress Scale (PSS-10) score ≥27\n* Active infection or inflammatory disease\n* Known autoimmune disease\n* Cognitive impairment or psychiatric condition interfering with participation\n* Concurrent participation in another interventional study","40 Years","65 Years",{"count":292,"type":20},54,[294],"NA","This clinical trial aims to learn whether a brief psychological therapy called Brief Acceptance and Commitment Therapy (Brief-ACT) can improve the effectiveness of neoadjuvant chemotherapy in patients with locally advanced breast cancer. It will also examine how this therapy affects stress levels and certain blood markers related to inflammation and tumor growth.\n\nThe main questions this study aims to answer are:\n\nDoes Brief-ACT improve the rate of pathological complete response (pCR) after chemotherapy? Does Brief-ACT reduce levels of inflammatory and angiogenic biomarkers such as C-reactive protein (CRP), interleukin-6 (IL-6), neutrophil-to-lymphocyte ratio (NLR), and vascular endothelial growth factor (VEGF)? Does Brief-ACT reduce psychological stress in patients undergoing chemotherapy?\n\nResearchers will compare patients who receive Brief-ACT in addition to standard chemotherapy with those who receive standard chemotherapy alone to see if there are differences in treatment response, stress levels, and biomarker levels.\n\nParticipants will:\n\nReceive neoadjuvant chemotherapy according to standard treatment protocols Be assigned to receive Brief-ACT sessions or no additional psychological intervention Attend regular clinic visits for treatment and monitoring Provide blood samples at specific time points for laboratory analysis Complete questionnaires to assess psychological stress",[66,297,298,27],"Breast Neoplasm Female","Locally Advanced Breast Cancer (LABC)",[170,300,301,302,303,304,305,306,307,308,309,310,311],"Locally advanced breast cancer","brief acceptance and commitment therapy","acceptance and commitment therapy","neoadjuvant chemotherapy","clinical chemotherapy response","inflammatory biomarkers","angiogenic biomarkers","interleukin-6","neutrophil to lymphocyte ratio","vascular endothelial growth factor","psychological stress","psycho-oncology","2026-04-29",{"date":243,"type":43},{"date":315,"type":20},"2026-04-28",{"date":317,"type":20},"2027-01",{"name":319,"class":147},"Universitas Airlangga",{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":21,"phases":330,"briefSummary":331,"conditions":332,"keywords":335,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":349},"100390210","phase-1-pavement-palbociclib-and-avelumab-in-metastatic-ar-triple-negative-breast-cancer-100390210","NCT04360941","PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer","PAveMenT: Phase Ib Study of Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer","PAveMenT","Inclusion Criteria Part A:\n\n1. Patients with recurrent inoperable locally advanced or metastatic breast cancer.\n2. Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced disease. Patients with ER+ breast cancer must have received at least one prior line of hormone therapy for advanced disease. Patients with HER2+ breast cancer must have received at least one prior line of HER2 directed therapy.\n3. Measurable disease (RECIST 1.1)\n4. Haematological and biochemical indices within the ranges stated in the study protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial.\n5. Women\u002Ffemale patients with child-bearing potential (defined as the fertile status following menarche and until becoming post-menopausal unless permanently sterile by methods that include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n\n   Women\u002Ffemales of child bearing potential or their male partners must use a highly effective method of contraception for 2 weeks before starting the study treatment, throughout the treatment period and for 1 month after discontinuation of treatment with palbociclib and avelumab (women\u002Ffemale patients) or 14 weeks (men\u002Fmale patients). Highly effective methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods, such methods include:\n   * Oral, intra-vaginal or transdermal combined hormonal contraception\n   * Oral, injectable or implantable progesterone-only contraception\n   * Intrauterine device\n   * Intrauterine hormone-releasing system,\n   * Bilateral tubal occlusion\n   * Vasectomised partner\n   * True abstinence:\\* When this is in line with the preferred and usual lifestyle of the subject\n\n   Key: \\* it is only considered highly effective if the patient is refraining from sexual intercourse during the entire period of risk associated with the study treatments\n6. 18 years of age or over.\n7. World Health Organisation (WHO) performance status 0 or 1\n8. Estimated life expectancy of at least 3 months in the opinion of the investigator\n9. Signed and dated informed consent.\n10. Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow up and other procedures\n\nInclusion Criteria Part B:\n\n1. Patients with recurrent inoperable locally advanced or metastatic AR+ triple negative breast cancer with ER, PgR and HER2 status determined locally and AR determined centrally on archival metastatic tissue. Archival tissue from the primary tumour (which must have been ER\u002FPgR negative and collected within 5 years prior to metastatic relapse) may be used for AR testing if no archival metastatic tissue is available.\n2. Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced disease.\n3. Measurable disease (RECIST 1.1) amenable to fresh biopsy\n4. Haematological and biochemical indices within the ranges stated in the study protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial.\n5. Female patients with child-bearing potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n\n   Women\u002Ffemales of child bearing potential or their male partners must use a highly effective method of contraception for 2 weeks before starting the study treatment, throughout the treatment period and for 1 month after discontinuation of treatment with palbociclib and avelumab (women\u002Ffemale patients) or 14 weeks (men\u002Fmale patients). Highly effective methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods, such methods include:\n   * Oral, intra-vaginal or transdermal combined hormonal contraception\n   * Oral, injectable or implantable progesterone-only contraception\n   * Intrauterine device\n   * Intrauterine hormone-releasing system,\n   * Bilateral tubal occlusion\n   * Vasectomised partner\n   * True abstinence:\\* When this is in line with the preferred and usual lifestyle of the subject\n\n   Key: \\* it is only considered highly effective if the patient is refraining from sexual intercourse during the entire period of risk associated with the study treatments\n6. Age 18 years of age or over\n7. World Health Organisation (WHO) performance status 0 or 1\n8. Estimated life expectancy of at least 3 months in the opinion of the investigator\n9. Signed and dated informed consent\n10. Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow up, and other procedures\n11. Available archival breast primary tumour tissue (or metastatic tissue if de novo metastatic disease)\n12. Patient willing to undergo a mandatory baseline fresh tumour tissue biopsy procedure (clinical or radiologically-guided)\n\nExclusion Criteria Parts A \\& B:\n\n1. Oral chemotherapy within two weeks, weekly iv chemotherapy within three weeks or any other systemic chemotherapy or investigational medicinal products during the previous four weeks.\n2. Hormonal therapy within 7 days except luteinizing hormone-releasing hormone (LHRH) analogues for ovarian suppression. Bisphosphonates or RANK ligand antagonists are permitted for the management of bone metastases.\n3. Previous exposure to immune checkpoint inhibitors or immune co-stimulatory drugs in the advanced setting. (Note: Patients who have received neoadjuvant and\u002For adjuvant pembrolizumab are eligible if treatment was completed at 6 months prior to metastatic relapse.)\n4. Previous treatment with palbociclib or any agents which inhibit CDK4\u002F6. (Note: Patients who have received adjuvant abemaciclib or ribociclib for early breast cancer are eligible if treatment was completed at least 12 months prior to metastatic relapse.)\n5. Major surgery (excluding minor procedures, e.g. placement of vascular access) within 4 weeks or radiation therapy within 14 days prior to study entry\n6. Patients with known symptomatic brain metastases requiring steroids, untreated brain metastases, leptomeningeal disease or spinal cord compression.\n7. Active infection requiring systemic therapy\n8. Any of the following within 12 months prior to study entry: myocardial infarction, history of myocarditis, uncontrolled angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack.\n9. Uncontrolled hypertension or cardiac dysrhythmia including atrial fibrillation\n10. Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.\n11. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n12. Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis (even if fully resolved), pulmonary fibrosis, end stage renal disease on haemodialysis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behaviour; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n13. Patients on warfarin or direct acting oral anticoagulants. Patients requiring anticoagulation for rate-controlled AF or previous venous thromboembolism should be switched to low-molecular weight heparin.\n14. Known HIV or AIDS-related illness, active infection requiring systemic therapy, or positive HBV or HCV test indicating acute or chronic infection\n15. Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI CTCAE v 5), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)\n16. Inability or unwillingness to swallow pills, or receive IV injections.\n17. Persisting toxicity related to prior therapy \\>Grade 1 (except for stable peripheral neuropathy grade ≤2 or alopecia grade ≤2).\n18. Pregnancy or lactation (women\u002Ffemales of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation)\n19. Diagnosis of other malignancy within 3 years, except for previous breast cancer, adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix, or low-grade (Gleason ≤6) prostate cancer\n20. Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable.\n21. Known prior or suspected hypersensitivity to investigational products or to any of the excipients\n22. Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines. Live vaccines must also be avoided for 3 months after the last dose of avelumab.\n23. Any psychiatric condition that would prohibit the understanding or rendering of informed consent\n24. Requirement for continued use of preparations containing St. John's Wort is specifically contraindicated. Other herbal medicinal or natural products that patient is intended to take during the trial must be explored at the beginning and during the course of the trial and discussed with the investigator.\n25. Requirement for continued use of CYP3A inhibitors, inducers or substrates (listed in Appendix 4).\n26. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine as this medicinal product contains lactose.\n27. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.",{"count":329,"type":20},45,[23],"This clinical study is aiming to determine the safest doses and schedule for the combination of two drugs named palbociclib and avelumab.\n\nThe study will also be investigating how effective the combination is for a subgroup of breast cancer patients whose cancer expresses the androgen receptor (AR) but not the oestrogen (hormone) or HER2 receptors. Palbociclib is a drug used in routine care for hormone-receptor (HR) positive and HER2 negative advanced breast cancer, the most common subtype of breast cancer.\n\nIt is possible that the combination of palbociclib and avelumab will be a more effective cancer treatment than each drug separately, but this is unknown and this study is needed to establish the best dosage and schedule of each drug as well as how effective the combination is.",[162,27,333,29,334,133],"Recurrent Breast Cancer","ER+ Breast Cancer",[336,337,338,339],"Palbociclib","Avelumab","Measurable Disease","Inoperable Disease","2026-03-31",{"date":342,"type":43},"2026-04-06",{"date":344,"type":43},"2020-08-11",{"date":346,"type":20},"2026-07-31",{"name":348,"class":147},"Royal Marsden NHS Foundation Trust",9,{"id":351,"slug":352,"hasResults":11,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":123,"minAge":17,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":21,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":372},"100521070","phase-1-a-phase-iii-study-of-fwd1802-in-patients-with-erher2--advanced-bc-100521070","NCT06064812","A Phase I\u002FII Study of FWD1802 in Patients With ER+\u002FHER2- Advanced BC.","A Phase I\u002FII, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of FWD1802in Patients With ER+\u002FHER2- Unresectable Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for enrollment in this clinical study:\n\n1. Voluntarily participate in the clinical trial and sign the informed consent form.\n2. Female, aged ≥18 years.\n3. Able to provide blood samples for central laboratory testing of ESR1 mutation status and other biomarker assessments. Phase I Study: ESR1 mutation status will be tested retrospectively. Phase II Study: Only subjects with confirmed ESR1 mutations will be enrolled (see Appendix 5 for details).\n4. Histologically or cytologically confirmed locally advanced or metastatic breast cancer that is ER-positive and HER2-negative.\n\n   Criteria for ER positivity: Immunohistochemistry staining shows nuclear staining in ≥10% of tumor cells.\n\n   Criteria for HER2 negativity: Immunohistochemistry staining intensity is 0 or 1+; if the intensity is 2+, it must be confirmed negative by in situ hybridization.\n5. Confirmed in menopause and not caused by ovarian function suppression drugs, must meet one of the following criteria:\n\n   Previous bilateral oophorectomy. Age ≥ 60 years.\n\n   Age \\\u003C 60 years (subdivided into the following conditions):\n   1. Never received chemotherapy, ovarian function inhibitors, or SERM drugs (tamoxifen, toremifene), with amenorrhea ≥12 months, and E2 and FSH levels in the postmenopausal range.\n   2. Received chemotherapy resulting in chemotherapy-induced amenorrhea ≥12 months, with E2 and FSH levels in the postmenopausal range.\n   3. Using SERM drugs (tamoxifen, toremifene), with E2 and FSH levels in the postmenopausal range.\n6. Premenopausal or perimenopausal female subjects must agree to receive and maintain treatment with ovarian function suppression (LHRH agonists) during the study treatment period (ovarian function suppression treatment must be initiated at least 14 days before the first dose of study drug).\n7. Prior treatment history must meet the following requirements:\n\n   1. Disease progression during or intolerance to standard therapy, or unsuitability for standard therapy.\n   2. Previous adjuvant endocrine therapy for at least 2 years, with recurrence during treatment or within 1 year after completion; OR at least one line of endocrine therapy for the advanced stage, with progression after at least 6 months of maintenance therapy on any line of advanced endocrine therapy (no limit on the number of endocrine therapy lines).\n   3. Previous chemotherapy for the advanced stage is ≤ 2 lines.\n   4. Prior use of fulvestrant, with an interval of at least 6 weeks between the last dose of fulvestrant and the first dose in this study.\n   5. An interval of at least 6 weeks is required between the last dose of prior tamoxifen and the first dose in this study.\n   6. Previous treatment with CDK4\u002F6 inhibitors is ≤ 1 line.\n8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (see Appendix 1 for details).\n9. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Tumor lesions that have previously received radiotherapy or other local-regional treatment can only be considered measurable lesions if disease progression is confirmed.\n10. Expected survival ≥ 3 months.\n11. Subjects must have adequate organ and bone marrow function at screening (no blood transfusion, human albumin administration, or use of hematopoietic growth factors within 7 days prior to screening tests), defined as follows:\n\n    1. Complete Blood Count:\n\n       Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL. White blood cell count (WBC) ≥ 3.0 × 10⁹\u002FL and ≤ 15 × 10⁹\u002FL. Platelet count (PLT) ≥ 100 × 10⁹\u002FL. Hemoglobin (HGB) ≥ 100 g\u002FL.\n    2. Liver Function:\n\n       Serum total bilirubin (TBIL) ≤ 1.5 × ULN. For subjects without liver metastases: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.\n\n       For subjects with liver metastases: ALT and AST ≤ 5 × ULN.\n    3. Renal Function:\n\n       Serum creatinine (Scr) ≤ 1.5 × ULN OR creatinine clearance (Clcr) calculated by the Cockcroft-Gault method ≥ 50 mL\u002Fmin.\n    4. Coagulation Function:\n\n       Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\n       International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN (for subjects on anticoagulant therapy, values should be within the therapeutic range):\n       1. For patients receiving warfarin, INR must be stable between 2.0 and 3.0.\n       2. For patients receiving heparin, APTT should be between 1.5 and 2.5 × ULN (or returned to the value prior to starting heparin therapy).\n       3. For prosthetic heart valves requiring anticoagulation, a stable INR between 2.5 and 3.5 is allowed.\n    5. Cardiac Function:\n\n    Left ventricular ejection fraction (LVEF) \\> 50% as shown by echocardiography.\n12. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and must be non-lactating. Women of childbearing potential must agree to use effective contraceptive methods from the time of signing the informed consent form until 6 months after the last dose of the study drug. Effective methods include double barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female subjects will be considered of childbearing potential unless they are naturally postmenopausal, have undergone artificial menopause, or have undergone sterilization (e.g., hysterectomy, bilateral salpingo-oophorectomy).\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will be excluded from the study:\n\n1. Leptomeningeal metastases, carcinomatous meningitis, spinal cord compression, or symptomatic or clinically unstable central nervous system (CNS) metastases.\n2. History of ongoing gastrointestinal diseases or other malabsorptive conditions that may impact the absorption of orally administered study drugs, including but not limited to:\n\n   1. Inability to swallow oral medications.\n   2. Requirement for intravenous nutrition.\n   3. Prior surgery affecting absorption, including total\u002Fpartial gastrectomy.\n   4. Crohn's disease, ulcerative colitis.\n   5. Treatment for active peptic ulcer disease within 6 months prior to the first dose.\n   6. Malabsorption syndrome, or uncontrolled nausea, vomiting, or diarrhea.\n3. Patients with symptomatic visceral metastases, or those with clinically significant and unstable pleural, peritoneal, pericardial effusions, or pulmonary lymphangitic carcinomatosis. Patients who have received intracavitary infusion therapy or drainage\u002Fparacentesis may be enrolled 14 days or more after the effusion has stabilized. Other conditions deemed by the investigator as unsuitable for endocrine therapy.\n4. Prior treatments do not meet the following washout periods:\n\n   1. Use of other investigational drugs or devices within 4 weeks prior to the first dose.\n   2. Treatment with CDK4\u002F6 inhibitors or mTOR inhibitors within 2 weeks, or other targeted therapies, chemotherapy, or immunotherapy within 4 weeks prior to the first dose.\n   3. Radiotherapy, endocrine drugs, or traditional Chinese medicines with anti-tumor indications within 2 weeks prior to the first dose (washout periods for fulvestrant and tamoxifen refer to Inclusion Criterion 7).\n   4. Treatment with mitomycin or nitrosoureas within 6 weeks prior to the first dose.\n   5. Use of drugs or herbal supplements known to be moderate\u002Fstrong inhibitors or inducers of CYP3A4 within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose (see Appendix 4).\n   6. Use of drugs that inhibit gastric acid production within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose (see Appendix 4).\n   7. Use of drugs that are P-glycoprotein (P-gp) inhibitors within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose (see Appendix 4).\n5. Toxicities from prior anti-tumor therapy have not recovered to Grade ≤1 (except for alopecia, and chemotherapy-induced peripheral neuropathy ≤ Grade 2).\n6. Major surgical procedure (excluding biopsy) within 4 weeks prior to the first dose of study drug, or incomplete healing of surgical incision.\n7. Known other active malignancy within the past 5 years (except for cured basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, papillary thyroid carcinoma, or ductal carcinoma in situ of the breast).\n8. History of interstitial lung disease, drug-induced interstitial lung disease, or any evidence of active pneumonitis on chest CT scan within 4 weeks prior to the first dose of study drug.\n9. Poorly controlled hypertension despite antihypertensive therapy (systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>95 mmHg).\n10. Active hepatitis B (defined as HBsAg positive and HBV DNA \\>500 IU\u002FmL or \\>2000 copies\u002FmL, or HBV DNA above the lower limit of detection if the local lower limit is \\>500 IU\u002FmL or \\>2000 copies\u002FmL); hepatitis C virus (HCV) infection (defined as HCV antibody positive and HCV-RNA positive or HCV-RNA above the lower limit of detection at the local site).\n\n    Known HIV infection or history of acquired immunodeficiency syndrome (AIDS); active tuberculosis; active syphilis infection.\n11. Any severe infection requiring systemic antibiotics within 14 days prior to dosing, or active infection requiring systemic treatment.\n12. Arterial or venous thrombotic events within 6 months, including cerebrovascular accident (e.g., transient ischemic attack, cerebral hemorrhage, etc.), deep vein thrombosis, or pulmonary embolism.\n13. History of active cardiac disease or cardiac dysfunction, including any of the following:\n\n    1. Idiopathic symptomatic bradycardia within 2 years prior to screening, or resting heart rate \\\u003C50 bpm at screening.\n    2. History of angina or symptomatic coronary artery disease within 1 year prior to screening.\n    3. History of congestive heart failure (NYHA Class ≥3), cardiomyopathy, or myocardial ischemia requiring long-term medication for control.\n    4. Acute myocardial infarction event within 6 months prior to screening.\n    5. History of ventricular arrhythmia, or any supraventricular arrhythmia ≥ Grade 2 requiring treatment or intervention within 1 year prior to screening, or presence of risk factors for ventricular arrhythmias.\n    6. Any factors that increase the risk of QTc prolongation or arrhythmic events, such as symptomatic heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under age 40 in a first-degree relative. Hypertrophic cardiomyopathy and clinically significant valvular stenosis.\n    7. Poorly controlled atrial fibrillation, history of coronary\u002Fperipheral artery bypass graft within the past 6 months, or cerebrovascular symptoms including transient ischemic attack.\n    8. QTcF (Fridericia's correction) \\> 470 ms on ECG.\n    9. Presence of ECG abnormalities considered clinically significant by the investigator, including complete left bundle branch block, second- or third-degree heart block, or sick sinus syndrome.\n14. History of severe allergic reactions to the study drug(s) or excipients used in the protocol.\n15. Prior use of any selective estrogen receptor degrader (other than fulvestrant) or investigational drugs inhibiting the ER signaling pathway.\n16. Patients with active or chronic corneal disease, other active eye disease requiring ongoing treatment, or any clinically significant corneal disease for which drug-induced keratopathy cannot be adequately monitored.\n17. History of drug abuse, alcohol abuse, or substance abuse.\n18. Use of live or attenuated live vaccines within 4 weeks prior to the first dose of study drug. Use of immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc., within 14 days prior to the first dose of study drug. History of allogeneic organ transplantation, allogeneic peripheral hematopoietic stem cell transplantation, or bone marrow transplantation.\n19. Conditions deemed by the investigator as unsuitable for participation in this study, including but not limited to a clear history of neurological disorders such as epilepsy or dementia, poor compliance, or any other circumstances the investigator believes may render the subject unsuitable for the study.",{"count":358,"type":20},99,[23,24],"A Phase I\u002FII, Open-label study to assess the safety, tolerability, pharmacokinetic, and antitumor efficacy of FWD1802 monotherapy in patients with ER+\u002FHER2- unresectable locally advanced or metastatic breast cancer. This clinical trial aims to explore the role of FWD1802 in the ER+\u002FHER2- advanced breast cancer patient population. The primary objectives are to address the following questions:\n\nPhase I Study:\n\nDetermine the Recommended Phase II Dose (RP2D) and\u002For Maximum Tolerated Dose (MTD) of FWD1802 in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer.\n\nPhase II Study:\n\nTo evaluate the efficacy of FWD1802 at the RP2D in patients with ESR1-mutated ER-positive\u002FHER2-negative locally advanced or metastatic breast cancer, using objective response rate (ORR) as the efficacy endpoint.",[29,27,161,362],"ER+\u002FHER2- Breast Cancer","2026-02-06",{"date":365,"type":43},"2026-02-10",{"date":367,"type":43},"2023-09-12",{"date":369,"type":20},"2028-03",{"name":371,"class":50},"Forward Pharmaceuticals Co., Ltd.",22,{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":123,"minAge":17,"maxAge":380,"enrollmentInfo":381,"targetDuration":4,"studyType":21,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":395},"100594801","phase-3-a-phase-3-study-of-hrs-8080-versus-treatment-chosen-by-physicians-in-locally-advanced-and-metastatic-breast-cancer-100594801","NCT07024173","A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer","A Multicenter, Open-label, Randomized Controlled Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer With Disease Progression After Previous Endocrine Therapy","Inclusion Criteria:\n\n1. Women aged 18 to 75 years old (including both values).\n2. ECOG Physical Strength Status (PS) : 0 to 1 point.\n3. Patients with locally advanced or metastatic breast cancer confirmed by histology.\n4. Patients previously received 1-2 lines of endocrine therapy.\n5. Expected survival \\> 6 months.\n6. The functional level of the organs must meet the requirements.\n7. Subjects that voluntarily participate in this clinical trial, be willing and able to abide by the procedures related to clinical visits and research, understand the research procedures and have signed the informed consent.\n\nExclusion Criteria:\n\n1. Patients with rapid disease progress and investigators determine that endocrine therapy is not suitable or tolerant.\n2. A history of severe clinical cardiovascular diseases.\n3. Patients with uncontrollable tumor-related pain as judged by investigators.\n4. Severe infection exists within 4 weeks before the first study administration.\n5. Patients with clinically significant endometrial abnormalities.\n6. Untreated active hepatitis.\n7. Patients known to be allergic to HRS-8080 components.\n8. Pregnant and lactating women, or those planning to become pregnant during the study period.","75 Years",{"count":382,"type":20},240,[63],"This study is a multicenter, open-label, randomized controlled Phase 3 clinical trial. It is planned to enroll 240 female patients with locally advanced or metastatic breast cancer followed by disease progression after previous endocrine therapy.",[27,29],"2026-01-22",{"date":388,"type":43},"2026-01-26",{"date":390,"type":43},"2025-07-23",{"date":392,"type":20},"2027-12",{"name":394,"class":50},"Shandong Suncadia Medicine Co., Ltd.",2,{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":123,"minAge":17,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":21,"phases":404,"briefSummary":406,"conditions":407,"keywords":410,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":148},"100533007","early-phase-1-neoadjuvant-therapy-and-contrast-enhanced-mammography-for-early-stage-breast-cancer-100533007","NCT06220214","Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer","Contrast Enhanced Digital Mammography for Predicting Pathologic Complete Response After Neoadjuvant Chemotherapy","Inclusion Criteria:\n\n* Diagnosis with either type of invasive locally advanced breast cancer regardless of hormone receptor or Her2 status\n* Plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitive surgery\n\nExclusion Criteria:\n\n* Pregnancy\n* Allergy\u002Fsensitivity to contrast agent\n* Decreased kidney function\n* Diabetes",{"count":157,"type":20},[405],"EARLY_PHASE1","The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to \"see through\" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner.\n\nParticipation may last up to 18 weeks.\n\nStudy procedures for this research are:\n\n* Undergoing 1-2 mammograms during and\u002For after your chemotherapy, but before primary breast surgery.\n* Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent\n* Let the research team record information from your medical record related to your condition and the treatment you receive.\n* Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.",[66,27,408,133,162,409],"Neoadjuvant Chemotherapy","TNBC, Triple Negative Breast Cancer",[411,412,413,414,303],"cedm","cedbt","contrast-enhanced digital mammography","contrast-enhanced digital breast tomosynthesis","2026-01-13",{"date":417,"type":43},"2026-01-15",{"date":419,"type":43},"2024-03-06",{"date":421,"type":20},"2026-08-31",{"name":423,"class":147},"Alison Stopeck",{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":123,"minAge":17,"maxAge":380,"enrollmentInfo":430,"targetDuration":4,"studyType":21,"phases":431,"briefSummary":432,"conditions":433,"keywords":438,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":4},"100616567","phase-2-shr-a1811-plus-pertuzumab-as-neoadjuvant-therapy-for-early-or-locally-advanced-hr-positive-her2-positive-breast-cancer-a-prospective-open-label-phase-ii-study-100616567","NCT07307287","SHR-A1811 Plus Pertuzumab as Neoadjuvant Therapy for Early or Locally Advanced HR-Positive HER2-Positive Breast Cancer: A Prospective, Open-Label, Phase II Study","Inclusion Criteria:\n\n1. Female, aged 18-70 years at the time of informed consent.\n2. Histologically confirmed invasive breast cancer, with no prior systemic anti-cancer therapy.\n3. Pathologically documented HR-positive (ER ≥ 1% and\u002For PR ≥ 1%) and HER2-positive disease, per the 2018 ASCO-CAP guidelines: IHC 3+ or IHC 2+ with ISH ratio ≥ 2.0.\n4. Clinical stage II-III (cT2-cT4 or cN+, cM0) per the 8th edition of the AJCC Cancer Staging Manual.\n5. At least one measurable lesion per RECIST v1.1 criteria.\n6. ECOG performance status 0-1.\n7. Estimated life expectancy of ≥ 12 months.\n8. Adequate organ function within 14 days prior to the first dose (without transfusion or growth factor support):\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; platelets ≥ 100 × 10⁹\u002FL; hemoglobin (Hb) ≥ 90 g\u002FL\n   2. Albumin ≥ 3.0 g\u002FdL; total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine transaminase (ALT)\u002Faspartate transaminase (AST) ≤ 2.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN; blood urea nitrogen (BUN) and creatinine ≤ 1.5 × ULN, or creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (per Cockcroft-Gault formula)\n   3. Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n   4. Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography\n   5. Fridericia-corrected QT interval (QTcF) ≤ 470 ms\n9. Premenopausal women with reproductive potential must have a negative serum β-human chorionic gonadotropin (β-hCG) test within 7 days before treatment, use effective barrier contraception throughout the study period and for 6 months after the last dose, and not be breastfeeding.\n10. Provision of signed written informed consent; willingness to comply with all study visits and procedures.\n\nExclusion Criteria:\n\n1. Breast cancer not confirmed by histopathology.\n2. Bilateral, inflammatory, or occult breast cancer.\n3. Any prior anti-cancer therapy (chemotherapy, radiotherapy, targeted, endocrine, etc.); radical radiotherapy ≤ 4 weeks or palliative radiotherapy ≤ 2 weeks before first dose.\n4. Concomitant anti-cancer therapy of any kind.\n5. Other malignancies within 5 years (except cured basal-cell skin cancer or cervical carcinoma in situ).\n6. Participation in another drug trial ≤ 4 weeks before enrolment.\n7. Systemic immunosuppressive therapy (e.g., \\> 10 mg\u002Fday prednisone equivalent) ≤ 2 weeks before first dose (nasal\u002Finhaled corticosteroids allowed).\n8. Live or attenuated vaccines ≤ 4 weeks before first dose.\n9. Major non-breast surgery ≤ 4 weeks before first dose or not fully recovered.\n10. Active autoimmune disease or history of recurrent autoimmunity (e.g., autoimmune hepatitis, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyper\u002Fhypothyroidism except stable hormone replacement). Controlled vitiligo, psoriasis, alopecia, insulin-dependent type 1 diabetes, or childhood asthma in complete remission allowed. Asthma requiring bronchodilators excluded.\n11. Immunodeficiency (HIV positive, congenital\u002Fsecondary), prior organ transplant.\n12. Uncontrolled or significant cardiovascular\u002Fcerebrovascular disease, including within 6 months: NYHA III\u002FIV heart failure, MI, stroke (except lacunar), pulmonary embolism, unstable angina, significant arrhythmia; cardiomyopathies; QTc \\> 470 ms (Fridericia, female), 2nd\u002F3rd degree AV block, atrial fibrillation ≥ EHRA 2b, uncontrolled hypertension.\n13. Interstitial lung disease or any moderate-severe pulmonary disorder that may interfere with drug-related lung toxicity assessment: idiopathic pulmonary fibrosis, organizing pneumonia\u002Fbronchiolitis obliterans, pulmonary embolism, severe asthma\u002FCOPD, restrictive\u002Fobstructive defects, autoimmune\u002Fconnective-tissue lung involvement, prior pneumonectomy.\n14. Active hepatitis B (HBsAg+ and HBV DNA ≥ 500 IU\u002FmL), hepatitis C (anti-HCV+ and HCV RNA \\> ULN), cirrhosis, or severe infection requiring antibiotics\u002Fantivirals\u002Fantifungals.\n15. Hereditary\u002Facquired bleeding or thrombotic diatheses (e.g., hemophilia, coagulopathy).\n16. Known hypersensitivity to study drugs or excipients.\n17. Pregnant or lactating women; women of child-bearing potential with positive baseline pregnancy test or unwilling to use effective contraception throughout the study.\n18. Any severe concomitant condition jeopardizing patient safety or compliance (e.g., uncontrolled hypertension, diabetes, active infection) or significant neurologic\u002Fpsychiatric disorder (epilepsy, dementia) that, in the investigator's opinion, renders",{"count":157,"type":20},[24],"Breast cancer is the most common malignancy in women, with approximately 20% classified as HER2-positive. Anti-HER2 blockade (trastuzumab plus pertuzumab) combined with chemotherapy constitutes the standard neoadjuvant regimen; however, the pathological complete response (pCR) rate in the HR-positive subgroup remains only 35-40%, and platinum-containing schedules are associated with significant hematologic toxicity. Antibody-drug conjugates (ADCs) integrate targeted delivery with potent cytotoxic payloads. SHR-A1811 (ruikang-trastuzumab), a domestically developed ADC by Hengrui Pharmaceutical, is conjugated with a topoisomerase I inhibitor (mean drug-to-antibody ratio \\[DAR\\] ≈ 6). Preclinical data demonstrate that SHR-A1811 exhibits superior efficacy to trastuzumab emtansine (T-DM1) in both trastuzumab-sensitive and resistant HER2-expressing tumor models, with a manageable safety profile.\n\nThis prospective, open-label, phase II trial will enroll patients with early-stage\u002Flocally advanced HR-positive\u002FHER2-positive breast cancer, who will receive neoadjuvant SHR-A1811 plus pertuzumab. At baseline, BluePrint gene profiling will be performed to stratify participants into luminal and non-luminal subtypes: patients with luminal subtype who achieve stable disease (SD) after 4 cycles will switch to a regimen of trastuzumab, pyrotinib, dalpiciclib, and an aromatase inhibitor for an additional 4 cycles; all other patients will continue ADC-based dual-target therapy for 2-4 further cycles, followed by surgical resection. Circulating tumor DNA (ctDNA) dynamics will be dynamically monitored at baseline, after 4 cycles of treatment, and preoperatively to evaluate early treatment sensitivity.\n\nThe primary endpoint is the pCR rate. Secondary endpoints include event-free survival (EFS), objective response rate (ORR), and safety profiles. Exploratory analyses will investigate the correlation between molecular subtypes and treatment responses, aiming to establish a chemotherapy-free, precision neoadjuvant strategy for HR-positive\u002FHER2-positive breast cancer.",[434,435,436,437,27],"SHR-A1811","HER2-Postive Breast Cancer","HR+ Breast Cancer","Early Breast Cancer",[434,435,436,437],"2025-12-14",{"date":441,"type":43},"2025-12-29",{"date":443,"type":20},"2025-12-20",{"date":445,"type":20},"2027-12-31",{"name":447,"class":147},"Tianjin Medical University Cancer Institute and Hospital",{"id":449,"slug":450,"hasResults":11,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":21,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":469},"100478356","phase-1-phase-1b-study-of-op-1250-palazestrant-in-combination-with-ribociclib-alpelisib-everolimus-or-atirmociclib-in-er-her2--breast-cancer-100478356","NCT05508906","Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer","A Phase 1b Open-Label Multicenter Study of OP-1250 (Palazestrant) in Combination With the CDK4\u002F6 Inhibitor Ribociclib, With the PI3K Inhibitor Alpelisib, With the mTOR Inhibitor Everolimus, or With CDK4 Inhibitor Atirmociclib in Adult Subjects With Advanced and\u002For Metastatic ER Positive, HER2 Negative Breast Cancer","Inclusion Criteria:\n\n* Female or male aged \\>18 years.\n* Willing and able to participate and comply with all study requirements.\n* Histologically- or cytologically-confirmed advanced or metastatic Breast Cancer (mBC).\n* ER+\u002FHER2- disease, as determined in the most recently obtained archival tumor tissue sample from a metastatic site, using locally accepted criteria by the local pathology report.\n* Evaluable disease with one of the following: Measurable disease, ie, at least 1 measurable lesion as per RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation) OR patients with predominantly bone disease (with or without other non-measurable lesions) are allowed if it is possible to evaluate on radiological examinations (eg. bone scan, PET\u002FCT, CT, MRI) even if lesions are non-measurable according to RECIST 1.1.\n* Life expectancy ≥6 months, as judged by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.\n* Has received no more than 1 prior hormonal regimen (Treatment Group 1). Has received no more than 2 prior hormonal regimens (Treatment Group 2 and Treatment Group 3) . Has received no more than 2 prior hormonal regimens for metastatic disease in Part 1 (Dose Escalation) and no more than 1 prior hormonal regimes in Part 2 (Dose Expansion) for metastatic disease, regardless of type of endocrine agent (Treatment Group 4) for advanced or metastatic disease. Prior hormonal regimens in combination with CDK4\u002F6 inhibitors are allowed in all treatment groups. For subjects in Treatment Group 4, no prior chemotherapy for metastatic breast cancer is allowed.\n* Has received no more than 1 prior chemotherapy (which includes antibody drug conjugates) for locally advanced or metastatic breast cancer.\n\nExclusion Criteria:\n\n* Prior or concurrent malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality.\n* History of cerebral vascular disease within 6 months prior to the first administration of study drug dose.\n* History of a pulmonary embolism, or deep venous thrombosis within the last 6 months, or subject has an increased risk of thrombosis as determined by the investigator.\n* History of pneumonitis or interstitial lung disease.\n* Leptomeningeal disease or spinal cord compression.\n* Medical history or ongoing gastrointestinal disorders that could affect absorption of oral therapeutics.\n* Known human immunodeficiency virus infection.\n* Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (eg, hepatitis B or hepatitis C virus), current alcohol abuse, or cirrhosis.\n* History of severe cutaneous reaction, such as Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms.\n* Active infection or at a high risk of developing a serious infection (e.g. participants with immunodeficiencies, uncontrolled diabetes mellitus, uncontrolled heart disease, poor general health, poor nutritional status).\n* Has clinically significant co-morbidities, such as, psychiatric disease, or any other condition that could impact the ability of the subject to participate in this study or otherwise has the potential to confound the study results.\n* Have received prior treatment with OP-1250.\n* Have received prior treatment with approved or investigational PI3K inhibitor (Treatment Group 2) or mTOR inhibitor (Treatment Group 3).",{"count":456,"type":20},190,[23],"This is a Phase 1b open-label, 2-part study in 3 treatment groups. The 3 treatment groups are as follows:\n\nTreatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).\n\nTreatment Group 2: Palazestrant (OP-1250) in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation).\n\nTreatment Group 3: Palazestrant (OP-1250) in combination with everolimus.\n\nTreatment Group 4: Palazestrant (OP-1250) in combination with atirmociclib.",[29,460,134,66,27],"ER-positive Breast Cancer","2025-10-20",{"date":463,"type":43},"2025-10-22",{"date":465,"type":43},"2022-08-31",{"date":467,"type":20},"2028-01-31",{"name":91,"class":50},16,{"id":471,"slug":472,"hasResults":11,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":11,"sex":123,"minAge":17,"maxAge":124,"enrollmentInfo":478,"targetDuration":4,"studyType":21,"phases":480,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":148},"100382025","phase-3-adjuvant-study-of-pyrotinib-in-her-2-positive-breast-cancer-100382025","NCT04254263","Adjuvant Study of Pyrotinib in HER-2 Positive Breast Cancer","Adjuvant Trastuzumab Plus Pyrotinib for Residual Invasive HER2-positive Breast Cancer After Neoadjuvant Chemotherapy Plus Anti-HER2 Target Therapy","ATP","Inclusion Criteria:\n\n* Female, Aged ≥18 and ≤70 years;\n* Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) ;\n* Completed neoadjuvant therapy, including chemotherapy and trastuzumab;\n* Residual invasive disease was detected pathologically in the surgical specimen of the breast or axillary lymph nodes after completion of neoadjuvant chemotherapy;\n* Been or being treated for early breast cancer with standard of care duration of trastuzumab;\n* Adjuvant treatment regimen needs to be determined before randomization;\n* Duration from Random time to the last use of trastuzumab≤1 year.\n* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;\n* Required laboratory values including following parameters:ANC: ≥ 1.5 x 109\u002FL; Platelet count: ≥ 100 x 109\u002FL; Hemoglobin: ≥ 9.0 g\u002FdL; Total bilirubin: ≤ 1.5 x upper limit of normal, ULN; ALT and AST: ≤ 1.5 x ULN; BUN and creatine clearance rate: ≥ 50 mL\u002Fmin; LVEF: ≥ 50%; QTcF: \\\u003C 470 ms\n* Signed informed consent form (ICF) .\n\nExclusion Criteria:\n\n* Metastatic disease (Stage IV) ;\n* Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;\n* Progressive disease during neoadjuvant therapy;\n* Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;\n* Treated or treating with anti-HER2 TKI, including but not limited to pyrotinib, lapatinib and neratinib.\n* Less than 4 weeks from the last clinical trial;\n* History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;\n* Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial;\n* Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period;\n* Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.",{"count":479,"type":20},316,[63],"This is a prospective, randomised, multicenter, no placebo-controlled, open label study for evaluating the efficacy and safety of pyrotinib in women with residual invasive HER2-positive breast cancer after neoadjuvant chemotherapy plus anti-HER2 target therapy. The main purpose is to investigate whether pyrotinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer based on the 1-year trastuzumab standard adjuvant treatment with or without pertuzumab.",[27],"2025-09-10",{"date":485,"type":43},"2025-09-11",{"date":487,"type":43},"2019-12-16",{"date":489,"type":20},"2028-08",{"name":491,"class":147},"RenJi Hospital",{"id":493,"slug":494,"hasResults":11,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":11,"sex":123,"minAge":500,"maxAge":501,"enrollmentInfo":502,"targetDuration":4,"studyType":21,"phases":504,"briefSummary":505,"conditions":506,"keywords":507,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":520},"100512793","breast-cancer-exercise-intervention-study-100512793","NCT05957068","Breast Cancer Exercise Intervention Study","Breast Cancer Exercise Intervention Study (BREXINT)","BREXINT","Inclusion Criteria:\n\n* Patients with histologically or cytologically proven stage 1, 2, or 3 breast cancer\n* Patients who have undergone curative breast surgery\n* Patients who have received (neo)adjuvant chemotherapy (if given) and\u002For radiotherapy (if given)\n* Females aged 21 years and older\n* ≤ 8 weeks from breast surgery, or the last adjuvant chemotherapy or radiotherapy session, whichever is latest.\n\nExclusion Criteria:\n\n* Cardiovascular, respiratory, musculoskeletal problems that preclude moderate physical activity.\n* Major medical problems that are deemed by the investigator to be unsuitable for enrollment.","21 Years","99 Years",{"count":503,"type":20},2156,[294],"This is a 24-week exercise programme consisting of aerobic exercise and muscle strength training, 3 sessions per week. The first 9 sessions are supervised by physiotherapists in person, followed by 63 sessions monitored remotely (video) or supervised by trainers at ActiveSG (Sport Singapore) gyms.",[137,27],[498,508,509,510],"Muscular Strength","Cardiorespiratory Fitness","Quality of Life","2025-09-03",{"date":513,"type":43},"2025-09-05",{"date":515,"type":43},"2023-07-01",{"date":517,"type":20},"2033-05-31",{"name":519,"class":147},"National Cancer Centre, Singapore",3,{"id":522,"slug":523,"hasResults":11,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":11,"sex":123,"minAge":17,"maxAge":528,"enrollmentInfo":529,"targetDuration":4,"studyType":103,"phases":4,"briefSummary":531,"conditions":532,"keywords":533,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":148},"100562619","to-evaluate-the-efficacy-and-safety-of-ipsilateral-supraclavicular-lymph-node-dissection-for-breast-cancer-patients-100562619","NCT06605521","To Evaluate the Efficacy and Safety of Ipsilateral Supraclavicular Lymph Node Dissection for Breast Cancer Patients","To Evaluate the Efficacy and Safety of Ipsilateral Supraclavicular Lymph Node Dissection for Breast Cancer Patients: A Prospective, Multicenter, Non-interventionist Real World Study","Inclusion Criteria:\n\n1. Female patients aged ≤ 80 years old.\n2. ECOG score 0-1 points;\n3. Breast cancer meets the following criteria: histologically diagnosed as invasive breast cancer, known ER, PR, HER2, KI67 status, pathologically diagnosed as ipsilateral supraclavicular lymph node metastasis (both cytology and histopathology);\n4. Estimated patient survival time exceeding three months;\n5. No obvious contraindications for surgery or radiotherapy;\n6. The researcher judged that they were able to comply with the research protocol.\n7. Those who participate in other clinical trials (including intervention or non intervention studies) at the same time and are judged by the researchers not to affect the research protocol can be enrolled normally.\n8. Voluntarily participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Stage IV (metastatic) breast cancer;\n2. Bilateral breast cancer;\n3. Received radiotherapy and surgical treatment (excluding local puncture) for ipsilateral supraclavicular metastatic lymph nodes before enrollment;\n4. History of breast cancer or other malignant tumors, but excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma;\n5. Individuals with severe primary diseases such as cardiovascular, cerebrovascular, liver, and kidney that are difficult to tolerate surgery or radiation therapy;\n6. Having a history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation;\n7. Suffering from severe comorbidities or other comorbidities that may interfere with the planned treatment, or any other circumstances in which the researcher deems the patient unsuitable to participate in this study.","80 Years",{"count":530,"type":20},300,"For newly diagnosed ISLNM breast cancer, on the basis of effective treatment of the new auxiliary system, the optimal local treatment of the supraclavicular region remains controversial. Although guidelines such as NCCN recommend simple clavicular radiation therapy, there are studies suggesting that supraclavicular lymph node dissection can improve prognosis, and many hospitals in China are still accustomed to performing supraclavicular lymph node dissection. Therefore, ipsilateral supraclavicular lymph node dissection is the first time to diagnose ipsilateral supraclavicular lymph node metastasis of breast cancer. The effectiveness and safety of (stage IIIc) treatment still require prospective research to confirm.This project is a prospective, multicenter, non-interference real world study. In the real world study, the investigators evaluated the efficacy and safety of ipsilateral supraclavicular lymph node dissection in the treatment of initially diagnosed ipsilateral supraclavicular lymph node metastasis breast cancer patients.",[27],[534,170],"Supraclavicular lymph node dissection","2024-09-18",{"date":537,"type":43},"2024-09-20",{"date":539,"type":43},"2023-04-04",{"date":541,"type":20},"2027-04-04",{"name":543,"class":544},"Henan Cancer Hospital","OTHER_GOV",{"id":546,"slug":547,"hasResults":11,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":103,"phases":4,"briefSummary":553,"conditions":554,"keywords":555,"overallStatus":202,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":4},"100554444","predicting-response-to-neoadjuvant-chemotherapy-in-locally-advanced-breast-cancer-100554444","NCT06499168","Predicting Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer","CD10 as a Prognostic and Predictive Factor to Neoadjuvant Chemotherapy Response in Locally Advanced Breast Cancer","Inclusion Criteria:\n\n* Patients above 18 years\n* Pathologically proven breast carcinoma\n* Locally advanced breast cancer\n\nExclusion Criteria:\n\n* Patients below 18 years.\n* Patients with metastatic disease\n* Patients with second primary cancer\n* Patients ineligible for chemotherapy",{"count":329,"type":20},"Female breast cancer is the second leading cause of global cancer incidence in 2022 and the fourth leading cause of cancer mortality worldwide. Breast cancer (BC) remains the most prevalent cancer diagnosis among women; nevertheless, considerable advancements in diagnostics and treatment approaches have significantly enhanced patient outcomes. In locally advanced cases, primary systemic chemotherapy is often indicated, and the choice of treatment is influenced by the evaluation of routine prognostic and predictive factors.\n\nNeoadjuvant chemotherapy (NCT) has emerged as a valuable approach to enhance the quality of life ,disease-free and overall survival for early and locally advanced BC patients Approximately 30% of BC cases achieve a pathological complete response (pCR) following NCT. Unfortunately, proper quantification of estrogen- and progesterone receptors (ER and PR), human epidermal growth factor receptor-2 (HER2\u002FNeu) and proliferation markers are insufficient to predict chemosensitivity of some breast tumors , so the identification of these cases during routine pathological examination of biopsy specimens could be especially useful in planning the oncotherapeutic strategy for proper patient management.\n\nCD10, has recently gained attention as an independent diagnostic and prognostic marker in various solid tumors with significant metastatic potential. This molecule has been shown to play a role in cell adhesion, migration, and extracellular matrix remodelling.\n\nA strong CD10 expression has been linked to hormone receptor negativity and HER-2\u002Fneu overexpression in breast cancer. Moreover, the dynamics of stromal CD10 expression undergo changes during neoadjuvant anthracycline-based chemotherapy.\n\nRecent research, has presented compelling data indicating that CD10 expression may serve as a predictive marker for the impact of neoadjuvant chemotherapy in breast cancer patients.",[27],[556],"response, neoadjuvant chemotherapy, breast cancer","2024-07-06",{"date":559,"type":43},"2024-07-12",{"date":561,"type":20},"2024-08",{"date":563,"type":20},"2027-08",{"name":565,"class":147},"Assiut University",{"id":567,"slug":568,"hasResults":11,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":11,"sex":123,"minAge":17,"maxAge":124,"enrollmentInfo":573,"targetDuration":4,"studyType":21,"phases":575,"briefSummary":576,"conditions":577,"keywords":578,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":148},"100522284","the-choice-of-treatment-methods-and-efficacy-of-labc-100522284","NCT06080620","The Choice of Treatment Methods and Efficacy of LABC","Treatment Selection and Efficacy of Locally Advanced Breast cancer-a Prospective Randomized Controlled Study","Inclusion Criteria:\n\n1. 18-70 year old female\n2. Patients with locally advanced breast cancer (stage IIIb - IIIc) first diagnosed;\n3. Clinical diagnosis of breast cancer, or puncture pathology suggests breast cancer;\n4. After evaluation by experienced clinical physicians, the patient's tumor has the possibility of surgical resection. Specific evaluation indicators include ultrasound assessment of the tumor not surrounding the axillary vein;\n5. Accept treatment plans including surgery, radiotherapy, and chemotherapy;\n6. Volunteer to participate in clinical research and sign an informed consent form;\n7. Willing to undergo follow-up and complete quality of life (EQ-5D series scale and FACT-B scale) and postoperative psychological status (Anxiety\u002FDepression Self Rating Scale) assessments;\n\nExclusion Criteria:\n\n1. Patients under 18 years old or over 70 years old;\n2. Those who have received breast cancer related surgery, radiotherapy or chemotherapy;\n3. Those who are not expected to receive surgery, radiotherapy or chemotherapy related to breast cancer\n4. History of other malignant tumors;\n5. Pregnant or lactating women;\n6. Accompanying active infection and fever;\n7. Other serious diseases that may significantly affect clinical trial compliance, such as severe cardiopulmonary dysfunction, liver and kidney dysfunction, poorly controlled diabetes and mental illness.",{"count":574,"type":20},50,[294],"The goal of this clinical trial is to compare the therapeutic effects of chemotherapy followed by surgery and surgery followed by chemotherapy in patients with locally advanced breast cancer（LABC). Patients with LABC will be randomly divided into two groups, each receiving chemotherapy followed by surgery or surgery followed by chemotherapy. The main comparison was between the disease-free survival (DFS) of two groups of patients, with the secondary study endpoint being overall survival (OS); Five year survival; Local recurrence or distant metastasis rate.",[27],[27,579],"prognosis","2023-10-06",{"date":582,"type":43},"2023-10-12",{"date":584,"type":20},"2023-10-08",{"date":586,"type":20},"2026-08-01",{"name":588,"class":147},"Peking Union Medical College Hospital"]