[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-stage-iv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-stage-iv":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,65,95,119,155,183,210,265,289,352,382,405,441,501,527,550,575,602],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":38,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100610263","a-study-of-meaning-centered-therapy-for-mexican-adults-with-advanced-cancer-100610263",false,"NCT07225309","A Study of Meaning-Centered Therapy for Mexican Adults With Advanced Cancer","Trial of Meaning Centered Psychotherapy for Mexican Patients With Advanced Cancer","Patient Eligibility Criteria:\n\nA patient cannot be considered eligible for this study unless ALL of the following conditions are met. Participant eligibility will be determined by an initial EMR review followed by a self-report screener and suicide risk assessment.\n\nInclusion Criteria:\n\nEMR Criteria\n\n\\- Documentation of Disease\n\n* Pathologically confirmed breast, prostate, colorectal, thyroid, cervix, uteri, or lung - solid tumor cancer (either most recent or new diagnosis)\n\n  * Definition of Disease \\[or Measurable Disease\\]\n* Diagnosed with stages III or IV\n\n  * Prior Treatment\n* Receiving ambulatory care at INCan\n\nSelf-Report Criteria\n\n* Age ≥ 18 years\n* Able to read and communicate in Spanish determined by the question: \"Can you read and communicate in Spanish? Yes\u002FNo\"\n* Professional role of administrators, clinicians (e.g., oncologists), mental health providers, supervised therapists-in-training (e.g., graduate students), or other related provider delivering the MCP-L experimental intervention\n* Providing care (or services) to Mexican cancer patients at INCan\n* Has access to internet and an electronic device\n* Agrees to be audio-recorded\n\nExclusion Criteria:\n\nEMR Criteria\n\n* Prior Treatment\n\n  * Received psychological or psychiatric care at INCan in the last 3 months\n  * In the judgment of the treating physician, protocol investigators, and\u002For study staff, presence of cognitive impairment (e.g., delirium or dementia) sufficient to preclude meaningful informed consent and\u002For study participation\n  * Diagnosed with a serious psychiatric condition\n\nSelf-Report Criteria\n\n* Received psychological or psychiatric care outside of INCan in the last 3 months\n* Presence of suicide risk determined by the Columbia-Suicide Severity Rating Scale\n* Too ill to participate determined by the question: \"Do you feel too ill to participate because of communication problems, uncontrollable pain, or other symptoms that prevent you from participating?\"\n\nProvider Eligibility Criteria:\n\nInclusion Criteria Self-Report Criteria\n\n* Age ≥ 18 years\n* Able to read and communicate in Spanish determined by the question: \"Can you read and communicate in Spanish? Yes\u002FNo\"\n* Professional role of administrators, clinicians (e.g., oncologists), mental health providers, supervised therapists-in-training (e.g., graduate students), or other related provider delivering the MCP-L experimental intervention\n* Providing care (or services) to Mexican cancer patients at INCan\n* Has access to internet and an electronic device\n* Agrees to be audio-recorded","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this study is to find out if Meaning-Centered Psychotherapy for Latinos (MCP-L) helps reduce anxiety and depression and improves quality of life compared to cognitive behavioral therapy (CBT). Investigators also want to learn what participants and providers think about the therapy, including how the therapy is designed, outside factors, available resources, and how the people involved affect how well MCP-L works.",[26,27,28,29,30,31,32,33,34,35,36,37],"Breast Cancer","Prostate Cancer","Colorectal Cancer","Thyroid Cancer","Breast Cancer Stage III","Breast Cancer Stage IV","Prostate Cancer Stage III","Prostate Cancer Stage IV","Colorectal Cancer Stage III","Colorectal Cancer Stage IV","Thyroid Cancer Stage III","Thyroid Cancer Stage IV",[39,40,41,42,43,44,45,46,47,48,49,50,51,52],"Breast cancer","Breast cancer Stage III","Breast cancer Stage IV","Prostate cancer","Prostate cancer Stage III","Prostate cancer Stage IV","Colorectal cancer","Colorectal cancer Stage III","Colorectal cancer Stage IV","Thyroid cancer","Thyroid cancer Stage III","Thyroid cancer Stage IV","25-240","Memorial Sloan Kettering Cancer Center","RECRUITING","2026-06-18",{"date":56,"type":57},"2026-06-22","ACTUAL",{"date":59,"type":57},"2026-05-01",{"date":61,"type":20},"2029-04-13",{"name":52,"class":63},"OTHER",2,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":76,"conditions":77,"keywords":84,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},"100568211","phase-1-a-study-of-abemaciclib-and-radiation-therapy-in-people-with-metastatic-breast-cancer-100568211","NCT06678269","A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer","A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer","Inclusion Criteria:\n\n* Aged ≥18 years at signing of informed consent.\n* Both male and female patients are allowed\n* Histologically confirmed metastatic breast cancer (mBC), current stage IV.\n* Plan for ablative radiotherapy (SBRT) to a bone metastasis.\n* Documented estrogen receptor (ER) positive and\u002For progesterone receptor (PgR) positive by immunohistochemistry. The threshold to qualify as ER or PgR positive is ≥1% per ASCO\u002FCAP guidelines.\n* HER2 negative tumor status confirmed by immunohistochemistry or FISH per ASCO\u002FCAP guidelines.\n* Any line of prior treatments (hormonal therapy and chemotherapy) is permitted including prior abemaciclib, palbociclib and ribociclib.\n* At the time of enrollment, treating physician has intent to resume abemaciclib (at any dose) following radiotherapy.\n* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last chemotherapy dose and enrollment (provided the patient did not receive radiotherapy).\n* Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment. No prior radiotherapy to the current intended target site is permitted (ie. reirradiation is excluded from this study).\n* The patient must be able to swallow oral medications.\n* The patient must have adequate organ function per the following criteria (as defined in Table 2):\n\nTable 2: Laboratory Value Guidance to Establish Adequate Organ Function Hematologic ANC: ≥1.5 x 10\\^9\u002FL Platelets: ≥100 x 10\\^9\u002FL Hemoglobin: ≥8 g\u002FdL Participants may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.\n\nHepatic Total bilirubin: ≤1.5 x ULN Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted ALT and AST: ≤3 x ULN\n\n* Patient may remain on hormonal therapy and abemaciclib before enrollment.\n* Patients must discontinue other CDK4\u002F6 inhibitor (palbociclib or ribociclib) for at least 7 days and recover from the acute effects of therapy (until the toxicity resolves to ≤Grade 1) except for residual alopecia and peripheral neuropathy.\n* Measurable or non-measurable disease is permitted as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n* Patients must have an Eastern Cooperative Oncology Group (ECOG) status of ≤2 or Karnofsky Performance Status (KPS) ≥60.\n* Negative β-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause.\n* Women of childbearing potential must agree and commit to the use of a highly effective method of contraception as determined to be acceptable by the investigator, from the time of informed consent until 28 days after the last dose of the investigational product. Men must agree and commit to use a barrier method of contraception while on treatment and for 4 weeks after last dose of investigational products.\n* Patients (or their legally authorized representative) must provide written, informed consent to participate in the study and follow the study procedures\n* At the discretion of the treating radiation oncologist, radiation to a metastatic bone lesion is indicated inclusive of bone lesions in the spinal column.\n\nExclusion Criteria:\n\n* Treatment to bone lesions in the calvarium are not eligible for the dose-finding or expansion portions of the study. Patients who otherwise have calvarial lesions not undergoing treatment on this protocol are eligible to enroll.\n* Patients currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device (other than the study drug\u002Fdevice used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.\n* The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to the start of study intervention, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.\n* Patients who received radiation therapy ≤14 days prior to initiation of investigational agents are excluded.\n* Patients are ineligible if they have serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n* Females who are pregnant or lactating.\n* The patient has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\]. Screening is not required for enrollment.\n* The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n* Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 diarrhea of any etiology screening).\n* Malignant spinal cord compression (ESCC2 or above)\n* Prior radiation therapy to the current target site.",{"count":73,"type":20},28,[75],"PHASE1","The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.",[78,79,26,31,80,81,82,83],"Metastatic Breast Cancer","Stage IV Breast Cancer","Breast Cancer Metastatic","HER2-negative Breast Cancer","HER2 Negative Breast Carcinoma","Hormone-receptor-positive Breast Cancer",[78,79,26,31,80,81,82,83,52,85],"24-138","2026-05-26",{"date":88,"type":57},"2026-05-28",{"date":90,"type":57},"2024-11-15",{"date":92,"type":20},"2028-11-30",{"name":52,"class":63},7,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":94},"100628287","phase-2-herizon-breast-a-ctdna-guided-adaptive-study-of-sequential-anti-her2-therapies-and-cns-prophylaxis-to-induce-long-term-remission-100628287","NCT07459673","HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission","Inclusion Criteria:\n\n* Male or female participants who are ≥18 years old with histologically confirmed diagnosis of unresectable locally advanced or MBC.\n* Stage IV at the diagnosis (i.e., de novo metastatic) as per AJCC 8.\n* HER2 IHC results of 3+.\n* Life expectancy of ≥12 weeks.\n* Must be deemed medically fit for surgery and be surgical candidates upfront, or potentially operable if there is response to induction therapy.\n* Must have measurable disease per PERCIST 1.0.\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Have adequate organ function as defined in the following table (Table 1). Specimens must be collected within 14 days prior to the start of study intervention.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n  * Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), as described in Appendix 3 during the intervention period. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n  * A WOCBP must have a negative urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of beta-human chorionic gonadotropin \\[β-hCG\\]) within 72 hours before the first dose of study intervention. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n  * Additional requirements for pregnancy testing during and after study intervention are located in Appendix 2.The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n  * Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of therapy.\n  * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:\n* Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n* Criteria for known Hepatitis B and C positive subjects: Hepatitis B and C screening tests are required as per MSK policy but do not need to be repeated prior to study unless there is a known history of Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.\n* Participants who have active hepatitis B infection (defined as HBsAg positive and\u002For detectable HBV DNA) are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Participants should remain on anti-viral therapy throughout study intervention and follow MSK guidelines for HBV anti-viral therapy post completion of study intervention.\n* Participants with a history of HCV infection (defined as anti-HCV Ab positive and detectable HCV RNA) are eligible if HCV viral load is undetectable at screening.\n* Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.\n\nTable 1 Adequate Organ Function Laboratory Values Hematological Absolute neutrophil count (ANC): ≥1500\u002FµL Platelets: ≥100 000\u002FµL Hemoglobin: ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL\n\nRenal Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤1.5 × ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × ULN\n\nHepatic Total bilirubin: ≤1.5 × ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN AST (SGOT) and ALT (SGPT)\n\nCoagulation\n\nInternational normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT):\n\n≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal. a Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks. b Creatinine clearance (CrCl) should be calculated per institutional standard. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.\n\nExclusion Criteria:\n\n* Patients diagnosed with HER2+ breast cancer as per American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines with HER2 IHC results of 1-2+ and positive FISH or ISH\n* Prior exposure to anti-HER2 therapy of any kind or any systemic anti-cancer treatment of any kind for breast cancer.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 2 weeks prior to the first dose of study intervention.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in doses \\>10 mg daily of oral prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Inhaled, intranasal, intra-articular, or topical steroid use are allowed.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, which have undergone potentially curative therapy are not excluded.\n* Has known CNS metastases and\u002For leptomeningeal carcinomatosis.\n* Has a history or evidence of active pneumonitis or interstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has grade \\>=3 neuropathy of any etiology.\n* Has an active infection requiring antibiotics.\n* Has a known history of Human Immunodeficiency Virus (HIV) infection.\n* Has an inability to swallow capsules or tablets.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* Has had an allogenic tissue\u002Fsolid organ transplant.\n* Has significant cardiovascular impairment within 12 months of the first dose of study drug: such as NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. Note: Medically controlled arrhythmia would be permitted.\n* Has a left ventricular ejection fraction (LVEF) below the institutional normal range of 50%, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).\n* Known intolerance to any of the study drugs (or any of the excipients).\n* Has had major surgery within 3 weeks prior to first dose of study interventions. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.",{"count":102,"type":20},60,[104],"PHASE2","Thie purpose of this study is to find out whether a personalized treatment approach-using a series of ctDNA tests along with standard imaging scans to help decide when to step up (escalate) or decrease (de-escalate) sequential treatments (given one after another)-combined with local therapies (which treat cancer in a specific part of the body) and treatments that prevent cancer from spreading to the central nervous system (CNS; including the brain and spinal cord) can result in long-lasting remission and possibly cure some participants with HER2+ metastatic breast cancer.",[26,107,31],"HER2-positive Breast Cancer",[109,107,31,52,110],"breast cancer","25-258","2026-05-20",{"date":113,"type":57},"2026-05-22",{"date":115,"type":57},"2026-03-04",{"date":117,"type":20},"2030-03-04",{"name":52,"class":63},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":136,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":94},"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":127,"type":20},30,[75],"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.",[78,26,31,131,132,133,134,135],"Triple Negative Breast Cancer","Triple Negative Breast Neoplasms","Metastatic Triple-Negative Breast Carcinoma","Locally Advanced Breast Cancer","Locally Advanced Triple-Negative Breast Carcinoma",[137,138,139,109,140,141,142,143,52,144,145,146,147],"metastatic TNBC","metastatic triple negative breast carcinoma","metastatic breast cancer","breast cancer stage IV","triple negative breast cancer","pembrolizumab","cryoablation","23-390","locally advanced breast cancer","locally advanced triple negative breast carcinoma","locally advanced triple negative breast cancer","2026-05-18",{"date":111,"type":57},{"date":151,"type":57},"2024-01-29",{"date":153,"type":20},"2027-01-29",{"name":52,"class":63},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":162,"minAge":17,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":21,"phases":166,"briefSummary":168,"conditions":169,"keywords":171,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":94},"100584465","phase-3-phase-iii-trial-of-camrelizumabapatiniberibulin-vs-physicians-choice-chemotherapy-in-advanced-triple-negative-breast-cancer-100584465","NCT06889688","Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer","A Multicenter, Phase III, Randomized Controlled Trial Comparing Camrelizumab Plus Apatinib and Eribulin Versus Physician's Choice Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. The subject voluntarily agrees to participate in this study and signs an informed consent form (ICF).\n2. Female subjects aged ≥18 and ≤70 years on the date of signing the ICF.\n3. Pathologically confirmed advanced triple-negative breast cancer (TNBC), defined as ER-negative (IHC ER-positive percentage \\\u003C1%), PR-negative (IHC PR-positive percentage \\\u003C1%), and HER2-negative (IHC-\u002F+, or IHC++ but FISH\u002FCISH-), with at least one measurable lesion per RECIST v1.1 criteria.\n4. Patients who have received at least 1 and up to 4 lines of prior systemic therapy for metastatic or locally advanced unresectable triple-negative breast cancer (TNBC) with disease progression. Prior systemic therapy (including at least 1 line of chemotherapy and neoadjuvant\u002Fadjuvant chemotherapy) must include at least a taxane or anthracycline. Subjects who relapse within 6 months after completion of neoadjuvant\u002Fadjuvant chemotherapy are considered as having failed first-line therapy.\n5. Capable of swallowing tablets.\n6. ECOG performance status of 0-1.\n7. Expected survival ≥12 weeks.\n8. Adequate function of vital organs, meeting the following criteria (without the use of blood products or growth factors during the screening period): Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL. Platelet count ≥100×10⁹\u002FL. Hemoglobin ≥9 g\u002FdL. Serum albumin ≥3 g\u002FdL. Thyroid-stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4 levels should be assessed; subjects with normal T3 and T4 levels are eligible). Total bilirubin ≤1.0×ULN (for subjects with Gilbert's syndrome or liver metastases, total bilirubin ≤1.5×ULN). ALT and AST ≤1.5×ULN (for subjects with liver metastases, ≤3×ULN). Alkaline phosphatase (ALP) ≤2.5×ULN. Renal function within 7 days prior to the first dose: serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin.\n9. Women of childbearing potential agree to use highly effective contraception starting at least 7 days prior to the first dose and continuing for 24 weeks after the last dose. A negative serum pregnancy test is required within 7 days prior to the first dose.\n\nExclusion Criteria:\n\n1. Subjects with untreated active brain metastases or leptomeningeal metastases.\n2. Participation in any other interventional clinical trial within 28 days prior to the first dose.\n3. History of severe allergic reactions to other monoclonal antibodies.\n4. Receipt of other antitumor therapies within 28 days prior to the first dose.\n5. Uncontrolled hypertension despite antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).\n6. Prior treatment with CTLA-4, Tim-3, or LAG-3 antibodies, or T-cell co-stimulatory therapies (previous use of PD-1 or PD-L1 antibodies is allowed).\n7. Prior treatment with anti-angiogenic agents or eribulin chemotherapy.\n8. Presence of any active autoimmune disease or a history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism). Subjects with vitiligo, or childhood asthma that has fully resolved without intervention in adulthood, may be included. Subjects with asthma requiring medical intervention with bronchodilators are excluded.\n9. Uncontrolled cardiac clinical symptoms or diseases, including: Heart failure classified as NYHA Class II or higher. Unstable angina. Myocardial infarction within the past year. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n10. Urinalysis indicating proteinuria ≥++ or confirmed 24-hour urinary protein ≥1.0 g.\n11. Known hereditary or acquired bleeding or thrombotic disorders (e.g., hemophilia, coagulopathy, thrombocytopenia, hypersplenism).\n12. Congenital or acquired immunodeficiency (e.g., HIV infection).\n13. Receipt of a live vaccine within 4 weeks prior to or during the study period.\n14. Allergy or contraindication to the investigational drugs.\n15. Underwent surgery within 3 months prior to enrollment or anticipated need for major surgical procedures during the study period.","FEMALE","70 Years",{"count":165,"type":20},246,[167],"PHASE3","This study evaluates the efficacy and safety of camrelizumab, apatinib, and eribulin versus physician's choice chemotherapy in advanced TNBC.Primary Objectives: Assess improvements in progression-free survival (PFS) and overall survival (OS).Secondary Objectives: Compare objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), duration of response (DoR), time to response (TTR), two-year OS rate, biomarker analysis, and quality of life (QoL).Safety: Assess and compare adverse event incidence and severity.",[31,170],"Triple -Negative Breast Cancer",[172,173],"Advanced Triple-Negative Breast Cancer","Immunotherapy","2026-04-19",{"date":176,"type":57},"2026-04-23",{"date":178,"type":57},"2025-02-21",{"date":180,"type":20},"2029-06-01",{"name":182,"class":63},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":193,"conditions":194,"keywords":195,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100621512","phase-2-trastuzumab-deruxtecan-in-first-line-her2-positive-metastatic-breast-cancer-with-proactive-toxicity-management-100621512","NCT07371585","Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management","Patient-Centered Study of Trastuzumab Deruxtecan (T-DXd) in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management Reflecting Real-World Clinical Practice","TOP-REAL","Inclusion Criteria:\n\n1. Able to understand the nature of the study and to voluntarily provide written informed consent prior to any trial-specific screening procedures and has sufficient cognitive capacity to comply with study requirements, including the use of digital health tools and devices.\n2. Male\u002Ffemale patients who are at least 18 years of age on the day of signing informed consent.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n4. Histologically or cytologically locally confirmed HR+\u002FHER2+ or HR-\u002FHER2+ BC with evidence of locally advanced disease, not amenable to resection or radiation therapy with curative intent, or metastatic disease:\n\n   1. HER2-positivity confirmed in a tumor sample obtained in the metastatic setting, defined as either IHC 3+ or in situ hybridization positive (ISH+) by local laboratory assessment as per the most recent American Society of Clinical Oncology (ASCO)-College of American Pathologists Guideline (CAP) guideline. The most recent test result prior screening period will be used to confirm eligibility.\n   2. Documented HR (ER and\u002For PR) positivity or negativity, confirmed by local laboratory assessment in a tumor sample obtained in the metastatic setting. ER and\u002For PR positivity is defined as \\>1% of cells expressing HR via IHC analysis as per most recent ASCO-CAP guideline. The most recent test result prior screening period will be used to confirm eligibility.\n5. No prior chemotherapy or HER2-targeted therapy for advanced or mBC (1 prior line of endocrine therapy is allowed for mBC). Participants who have received chemotherapy or HER2-targeted therapy in the neoadjuvant or adjuvant setting at any time are eligible.\n\n   Note: Patients that received an antibody-drug conjugate containing an exatecan derivative (topoisomerase I inhibitor) in the adjuvant setting, must have a disease-free interval of ≥12 months since the last dose.\n6. Evaluable disease as defined by RECIST v1.1.\n\n   Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.\n7. Adequate FFPE tumor tissue sample available from the metastatic setting (preferably) for retrospective HER2 central analysis confirmed by central laboratory. An adequate sample of tumor tissue must be provided from either a newly acquired biopsy from a region that has not been previously irradiated or the most recent archival sample.\n8. Patients with Brain Metastases (BM): Eligible if either previously untreated or previously treated BM, provided there is no clinical indication for immediate local therapy. For untreated BM, lesions must be ≤2.0 cm in largest diameter; lesions \\>2.0 cm require discussion with and approval from the Medical Monitor. Patients must not require \\>3 mg\u002Fday of dexamethasone (or equivalent corticosteroid) for symptom control. If receiving anticonvulsants, the regimen must be stable for ≥14 days prior to first dose. A washout period prior enrollment of ≥3 weeks since stereotactic radiosurgery or gamma knife, whole-brain radiotherapy, or radiotherapy or surgery for spinal cord compression is required.\n\n   Note: Patients with leptomeningeal disease may be eligible after discussion with the Medical Monitor.\n9. Adequate hematologic and end-organ function, defined by the following laboratory results (see protocol)\n10. LVEF ≥ 50% within 28 days before Cycle 1 Day 1.\n11. Life expectancy of ≥ 12 weeks at screening.\n12. Adequate treatment washout period before first dose of study intervention, defined as (see protocol)\n13. Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified highly effective method of contraception.\n14. Access to a smartphone with internet connection that allows them to carry out the required assessments at the specified timepoints and with the following characteristics:\n\n    * Resilience PRO: Android 8.0 (or newer) OR iOS 15.0 (or newer)\n    * Cankado PRO-React: Android 13.0 (or newer) OR iOS 17.0 (or newer)\n15. Only applicable in France: patients affiliated to the social security system.\n\nExclusion Criteria:\n\n1. Patients with HER2-negative disease.\n2. Subjects who, in the opinion of the investigator, are unable to comply with the protocol requirements or who have any comorbidity or condition that may hinder study follow-up, response evaluation, or the informed consent process, including inability to read and understand the local language of the study site sufficiently to interact effectively with study materials and tools (including digital applications).\n\n   Note: Other languages for app-based questionnaires may be provided upon patient request and based on availability of such questionnaires and tools.\n3. History of other primary malignancy unless treated with curative intent with no evidence of active disease within 3 years before the first dose of study treatment and of low potential risk for recurrence. Exceptions include: basal cell carcinoma of the skin and squamous cell carcinoma of the skin that has undergone potentially curative therapy, adequately resected non-melanoma skin cancer, in situ cancer of the cervix, curatively treated ductal carcinoma in situ (DCIS), contralateral breast cancer, Stage 1, grade 1 endometrial carcinoma or other solid malignant tumors with an expected curative outcome after Medical Monitor approval.\n4. Persistent toxicities that the investigator deems related to previous anti-cancer therapy (excluding alopecia), not yet resolved to grade ≤ 1 or baseline. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study treatment may be included (e.g., hearing loss). Participants with stable Grade 2 toxicities (defined as no worsening to \\>Grade 2 for at least 3 months prior to enrollment and managed with standard of care treatment) may be eligible per the discretion of the investigator (e.g., Grade 2 chemotherapy-induced neuropathy).\n5. Untreated spinal cord compression\n6. History of significant cardiovascular disease, defined as:\n\n   * New York Heart Association Class III or greater congestive heart failure or known left ventricular ejection fraction of \\\u003C 50%.\n   * Participants with a medical history of myocardial infarction within 6 months before enrollment or symptomatic CHF (NYHA Class II to IV). Participants with troponin levels above upper limit of normal (ULN) at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrollment to rule out myocardial infarction.\n   * History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation (Mean resting corrected QTcF interval \\>470ms (females) or \\>450msec (males)). Note: Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted upon discussion with the Medical Monitor.\n7. History of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening. Patients with a history of grade 1 drug-induced ILD\u002Fpneumonitis, who are now fully recovered, must be discussed with the Medical Monitor for approval.\n8. Meets one of the following lung criteria:\n\n   * Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of study enrollment, prior pneumonectomy (complete), severe asthma, severe chronic obstructive pulmonary disorder (COPD), restrictive lung disease, pleural effusion, post COVID-19 pulmonary fibrosis, etc,).\n   * Any autoimmune, connective tissue or inflammatory disorders (eg, rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the electronic Case Report Form (eCRF) for participants who are included in the study.\n9. Received a live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of study treatment.\n\n   Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of study treatment.\n10. Active serious infection requiring IV antibiotics, antivirals, or antifungals.\n11. Active HIV, HBV (defined as having a positive HbsAg test) or HCV.\n\n    1. Participants with a known history of human immunodeficiency virus (HIV) are eligible, if viral load is undetectable for ≥ 6 months prior to enrollment, and subjects are receiving effective anti-retroviral HIV therapy, if indicated. HIV testing is not required for subjects without a known history of HIV, unless mandated by a local health authority.\n    2. For patients with a known history of HBV infection, a hepatitis B core antibody test should be conducted at screening. If positive, hepatitis B DNA testing will be performed and if active HBV infection is ruled out, the patient may be eligible.\n    3. Patients who are HCV antibody positive with polymerase chain reaction negative for HCV RNA may be eligible\n12. Other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n13. Received prior chemotherapy or HER2-targeted therapy for advanced or mBC.\n14. Prior exposure in the adjuvant setting to an antibody-drug conjugate containing an exatecan derivative (topoisomerase I inhibitor), with a disease-free interval of less than 12 months since the last dose\n15. Requirement for ongoing therapy with or prior use of any prohibited medications.\n16. Participation in other studies involving investigational drug(s) within 30 days prior to enrollment or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial. If the patient is enrolled or planned to be enrolled in another study that does not involve an investigational drug, the agreement of the Medical Monitor is required to establish eligibility.\n17. Known hypersensitivity or allergy to T-DXd, their metabolites, formulation excipient, or other monoclonal antibodies.\n18. Positive serum pregnancy test or women who are lactating.\n19. Only applicable in France: patients deprived of their liberty or under protective custody or guardianship.",{"count":19,"type":20},[104],"This is an open-label, single arm, non-randomized, multicenter, phase 2 study assessing the efficacy and safety of T-DXd as first-line treatment in HER2-positive advanced\u002Fmetastatic BC patients (N=300). The study integrates digital health tools for proactive toxicity management and potentially facilitate early detection of ILD\u002Fpneumonitis.",[31],[196,197,198,199],"Trastuzumab deruxtecan","digital health tools","first line","proactive toxicity management","2026-03-26",{"date":202,"type":57},"2026-03-27",{"date":204,"type":57},"2026-02-18",{"date":206,"type":20},"2030-07-01",{"name":208,"class":63},"SOLTI Breast Cancer Research Group",27,{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":264},"100536733","phase-2-tart-cherry-juice-as-a-dietary-supplement-for-the-prevention-of-paclitaxel-induced-neuropathy-100536733","NCT06268665","Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy","A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy","Inclusion Criteria:\n\n* Histologically confirmed invasive breast or ovarian cancer (Stage I, II, III, or IV) as per AJCC 8th Edition, 2018 Staging Criteria.\n* Must be planning to receive paclitaxel weekly for 12 weeks (12 weeks total) as part of neoadjuvant, adjuvant, or metastatic cancer treatment.\n\n  * Concurrent biologic therapy (e.g., trastuzumab and pertuzumab) is allowed.\n  * Currently receiving hormone therapy, bisphosphonates, denosumab or LHRH-agonists is allowed.\n  * Concurrent use of immune checkpoint inhibitor therapy is allowed.\n  * (Neo)adjuvant chemotherapy with doxorubicin and cyclophosphamide is allowed.\n  * Concurrent use of carboplatin with weekly paclitaxel in the study is allowed.\n* May participate concurrently in other cancer trials.\n* Must be able to complete questionnaires in English or Spanish.\n* Age ≥ 18 years old at the time of consent.\n* ECOG performance status of 0 - 1 (Karnofsky scale ≥ 70%, see Appendix).\n* Ability to understand and the willingness to sign a written informed consent document.\n* Individuals of child-bearing potential must agree to use birth control (e.g., hormonal or barrier method; abstinence, an intrauterine device) prior - to study entry, for the duration of study participation (including dose interruptions), and for 3 months after the last dose of tart cherry juice supplement; or be surgically sterilized (e.g., hysterectomy or tubal ligation).\n* Patients with known human immunodeficiency virus (HIV) are allowed in the study, but HIV-positive patients must have:\n\n  * A stable regimen of highly active anti-retroviral therapy (HAART)\n  * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\n  * A CD4 count above 250 cells\u002FµL and an undetectable HIV viral load on standard PCR-based tests within the last year.\n* Stated willingness to not drink any additional tart cherry or any cherry juice while on the study.\n* Ability and willingness to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n* Have received any prior therapy with taxanes, vinca alkaloids, eribulin, ixabepilone, or platinum. Doxorubicin is allowed (≥ 2 week washout period required).\n* Active or history of peripheral neuropathy, or any chronic diseases associated with peripheral neuropathy such as diabetes mellitus, alcohol use disorder, or systemic lupus erythematosus.\n* Currently taking anticoagulant medication.\n* Currently taking Vitamin E, glutamine, alpha lipoic acid, gabapentin, nortriptyline, amitriptyline or duloxetine. If a patient is taking any of these supplements\u002Fmedications, they must agree to stop at the time of registration. Multivitamins containing Vitamin E are allowed, however Vitamin E \\> 1,000 international units (IU) must be discontinued at the time of registration.\n* Patients may not use cold therapy gloves for chemotherapy induced neuropathy.\n* Known allergy to cherries.\n* Inability to swallow liquid.\n* Pregnant or breastfeeding individuals (lactating individuals must agree not to breast feed while taking study juice supplementation).\n* Any condition that would prohibit the understanding or rendering of informed consent.\n* Any condition that in the opinion of the investigator would interfere with safety or compliance while on trial.",{"count":218,"type":20},86,[104],"This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy.\n\nEligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2).",[26,222,223,30,31,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255],"Breast Cancer Stage I","Breast Cancer Stage II","Invasive Breast Cancer","Ovarian Cancer","Ovarian Cancer Stage 1","Ovarian Cancer Stage II","Ovarian Cancer Stage III","Ovarian Cancer Stage IV","Ovarian Cancer Stage IA","Ovarian Cancer Stage IB","Ovarian Cancer Stage IC","Ovarian Cancer Stage 2","Ovarian Cancer Stage 3","Ovarian Cancer Stage IIIb","Ovarian Cancer Stage IIIC","Breast Cancer Stage IIIA","Breast Cancer Invasive","Breast Cancer, Stage IA","Breast Cancer, Stage IB","Breast Cancer Stage IIA","Breast Cancer Stage IIB","Breast Cancer Stage IIIB","Breast Cancer Stage IIIc","Cancer, Breast","Tumors, Breast","Mammary Cancer","Mammary Carcinoma","Breast Carcinoma","Breast Neoplasm","Malignant Breast Neoplasm","Malignant Tumor of Breast","Cancer of Ovary","Ovary Cancer","Ovary Neoplasm","2026-03-02",{"date":115,"type":57},{"date":259,"type":57},"2024-08-15",{"date":261,"type":20},"2027-12",{"name":263,"class":63},"University of California, Davis",1,{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":162,"minAge":17,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":21,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":288},"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":273,"type":20},99,[75,104],"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.",[78,134,31,277],"ER+\u002FHER2- Breast Cancer","2026-02-06",{"date":280,"type":57},"2026-02-10",{"date":282,"type":57},"2023-09-12",{"date":284,"type":20},"2028-03",{"name":286,"class":287},"Forward Pharmaceuticals Co., Ltd.","INDUSTRY",22,{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":318,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":64},"100374021","phase-1-sharon-a-clinical-trial-for-metastatic-cancer-using-chemotherapy-and-patients-own-stem-cells-100374021","NCT04150042","SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells","SHARON: Study of Metastatic Cancers in Patients Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives","SHARON","Inclusion Criteria\n\n* Age ≥ 18 years.\n* Pancreatic or breast cancer, as described below.\n* Stage IV (based on AJCC staging guidelines) at the time of enrollment.\n\n  a. Note that potential subjects with stage IV cancer that have had a complete response from prior chemotherapy are still potentially eligible.\n* Expected survival time ≥ 6 months, as determined by the investigator.\n* Life expectancy not severely limited by diseases other than malignancy, as determined by the investigator.\n* Karnofsky score ≥ 60%.\n* No chemotherapy within 2 weeks of enrollment.\n* Prior surgical resection or ablation of the primary tumor is allowed but not required.\n* If post-surgical, the subject must be at least 28 days post-op with the surgical wounds healed and significant complications resolved.\n* Potential subjects who have received previous chemotherapy and\u002For PARP inhibitors may be enrolled.\n* Measurable or non-measurable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1.\n* For potential subjects with a germline BRCA1, BRCA2, or PALB2 mutation:\n\n  a. The mutation must be known to be deleterious or suspected to cause functional impairment as assessed by a CLIA-certified laboratory according to the variant classification criteria described in the study protocol.\n* For potential subjects with somatic BRCA1, BRCA2, or PALB2 mutations:\n\n  1. The mutation must be a known or suspected deleterious mutation as assessed by a CLIA-certified laboratory according to the variant classification criteria described in the study protocol.\n  2. There must be biallelic loss or inactivation of the mutated BRCA1, BRCA2, or PALB2 gene as assessed by a CLIA-certified laboratory.\n  3. The Genetics Review Committee for this trial, which is comprised of a core group of investigators and whose actions are performed in accordance with the committee's charter, must agree that the biallelic mutations are deleterious or suspected deleterious.\n* For subjects without a BRCA1, BRCA2, or PALB2 mutation\n\n  1. Subject must have received at least 16 weeks of first-line (platinum-based\\*) chemotherapy with no evidence of treatment failure, where treatment failure is defined as growing tumors, new lesions, or a steadily rising tumor marker during or within eight weeks of completion of the first line therapy.\n  2. \\* Subjects can also have been treated with FOLFIRINOX but switched to FOLFIRI due to oxaliplatin side effects.\n* For potential subjects with pancreatic cancer:\n\n  1. Pancreatic ductal adenocarcinoma or pancreatic acinar cell carcinoma.\n  2. If the potential subject has had surgical resection of the primary tumor, then there must be no evidence of disease progression between the time of surgical resection of the primary tumor and screening for enrollment if the patient is seeking enrollment in the immediate post-surgery period.\n* For potential subjects with breast cancer:\n\n  1. Adenocarcinoma of the breast.\n  2. HER2-negative cancer as per American Society of Clinical Oncology\u002FCollege of American Pathologists human epidermal growth factor receptor 2 (HER2) testing in breast cancer guidelines.\n  3. Male or female sex.\n* Histological or cytological confirmation of the primary cancer diagnosis is required.\n* Metastatic disease must be histologically or cytologically confirmed unless in the clinical judgment of the investigator a biopsy is not needed for diagnostic purposes.\n* Female participants of childbearing potential must agree to do one of the following from the time of signing of the informed consent through 6 months after the last dose of melphalan:\n\n  1. Simultaneously practice two effective barrier methods of contraception. Oral and injectable contraceptives are not allowed. Barrier methods of birth control (e.g., diaphragm and spermicide, or condom and spermicide) are required.\n  2. Practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal) are not acceptable methods of contraception.\n* Male participants:\n\n  1. Unless the male is in a monogamous relationship with a female that does not have child-bearing potential, male subjects (even if surgically sterilized) must agree to do one of the following from the time of signing of the informed consent through 6 months after the last dose of melphalan:\n\n     1. Practice effective barrier contraception, plus a second method of effective contraception.\n     2. Practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods, and withdrawal) are not acceptable methods of contraception.\n\nExclusion Criteria\n\n* Rapid disease progression or clinical features concerning for onset of rapid symptomatic deterioration, as determined by the investigator.\n* Biliary tract obstruction.\n* Current cholangitis. A biliary stent in situ does not otherwise exclude protocol participation.\n* A history of only one episode of cholangitis and fewer than 30 days have passed since discontinuation of antibiotic treatment.\n* A history of multiple episodes of cholangitis and after discussion between the site study team and sponsor medical monitor and careful evaluation for suitability the patient is deemed to be unsuitable for the trial due to risk of recurring cholangitis.\n* Portal hypertension.\n* Sinistral portal hypertension.\n* Obliteration or significant obstruction of the major veins or arteries (e.g., portal vein, superior mesenteric artery, superior mesenteric vein).\n* Clinically significant malignant ascites or malignant pleural effusion, as determined by the investigator.\n* Metastatic lesion to the heart or eye.\n* Chemotherapy for an indication other than treatment of the current cancer within the past 1 year with a more than 30% risk of recurrence as determined by the investigator.\n* Known or suspected metastatic involvement of the central nervous system.\n* Left ventricular ejection fraction less than 45% by Multigated Acquisition Scan or echocardiogram (or significantly below the lower limit of normal for the specific test).\n* Clinically significant structural heart disease or vascular disease.\n* Myocardial infarction within 6 months prior to enrollment; New York Heart Association (NYHA) Class III or IV heart failure; angina; uncontrolled ventricular arrhythmias; or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.\n* Clinically significant prolongation of QTc (Bazett formula) on EKG, defined as \\> 0.45 s in males and \\> 0.47 s in females.\n* Severe hypertension, which is defined as the presence of any of the following:\n\n  1. History of hypertensive crisis, hypertensive emergency, or malignant hypertension within the last year.\n  2. Sustained or persistent systolic BP \\> 165 mm Hg or diastolic \\> 110 mm Hg.\n* Other clinically significant cardiovascular disease.\n* NOTE:\n\n  1. A past history of severe hypertension that is well-controlled with therapy or that was addressed by removal of the cause (e.g., removal of a medicine that caused the severe hypertension) is not an exclusion criterion.\n  2. The presence of a pacemaker is not a contraindication and is not considered an exclusion criterion\n* History or evidence of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis).\n* If a smoker, refusal to stop smoking for the duration of the trial.\n* FEV1 or DLCO (adjusted for hemoglobin) \\\u003C 50% of predicted.\n* Total bilirubin \\> 2x upper normal limit, except that potential subjects with Gilbert's Disease are permitted to exceed 2x upper normal limit.\n* ALT or AST \\> 2.5x upper normal limit.\n* Alkaline phosphatase \\> 2.5x upper normal limit, in conjunction with elevated GGT.\n* Albumin \\\u003C 3.0 g\u002Fdl.\n* Clinical evidence of sinusoidal obstruction syndrome.\n* Corrected creatinine clearance consistently \\\u003C 50 ml\u002Fmin\u002F1.73 m\\^2.\n* Clinically significant renal disease.\n* Hemolytic anemia.\n* Family history of catalase deficiency or history or evidence of a severe adverse reaction to hydrogen peroxide consistent with catalase deficiency, unless testing has demonstrated that the patient is not catalase-deficient.\n* Evidence of bone marrow insufficiency or failure, in the judgment of the investigator.\n* A hemoglobin \\\u003C 9 g\u002FdL.\n* G6PD deficiency as measured by quantitative enzyme levels below the normal reference range in blood.\n* Pre-existing bleeding diathesis or coagulopathy.\n* Potential subject is pregnant.\n* Breast feeding and unwilling to stop.\n* Wilson's disease.\n* Primary or secondary hemochromatosis.\n* Hgb A1c \\> 9%.\n* Hyperuricemia that is not responsive to therapy.\n* Plasma oxalate greater than 10 µM, which is not responsive to measures to reduce the level below 10 µM.\n* History of clinically significant elevation of plasma oxalic acid or complications related to oxalic acid.\n* Prior or current hepatitis B or C.\n* HIV infection or seropositivity for HIV.\n* Active, clinically significant bacterial, viral, or fungal infection.\n* History of colonization with a multidrug-resistant \"superbug\" that poses a high risk of an untreatable infection in the setting of neutropenia.\n* Uncontrolled seizure disorder.\n* If a potential subject has received radiation, then any of the following:\n\n  1. A volume ≥ 700 ml of normal liver received a dose ≥ 10 Gy.\n  2. The mean dose to normal liver (i.e., liver minus gross tumor volume) was ≥ 10 Gy.\n  3. The mean dose to normal lung (i.e., lung minus gross tumor volume) was ≥ 4 Gy.\n* History of significant allergy or other contraindication to BCNU, melphalan, vitamin B12b, vitamin C, pegfilgrastim, or Neupogen, or to any excipient in those drugs.\n* Use of any of the following cytochrome P450 2b6 (CYP2b6) inducers within 21 days of the planned date of BCNU treatment: phenobarbital, carbamazepam, rifampicin, phenytoin, sulfinpyrazone, or verapamil.\n* Disulfiram (Antabuse) use within 30 days of the planned ethanol administration.\n* Current chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine, corticosteroids).\n* Prior bone marrow stem cell transplant.\n* Except for adjuvant therapy for breast cancer or pancreatic cancer, prior radiation therapy to the brain, kidneys, pelvis, or GI tract or treatment with yttrium-90.\n* Prior treatment with bleomycin or BCNU.\n* Prior treatment, within 30 days of enrollment, with a drug that has not been FDA-approved for any indication (cancer or otherwise).\n* Subject has not fully recovered (i.e., there remain toxicities \\> Grade 1) from the reversible effects of prior chemotherapy, with the exception of chemotherapy-induced alopecia and grade 2 peripheral neuropathy, unless in the opinion of the principal investigator the effects are not of clinical significance.\n* Any concurrent anticancer treatment.\n* Serious underlying medical or psychiatric illness or another condition that in the clinical judgment of the principal investigator is likely to interfere with the potential subject completing participation in the trial, based on safety concerns or otherwise.\n* Inability or unwillingness to adhere to the study protocol.\n* Unwillingness to receive ethanol.",{"count":298,"type":20},24,[75],"The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer. The investigational treatment will involve 2 cycles of a combination of intravenous melphalan, BCNU, vitamin B12b, and vitamin C with autologous hematopoietic stem cell infusion. A dose-escalation schedule is being employed for the vitamin C.",[302,303,304,305,306,307,308,309,80,31,310,81,82,311,312,313,314,315,316,317],"Pancreatic Adenocarcinoma Metastatic","BRCA1 Mutation","BRCA2 Mutation","Pancreatic Acinar Cell Carcinoma","Pancreatic Ductal Adenocarcinoma","Pancreatic Cancer","Metastatic Pancreatic Cancer","Metastatic Pancreatic Ductal Adenocarcinoma","Pancreatic Cancer Stage IV","Adenocarcinoma of the Breast","PALB2 Gene Mutation","Pancreas Cancer, Metastatic","Pancreas Cancer, Recurrent","Pancreas Cancer","Stage IV Pancreatic Cancer","Stage 4 Pancreatic Cancer",[319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,109,335,336,337,338,339,340,139,341,342],"pancreatic adenocarcinoma","pancreatic cancer","BRCA","BRCA1","BRCA2","melphalan","BCNU","carmustine","vitamin C","vitamin B12b","autologous stem cell infusion","stage 4 pancreatic cancer","metastatic pancreatic cancer","pancreatic acinar cell carcinoma","pancreatic ductal adenocarcinoma","PDAC","stage 4 breast cancer","stage IV pancreatic cancer","stage IV breast cancer","stem cells","HER2-negative breast cancer","PALB2","BRCA pancreatic cancer","BRCA breast cancer","2026-01-27",{"date":345,"type":57},"2026-01-29",{"date":347,"type":57},"2021-01-13",{"date":349,"type":20},"2028-12",{"name":351,"class":287},"General Oncology, Inc.",{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":11,"sex":162,"minAge":17,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":361,"phases":4,"briefSummary":362,"conditions":363,"keywords":366,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":264},"100579906","her2-pet-as-a-precision-imaging-tool-for-treatment-with-her2-adc-in-her2-expressing-mbc-100579906","NCT06830382","HER2-PET as a Precision Imaging Tool for Treatment With HER2-ADC in HER2-expressing mBC","A Multicentre, Prospective, Open-label Study With [68Ga]Ga-ABY-025 PET-imaging to Characterize HER2-expression and Explore the Therapy-predictive Value for HER2-antibody Drug Conjugates in Patients With Metastatic Breast Cancer","Inclusion Criteria:\n\n* Female patients age ≥18 years.\n* Metastatic or locally advanced breast cancer with disease progression after ≥ 1 line of chemotherapy in the palliative setting, or with disease relapse within six months after completion of (neo-) adjuvant chemotherapy.\n* The patient must be able and willing to provide written consent to participate in the study.\n* At least one metastatic lesion ≥ 10 mm is available for biopsy\n\n  o Exception can be made when a recent biopsy is available (no more than 12 months old and without exposition to HER2-targeted therapy or local radiotherapy to the specific lesion).\n* At least one additional metastatic index lesion ≥ 10 mm for evaluation of treatment effect (according to RECIST v1.1)\n* WHO performance status ≤ 2.\n* Expected survival \\> 12 weeks.\n* Contraceptives: Females of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of the study treatment phase and for six months after the last dose of \\[68Ga\\]Ga-ABY-025. Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone- releasing intrauterine devices (IUDs), and copper IUDs. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Women must refrain from donating eggs during this same period. Should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. If a female participant is of child-bearing potential (females are considered not of childbearing potential if they are at least one year postmenopausal and\u002For surgically sterile), she must have a documented negative serum Pregnancy testing prior to each administration of the IMP is obligatory.\n\nExclusion Criteria:\n\n* Contra-indications for treatment for trastuzumab deruxtecan and inability to undergo this treatment as per local treatment routines.\n* A previously documented metastatic tumor biopsy that was HER2-positive (IHC 3+ and\u002For HER2 gene amplification).\n* Other manifest malignancies except for basal cell carcinoma of the skin.\n* Inadequate cardiac, renal, bone marrow or liver function\n* Patients with increased risk of complications from biopsies, i.e. increased risk of bleeding, defined as\n\n  * prothrombin time test (INR value) \\>1.4, platelet count \\\u003C70 (109\u002Fl), activated partial thromboplastin time (APTT) \\>30s.\n  * known bleeding disorders such as haemophilia, von Willebrand disease or platelet disorders.\n  * any anticoagulants or antiplatelet treatment that cannot be temporarily paused",{"count":360,"type":20},70,"OBSERVATIONAL","This is a prospective, multi-center, open-label, exploratory diagnostic phase II imaging trial for patients with metastatic breast cancer with at least one line of systemic therapy.\n\nThe overarching aim of the HER2-Ex PET trial is to study the role of precision imaging utilizing positron emission tomography (PET) with the HER2-specific tracer \\[68Ga\\]Ga-ABY-025 (hereafter referred to as HER2-PET) in enhancing treatment planning for patients with metastatic HER2-expressing breast cancer Patients will be allocated based on HER2-status on PET and biopsy. Patients with HER2-expressing lesions in a fresh or archived tumour biopsy will be treated with T-DXd.\n\nThe study hypothesis is that PET\u002FCT precision imaging with a contemporary HER2-radiotracer (\\[68Ga\\]Ga-ABY-025) can be used and can lead to a potentially better identification of patients who benefit from T-DXd treatment, thereby achieving improved treatment responses as well as fewer side effects. This study's diagnostic approach provides a more individualized treatment strategy. Additionally, this study can potentially give us a better biological understanding of HER2-expressing mBC.",[31,364,365],"HER2-low Breast Cancer","Molecular Imaging",[367,368,369,370,139,371,372],"HER2-PET","molecular imaging","precision imaging","HER2-low mBC","HER2-ADC","ABY-025","2025-11-17",{"date":375,"type":57},"2025-11-20",{"date":377,"type":57},"2025-10-03",{"date":379,"type":20},"2032-04-01",{"name":381,"class":63},"Renske Altena",{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":390,"enrollmentInfo":391,"targetDuration":4,"studyType":21,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":264},"100505826","phase-2-phase-ii-study-of-dato-dxd-in-triple-negative-breast-cancer-patients-with-newly-diagnosed-or-progressing-brain-metastases-100505826","NCT05866432","Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases","Phase II Study of Datopotamab-Deruxtecan (Dato-DXd; DS-1026a) in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases","TUXEDO-2","Inclusion Criteria:\n\n* Histologically confirmed breast cancer\n* Triple-negative disease as defined by immunohistochemistry (IHC) and\u002For c-erb-B2 gene amplification status. For the definition of hormone-receptor negative disease, a cut-off of \\\u003C10% tumour cells with positive staining of oestrogen- and progresteron-receptors is required\n* Newly diagnosed untreated brain metastases or brain metastases progressing after prior local therapy\n* Measurable disease (RANO-BM criteria)\n* No indication for immediate local treatment\n* Accompanying type II leptomeningeal disease allowed (suspected LMD by clinical findings and neuroimaging)\n* KPS ≥70%, ECOG ≤2 Indication for systemic anti-cancer treatment\n* Prior exposure to PD-1, PD-L1 inhibitors and TROP-2 targeted agents allowed\n* Life expectancy of at least 3 months\n* Age ≥18 years\n* Patient must be able to tolerate therapy\n* Adequate bone-marrow, liver and kidney function\n* Adequate treatment washout period before enrolment, defined as:\n* Major Surgery: ≥3 weeks\n* Radiation therapy to the chest: ≥4 weeks\n* Palliative radiation therapy to other areas: ≥2 weeks\n* Chemotherapy, small-molecule targeted agents: ≥3 weeks\n* Antibody-based treatment: ≥4 weeks (concurrent therapy with denosumab allowed)\n* Patient must be capable of understanding the purpose of the study and have given written informed consent\n\nExclusion Criteria:\n\n* Known hypersensitivity to Dato-DXd or any of the drug components\n* Use of any investigational agent within 28 days prior to initiation of treatment\n* History of malignancies other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 3 years including contralateral breast cancer\n* Other anticancer therapy, including cytotoxic, targeted agents, immunotherapy, antibody, retinoid, or anti-cancer hormonal treatment with the exception of osteoprotective therapies such as denosumab or bisphosphonates\n* Concomitant radiotherapy\n* A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs\n* Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), left ventricular ejection fraction \\\u003C50%, arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities, and long QT syndrome (QTc interval \\>470 ms)\n* Inadequate bone marrow function at baseline prior to study entry\n* Inadequate kidney function\n* Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease including active or uncontrolled infections with hepatitis B and C\n* Participants with known hepatitis B and C are eligible if they:\n\n  1. Have been curatively treated for HCV infection as demonstrated clinically and by viral serologies\n  2. Have received HBV vaccination with only anti-HBs positivity and no clinical signs of hepatitis\n  3. Are HBsAg- and anti-HBc+ (i.e., those who have cleared HBV after infection) and meet conditions i-iii below:\n  4. Are HBsAg+ with chronic HBV infection (lasting 6 months or longer) and meet conditions 1-3 below:\n  5. HBV DNA viral load \\\u003C2000 IU\u002FmL\n  6. Have normal transaminase values, or, if liver metastases are present, abnormal transaminases, with a result of AST\u002FALT \\\u003C3 × ULN, which are not attributable to HBV infection\n  7. Start or maintain antiviral treatment\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has a history of non-infectious ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening\n* Subjects with bronchopulmonary disorders who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study\n* Patients with active opportunistic infections\n* Known human immunodeficiency virus (HIV) infection that is not well controlled\n* Pregnant or lactating women\n* Women with childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy.\n* Male subjects unable or unwilling to use adequate contraception methods\n* Patients with known substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results\n* Patients requiring concomitant use of chronic systemic (IV or oral) corticosteroids at doses higher than 8 mg dexamethasone per day or other immunosuppressive medications except for managing adverse events; (inhaled steroids or intra articular steroid injections are permitted in this study)\n* Patients with significant corneal disease","100 Years",{"count":392,"type":20},20,[104],"Datopotamab-deruxtecan in triple-negative breast cancer patients with newly diagnosed or progressing brain metastases.",[31],"2025-09-22",{"date":398,"type":57},"2025-09-25",{"date":400,"type":57},"2023-07-01",{"date":402,"type":20},"2026-05-23",{"name":404,"class":63},"Medical University of Vienna",{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":361,"phases":4,"briefSummary":414,"conditions":415,"keywords":427,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":264},"100595293","radiomics-to-predict-her2-status-and-t-dxd-efficacy-in-metastatic-breast-cancer-the-radiospher2-study-100595293","NCT07030569","RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study","RADIOSPHER2","Inclusion Criteria:\n\n* Patients with metastatic breast cancer underwent a liver, lung, pleural or bone biopsy in the metastatic setting, performed from 01Jan2005 to 01Jan2024.\n\nExclusion Criteria:\n\n* Not available imaging (CT scan and\u002For PET-FdG scan) in the three months before the biopsy or before the last previous treatment interruption;\n* Unknown HER2 status;\n* Node, soft tissue or other visceral as biopsy site.",{"count":413,"type":20},500,"RADIOSPHER2 study is a monocentric, retrospective, observational study aiming at identifying a radiomics signature able to predict HER2 expression (0 vs low vs overexpression) and trastuzumab deruxtecan efficacy in metastatic breast cancer patients. The study also encompasses translational analyses and inter-modal correlations in order to provide novel insights about HER2 spatial and temporal heterogeneity, at the macroscopic and microscopic levels.",[416,417,80,31,249,418,26,419,420,421,422,423,424,107,425,426],"Radiomic","Radiomics","Breast Neoplasms","Breast Cancer With Bone Metastasis","Breast Cancer With Metastatic Bone Disease","Trastuzumab","HER2","HER2 + Breast Cancer","HER2 Positive Breast Carcinoma","Her2\u002FNeu Positive Advanced Solid Tumors","HER2\u002FNeu-positive Breast Cancer",[417,428,429,430,431],"HER2 expression","Trastuzumab Deruxtecan","Pathomics","HER2 heterogeneity","2025-06-12",{"date":434,"type":57},"2025-06-22",{"date":436,"type":57},"2024-02-01",{"date":438,"type":20},"2027-01-01",{"name":440,"class":63},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano",{"id":442,"slug":443,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":447,"eligibilityCriteria":448,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":361,"phases":4,"briefSummary":451,"conditions":452,"keywords":488,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":298},"100578016","predicting-clinical-outcomes-during-first-line-cdk46-inhibitors-plus-endocrine-therapy-in-patients-with-advanced-hormone-receptor-positive-her2-negative-breast-cancer-the-retrospective-prospective-multicenter-italian-palmares-2-study-100578016","NCT06805812","Predicting clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","Predictive Impact of Peripheral Blood Lymphocytes on clinicAL outcoMes During First-line CDK4\u002F6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study","PALMARES-2","Inclusion Criteria:\n\n* Diagnosis of HR+\u002FHER2- advanced Breast Cancer (aBC), as defined as at least 1% estrogen receptor (ER) and\u002For progesterone receptor (PgR) positivity at IHC. HER2 negativity is defined on the basis of an IHC score of 0, 1+, or 2+ with absence of gene amplification at in situ hybridization (ISH) analyses.\n* Have received or are candidate to receive treatment with palbociclib, ribociclib or abemaciclib in combination with endocrine therapy as first-line treatment for HR+\u002FHER2- aBC.\n\nExclusion Criteria:\n\n* Less than 3 months of follow up from the CDK4\u002F6i start to the date of data cut-off;\n* Have received CDK4\u002F6i as monotherapy;\n* Have received CDK4\u002F6i as adjuvant treatment for localized disease.",{"count":450,"type":20},3500,"PALMARES-2 is a retrospective\u002Fprospective, observational, multicenter, population-based study, aiming at providing real-world evidences on HR+\u002FHER2- aBC patients treated with first-line CDK4\u002F6i plus ET. The present study has the objective to collect data coming from different sources, i.e. RWD, medical images and biological samples, from patients treated with CDK4\u002F6i as first-line of therapy for HR+\u002FHER2- aBC. In consideration of the complexity of data collected and different objectives of the study, this master protocol foresees different sub-studies, which encompasses different methodologies for data collection, data extraction and analyses.",[453,31,454,249,455,418,456,26,420,457,250,458,459,460,461,462,463,464,465,466,467,468,469,470,471,472,473,474,475,476,477,478,479,480,481,482,483,484,485,486,487],"Breast Adenocarcinoma","Breast Cancer, Metastatic","Breast Diseases","Breast Neoplasms, Male","Breast Cancers","Breast Tumors","HR+ HER2- Men, Pre\u002FPostmenopausal Advanced Breast Cancer","HR+ Advanced or Metastatic Breast Cancer","HR+\u002FHER2- Breast Cancer","HRpos Breast Neoplasms","HR-positive, HER2-negative Advanced Breast Cancer","HR-positive, HER2-negative and PIK3CA Mutation Advanced Breast Cancer","HR-positive Breast Cancer","Hormone Receptor-Positive Breast Cancer","Hormone Receptor Positive Breast Adenocarcinoma","Hormone Receptor Positive Breast Carcinoma","Hormone Receptor Positive Breast Neoplasms","Hormone Receptor Positive HER-2 Negative Breast Cancer","Hormone Receptor Positive Malignant Neoplasm of Breast","Hormone Receptor Positive Metastatic Breast Cancer","Hormone Receptor Positive, HER2 Negative Breast Cancer","Hormone Receptor Negative Breast Cancer","Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer","Hormone Receptor Positive Breast Cancer","Hormone Receptor Positive (ER+\u002FPR+, and Her2-) Metastatic Breast Cancer","Hormone Receptor Positive, HER2-negative Neoplasms","Hormone Receptor Positive, HER2-low Neoplasms","Hormone Receptor Positive (HR+), HER2-negative Breast Cancer","Hormone Receptor (HR)-Positive Breast Cancer","Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer","Palbociclib","Ribociclib","Abemaciclib","CDK4\u002F6 Inhibitor","CDK4\u002F6 Inhibitors",[489,490,483,484,485,491,492,78],"HR+\u002FHER2- Advanced Breast Cancer","HR+\u002FHER2- Metastatic Breast Cancer","CDK4\u002F6i","Cyclin-Dependent Kinase 4\u002F6 inhibitors","2025-01-28",{"date":495,"type":57},"2025-02-03",{"date":497,"type":57},"2023-05-01",{"date":499,"type":20},"2040-12-31",{"name":440,"class":63},{"id":502,"slug":503,"hasResults":11,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":11,"sex":16,"minAge":508,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":21,"phases":511,"briefSummary":512,"conditions":513,"keywords":514,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":526},"100521916","phase-1-a-study-of-oral-mbq-167-in-participants-with-advanced-breast-cancer-100521916","NCT06075810","A Study of Oral MBQ-167 in Participants With Advanced Breast Cancer","A Phase 1 Open-Label, First-in-Human Trial of Oral MBQ-167 as Single Agent in Participants With Advanced Breast Cancer","Key Inclusion Criteria:\n\n* The investigator will evaluate these and other criteria to determine whether a participant can be included in this study.\n* Histologically and\u002For cytologically confirmed advanced breast cancer which has progressed after treatment with approved therapies or for which there are no standard therapies available.\n* Participants with known brain metastases may be eligible if specific conditions are met.\n* Life expectancy ≥6 months, in the opinion of the investigator, after starting MBQ-167.\n* Are able to swallow capsules twice daily with a meal.\n\nKey Exclusion Criteria:\n\n* The investigator will evaluate these and other criteria to determine whether a participant should be excluded from this study.\n* Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of MBQ-167.\n* Females who are pregnant or breastfeeding.\n* Participants who have received any anticancer treatment within 4 weeks or any investigational agent within 28 days prior to the first dose of trial drug or who have not recovered from any acute toxicity greater than Grade 0 or 1 related to previous anticancer treatment.\n* Participants who have received any anticancer treatment within 4 weeks or any investigational agent within 28 days prior to the first dose of trial drug or who have not recovered from any acute toxicity greater than Grade 0 or 1 related to previous anticancer treatment.\n* Active malignancies other than advanced breast cancer will be excluded from the study.","21 Years",{"count":510,"type":20},48,[75],"A Phase 1, open-label, dose-escalation clinical trial of MBQ-167 in participants with advanced Breast Cancer for whom Standard of Care (SOC) has failed or has proven intolerable.",[26,250,31],[515,78,516],"Advanced Breast Cancer","Recurrent Breast Cancer","2024-12-09",{"date":519,"type":57},"2024-12-12",{"date":521,"type":57},"2023-11-09",{"date":523,"type":20},"2025-10-31",{"name":525,"class":287},"MBQ Pharma",4,{"id":528,"slug":529,"hasResults":11,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":11,"sex":162,"minAge":17,"maxAge":163,"enrollmentInfo":534,"targetDuration":4,"studyType":21,"phases":536,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":540,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":4},"100560526","phase-4-inetetamab-combined-with-paclitaxel-withwithout-pertuzumab-for-previously-treated-her2-positive-advanced-breast-cancer-100560526","NCT06578299","Inetetamab Combined With Paclitaxel With\u002FWithout Pertuzumab for Previously Treated HER2-positive Advanced Breast Cancer","The Real World Study of First Line Treatment of HER2 Positive Recurrent\u002FMetastatic Breast Cancer With Inetetamab Combined With Paclitaxel With\u002FWithout Pertuzumab（INTPOWER）","Inclusion Criteria:\n\n1. Age 18 - 70 years, female\n2. Patients with HER2-positive breast cancer defined as immunohistochemical (IHC) test + + +, or FISH test positive\n3. Participants must have histologically or cytologically confirmed invasive breast cancer with locally recurrent inoperable or radiological evidence of metastatic disease\n4. Have not received first-line anti-HER2 treatment or (neo) adjuvant anti-HER2 drug treatment that is effective and has been discontinued for more than 12 months\n5. Patients with assessable target lesion as per RECIST 1.1 and irRECIST criteria;\n6. ECOG PS score 0 or 1, estimated survival time ≥3 months, and can be followed-up;\n7. The cardiopulmonary function is basically normal, with LVEF ≥ 50%;\n8. Adequate organ function;\n9. Female patients of childbearing age who have negative pregnancy tests and voluntarily adopt effective and reliable contraceptive measures；\n10. The patient voluntarily signs an informed consent form.\n\nExclusion Criteria:\n\n1. Participated in other clinical trials within 4 weeks;\n2. Have received any systematic anti-tumor treatment during the recurrence\u002Fmetastasis stage (excluding endocrine therapy previously performed for recurrence\u002Fmetastasis stage);\n3. During the (neo) adjuvant phase, other anti-HER2 treatments were received in addition to trastuzumab and pertuzumab;\n4. Patients who experience disease progression during (neo) adjuvant trastuzumab treatment, as well as patients who experience recurrence\u002Fmetastasis within 12 months after completing (neo) adjuvant system treatment;\n5. Evidence of central nervous system metastasis or leptomeningeal disease;\n6. Individuals with a known history of allergies to the components of this medication regimen;\n7. Pregnant or lactating women;\n8. Left ventricular ejection fraction\\\u003C50% for cardiac function; Patients with obvious clinical manifestations such as arrhythmia, myocardial ischemia, severe atrioventricular block, heart dysfunction, and severe heart valve disease;\n9. The researchers believe that it is not appropriate to participate in this trial, as any other medical, social, or psychological factors may affect safety or compliance with research procedures.",{"count":535,"type":20},100,[537],"PHASE4","This study is designed to comprehensively evaluate the HER2 positive recurrent\u002Fmetastatic breast cancer patients in the real world who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab, including basic characteristics, efficacy and safety. The results of this study are helpful to further understand the efficacy and safety of HER2 positive patients with recurrent\u002Fmetastatic breast cancer who receive the combination of Inetetamab and Paclitaxel ± Pertuzumab in the first line, and help clinical decision-making.",[31],"NOT_YET_RECRUITING","2024-08-27",{"date":543,"type":57},"2024-08-29",{"date":545,"type":20},"2024-08-30",{"date":547,"type":20},"2027-08-30",{"name":549,"class":63},"Fudan University",{"id":551,"slug":552,"hasResults":11,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":21,"phases":560,"briefSummary":561,"conditions":562,"keywords":563,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":574},"100534241","phase-2-hrher2--advanced-or-metastatic-breast-cancer-patients-treated-with-sacituzumab-govitecan-100534241","NCT06236269","HR+\u002FHER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan","Prospective Biomarker Analysis in HR+\u002FHER2- Advanced or Metastatic Breast Cancer Patients Treated With Sacituzumab Govitecan","ACROSS-TROP2","Inclusion Criteria:\n\n1. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.\n2. Patients must be male or female (pre\u002Fperi or postmenopausal) ≥ 18 years of age.\n3. ECOG performance status of 0 or 1(see Appendix 1).\n4. Histologically or cytologically confirmed breast cancer with evidence of locally advanced disease, not amenable to resection or radiation therapy with curative intent or metastatic disease.\n5. HR+\u002FHER2- BC by local testing, not amenable to surgical therapy will be enrolled in this study.\n\n   1. HER2 negativity is defined as either of the following by local laboratory assessment: IHC 0, IHC 1+ or IHC2+\u002Fin situ hybridization (ISH) negative as per the most recent American Society of Clinical Oncology (ASCO)-College of American Pathologists Guideline (CAP) guideline. If a patient has had multiple HER2 results after metastatic disease, the most recent test result prior screening period will be used to confirm eligibility.\n   2. ER and\u002For PR positivity are defined as \\>1% of cells expressing HR via IHC analysis as per most recent ASCO-CAP guideline. If a patient has had multiple ER\u002FPgR results after metastatic disease, the most recent test result prior screening period will be used to confirm eligibility.\n6. Disease refractory to CDK4\u002F6 inhibitors, defined as recurrence during or within 12 months after the end of adjuvant treatment or progression during or within 6 months after the end of treatment for advanced\u002Fmetastatic disease.\n7. No more than 1 prior systemic chemotherapy or antibody-drug conjugate (ADC) regimens for metastatic disease. Adjuvant or neoadjuvant therapy for early-stage disease will qualify as one of the required prior chemotherapy regimens if the development of unresectable, locally advanced, or metastatic disease occurred within a 12-month period of time of the therapy. Note: treatments for bone metastases (eg, bisphosphonates, denosumab, etc.), targeted therapies (eg, PARP inhibitors, CDK 4\u002F6 inhibitors, immunotherapy etc.) and hormonal therapy are not considered as prior systemic chemotherapy treatments for advanced disease.\n8. Radiologic or objective evidence of disease progression on or after the last systemic therapy prior to starting study treatment\n9. Measurable or non-measurable disease but evaluable (identification of target and\u002For non-target lesions by RECIST Vs1.1).\n10. Patients must have a site of disease amenable to safely perform a biopsy, as per Investigator's assessment, and be a candidate for tumor biopsy according to the treating institution's guidelines.\n11. Possibility of performing a biopsy prior to the start of treatment and its repetition after 2 weeks (14-21 days) and at End of Treatment (EOT) on the same location. It will be provided formalin-fixed paraffin-embedded (FFPE) tumor block. The tumor tissue should be of good quality based on total and viable tumor content and must be evaluated centrally for quality prior to enrollment. Patients whose tumor tissue is not evaluable for central testing are not eligible. It is recommended to send the biopsy directly to the central lab after confirming the existence of a tumor, so as not to delay the inclusion, without the need to carry out IHC studies in the same sample.\n\n    * Acceptable samples include core needle biopsies for deep tumor tissue or excisional, incisional, punch, or forceps biopsies for cutaneous, subcutaneous, bone or mucosal lesions or biopsies from bone metastases. Lymph node biopsies are also permitted.\n    * Fine needle aspiration, brushing, cell pellet from pleural effusion and lavage samples are not acceptable.\n12. Patients must have normal organ and bone marrow function measured within 35 days prior to administration of study treatment as defined below:\n\n    * Haemoglobin ≥ 9.0 g\u002FdL \\*\n    * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL\\*\n    * Platelet count ≥ 100 x 109\u002FL\\*\n    * Total bilirubin (TBL) ≤ 1.5 × upper limit of normal (ULN) or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia).\n    * AST (SGOT) \u002F ALT (SGPT) ≤ 2.5 x ULN unless liver metastases are present in which case, they must be ≤ 5x ULN\n    * Creatinine ≤ 1.5 x ULN or Creatinine clearance estimated of ≥30mL\u002Fmin using the Cockcroft-Gault equation.\n    * Serum albumin \\>3 g\u002FdL\n    * International normalized ratio (INR) or prothrombin time (PT) and either partial thromboplastin or activated partial thromboplastin time (aPTT) ≤ 1.5 ×ULN \\*Without transfusional or growth factor support within 1 week of study treatment initiation.\n13. Patients must have a life expectancy ≥ 16 weeks.\n14. Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 2.\n15. Willing and able to comply with the requirements and restrictions in this protocol.\n\nExclusion Criteria:\n\n1. Patients with HER2-positive or TNBC disease.\n2. Other malignancy unless curatively treated with no evidence of disease for ≥3 years except: non-melanoma skin cancer, in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma or other malignant tumors with an expected curative outcome after medical monitor approval.\n3. Has unresolved toxicities from previous anticancer therapy (≥ CTCAE version 5.0 grade 1) caused by previous cancer therapy, excluding alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion. Note: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to ≥Grade 2 for at least 2 months prior to enrollment and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, such as: Chemotherapy-induced neuropathy, Fatigue, Residual toxicities from prior IO treatment Grade 1 or Grade 2 endocrinopathies. Note: if patients received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n4. Patients may not be participating in a study with an investigational agent or investigational device within 2 weeks or 5 half-lives, whichever is longer, prior to allocation. Patients participating in observational studies are eligible.\n5. Patients with symptomatic uncontrolled brain metastases. Participants with a history of treated Central Nervous System (CNS) metastases are eligible, provided they meet all of the following criteria:\n\n   * Biopsiable disease outside the CNS is present.\n   * No evidence of interim CNS progression between the completion of CNS directed therapy and the screening radiographic study.\n   * Metastases are limited solely to cerebellar and supratentorial lesions.\n   * Stable requirement for corticosteroids (≤ 20 mg oral prednisone or equivalent) or anticonvulsants during \\>4 weeks as therapy for CNS disease.\n   * No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to enrolment.\n   * No evidence of progression or haemorrhage after completion of CNS directed therapy.\n   * Patients with spinal cord compression are excluded unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.\n6. History of significant cardiovascular disease, defined as:\n\n   * New York Heart Association Class III or greater congestive heart failure or known left ventricular ejection fraction of \\\u003C 40%.\n   * Unstable angina or myocardial infarction within 6 months before enrolment.\n   * History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.\n7. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment.\n8. Have active serious infection requiring requiring IV antibiotics, antivirals, or antifungals.\n9. Have a known history of Human Immunodeficiency Virus (HIV).\n10. Have active HBV (defined as having a positive HbsAg test) or HCV.\n\n    1. For patients with a history of HBV infection, a hepatitis B core antibody test should be conducted at screening. If positive, hepatitis B DNA testing will be performed and if active HBV infection is ruled out, the patient may be eligible.\n    2. Patients who are HCV antibody positive with polymerase chain reaction negative for HCV RNA may be eligible.\n11. Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n12. Has received a live vaccine within 30 days prior to randomization.\n13. Prior treatment with Sacituzumab-govitecan.\n14. Known or severe (≥ Grade 3) hypersensitivity or allergy to sacituzumab govitecan, their metabolites, or formulation excipient.\n15. Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 7.5.\n16. Positive serum pregnancy test or women who are lactating (see Appendix 2).",{"count":559,"type":20},50,[104],"This is an open-label, single arm, non-randomized, multicenter phase II study for the identification of predictive biomarkers of sacituzumab govitecan benefit and the understanding of key resistance mechanisms in HR+\u002FHER2- advanced\u002Fmetastatic breast cancer patients",[31],[564,109,565],"sacituzumab govitecan","CelTIL","2024-07-18",{"date":568,"type":57},"2024-07-19",{"date":570,"type":57},"2024-03-15",{"date":572,"type":20},"2027-02-20",{"name":208,"class":63},10,{"id":576,"slug":577,"hasResults":11,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":582,"enrollmentInfo":583,"targetDuration":4,"studyType":21,"phases":585,"briefSummary":586,"conditions":587,"keywords":588,"overallStatus":540,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":601},"100505403","phase-4-clinical-study-of-huaier-granules-in-patients-with-advanced-breast-cancer-without-visceral-metastasis-100505403","NCT05860907","Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis","A Multicenter, Open-label, Randomized, Controlled, Prospective Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral Metastasis","Inclusion Criteria:\n\n* 18 years old ≤ age ≤ 75, regardless of gender.\n* For breast cancer patients who are clinically or pathologically diagnosed as non visceral metastasis, if the patient has only local recurrence or metastasis, the clinician judges that it is not suitable or refuses to use local treatment with radical intensity, such as surgical resection or radiotherapy.\n* Prior to enrollment, no more than first-line chemotherapy\u002Fendocrine therapy\u002Ftargeted therapy\u002Fimmunotherapy were allowed;If the patient has previously received first-line therapy, the outcome of treatment should be clinically assessed as disease progression or intolerance.\n* There is at least one measurable lesion that meets the RECIST 1.1 standard, or only bone metastases (including osteolytic lesions or mixed lesions).\n* The liver and kidney functions meet the following conditions: AST and ALT\\\u003C3 ULN, total bilirubin ≤ 2 ULN, and blood creatinine\\\u003C1.5 ULN.\n* Other laboratory tests meet the following requirements: Hb ≥ 9g\u002Fdl, platelet count ≥ 60 × 10\\^9\u002FL, absolute neutrophil count\\>1.0 × 10\\^9\u002FL.\n* Expected survival time ≥ 12 weeks.\n* The patient's ECOG physical state score is 0 or 1.\n* The subjects participated in the study voluntarily and signed an informed consent form.\n\nExclusion Criteria:\n\n* Any other malignancies diagnosed within 5 years prior to enrollment, except those with a low risk of metastasis and death (5-year survival \\> 90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ.\n* There is visceral metastasis of breast cancer.\n* Patients with advanced (local recurrence or metastasis) breast cancer who plan to receive radical local treatment.\n* Serious infections (CTCAE\\>Level 2) have occurred within 4 weeks prior to enrollment, such as severe pneumonia, bacteremia, infection complications that require hospitalization; Symptoms and signs of infection or the need for oral or intravenous antibiotic treatment within 2 weeks prior to enrollment, except for prophylactic use of antibiotics.\n* Suffering from severe acute and chronic diseases.\n* Suffering from severe diabetes whose blood sugar cannot be effectively controlled.\n* Patients who cannot take oral medication or are allergic to the ingredients of Huaier granules.\n* Drug abusers, or those who suffer from psychological or mental illnesses that may interfere with research compliance.\n* Pregnant or lactating women.\n* The researcher believes that it is not suitable to participate in this study.","75 Years",{"count":584,"type":20},384,[537],"This is a multicenter, open-label, randomized controlled, prospective clinical study to evaluate the efficacy and safety of Huaier Granules in patients with advanced breast cancer without visceral metastasis.",[31],[589,590,591,592],"non-visceral metastasis","Huaier granule","randomized controlled","prospective clinical study","2023-09-22",{"date":595,"type":57},"2023-09-26",{"date":597,"type":20},"2023-10",{"date":599,"type":20},"2027-10",{"name":549,"class":63},13,{"id":603,"slug":604,"hasResults":11,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":608,"eligibilityCriteria":609,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":21,"phases":612,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":264},"100468228","stereotactic-ablative-radiotherapy-for-oligometastatic-breast-cancer-100468228","NCT05377047","Stereotactic Ablative Radiotherapy for OligoMetastatic Breast Cancer","Treatment of Oligometastatic Breast Cancer - a Randomised Phase 3 Trial Comparing Stereotactic Ablative Radiotherapy and Systemic Treatment With Systemic Treatment Alone as 1st Line Treatment","TAORMINA","Inclusion Criteria:\n\n1. Histologically or cytological confirmed recurrent OMBC.\n2. Age ≥18 years old.\n3. OMBC defined as 1-5 metastases in a maximum of two organs confirmed by PET-CT.\n4. Patients already on 1st line systemic treatment can be enrolled if repeated tumour evaluations show stable disease.\n5. Patients with de novo stage IV OMBC must have a controlled primary tumour regardless of primary surgery or primary systemic treatment.\n6. Patients with local recurrence and OMBC must have a controlled local recurrence.\n7. ECOG\u002FWHO 0-2.\n8. Life expectancy \\> 6 months.\n9. Known ER, PgR and HER2 status of either primary tumour or metastasis (preferred).\n10. If measurable lesions, each ≤ 5 cm.\n11. Symptomatic bone metastases are allowed if ablative therapy can be delivered (femoral metastasis not allowed).\n12. Adequate organ function for the planned treatment according to local guide-lines.\n13. For patients with liver metastasis:\n\n    * No cirrhosis or hepatitis\n    * Hepatic function:\n\n      * Total bilirubin level \\\u003C 3.0 x institutional ULN\n      * ALT, AST, GGT, and alkaline phosphatase levels \\\u003C 3.0 x institutional ULN\n      * Albumin \\> 2.5 mg\u002FdL\n    * Metastasis not adjutant to stomach or small bowel.\n14. For patients with abdominal metastases: adequate renal function with a calculated creatinine clearance of \\> 60mL\u002Fmin.\n15. Toxicities from previous adjuvant therapies (excluding alopecia) must have recovered to grade 1 (defined by CTCAE 5.0). Stable grade 2 peripheral neuropathy are considered individually by the investigator.\n16. Negative pregnancy test within 14 days prior to start of treatment\\*.\n17. If childbearing potential, willing to use an effective form of contraception\\*.\n18. No other malignancy during the last 5 years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix.\n19. Signed informed consent and willingness to follow the trial procedures.\n\nExclusion Criteria:\n\n1. \\> 1 line of systemic treatment for OMBC due to previous progressing disease (previous treatment of isolated local recurrences with a 2nd adjuvant treatment not included).\n2. Oligometastases in brain.\n3. Malignant pleural effusion or ascites.\n4. Metastasis growth that involves \\> 3 vertebra and adjacent spinal cord, spine instability or neurological deficit resulting from compression, 25% spinal canal compromise or progressive neurological deficit.\n5. Unable to undergo imaging by either CT scan or MRI.\n6. Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance.\n7. Pregnancy or breast-feeding.\n8. Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).",{"count":611,"type":20},345,[23],"TAORMINA is an international, multicentre, randomised phase 3 trial for patients with oligometastatic breast cancer (OMBC) that will be allocated to combined stereotactic ablative radiotherapy (SABR) + systemic therapy (investigational arm) versus systemic therapy alone (control arm) as 1st line therapy.",[31,615],"Oligometastatic Disease","2022-10-18",{"date":618,"type":57},"2022-10-21",{"date":620,"type":57},"2022-09-19",{"date":622,"type":20},"2027-12-31",{"name":624,"class":625},"Vastra Gotaland Region","OTHER_GOV"]