[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-breast-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,85,0,25,[9,47,80,109,143,172,198,219,271,302,350,371,381,404,424,448,467,495,519,542,565,590,619,639,651],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053594","phase-4-real-world-study-of-pyrotinib-containing-regimens-of-advanced-her2-positive-breast-cancer-100053594",false,"NCT07600164","Real-world Study of Pyrotinib-containing Regimens of Advanced HER2-positive Breast Cancer","Real-world Study of Pyrotinib-containing Regimens in First-line or Second-line Treatment of Advanced HER2-positive Breast Cancer","Inclusion Criteria:\n\n1. Aged ≥ 18 years old;\n2. Histopathologically confirmed HER2-positive inoperable locally advanced or metastatic breast cancer;\n3. Patients with first-line or second-line advanced disease:\n\n   First-line advanced disease: no prior systemic therapy for locally advanced or metastatic disease. For patients who received neoadjuvant or adjuvant therapy, the disease-free interval (DFI) after the completion of the last chemotherapy or HER2-targeted therapy was more than 12 months; Second-line advanced disease: prior treatment with taxane combined with trastuzumab, with or without pertuzumab, in the advanced setting; or recurrence occurring during neoadjuvant\u002Fadjuvant therapy, or a disease-free interval (DFI) of ≤ 12 months after completion of the last neoadjuvant\u002Fadjuvant chemotherapy and HER2-targeted therapy;\n4. Planned to receive pyrotinib-containing regimen, and judged by investigators based on clinical practice to have potential subsequent treatment with Ruikang trastuzumab after failure of pyrotinib-containing therapy;\n5. Traceable medical records available throughout the treatment period.\n\nExclusion Criteria:\n\n1. Failure to sign the informed consent form;\n2. Pregnant or lactating females;\n3. Patients participating in any interventional clinical trial involving investigational drugs or marketed drugs at enrollment;\n4. Other conditions deemed ineligible for enrollment by the investigator's judgment.","ALL","18 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Given that pyrotinib has been proven to exert significant efficacy against HER2-positive advanced breast cancer in multiple Phase III studies, and the novel ADC drug disitamab vedotin has demonstrated potent anti-tumor activity, there remains insufficient real-world data on their sequential administration. This multicenter, prospective real-world study plans to enroll 500 patients with HER2-positive advanced breast cancer receiving first-line or second-line treatment. It aims to evaluate the efficacy and safety of sequential disitamab vedotin treatment after disease progression or intolerance to pyrotinib-based regimens (first-line: pyrotinib plus trastuzumab combined with chemotherapy; second-line: pyrotinib plus capecitabine). The primary endpoint is real-world second progression-free survival (rwPFS2), while secondary endpoints cover real-world progression-free survival (rwPFS), tumor response, overall survival (OS), time to treatment failure, safety profiles and patient-reported outcomes. It is currently expected to further validate the efficacy and safety of pyrotinib in patients with advanced HER2-positive breast cancer in the real-world setting, and to evaluate the efficacy and safety of recindopril trastuzumab following pyrotinib-containing regimens.",[27,28],"HER2 + Breast Cancer","Advanced Breast Cancer",[30,31,32,33],"HER2-positive breast cancer","Advanced breast cancer","pyrotinib","Trastuzumab Rezetecan","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2026-07-06",{"date":42,"type":21},"2031-12-30",{"name":44,"class":45},"Peking University People's Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100053940","phase-2-study-to-evaluate-the-safety-and-tolerability-of-camizestrant-in-combination-with-atirmociclib-in-women-with-advanced-breast-cancer-100053940","NCT07427394","Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer","A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)","SERENA-1b","Main Inclusion Criteria:\n\n* Participants with advanced adenocarcinoma of the breast and must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease.\n* Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting investigational medicinal products.\n* Eastern cooperative oncology group (ECOG)\u002FWorld Health Organization (WHO) performance status 0 to 1, and a minimum life expectancy of 12 weeks.\n* At least one lesion that is measurable and\u002For non-measurable, as per RECIST 1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray, or clinical examination.\n* Menopausal status\n\n  * Pre-menopausal women must start GnRH agonist therapy at least 4 weeks before study treatment and continue throughout the study.\n  * Post-menopausal women must meet one of these criteria: bilateral oophorectomy, age ≥60 years, age ≥50 years with ≥12 months amenorrhea and intact uterus without hormonal therapy, or age \\\u003C60 years with ≥12 months amenorrhea and post-menopausal hormone levels.\n* Histological or cytological confirmation of adenocarcinoma of the breast.\n* Participants of childbearing potential must agree to use one highly effective contraceptive measure.\n* Documentation of ER-positive tumor irrespective of progesterone receptor status.\n\nMain Exclusion Criteria:\n\n* A participant who has received 2 or more lines of CDK4\u002F6 inhibitors in the advanced disease setting.\n* A participant who has received prior camizestrant or atirmociclib treatment in the advanced disease setting.\n* Patients previously treated with other next generation selective estrogen receptor degrader (SERDs) or other experimental ETs in the advanced disease setting.\n* Patients previously treated with other experimental cyclin-dependent kinase (CDK) inhibitors are not eligible.\n* Inability to swallow oral medications.\n* Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia).\n* Presence of life-threatening metastatic visceral disease.\n* Any evidence of severe or uncontrolled systemic diseases.\n* Contraindication to or known intolerance\u002Fhypersensitivity of\u002Fto camizestrant or atirmociclib.","FEMALE",{"count":57,"type":21},24,[59],"PHASE2","A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4\u002F6 (CDK4\u002F6) inhibitor.",[28],[63,64,65,66,67,68,69,70],"Estrogen receptor (ER)-positive","Human epidermal growth factor receptor 2 (HER2)-negative","Cyclin-Dependent Kinase (CDK) 4 inhibitors","Pharmacokinetics","Anti-tumor activity","Selective Estrogen Receptor Degrader (SERD)","Safety","Tolerability",{"date":37,"type":38},{"date":73,"type":38},"2026-05-06",{"date":75,"type":21},"2027-12-03",{"name":77,"class":78},"AstraZeneca","INDUSTRY",6,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100592715","phase-1-a-phase-1-study-of-bms-986500-as-monotherapy-or-combination-therapy-in-advanced-solid-tumors-100592715","NCT06997029","A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors","A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4\u002F6 Inhibitor Pre-treated Advanced Breast Cancer","Inclusion Criteria:\n\n* Participants must be ≥ 18 years of age.\n* Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.\n* Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* For Part 2A only, participants must have CCNE1-amplified ovarian cancer\n\nExclusion Criteria:\n\n* Participants must not have an active brain metastasis.\n* Participants must not have impaired cardiac function or clinically significant cardiac disease.\n* Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.\n* Participants must not have Grade ≥ 2 peripheral neuropathy.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":88,"type":21},234,[90],"PHASE1","The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4\u002F6 inhibitor pre-treated advanced breast cancer.",[93,28,94],"Advanced Solid Tumor","Advanced Ovarian Cancer",[96,97,98],"cancer","oncology","solid tumor","2026-07-01",{"date":101,"type":38},"2026-07-02",{"date":103,"type":38},"2025-08-01",{"date":105,"type":21},"2028-12-14",{"name":107,"class":78},"Bristol-Myers Squibb",21,{"id":110,"slug":111,"hasResults":12,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":17,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":128,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":142},"100379579","phase-1-metarrestin-ml-246-in-subjects-with-metastatic-solid-tumors-100379579","NCT04222413","Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","* INCLUSION CRITERIA:\n* Adult (\\>= 18 years) subjects with:\n\n  * histologically or cytologically confirmed solid tumors (Phase IA).\n\nOR\n\n--histologically or cytologically confirmed pancreatic, colorectal, or breast cancer (Phase IB)\n\nOR\n\n* Pediatric (\\>=12 and \\\u003C 18 years) subjects with histologically or cytologically confirmed solid tumors other than rhabdomyosarcoma (RMS) including embryonal, alveolar, spindle cell\u002Fsclerosing and pleomorphic subtypes of RMS (Phase IB).\n* Subjects must have disease that:\n\n  * is not amenable to potentially curative resection,\n  * spread at least to one other organ system other than primary tumor or recurred after removal of primary tumor\n  * has site measurable per RECIST 1.1\n  * progressed on or after at least one line of standard systemic chemotherapy (Phase IA and IB1)\n  * have no standard therapy option available (Phase IB2)\n* Patients must have recovered from any acute toxicity related to prior therapy or surgery or disease to a grade 1 or less.\n* Performance status\n\n  --Karnofsky \\>= 70% (for patients \\>= 16 years old), Lansky \\>= 70% (for patients \\\u003C16 years old)\n* Adequate hematological function defined by:\n\n  * absolute neutrophil count (ANC) \\>= 1.0 x 10(9)\u002FL,\n  * transfusion-independent platelet count \\>= 100 x 10(9)\u002FL,\n  * Hgb \\>= 9 g\u002F dL (patients who have received \\\u003C= 2 PRBC transfusions within 48 hours are eligible)\n* Adequate coagulation as defined by:\n\n  --INR\\\u003C1.5 (or \\\u003C 3.0 if subjects are currently taking anticoagulated medications) Note: increase of the upper limit of INR is restricted only to subjects who are receiving anticoagulation for medical reasons (DVT\u002FPE prophylaxis, treatment for a thromboembolic event) and have increased INR because of these medications. Patients who have an elevated INR due to compromised liver function or any other medical conditions remain excluded\n* Adequate hepatic function defined by:\n\n  * a total bilirubin level \\\u003C= 1.5 x ULN, (total bilirubin \\\u003C= 2.0 x ULN in case of prior diagnosis of Gilbert syndrome)\n  * an AST level \\\u003C= 3xULN\n  * an ALT level \\\u003C= 3 xULN\n* Adequate renal function defined by:\n\n  * Creatinine OR Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)\n\n    ---\\\u003C 1.5x institution upper limit of normal OR\n\n    ---\\>= 45 mL\u002Fmin\u002F1.73 m\\^2 for participant with creatinine levels \\>= 1.5 X institutional ULN\n  * Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.\n* The effects of the study treatment on the developing human fetus are unknown; thus, individuals of childbearing potential and individuals who can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior\n\nto study entry, for the duration of study therapy and up to 120 days after the last dose of the study drug.\n\n* Nursing participants must be willing to discontinue nursing at the time of the study treatment initiation.\n* Weight \\>= 35 kg.\n* Ability of subject or parent\u002Fguardian to understand and the willingness to sign a written informed consent document.\n* Subjects must have lesion(s) accessible for biopsy (other than used for measurement of disease) and be willing to undergo mandatory study biopsies (Cohort IB1 only).\n* Ability to swallow oral capsules.\n\nEXCLUSION CRITERIA:\n\n* Anticancer treatment within designated period before treatment initiation including:\n\n  * minor surgical procedure (such as biliary stenting) within 14 days. Note: if liver function tests after biliary stenting or renal function tests after ureteral stenting return to normal, within 5 days after biliary or ureteral stenting;\n  * major surgical procedure or curative radiation treatment within 28 days;\n  * palliative radiation treatment within 14 days;\n  * chemotherapy or experimental drug treatment with published half-life known to be 72 hours or less within 14 days;\n  * experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days;\n  * chemotherapy regimen containing an alkylating antineoplastic agent (cyclophosphamide, chlorambucil, melphalan, or ifosfamide), alkylating-like (platinumbased chemotherapeutic drugs, platinum analogues), and non-classical alkylating agent (dacarbazine, temozolomide) within 28 days.\n* Patients receiving any medications or substances that are moderate and strong inhibitors or inducers of CYP3A4 and are not able to safely stop these medications are excluded from this study; patients must stop strong CYP3A4 inhibiting\u002Finducing medications within 5 published half-lives and moderate within 3 published half-lives prior to the treatment initiation.\n\nNote: dihydropyridine calcium - channel blockers are permitted for management of underling disease\n\n* Subjects with cardiomyopathy diagnosed within 6 months prior to treatment initiation including but not limited to the following:\n\n  * hypertrophic cardiomyopathy\n  * arrhythmogenic right ventricular cardiomyopathy\n  * abnormal ejection fraction (echocardiogram \\[ECHO\\]) \\\u003C= 53% (if a range is given then the upper value of the range will be used)\n  * previous moderate or severe impairment of left ventricular systolic function (LVEF \\\u003C45%)\n  * severe valvular heart disease\n  * atrial fibrillation with a ventricular rate \\>100 bpm on EKG at rest\n  * Fridericia's corrected QT interval (QTcF) \\>= 480 msec (adults) or \\>= 460 msec (pediatric subjects, aged 12 to \\\u003C18 years) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome.\n* HIV, HCV, HBV positive patients on antiviral drugs are excluded due to the absence of previous experience with concurrent use of antiviral medications and the investigational drug product to be evaluated in the current study and possible for adverse pharmacokinetic and\u002For pharmacodynamic interactions.\n* Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Note: subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ previously treated with curative intent are NOT excluded.\n* Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures.\n* Subjects with central nervous system (CNS) metastases or CNS disorders known to increase possible neurotoxicity of metarrestin in case of compromised blood-brain barrier (e.g. recent stroke (\\\u003C3 months of treatment initiation), infectious causes).\n* Significant acute or chronic infections including tuberculosis with presence of clinical symptoms or physical findings.\n* Patients with a history of any seizures or increased risk of seizures on screening EEGs defined by 1) interictal epileptiform discharges, 2) temporal intermittent rhythmic delta activity (TIRDA), or 3) electrographic or clinical seizures on EEG.\n* Clinically relevant diseases (for example, inflammatory bowel disease) and \u002F or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject's tolerance or ability to participate in the trial.\n* Patients with previous gastric bypass, patients receiving nutrition via feeding tubes or parenterally, or patients with malabsorptive conditions (damage to the intestine from infection, inflammation, trauma, or surgery, celiac disease, Crohn's disease, chronic pancreatitis, or cystic fibrosis resulting malabsorption). Patients with refractory nausea and vomiting. Note: patients with gastric banding are allowed.\n* Pregnant individuals.","12 Years","120 Years",{"count":119,"type":21},116,[90],"Background:\n\nMetastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs.\n\nObjective:\n\nTo find a safe dose of metarrestin and to see if this dose shrinks tumors.\n\nEligibility:\n\nAdults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options.\n\nDesign:\n\nParticipants will be screened with:\n\n* blood tests\n* physical exam\n* documentation of disease confirmation or tumor biopsy\n* electrocardiogram to evaluate the heart\n* review of their medicines and their ability to do their normal activities\n\nParticipants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary.\n\nParticipants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body.\n\nAdult participants may have tumor biopsies.\n\nParticipants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends.\n\n...",[123,124,125,28,126,127],"Advanced Solid Tumors","Metastatic Pancreatic Cancer","Pediatric Solid Tumor","Malignant Peripheral Nerve Sheath Tumor","Colorectal Neoplasms",[129,130,131,132,133],"First-In-Class Investigational Agent","Peri-Nucleolar Compartment (PNC)","effective therapies against metastasis","Oral Administration","Maximum Recommended Starting Dose",{"date":101,"type":38},{"date":136,"type":38},"2020-10-27",{"date":138,"type":21},"2028-12-31",{"name":140,"class":141},"National Cancer Institute (NCI)","NIH",2,{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100633256","phase-1-study-of-rgt-490-in-patients-with-pik3ca-mutated-advanced-solid-tumors-100633256","NCT07524322","Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors","A Phase 1\u002F1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic PIK3CA-Mutated Solid Tumors Including HR+\u002FHER2- Breast Cancers","Inclusion Criteria:\n\n* Adults with metastatic or locally advanced, unresectable solid tumors that have progressed on or after at least one available therapy.\n* Presence of one or more documented activating PIK3CA mutation in tumor tissue and\u002For blood.\n* At least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* An ECOG performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Diabetes mellitus requiring anti-hyperglycemic medication.\n* Prior treatment with PI3Kα inhibitors\n* Symptomatic, untreated, or uncontrolled central nervous system metastases.\n* Receipt of any local or systemic anticancer therapy or investigational anticancer agent within a protocol-defined washout period prior to study treatment.\n* Unresolved clinically significant toxicities from prior anticancer therapy\n* History of a another malignancy within 2 years prior to screening (exception adequately treated cancers).",{"count":151,"type":21},63,[90],"This is a phase 1\u002F1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer.\n\nParticipants enrolled in the study have advanced disease that is not amendable to curative treatment and whose tumors harbor alterations in the PI3KCA gene.",[155,156,157,158,159,28,160,161,162],"Breast Cancer","Ovarian Cancer","Endometrial Cancer","PIK3CA Mutation","HER2- Negative Breast Cancer","Unresectable Solid Tumor","Hormone Receptor Positive Tumor","Cervical Cancer","2026-06-30",{"date":101,"type":38},{"date":166,"type":21},"2026-06",{"date":168,"type":21},"2028-10",{"name":170,"class":78},"Regor Pharmaceuticals Inc.",5,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":182,"phases":4,"briefSummary":183,"conditions":184,"keywords":185,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":194,"leadSponsor":196,"locationsCount":46},"100645365","timing-of-ctdna-testing-in-hrher2--advanced-breast-cancer-100645365","NCT07681323","Timing of ctDNA Testing in HR+\u002FHER2- Advanced Breast Cancer","Timing of ctDNA Testing in Advanced Breast Cancer: Impact on Prognosis and Treatment Strategies - A Prospective Observational Study (TIMING)","TIMING","Inclusion Criteria:\n\n* Histologically confirmed advanced breast cancer, molecular subtype HR+\u002FHER2-\n* Age ≥18 years\n* Expected survival \\>3 months\n* Willing to undergo ctDNA testing and sign informed consent form\n\nExclusion Criteria:\n\n* The subject has not signed the informed consent form.\n* Pregnant or breastfeeding women.\n* Other situations deemed by the investigator as unsuitable for inclusion in the study.",{"count":181,"type":21},400,"OBSERVATIONAL","This multicenter, prospective observational cohort study aims to investigate the impact of ctDNA level and key actionable gene mutation status on prognosis and treatment response in patients with advanced HR+\u002FHER2- breast cancer.",[28],[186,187,188,189],"ctDNA","multigene testing","HR+\u002FHER2- breast cancer","treatment strategy","NOT_YET_RECRUITING","2026-06-26",{"date":101,"type":38},{"date":163,"type":21},{"date":195,"type":21},"2029-06-30",{"name":197,"class":78},"Geneplus-Beijing Co. Ltd.",{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},"100545349","phase-3-saruparib-azd5305-plus-camizestrant-compared-with-cdk46-inhibitor-plus-endocrine-therapy-or-plus-camizestrant-in-hr-positive-her2-negative-ihc-0-1-2-ish-non-amplified-brca1-brca2-or-palb2m-advanced-breast-cancer-100545349","NCT06380751","Saruparib (AZD5305) Plus Camizestrant Compared With CDK4\u002F6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+\u002F ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer","A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared With Physician's Choice CDK4\u002F6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+\u002F ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)","EvoPAR-BR01","Inclusion Criteria:\n\n* Adult females, pre\u002Fperi-menopausal and\u002For post-menopausal, and adult males\n* Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer\n* Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease\n* ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks\n* FFPE tumour tissue from each participant\n* Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2\n* Adequate organ and marrow function\n\nExclusion Criteria:\n\n* Participants with history of MDS\u002FAML or with features suggestive of MDS\u002FAML\n* Participants with any known predisposition to bleeding\n* Any history of persisting severe cytopenia\n* Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections\n* Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection\n* History of another primary malignancy\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy excluding alopecia\n* Spinal cord compression, brain metastases, carcinomatous meningitis, or leptomeningeal disease\n* Evidence of active and uncontrolled hepatitis B and\u002For hepatitis C\n* Evidence of active and uncontrolled HIV infection\n* Active tuberculosis infection\n* Cardiac criteria, including history of arrythmia and cardiovascular disease\n* Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions\n* Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study\n* Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks before the first dose of study treatment\n* Prior treatment with systemic anti-cancer therapy for locoregionally recurrent or metastatic disease is not permitted, apart from treatment with ET up to 28 days before randomisation\n* Prior treatment within 28 days with blood product support or growth factor support\n* Any systemic concurrent anti-cancer treatment\n* Concomitant use of the following types of medications or herbal supplements within 21 days or at least 5 half-lives of randomisation:\n\n  1. Strong and moderate CYP3A4 inducers\u002Finhibitors\n  2. Sensitive CYP2B6 substrates\n  3. Substrates of CYP2C9 and\u002For CYP2C19 which have a narrow therapeutic index, eg, warfarin (and other coumarin-derived vitamin K antagonist anticoagulants) and phenytoin.\n* Concomitant use of drugs that are known to prolong QT and have a known risk of TdP\n* Systemic use of atropine\n* The following exclusion criteria apply to treatments administered for early breast cancer:\n\n  1. Disease progression ≤ 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy\n  2. Disease progression ≤ 1 year (365 days) from the last dose of treatment with a PARPi and\u002For platinum agent for early breast cancer\n  3. Disease progression ≤ 1 year (365 days) from the last dose with a CDK4\u002F6i in the adjuvant setting\n  4. Disease progression ≤ 1 year (365 days) from the last dose of an oral SERD including camizestrant.",{"count":20,"type":21},[208],"PHASE3","The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4\u002F6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+\u002F ISH non-amplified) advanced breast cancer",[28],{"date":212,"type":38},"2026-06-29",{"date":214,"type":38},"2024-08-01",{"date":216,"type":21},"2030-10-18",{"name":77,"class":78},301,{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":228,"briefSummary":229,"conditions":230,"keywords":231,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":270},"100592470","phase-1-phase-12-study-of-etx-636-in-participants-with-advanced-solid-tumors-100592470","NCT06993844","Phase 1\u002F2 Study of ETX-636 in Participants With Advanced Solid Tumors","A Phase 1\u002F2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors","Key Inclusion Criteria:\n\n* Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy.\n* Tumor harboring an activating PIK3CA mutation detected in either tumor tissue or ctDNA.\n* At least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* An ECOG performance status score of 0 or 1.\n* Adequate organ function.\n\nAdditional key inclusion criterion for Parts B and C:\n\n\\- Confirmed metastatic or locally advanced HR+\u002FHER2- breast cancer not amenable to surgical resection with curative intent and must have received at least 1 prior CDK4\u002F6 inhibitor and at least 1 prior anti-estrogen therapy.\n\nKey Exclusion Criteria:\n\n* Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied.\n* Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.\n* Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2.\n* Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment.\n* Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy.\n* Has had radiotherapy outside the target tumor lesions within 14 days prior to start of treatment.",{"count":227,"type":21},233,[90,59],"Phase 1\u002F2, open-label study of ETX-636 in participants with advanced solid tumors",[123,28],[96,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259,260],"breast cancer","solid tumors","PIK3CA","PI3Kα inhibitor","Breast Neoplasms","Neoplasms by Site","Neoplasms","Breast Diseases","HER2-negative breast cancer","HR-positive breast cancer","Gynecologic cancer","Endometrial cancer","Ovarian cancer","Cervical cancer","Head and neck cancer","Head and neck squamous cell carcinoma","Fulvestrant","Antineoplastic Agents","PI3Kα","PI3K alpha","PI3Kα mutation","Alpelisib","Estrogen Receptor Antagonists","Estrogen Antagonists","Hormone Receptor Antagonists","Hormone Antagonists","Hormones, Hormone Substitutes, and Hormone Antagonists","Physiological Effects of Drugs","PIK3CA mutation","2026-06-21",{"date":263,"type":38},"2026-06-23",{"date":265,"type":38},"2025-06-10",{"date":267,"type":21},"2027-12-30",{"name":269,"class":78},"Ensem Therapeutics",15,{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":283,"conditions":284,"keywords":288,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":297,"leadSponsor":299,"locationsCount":301},"100641445","decision-support-tool-for-patients-with-advanced-breast-cancer-100641445","NCT07635147","Decision Support Tool for Patients With Advanced Breast Cancer","Communicating Options for Advanced Breast Cancer Support and Treatment (COAST)","COAST","Inclusion Criteria:\n\n* Male or female 18 years and older\n* Diagnosis of Stage IV breast cancer\n* English, Spanish or Mandarin speaking\n\nExclusion Criteria:\n\n* Early breast cancer\n* Individuals speaking languages other than English, Spanish, or Mandarin as their primary language",{"count":280,"type":21},100,[282],"NA","The goal of this pilot study is to understand and improve the shared decision-making process between people with advanced breast cancer and their providers regarding their care and treatment. As part of this study, the researchers will evaluate a decision support tool called COAST that was designed to support patients and providers in having meaningful conversations. The main questions it aims to answer are:\n\n1. Can the COAST tool improve the quality of communication between patients and their oncology providers?\n2. Is the COAST tool acceptable, appropriate, and easy to use at NYP-Weill Cornell Medicine, NYP-Brooklyn Methodist Hospital and NYP-Queens?\n\nParticipants will be asked to fill out two surveys: one before they use the COAST tool and another about 2 - 4 weeks later. Some patients will also be invited for an interview.",[285,28,286,287],"Breast Cancer Metastatic","Stage 4 Breast Cancer","Stage IV (Metastatic) Breast Cancer",[289,290,291,292],"Decision support tool","advanced breast cancer","communication","Treatment preferences","2026-06-18",{"date":295,"type":38},"2026-06-22",{"date":166,"type":21},{"date":298,"type":21},"2028-02",{"name":300,"class":45},"Weill Medical College of Cornell University",3,{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":324,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":342,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":349},"100564176","phase-1-open-label-study-of-bbo-10203-in-subjects-with-advanced-solid-tumors-100564176","NCT06625775","Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)","Inclusion Criteria:\n\n* Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive\u002FHER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)\n* Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)\n* Stable brain metastases\n* Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC)\n* Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy\n* BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4\u002F6i\n* BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted\n* BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required\n\nExclusion Criteria:\n\n* Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR\u002FMSI-H tumors\n* Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1\u002FBRAF\u002FRET\u002FMET\u002FEGFR exon20 insertion\u002FNTRK\u002FHER2)\n* Patients with untreated and\u002For non-stable brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol",{"count":310,"type":21},392,[90],"First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.",[314,315,28,316,317,318,319,320,321,322,323],"Solid Tumor, Adult","Metastatic Breast Cancer","HER2 Mutation-Related Tumors","HER2-positive Metastatic Breast Cancer","KRAS Mutant Metastatic Colorectal Cancer","Metastatic Lung Cancer","Metastatic Colorectal Cancer","Advanced Lung Cancer","HR-positive, HER2-negative Advanced Breast Cancer","HER2-positive Advanced Breast Cancer",[325,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341],"BREAKER-101","BridgeBio Oncology Therapeutics","BBOT","Phase1","Phase 1a\u002F1b","Trastuzumab","Breast","Colorectal","Non-Small Cell Lung Cancer","CRC","NSCLC","Metastatic Cancer","Advanced Cancer","HER2-positive","HR-positive","HR-positive, HER2-negative","HER2-negative",{"date":263,"type":38},{"date":344,"type":38},"2024-10-29",{"date":346,"type":21},"2028-11",{"name":348,"class":78},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)",40,{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":22,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":46},"100642456","phase-2-a-clinical-study-of-sys6023-combination-therapy-for-advanced-breast-cancer-100642456","NCT07597629","A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer","A Phase II Clinical Study Evaluating the Efficacy and Safety of SYS6023 Combination Therapy for Unresectable Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years old;\n* 2\\. Histologically or cytologically confirmed unresectable locally advanced or metastatic breast cancer:\n* 3\\. Sufficient tumor specimens must be provided for biomarker testing (human epidermal growth factor receptor 3-HER3), preferably obtained during or after the most recent treatment period; During safety run-in period, subjects who cannot provide sufficient tissue samples may be screened after sponsor's evaluation and approval;\n* 4\\. Documented disease progression or intolerability with the most recent systemic anti-tumor treatment;\n* 5\\. According to RECIST 1.1, at least one evaluable lesion (safety run-in period) or measurable lesion (cohort expansion phase);\n* 6\\. ECOG PS score 0-1;\n* 7\\. Expected survival ≥ 3 months;\n* 8\\. Adequate organ function with laboratory tests meeting criteria (no blood transfusion or hematopoietic growth factor therapy within 14 days before testing): ANC ≥ 1.5 × 10\\^9\u002FL PLT ≥ 100 × 10\\^9\u002FL Hb ≥ 90 g\u002FL TBIL ≤ 1.5 × ULN ALT, AST ≤ 2.5 × ULN; for participants with liver metastasis, ALT and AST ≤ 5 × ULN Creatinine clearance rate (Ccr) \\> 35 mL\u002Fmin (calculated according to Cockcroft-Gault formula) Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; International normalized ratio (INR) ≤ 1.5 × ULN Left ventricular ejection fraction (LVEF) ≥ 55% (only applicable to Cohort 2)\n* 9\\. Eligible individuals with reproductive potential must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partners during the trial and for at least 7 months after the last dose; Women of childbearing potential must have a negative blood pregnancy test within 7 days before enrollment;\n* 10\\. Fully understand this clinical trial and voluntarily sign the written informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Prior treatment with HER3-targeted ADC therapy;\n* 2\\. Applicable to Cohort 1: a. Prior treatment with any topoisomerase I inhibitor-loaded ADC therapy; b. Current presence or impending visceral crisis that has caused or may cause impending organ damage and\u002For other life-threatening complications;\n* 3\\. Applicable to Cohort 2: a. Prior exposure to anthracyclines with cumulative dose exceeding 360 mg\u002Fm\\^2doxorubicin equivalent; b. LVEF once dropped to \\\u003C 40% during prior anti-HER2 drug therapy, or symptomatic CHF occurred;\n* 4\\. History of other malignancies within 3 years before randomization\u002Ffirst dose or concurrent active malignancies (except cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., which are allowed to enroll);\n* 5\\. Untreated (including those detected during screening period) or unstable brain parenchymal metastasis, spinal cord metastasis or compression, carcinomatous meningitis. Subjects with treated stable brain metastases may be considered for enrollment (Note: refers to participants who have received local brain treatment, whose symptoms are stable, imaging tests show stability for at least 28 days before randomization\u002Ffirst dose, no evidence of progressive brain edema, and no need for glucocorticoids or other symptom control measures);\n* 6\\. Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE 6.0 grade ≤ 1 (except for toxicities such as alopecia that researchers judge to have no safety risk);\n* 7\\. Major surgery within 28 days before randomization\u002Ffirst dose, or planned to undergo systemic or local tumor resection during the study period;\n* 8\\. History of severe bleeding risk (e.g., gastrointestinal varices) or bleeding diathesis, any gastrointestinal bleeding or other bleeding of ≥ CTCAE grade 2 within 28 days before randomization\u002Ffirst dose; Abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 months before randomization\u002Ffirst dose;\n* 9\\. History of severe cardiovascular disease, including but not limited to:\n\n  1. Acute coronary syndrome within 6 months before randomization\u002Ffirst dose;\n  2. Stroke or transient ischemic attack within 6 months before randomization\u002Ffirst dose;\n  3. Pulmonary embolism or deep vein thrombosis within 3 months before randomization\u002Ffirst dose (intermuscular vein thrombosis may be enrolled if assessed as low risk by researchers);\n  4. CHF with NYHA functional classification ≥ II;\n  5. Documented history of cardiomyopathy that has not currently recovered;\n  6. Pericarditis;\n  7. Severe arrhythmia, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular block, etc.;\n  8. Baseline average QTcF \\> 450 ms (calculated using Fridericia formula), or history or family history of long QT syndrome;\n  9. Uncontrolled hypertension (defined as persistent systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg despite antihypertensive medication);\n* 10\\. Presence of non-infectious lung disease\u002Fpneumonia requiring treatment at randomization\u002Ffirst dose, or history of interstitial lung disease\u002Fpneumonia requiring glucocorticoid treatment during prior anti-tumor therapy;\n* 11\\. Active bacterial, fungal or viral infection within 14 days before randomization\u002Ffirst dose (defined as requiring intravenous anti-bacterial, anti-fungal or anti-viral drug therapy). Individuals receiving prophylactic anti-infective therapy without clinical manifestations of active infection may be considered for enrollment;\n* 12\\. Active hepatitis B or hepatitis C, defined as HBsAg positive and HBV DNA \\> 2000 IU\u002FmL for active hepatitis B; defined as HCV-Ab positive and HCV RNA \\> ULN for active hepatitis C;\n* 13\\. History of immunodeficiency or positive HIV antibody test during screening;\n* 14\\. Use of strong CYP3A4 inducers or inhibitors, OATP1B1 or OATP1B3 inhibitors before randomization\u002Ffirst dose (within 5 half-lives of inducer or inhibitor) or need to use such drugs during study treatment;\n* 15\\. Known or suspected hypersensitivity to the study drug or its components;\n* 16\\. Lactating women;\n* 17\\. Presence of other conditions that may interfere with participants' participation in study procedures, not in line with participants' maximum benefit from participating in the study, or affect study results: such as history of mental illness, drug abuse or substance abuse, any other clinically significant disease or condition, etc.",{"count":358,"type":21},36,[59],"This is an open-label, multicenter Phase II clinical study conducted in subjects with advanced breast cancer.",[28],"2026-06-15",{"date":364,"type":38},"2026-06-16",{"date":366,"type":38},"2026-05-25",{"date":368,"type":21},"2029-05-30",{"name":370,"class":78},"CSPC Megalith Biopharmaceutical Co.,Ltd.",{"id":372,"slug":4,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":60,"conditions":375,"keywords":376,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":377,"startDateStruct":378,"completionDateStruct":379,"leadSponsor":380,"locationsCount":79},"100625804",{"count":57,"type":21},[59],[28],[63,64,65,66,67,68,69,70],{"date":364,"type":38},{"date":73,"type":38},{"date":75,"type":21},{"name":77,"class":78},{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":403},"100591599","phase-3-phase-3-study-of-rly-2608--fulvestrant-vs-capivasertib--fulvestrant-as-treatment-for-locally-advanced-or-metastatic-pik3ca-mutant-hrher2--breast-cancer-100591599","NCT06982521","Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+\u002FHER2- Breast Cancer","A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+\u002FHER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment With a CDK4\u002F6 Inhibitor","ReDiscover-2","Inclusion Criteria:\n\n* Patient has ECOG performance status of 0-1\n* One or more known primary oncogenic PIK3CA mutation(s)\n* Adult females, pre- and\u002For post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with a gonadotropin-releasing hormone (GnRH) agonist. Patients are to have commenced treatment with a GnRH agonist at least 4 weeks prior to randomization and must be willing to continue on it for the duration of the study.\n* Histologically or cytologically confirmed diagnosis of HR+\u002FHER2- locally advanced or metastatic breast cancer (ABC) with radiological or objective evidence of recurrence or progression; locally advanced disease must not be amenable to resection with curative intent\n* Measurable disease per RECIST v1.1 or evaluable bone-only disease.\n* Must have radiological evidence of progression on or after previous treatment for HR+\u002FHER2- ABC with:\n\n  1. At least 1 and no more than 2 lines of endocrine therapy (ET) in the (neo)adjuvant setting with recurrence on or within 12 months of completion or in the ABC setting\n  2. 1 prior line of CDK4\u002F6 inhibitor therapy in one of the following settings:\n\n     1. CDK4\u002F6 inhibitor + ET in the ABC setting\n     2. CDK4\u002F6 inhibitor therapy in the adjuvant setting if progression occurred during or within 12 months of completion of adjuvant CDK4\u002F6 inhibitor with ET\n     3. Patients who progressed during or within 12 months of completion of adjuvant CDK4\u002F6 inhibitor and after receiving CDK4\u002F6 inhibitor therapy in the advanced setting are considered to have had \\>1 prior line of CDK4\u002F6 inhibitor and are not eligible\n\nExclusion Criteria:\n\n* Prior treatment with any of the following:\n\n  1. CDK2 or selective CDK4 inhibitors or any investigational therapies targeting cyclin dependent kinases\n  2. PIK3, AKT, or mTOR inhibitors or any agent whose mechanism of action is the inhibit the PIK3\u002FAKT\u002FmTOR pathway\n  3. Immunotherapy\n  4. Antibody drug conjugates\n* Type 1 diabetes, or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥ 140 mg\u002FdL, or glycosylated hemoglobin (HbA1c) ≥7.0% (≥ 53 mmol\u002Fmol).\n* Clinically significant, uncontrolled cardiovascular disease\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events\n* Known active uncontrolled or symptomatic CNS metastases associated with progressive neurological symptoms or requiring ongoing corticosteroids or anticonvulsants for symptomatic control\n* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\n* History of hypersensitivity to fulvestrant or drugs in a similar class as fulvestrant, RLY-2608, or capivasertib, including their excipients\n* Known activating AKT mutations, loss-of-function PTEN mutations, or loss of PTEN expression resulting in oncogenic pathway activation downstream of PI3K",{"count":390,"type":21},540,[208],"This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+\u002FHER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4\u002F6 inhibitor.",[158,159,161,155,315,28],"2026-06-10",{"date":396,"type":38},"2026-06-11",{"date":398,"type":38},"2025-08-26",{"date":400,"type":21},"2031-12-31",{"name":402,"class":78},"Relay Therapeutics, Inc.",192,{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":22,"phases":413,"briefSummary":414,"conditions":415,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":420,"leadSponsor":422,"locationsCount":46},"100636037","phase-2-exploratory-study-of-shr-a1811-via-different-administration-routes-in-patients-100636037","NCT07560475","Exploratory Study of SHR-A1811 Via Different Administration Routes in Patients","Exploratory Study of Efficacy and Safety of Different Administration Routes of SHR-A1811 in Patients With HER2-Positive Advanced Breast Cancer","Inclusion Criteria:\n\n1. Aged ≥ 18 years old.\n2. Pathologically confirmed HER2-positive advanced breast cancer. HER2 positivity is defined as IHC 3+ in \\>10% immunoreactive cells or HER2 gene amplification confirmed by in situ hybridization (ISH), which shall be verified by the pathology department of the participating center.\n3. Patients with advanced breast cancer who have received no more than 2 lines of prior systemic therapies.\n4. Expected survival time ≥ 4 months.\n5. Have at least one measurable lesion per RECIST 1.1 criteria (helical CT scan lesion diameter ≥ 10 mm with slice thickness ≤ 5 mm).\n6. Adequate major organ function without blood transfusion.\n7. Voluntarily participate in the study, sign informed consent form, with good compliance and willingness to complete follow-up visits.\n\nExclusion Criteria:\n\n1. Prior treatment with anti-HER2 antibody-drug conjugates (ADC).\n2. Known leptomeningeal metastasis or active brain metastasis.\n3. A history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ, cutaneous basal cell carcinoma and squamous cell carcinoma. Malignancies cured solely by surgery more than 5 years prior to enrollment are allowed.\n4. Major surgery or severe trauma within 4 weeks before enrollment, or planned major surgery during the study period.\n5. Participation in other investigational new drug clinical trials within 4 weeks prior to enrollment.\n6. Presence of hereditary bleeding tendency or coagulation disorders.\n7. Uncontrolled hypertension with systolic blood pressure \\>140 mmHg or diastolic blood pressure \\>90 mmHg despite standard antihypertensive therapy.\n8. A history of clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, active pneumonia, pulmonary fibrosis and radiation pneumonitis (excluding asymptomatic post-radiation changes without treatment requirement).\n9. A history of severe cardiac diseases or uncontrolled cardiac conditions, including NYHA class II or higher cardiac insufficiency, unstable angina, myocardial infarction within one year, and arrhythmias requiring clinical intervention.\n10. Conditions affecting drug intake and absorption, such as dysphagia, chronic diarrhea and intestinal obstruction.\n11. Known allergy to any component of the study drugs.\n12. Uncontrolled pleural effusion or ascites that cannot be relieved by drainage or other clinical interventions.\n13. Severe uncontrolled comorbidities, including immune deficiency disorders (e.g. HIV positivity, history of organ transplantation), active hepatitis B or hepatitis C, and severe ongoing infections requiring systemic anti-infective treatment.\n14. Any other conditions considered inappropriate for study enrollment by the investigator.",{"count":412,"type":21},60,[59],"An Exploratory Study on the Efficacy and Safety of Different Administration Routes of SHR-A1811 in the Treatment of HER2-Positive Advanced Breast Cancer",[416,28,27],"HER2positive","2026-06-09",{"date":396,"type":38},{"date":394,"type":21},{"date":421,"type":21},"2029-12-31",{"name":423,"class":45},"Tianjin Medical University Cancer Institute and Hospital",{"id":425,"slug":426,"hasResults":12,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":436,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":447},"100565140","phase-1-a-first-in-human-study-of-men2312-in-adults-with-advanced-breast-cancer-100565140","NCT06638307","A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer","A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer","Key Inclusion Criteria:\n\n* Participant has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.\n* Presence of genetic alterations in PIK3CA\u002FAKT1\u002FPTEN in participants' tumor tissue.\n* Participant must have received at least 1 prior line of endocrine therapy for advanced\u002Fmetastatic disease or participant who has radiological evidence of breast cancer recurrence or progression during or within 12 months from the end of adjuvant treatment with endocrine therapy, as these participants are considered as first-line relapsed participants.\n* Progression on previous cyclin-dependent kinase 4 and 6 inhibitor treatment in combination with fulvestrant or aromatase inhibitor is required.\n\nKey Exclusion Criteria:\n\n* Active or newly diagnosed central nervous system metastases.\n* Participants with advanced, symptomatic visceral spread, who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement \\>50%.\n* Participants with any toxicities related to prior radiation therapy that have not resolved to baseline or to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 Grade ≤1, except alopecia and peripheral sensory neuropathy (Grade ≤2).\n\nNote: Other inclusion\u002Fexclusion criteria may apply.",{"count":432,"type":21},240,[90],"This is a first-in-human study of MEN2312, a lysine acetyltransferase 6 (KAT6) inhibitor, in adult participants with advanced breast cancer.",[28],[437,438,28,439],"First-In-Human","MEN2312","KAT6",{"date":396,"type":38},{"date":442,"type":38},"2024-10-25",{"date":444,"type":21},"2026-10",{"name":446,"class":78},"Stemline Therapeutics, Inc.",42,{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":454,"targetDuration":456,"studyType":182,"phases":4,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":46},"100575790","a-prospective-multicenter-observational-cohort-study-assessing-the-efficacy-and-safety-of-radiotherapy-sensitized-immunotherapy-in-advanced-breast-cancer-100575790","NCT06776861","A Prospective, Multicenter, Observational Cohort Study Assessing the Efficacy and Safety of Radiotherapy-sensitized Immunotherapy in Advanced Breast Cancer","Inclusion Criteria:\n\nSubjects are eligible for inclusion in the study only if all the following criteria apply:\n\n1. Men or women who are 18 years of age or older on the day of signing the informed consent;\n2. Patients with advanced breast cancer that is inoperable or has metastasized, confirmed by histology or cytology;\n3. Patients who, after MDT discussion at the metastatic breast cancer stage, are considered suitable for radiotherapy and have completed radiotherapy;\n4. Patients who have previously received and continue to use immunotherapy, or are planned to receive immunotherapy, and are scheduled to receive a systemic treatment regimen including immunotherapy as chosen by the physician within 3 weeks after completing radiotherapy;\n5. Patients with a traceable medical history during treatment;\n6. Subjects who are able to sign an informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Subjects with brain metastases or leptomeningeal metastases; if there are any suspected symptoms or signs of CNS involvement, they should be excluded by a cranial MRI scan;\n2. Have not signed the informed consent form;\n3. Pregnant or lactating women;\n4. Other conditions deemed unsuitable for inclusion in the study by the investigator.",{"count":455,"type":21},150,"2 Years","A prospective, multicenter, observational cohort study assessing the efficacy and safety of radiotherapy-sensitized immunotherapy in advanced breast cancer.",[28],"2026-06-06",{"date":417,"type":38},{"date":462,"type":38},"2024-09-24",{"date":464,"type":21},"2028-09-10",{"name":466,"class":45},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":55,"minAge":18,"maxAge":474,"enrollmentInfo":475,"targetDuration":4,"studyType":22,"phases":477,"briefSummary":478,"conditions":479,"keywords":480,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":490,"leadSponsor":492,"locationsCount":494},"100616808","phase-1-a-trial-to-evaluate-ovarian-suppression-following-subcutaneous-zoladex-108-mg-in-premenopausal-women-with-hr-her2--advanced-breast-cancer-100616808","NCT07310420","A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer","Phase 1 Single-arm, Open-label, Multicenter Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced Breast Cancer","Inclusion Criteria:\n\n1. Age and gender:\n\n   1. Gonadotropin-releasing Hormone (GnRH) treatment-naïve: Female participants aged 18 to 55 years, inclusive.\n   2. GnRH treatment-exposed \\\u003C6 months: Female participants aged 18 to 55 years, inclusive, if GnRH treatment started within \\\u003C6 months of signing the informed consent.\n2. Advanced or metastatic breast cancer: Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent per investigator's assessment.\n3. HR+: Either estrogen receptor positive (ER+) or progesterone receptor positive (PR+) breast cancer, defined as 1% to 100% of tumor nuclei are positive for ER or PR via immunohistochemistry.\n4. HER2-: Via American Society of Clinical Oncology, College of American Pathology (ASCO-CAP) guidelines.\n5. Prior treatment:\n\n   1. Participants may have received prior radiotherapy.\n   2. Participants may have received or be receiving a cyclin-dependent kinase (CDK) 4\u002F6 inhibitor, a phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha-protein kinase B (PIK3CA-AKT) inhibitor, or bisphosphonates if initiated and at a stable dose for at least 2 weeks before trial enrollment.\n   3. GnRH treatment-naïve participants will have no history of GnRH agonist or other endocrine therapy in the advanced\u002Fmetastatic setting.\n   4. GnRH treatment-exposed participants may have received a GnRH agonist or other endocrine therapy provided they had established premenopausal status prior to initiating GnRH agonist therapy, within 6 months prior to trial enrollment.\n6. Chemotherapy History:\n\n   a. A participant may have received adjuvant or neoadjuvant chemotherapy in early-stage breast cancer.\n\n   i. Any participant who received prior adjuvant or neoadjuvant chemotherapy are eligible provided the criteria for premenopausal status.\n\n   b. All chemotherapy-related toxicities must have recovered to Common Terminology Criteria for Adverse Events (CTCAE) v6.0 ≤Grade 1 before trial participation, except for alopecia, peripheral neuropathy, or paresthesia (≤Grade 2).\n7. Concurrent Medications:\n\n   1. Cyclin-dependent kinase 4\u002F6 (CDK4\u002F6) inhibitors are permitted if initiated and tolerated without ongoing toxicity CTCAE v6.0 \\>Grade 1 for at least 2 weeks before trial enrollment.\n   2. PIK3CA\u002FAKT inhibitors are permitted if started at least 2 weeks before the trial and tolerated without ongoing toxicity CTCAE v6.0 \\>Grade 1.\n   3. Concomitant use of bisphosphonates is permitted if initiated and tolerated without ongoing toxicity CTCAE v6.0 \\>Grade 1 for at least 2 weeks before trial enrollment.\n   4. Concomitant use of endocrine therapy (eg, aromatase inhibitor, fulvestrant, or other FDA-approved selective estrogen receptor degraders \\[SERDs\\]) is permitted.\n8. Informed consent: Able to understand and willing to provide informed consent and able to comply with the trial procedures and restrictions.\n9. Contraceptive use: Female participants may be enrolled if they are:\n\n   1. Practicing true abstinence for at least 28 days prior to investigational product (IP) administration until 30 days after the last IP administration and having a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1, OR\n   2. Using 2 forms of highly effective nonhormonal contraception, including 1 physical barrier (condom or diaphragm) plus another nonhormonal method (eg, intrauterine device, spermicidals) from Screening or at least 2 weeks prior to IP administration (whichever is earlier) until 30 days after the last IP administration and having a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1.\n10. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n\nExclusion Criteria:\n\n1. Postmenopausal: Naturally or surgically postmenopausal (regardless of age).\n2. Body mass index (BMI): \\\u003C18 kg\u002Fm\\^2 or \\>35.0 kg\u002Fm\\^2.\n3. Prior surgical or radiation procedures: History of bilateral oophorectomy or prior radiotherapy to the ovaries.\n4. Recent radiotherapy:\n\n   1. Radiotherapy for breast cancer within 4 weeks prior to trial enrollment.\n   2. All radiotherapy-related toxicities (except alopecia) must have recovered to CTCAE v6.0 ≤Grade 1 before trial enrollment.\n5. Radiotherapy during trial: Planned radiotherapy during trial period.\n6. Selective estrogen receptor modulator (SERM) use during trial: Participants may not receive tamoxifen or other SERMs during the trial and must discontinue any SERMs prior to enrollment, other endocrine therapies (eg, aromatase inhibitor, fulvestrant, or other FDA-approved SERDs) are allowed.\n7. Hypersensitivity: Known hypersensitivity, idiosyncratic, or allergic reactions to goserelin, GnRH, GnRH agonists\u002Fanalogs, or any trial drug components.\n8. Expected survival: Estimated life expectancy \\\u003C6 months from the start of trial therapy, based on the principal investigator's (PI) clinical judgment.\n9. Performance status: ECOG performance status ≥3.\n10. Life-threatening disease or metastasis: Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, symptomatic pulmonary lymphangitic spread, symptomatic pleural disease, or any symptomatic brain\u002Fleptomeningeal metastases (proven or suspected). Participants with asymptomatic or stable\u002Ftreated brain metastases are eligible to enroll if neurologically stable and are receiving a stable or decreasing corticosteroid dose at the time of enrollment. Participants with discrete pulmonary parenchymal metastases are eligible if respiratory function is not compromised.\n11. Hepatic function:\n\n    1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2×upper limit of normal (ULN) if no liver metastases, or \\>5×ULN with liver metastases.\n    2. Total bilirubin ≥1.5×ULN (≥2.5×ULN for Gilbert's syndrome).\n12. Renal function: Creatinine clearance (CrCl) ≤30 mL\u002Fmin as calculated by the Cockcroft-Gault formula.\n13. Hematologic parameters:\n\n    1. Hemoglobin (Hgb) \\\u003C8.0 g\u002FdL.\n    2. White blood cell (WBC) count \\\u003C3000\u002Fmm\\^3.\n    3. Platelets \\\u003C100,000\u002Fmm\\^3.\n14. Other malignancies: Active malignancy within the past 3 years, except for adequately treated basal or squamous cell skin cancer or in situ cervical carcinoma.\n15. Concurrent medical conditions: Presence of any severe, uncontrolled, or serious illness, medical condition (including psychiatric\u002Faddictive disorders), or clinical finding that could compromise trial adherence, as assessed by the investigator.\n16. Investigational drug exposure: Exposure to any investigational drug or device within 30 days prior to trial enrollment.\n17. Pregnancy: Participant has childbearing potential with a positive serum pregnancy test or positive urine pregnancy test at Screening or Day 1.\n18. Breastfeeding: Participant is currently breastfeeding.\n19. Contraceptive use: Sexually active with a male partner and not willing to use nonhormonal contraceptive methods throughout the trial. Exceptions: male partner is vasectomized (provided he is her sole sexual partner, and he has received medical assessment of the surgical success), participant has had bilateral salpingectomy or tubal occlusion hysterectomy.\n20. Cardiac conditions:\n\n    1. Corrected QT interval (QTc) using Fridericia's correction (QTcF) \\>450 ms at Screening.\n    2. Uncontrolled or symptomatic heart disease, including:\n\n    i. New York Heart Association (NYHA) Class III or IV heart failure.\n\n    ii. Myocardial infarction within the past 6 months.\n\n    iii. Unstable angina or significant arrhythmias requiring intervention.\n\n    c. Documented congenital QT syndrome.\n21. Clinically relevant abnormal medical history or abnormal findings on physical examination, vital signs, echocardiogram (ECG), or laboratory tests at Screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant.\n22. History of multiple and\u002For severe allergies to drugs or foods or a history of severe anaphylactic reaction.\n23. History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within the last 1 year prior to IP administration.\n24. Major surgery within 30 days prior to IP dosing or a major surgical procedure planned during the trial.\n25. Any other condition that precludes adequate understanding, cooperation, and compliance with trial procedures or any condition that could pose a risk to the participant's safety, as per the investigator's judgment.","55 Years",{"count":476,"type":21},88,[90],"The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH).",[28],[481,482,483,484,155,485],"Ovarian Suppression","ZOLADEX","HR+","HER2-","Goserelin Implant","2026-06-02",{"date":488,"type":38},"2026-06-03",{"date":163,"type":21},{"date":491,"type":21},"2027-03-30",{"name":493,"class":78},"TerSera Therapeutics LLC",11,{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":55,"minAge":18,"maxAge":502,"enrollmentInfo":503,"targetDuration":4,"studyType":22,"phases":504,"briefSummary":505,"conditions":506,"keywords":507,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":515,"leadSponsor":517,"locationsCount":46},"100637213","phase-2-efficacy-and-safety-of-trastuzumab-rezetecan-or-trastuzumab-deruxtecan-in-advanced-breast-cancer-100637213","NCT07630103","Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer","A Comparison of the Efficacy and Safety of Trastuzumab Rezetecan(SHR-A1811) Versus Trastuzumab Deruxtecan(DS-8201) in Patients With HER2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab","Inclusion Criteria:\n\n* Female patients aged ≥18 and ≤75 years.\n* Histologically or cytologically confirmed HER2-positive (IHC 3+ and\u002For ISH positive) unresectable or metastatic breast cancer.\n* Prior treatment with trastuzumab and a taxane in the recurrent or metastatic setting. Or recurrence during or within 12 months (disease-free interval, DFI) after completing neoadjuvant\u002Fadjuvant chemotherapy and\u002For anti-HER2 targeted therapy.\n* Documented radiological disease progression (during or after the most recent prior therapy).\n* ECOG Performance Status of 0 or 1.\n* At least one measurable lesion according to RECIST v1.1 criteria.\n* Adequate organ function meeting the following criteria (without the use of any blood components, cytokines, or growth factors for correction within 14 days prior to the first dose):\n\nAbsolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL; Platelet count (PLT) ≥100 × 10⁹\u002FL; Hemoglobin (Hb) ≥90 g\u002FL (9.0 g\u002FdL); Albumin ≥3.0 g\u002FdL;Total bilirubin ≤1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (≤5.0 × ULN for patients with liver metastases); Serum creatinine ≤1.5 × ULN OR creatinine clearance ≥60 mL\u002Fmin (calculated using the Cockcroft-Gault formula); QTcF interval ≤470 ms; Left ventricular ejection fraction (LVEF) ≥50% as measured by echocardiography (ECHO) or multigated acquisition scan (MUGA)\n\n* Female subjects of childbearing potential must have a negative pregnancy test at screening and must agree to use highly effective contraception methods from the signing of the informed consent form until 7 months after the last dose of the investigational product.\n* Willing and able to provide written informed consent, with good compliance, and willing to cooperate with follow-up visits and study-related procedures.\n\nExclusion Criteria:\n\n* Patients with known untreated spinal cord compression or active central nervous system (CNS) metastases, except for those who have been treated and have remained stable for at least 1 month and have discontinued corticosteroids for \\>2 weeks.\n* History of other malignancies within the past 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.\n* Uncontrolled third-space fluid accumulation (e.g., massive ascites, pleural effusion, pericardial effusion) that cannot be managed by drainage or other methods.\n* Having undergone major cancer-related surgery, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, biotherapy, or other clinical investigational therapy within 4 weeks prior to the first dose.\n* Prior treatment with an antibody-drug conjugate containing an exatecan derivative (a topoisomerase I inhibitor).\n* Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes (at doses \\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to the first dose, excluding topical, nasal spray, or inhaled corticosteroids.\n* Presence of any active autoimmune disease or a history of autoimmune disease that may potentially recur.\n* History of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n* Patients with known or suspected interstitial lung disease (ILD); or presence of other moderate-to-severe pulmonary diseases that may significantly impair respiratory function or interfere with the detection or management of drug-related pulmonary toxicity within 3 months prior to the first dose, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia\u002Fbronchiolitis obliterans, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), obstructive\u002Frestrictive lung disease, etc.; and any autoimmune, connective tissue, or inflammatory disorders involving the lungs, such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.; or history of pneumonectomy. Patients who experienced ≥Grade 3 ILD during prior treatment with immune checkpoint inhibitors are excluded.\n* Presence of active hepatitis B (HBsAg positive and HBV DNA ≥500 IU\u002FmL), hepatitis C (anti-HCV positive and HCV RNA above the upper limit of normal), or liver cirrhosis; or severe infections requiring systemic antibiotic, antiviral, or antifungal therapy.\n* Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1 (according to NCI-CTCAE v6.0).\n* Known hypersensitivity to any of the study drugs or their excipients.\n* Any other severe physical or mental illness or abnormal laboratory finding that, in the investigator's judgment, may increase the risk associated with study participation, interfere with the study results, or make the patient unsuitable for participation in this study.","75 Years",{"count":280,"type":21},[59],"This study is a prospective, open-label, multicenter, randomized, parallel Phase II clinical trial. This study aims to investigate the efficacy and safety of trastuzumab rezetecan or trastuzumab deruxtecan in HER2 positive advanced\u002Fmetastastic breast cancer",[28],[508,290,509,510],"ADC","T-DXd","SHR-A1811","2026-06-01",{"date":513,"type":38},"2026-06-05",{"date":166,"type":21},{"date":516,"type":21},"2031-12",{"name":518,"class":45},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":22,"phases":529,"briefSummary":530,"conditions":531,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":534,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":541},"100553499","phase-2-safety-and-efficacy-of-t-dxd-vs-cdk46i-based-et-as-first-line-therapy-of-hr-positive-and-her2-lowultralow-advanced-breast-cancer-patients-classified-as-non-luminal-subtype-100553499","NCT06486883","Safety and Efficacy of T-DXd vs. CDK4\u002F6i-based ET as First-line Therapy of HR-positive and HER2-low\u002FUltralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype","A Randomized Phase II Study to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan Versus CDK4\u002F6 Inhibitor-based Endocrine Therapy as First-line Therapy of HR-positive and HER2-low\u002FUltralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype According to Gene Expression Profiling.","PONTIAC","Inclusion Criteria:\n\n1. Patients must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.\n2. Female or male patients ≥ 18 years of age at the time of signing ICF.\n3. ECOG performance status of 0-1.\n4. Minimum life expectancy of ≥ 12 weeks at screening.\n5. Evidence of HER2-low expression (1+ by immunohistochemistry (IHC) or 2+ and negative by an in situ hybridization \\[ISH\\] test) or HER2-ultralow (IHC 0 with faint membrane staining and in ≤ 10% of tumor cells) breast cancer according to the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines determined by a MEDSIR's designated central laboratory, using Ventana 4B5 antibody. This assessment has to be done on the most recently available (archived or newly collected) formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (≤ 6 weeks or FFPE of a tumor sample obtained after last prior systemic therapy) from core or excisional biopsy from a locally recurrent (breast or locoregional lymph nodes) or metastatic tumor lesion, excluding bone metastases.\n6. Non-luminal breast cancer subtype as per central PAM50 analysis determined in the most recently available (archived or newly collected) FFPE tumor tissue blocks (≤ 6 weeks or FFPE of a tumor sample obtained after last prior systemic therapy) from core or excisional biopsy from a locally recurrent (breast or locoregional lymph nodes) or metastatic tumor lesion with the exception of bone metastases.\n7. Patients must have HR-positive (estrogen receptor \\[ER\\] and\u002For progesterone receptor \\[PgR\\]-positive defined as ≥ 1% positive stained cells) status according to the most recent ASCO\u002FCAP guidelines locally determined prior to study entry.\n8. Unresectable locally recurrent or metastatic breast cancer documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.\n9. Evaluable disease according to RECIST v.1.1. Patients with bone-only disease are not allowed. Patients with bone metastases with soft tissue masses measuring \\> 10 mm are eligible.\n10. Patients must have endocrine resistance criteria:\n\n    • disease progression during adjuvant ET or within the first year of completing adjuvant ET;\n\n    or endocrine sensitivity criteria:\n\n    • de novo metastatic disease or disease progression ≥ 12 months after completing adjuvant ET with at least one of the following requirements:\n    * Estrogen receptor ≤ 50% positive stained cells;\n    * and\u002For high histological grade or Ki67 \\> 50% on primary tumor;\n    * and\u002For liver metastases;\n    * and\u002For known non-luminal subtype as per local PAM50 analysis.\n11. No prior treatment with any systemic therapy for advanced disease.\n12. Patients treated with a CDK4\u002F6i in the adjuvant setting with a treatment-free interval (TFI) ≥ 12 months following CDK4\u002F6i treatment completion are eligible.\n13. Patients have adequate bone marrow, liver, and renal function:\n\n    * Hematological (without platelet, red blood cell transfusion, and\u002For granulocyte colony-stimulating factor support within 14 days before first study treatment dose): White blood cell (WBC) count \\> 3.0 x 109\u002FL, absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL, platelet count ≥ 100.0 x 109\u002FL, and hemoglobin ≥ 9.0 g\u002FdL (≥ 5.6mmol\u002FL).\n    * Hepatic: Serum albumin ≥ 2.5 g\u002FdL; total bilirubin ≤ 1.5 times upper limit of normal (x ULN) (≤ 3 x ULN in patients with liver metastases or know history of Gilbert's disease); alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver\u002For bone metastases); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN (≤ 5 x ULN in patients with liver metastases).\n    * Renal: Creatinine clearance ≥ 30 mL\u002Fmin as determined by Cockcroft Gault (using actual body weight).\n    * Coagulation: International normalized ratio or prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN.\n14. Resolution of all acute toxic effects of prior anti-cancer therapy to Grade ≤ 1 as determined by the US National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v.5.0) (except for alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).\n15. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 14 days before study treatment initiation. In addition, they must agree to use one highly effective method of birth control from the time of screening until 7 months after the last dose of T-DXd, or within the time period specified per local prescribing guidelines after the final dose of physician's choice of CDK4\u002F6i plus ET. Female patients must refrain from egg cell donation and breastfeeding during this same period.\n16. Male participants who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening until 4 months after the last dose of T-DXd, or within the time period specified per local prescribing guidelines after the final dose of physician's choice of CDK4\u002F6i plus ET. Male participants must not donate or bank sperm during this same period.\n17. Patients must be accessible for treatment and follow-up.\n\nExclusion Criteria:\n\n1. Current participation in another therapeutic clinical trial, except other translational studies.\n2. Treatment with approved or investigational cancer therapy within 3 weeks prior to initiation of study drug.\n3. Treatment with chloroquine\u002Fhydroxychloroquine within 14 days prior to initiation of study drug.\n4. Have previously been treated with T-DXd and\u002For fulvestrant. Note: patients who experienced relapse after more than 1 year from completion of fulvestrant are eligible.\n\n   Note I: previous treatment with anti-HER2 therapies in (neo-) adjuvant setting will be allowed for participants who showed conversion from HER2-positive expression in primary breast tumor sample to HER2-low or HER2-ultralow expression (HER2 loss) in relapsed tumor sample.\n5. Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions \\[pleural, pericardial, and\u002For peritoneal\\] and pulmonary lymphangitis).\n6. Impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the absorption of CDK4\u002F6i, such as history of GI surgery which may result in intestinal blind loops and patients with clinically significant gastroparesis, short bowel syndrome, unresolved nausea, vomiting, active inflammatory bowel disease, or diarrhea of CTCAE Grade \\> 1.\n7. Known central nervous system (CNS) involvement (brain metastases and\u002For leptomeningeal carcinomatosis). Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy.\n8. Have a concurrent malignancy or malignancy within 5 years of study enrollment with the exception of carcinoma in situ of the cervix and basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required.\n9. Known allergy or hypersensitivity reaction to any of the investigational medicinal products (IMPs) or their inactive ingredients.\n10. Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks prior to start of study treatment.\n11. Major surgical procedure or significant traumatic injury within 4 weeks before the first dose of study treatment or anticipation of need for major surgery within the course of the study treatment.\n12. Has an active cardiac disease or a history of cardiac dysfunction or conduction abnormalities including, but not confined, to any of the following:\n\n    * Participants with a medical history of myocardial infarction within 6 months before screening, symptomatic congestive heart failure (NYHA Class II to IV), unstable angina pectoris, or a recent (\\\u003C 6 months) cardiovascular event including stroke. Participants with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation to rule out myocardial infarction.\n    * Left ventricular ejection fraction (LVEF) \\\u003C 55% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO).\n    * History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, or ventricular tachycardia), which is symptomatic or requires treatment (NCI-CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers will be permitted to enroll.\n    * QT interval corrected by Fridericia's formula (QTcF) prolongation to \\> 470 ms (females) or \\> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG).\n    * History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes.\n    * Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.\n13. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of the study enrolment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, post COVID-19 pulmonary fibrosis, etc.), and any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy (complete).\n14. Has a history of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n15. Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol.\n16. Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test and a positive hepatitis B core antibody \\[HBcAb\\] test, accompanied by a negative HBV DNA test), and \\> 6 months off anti-viral treatment are eligible. Those participants should be closely monitored for HBV reactivation and have access to a local hepatitis B expert during and after the study.\n17. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n18. Patients with HCV co-infection or history of HCV co-infection.\n19. Patients with cirrhosis or fibrosis on prior imaging or biopsy.\n20. Has an active primary immunodeficiency or known human immunodeficiency virus (HIV) infection.\n21. Other active uncontrolled infection at the time of enrollment.\n22. Receipt of live or attenuated vaccine within 30 days prior to the first dose of study treatment.\n23. A history of uncontrolled seizures, CNS disorders, or serious and\u002For unstable pre-existing psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs or interfering with subject safety.\n24. Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers (for examples, see the Prohibited Medications Section).\n25. Known substance abuse or any other concurrent severe and\u002For uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation.\n26. Inability or unwillingness to comply with the requirements of the protocol in the opinion of the investigator.",{"count":528,"type":21},200,[59],"This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive\u002FHER2-negative and classified as non-luminal by gene expression profiling (PAM50). Patients will be treated with trastuzumab deruxtecan (T-DXd) or with physician's choice of CDK4\u002F6 inhibitor (CDK4\u002F6i) plus endocrine therapy (ET). The main purpose of the study is to analyze the efficacy of T-DXd in patients who have HR-positive and HER2-low\u002Fultralow advanced breast cancer classified as non-luminal subtype.",[28,532,533],"Advanced Breast Carcinoma","Hormone Receptor Positive Breast Carcinoma",{"date":486,"type":38},{"date":536,"type":38},"2025-06-30",{"date":538,"type":21},"2028-01",{"name":540,"class":45},"MedSIR",72,{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":22,"phases":550,"briefSummary":551,"conditions":552,"keywords":553,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":46},"100639632","phase-2-trastuzumab-deruxtecan-and-lovastatin-in-her2-low-and-ultralow-advanced-or-metastatic-breast-cancer-100639632","NCT07619365","Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer","Phase II Trial Evaluating Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer (MBC)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed HER2 low (IHC 1+ or 2+ with negative in-situ hybridization) or ultralow (IHC 0 with incomplete\u002Ffaint membrane staining in \\>0 but ≤10% of tumor cells) breast cancer. Patients may be advanced\u002Funresectable or metastatic.\n* Patients must have received no more than 1 prior line of chemotherapy (e.g. capecitabine). There is no limit on the prior number of endocrine-based therapies for patients with hormone-receptor positivity.\n* Measurable disease per RECIST 1.1.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.5 K\u002Fcumm\n  * Platelets ≥ 100 K\u002Fcumm\n  * Hemoglobin ≥ 9.0 g\u002FdL\n  * Total bilirubin ≤ 1.5 x IULN\n  * AST(SGOT)\u002FALT(SGPT) ≤ 3.0 x IULN\n  * Creatinine clearance \\> 30 mL\u002Fmin by Cockcroft-Gault\n* The effects of T-DXd and lovastatin on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 7 months after the last dose of either study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s\u002Fhe must inform her treating physician immediately.\n* Patients must have left ventricular ejection fraction (LVEF) of ≥50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before C1D-1.\n* Agreement to adhere to Lifestyle Considerations throughout study duration\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Prior treatment with T-DXd or other topoisomerase I ADC including sacituzumab govitecan, datopotamab deruxtecan, or investigational ADCs with topoisomerase I payloads.\n* Prior statin use within 7 days prior to C1D-1.\n* Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade ≤1 or baseline. Participants with chronic grade 2 toxicities may be eligible per the discretion of the Investigator after consultation with the Study PI or designee (e.g., grade 2 chemotherapy-induced neuropathy).\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial\n* Currently receiving any other investigational agents, or receipt of any investigational agents within 3 weeks or 5 half-lives, whichever is shorter, prior to C1D-1.\n* Receipt of chemotherapy, immunotherapy, endocrine therapy, or other systemic anticancer therapy within 3 weeks or 5 half-lives, whichever is shorter, prior to C1D-1.\n* Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression, and patients are not taking steroids to control edema or other symptoms.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to T-DXd, lovastatin, or other agents used in the study.\n* Patients with clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e. pulmonary emboli within three months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (i.e. Rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior pneumonectomy.\n* Patients with a history of non-infectious ILD\u002Fpneumonitis that required steroids or has current ILD\u002Fpneumonitis. Patients with a history of infectious ILD\u002Fpneumonitis should be discussed with the study PI.\n* Prior intolerance to statin therapy, defined as intolerable muscle symptoms or significant transaminitis elevation (\\>3x ULN) or CK elevation (\\>5x ULN) attributed to statin therapy within the last 2 years prior to C1D-1.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or clinically significant cardiac arrhythmia.\n* History or current significant cardiovascular disease, stroke, severe dyslipidemia, or vascular disorders that require continuous statin dosing. Uncertain cases should be discussed with the study PI for clarification of eligibility.\n* Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of C1D1.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.\n* Use of strong inhibitors of CYP3A4 within 5 half-lives of the medication prior to C1D-1.",{"count":412,"type":21},[59],"The purpose of this study is to evaluate use of lovastatin, a drug that may lower CAV-1 levels, in order to increase HER2 expression on cells and enhance the uptake and efficacy of trastuzumab deruxtecan (T-DXd) in HER2-low and ultralow advanced metastatic breast cancer. Trastuzumab deruxtecan (T-DXd) is an FDA approved antibody drug conjugate for HER2-low and ultralow breast cancer and lovastatin is a cholesterol lowering agent.",[155,28,315],[554,555,556],"Antibody drug conjugate","HER2 low","HER2 ultralow","2026-05-29",{"date":486,"type":38},{"date":560,"type":21},"2026-08-31",{"date":562,"type":21},"2031-08-31",{"name":564,"class":45},"Washington University School of Medicine",{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":22,"phases":574,"briefSummary":575,"conditions":576,"keywords":579,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":4},"100639670","phase-2-a-phase-ii-study-of-zongertinib-plus-fulvestrant-in-participants-with-hr-positiveher2-negative-advanced-breast-cancer-harboring-her2-mutations-100639670","NCT07619066","A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive\u002FHER2-negative Advanced Breast Cancer Harboring HER2 Mutations.","A Two-stage, Single-arm Phase II Study of Zongertinib Plus Fulvestrant in Participants With Hormone Receptor-positive\u002FHER2-negative Advanced Breast Cancer Harboring HER2 Mutations.","AGATHA","Inclusion Criteria:\n\n1. Participant, or legal representative (if applicable), must be capable to understand the purpose of the Study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.\n2. Female or male participants ≥ 18 years of age at the time of signing ICF.\n3. Pre- or perimenopausal women and men provided they are being treated with a LHRH analogue for at least 28 days (if shorter, post-menopausal levels of serum estradiol\u002Ffollicle-stimulating hormone \\[FSH\\] must be confirmed analytically) prior to initiation of the Study treatment, or post-menopausal women.\n4. Histologically- or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either unresectable locally advanced or metastatic disease confirmed by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.\n5. Documentation of HR-positive (estrogen receptor \\[ER\\] and\u002For progesterone receptor \\[PgR\\] expression in ≥1% of tumor cells) and HER2-negative (0-1+ by immunohistochemistry \\[IHC\\] or 2+ and negative by in situ hybridization \\[ISH\\] test) tumor according to the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines as per local assessment on the most recent analyzed biopsy.\n6. Known activating HER2 mutation.\n7. Measurable disease according to RECIST v.1.1.\n8. ECOG performance status of 0-1.\n9. Participants must have experienced disease progression after at least one line of endocrine therapy (including CDK4\u002F6 inhibitor). Participants who received CDK4\u002F6 inhibitor-based therapy in the adjuvant setting are also eligible provided that disease progression occurred after at least 12 months of treatment but within 12 months following completion of the CDK4\u002F6 inhibitor.\n10. Participants must not have received more than two prior chemotherapy regimens for advanced disease (an ADC is counted as one line of chemotherapy).\n11. No prior treatment with a HER2-directed tyrosine kinase inhibitor is permitted, but other HER2-targeted agents (such as T-DXd) and fulvestrant are allowed in any setting.\n12. Participants must have adequate bone marrow, liver, and renal function.\n13. Resolution of all acute toxic effects of prior anticancer therapy to grade ≤ 1 as determined by the US National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 (v.6.0) (except for alopecia or other toxicities not considered a safety risk for the participant at investigator's discretion).\n14. Willing to provide biological samples.\n15. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 7 days before Study treatment dose. In addition, they must agree to use one highly effective method of birth control from the time of screening until 2 years after the last dose of Study treatments. Female participants must refrain from egg cell donation and breastfeeding during this same period. Women who are nursing can be enrolled if they stop nursing. In this case, the patient cannot resume nursing until 30 days after the last dose of Study treatment.\n16. Male participants who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening until 2 years after the last dose of Study treatment. Male participants must not donate or bank sperm during this same period.\n17. Minimum life expectancy of ≥ 12 weeks at screening.\n\nExclusion Criteria:\n\n1. Participation in another clinical trial, interventional or observational, until the Study's safety visit. Note: Participation in retrospective studies or data analysis is allowed.\n2. Treatment with any approved or investigational cancer therapy within 21 days or 5 half-lives (whichever is shorter) prior to initiation of Study treatments, except for fulvestrant, which may be administered within a shorter interval.\n3. Participants who must or wish to continue the intake of restricted medication or any drug considered likely to interfere with the safe conduct of the trial.\n4. Known active uncontrolled or symptomatic central nervous system (CNS) metastases and\u002For leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and\u002For progressive growth.\n\n   Note: Participants with a history of CNS metastases are eligible if they have been previously treated with local therapy, are clinically stable, and off anticonvulsants and steroids for at least 14 days before the first dose of Study treatment.\n5. Have a concurrent malignancy or malignancy within 5 years of Study enrollment with the exception of carcinoma in situ of the cervix, non-melanoma skin carcinoma, or stage I endometrioid uterine cancer that have been previously treated with curative intent. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required.\n6. Known allergy or hypersensitivity reaction to any investigational medicinal products (IMPs) (zongertinib and fulvestrant) or their incorporated substances.\n7. History of malabsorption syndrome or any other condition that would interfere with enteral absorption in the opinion of the investigator (e.g., ongoing gastrointestinal obstruction\u002Fmotility disorder, malabsorption syndrome, nausea, vomiting, Crohn's disease, ulcerative colitis, chronic diarrhea, prior gastric bypass) or results in the inability or unwillingness to swallow pills.\n8. Radiotherapy within 2 weeks prior to the first dose of Study treatments, except palliative radiotherapy to regions other than the chest, which is allowed up to 1 week before the first dose of Study treatments.\n9. Major surgical procedure or significant traumatic injury within 14 days before the first dose of Study treatments or anticipation of need for major surgery within the course of the Study treatment.\n10. Clinically relevant cardiovascular\u002Fcerebrovascular disease and\u002For cardiac dysfunction or conduction abnormalities.\n11. Active or known pre-existing history of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, or suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n12. Coagulopathy or any history of coagulopathy within 6 months before Study enrollment, including history of deep vein thrombosis or pulmonary embolism. However, participants with the following conditions will be allowed to participate:\n\n    * Adequately treated catheter-related venous thrombosis occurring more than 28 days prior to Study entry.\n    * Treatment with an anticoagulant (e.g., warfarin or heparin) for a thrombotic event occurring more than 6 months before randomization, or for an otherwise stable and allowed medical condition (e.g., well controlled atrial fibrillation), provided dose and coagulation parameters (as defined by local standard of care) are stable for at least 28 days prior to Study entry. Due to the intramuscular route of administration, fulvestrant should be used with caution in patients with anticoagulant treatment.\n13. Participants with chronic hepatitis B virus (HBV) infection with active disease who meet the criteria for anti HBV therapy (according to local\u002Finstitutional standard) and who have not been treated with suppressive antiviral therapy prior to initiation of Study treatments or patients with a history of hepatitis C virus (HCV) infection who meet one or both of the following criteria:\n\n    * Currently receiving curative antiviral treatment.\n    * HCV viral load is above the limit of quantification (HCV RNA positive).\n14. Participants with history of human immunodeficiency virus (HIV) infection who meet one or more of the following criteria:\n\n    * CD4+ count \\\u003C 350 cells\u002FμL.\n    * Viral load \\> 400 copies\u002FμL (local lab assessment).\n    * Participants not receiving antiretroviral therapy, or who have received established antiretroviral therapy for less than 4 weeks prior to initiation of Study treatment.\n    * History of AIDS-defining opportunistic infections within 12 months prior to start of Study treatment.\n\n    Note: Participants with a history of HIV who do not meet any of the criteria above are eligible to participate but the patient must be under the care of a HIV\u002FInfectious Diseases specialist, or an HIV\u002FInfectious Diseases specialist must be consulted prior to inclusion.\n15. Other active uncontrolled infection at the time of enrollment.\n16. Participants with severe hepatic impairment (classified as Child-Pugh C or score 10-15).\n17. A history of uncontrolled seizures, CNS disorders, or serious and\u002For unstable pre-existing psychiatric disability judged by the Investigator to be clinically significant and adversely affecting compliance to Study treatment or interfering with participant's safety.\n18. Known substance abuse or any other concurrent severe and\u002For uncontrolled medical condition that would, in the investigator's judgment, contraindicate participant participation.\n19. Pregnant or lactating women or participants not willing to apply highly effective contraception as defined in the protocol.\n20. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the Study\n21. Inability or unwillingness to comply with the requirements of the protocol in the opinion of the investigator.",{"count":7,"type":21},[59],"An international, multicenter, two-stage optimal Simon's design, single-arm phase II clinical trial to evaluate zongertinib plus fulvestrant combination therapy in participants with hormone receptor-positive\u002FHER2-negative advanced breast cancer harboring HER2 mutations.",[28,577,578],"Hormone Receptor Positive \u002F HER2-negative Breast Cancer","HER2 Mutation",[580,31,581,582],"HER2 mutations","endocrine therapy","HER2","2026-05-27",{"date":511,"type":38},{"date":586,"type":21},"2026-10-04",{"date":588,"type":21},"2028-11-28",{"name":540,"class":45},{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":22,"phases":599,"briefSummary":600,"conditions":601,"keywords":607,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":617,"locationsCount":151},"100525326","phase-1-bgb-43395-alone-or-as-part-of-combination-therapies-in-participants-with-breast-cancer-and-other-advanced-solid-tumors-100525326","NCT06120283","BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors","A Phase 1a\u002F1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+\u002FHER2- Breast Cancer and Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and others. For combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced\u002Fmetastatic disease including prior endocrine therapy and CDK4\u002F6 inhibitor in either the adjuvant or advanced\u002Fmetastatic setting.\n* Phase 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have received at least 1 prior line of treatment including endocrine therapy and a CDK4\u002F6 inhibitor. For combination with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Phase 1b: Participants with HR+\u002FHER2- breast cancer.\n* Phase 1b: For combination with fulvestrant, participants with HR+\u002FHER2- breast cancer enrolled in regions where CDK4\u002F6 inhibitors are approved and available must have received 1-2 lines of therapy for advanced\u002Fmetastatic disease including endocrine therapy and a CDK4\u002F6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. Prior cytotoxic treatment is prohibited. For combination cohorts with letrozole, participants must be CDK4\u002F6 inhibitor treatment naïve and have not received any previous systemic treatment for advanced disease.\n* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.\n* Female participants with metastatic HR+\u002FHER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.\n* Adequate organ function without symptomatic visceral disease.\n\nExclusion Criteria:\n\n* Known leptomeningeal disease or uncontrolled, untreated brain metastases.\n* Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).\n* Uncontrolled diabetes.\n* Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.\n* Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU\u002FmL (or ≥ 2500 copies\u002FmL) at screening.\n* Participants with active hepatitis C infection.\n* Prior allogeneic stem cell transplantation, or organ transplantation.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":598,"type":21},399,[90],"This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.",[93,28,315,602,533,603,604,605,606],"Hormone-receptor-positive Breast Cancer","Hormone Receptor Positive Malignant Neoplasm of Breast","HER2-negative Breast Cancer","Hormone Receptor Positive HER-2 Negative Breast Cancer","Non-small Cell Lung Cancer",[232,608,290,609,240,605,610,611],"advanced solid tumor","hormone receptor positive breast cancer","BGB-43395","non-small cell lung cancer","2026-05-26",{"date":583,"type":38},{"date":615,"type":38},"2023-12-01",{"date":346,"type":21},{"name":618,"class":78},"BeOne Medicines",{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":22,"phases":627,"briefSummary":628,"conditions":629,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":630,"lastUpdatePostDateStruct":631,"startDateStruct":633,"completionDateStruct":635,"leadSponsor":637,"locationsCount":4},"100637333","phase-2-metronomic-oral-paclitaxel-monotherapy-and-combined-immunotherapy-for-advanced-her2-negative-breast-cancer-a-two-stage-dose-exploration-and-expansion-trial-100637333","NCT07602907","Metronomic Oral Paclitaxel Monotherapy and Combined Immunotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose Exploration and Expansion Trial","Inclusion Criteria:\n\n1.Age ≥ 18 years, male or female. 2.Histologically confirmed unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer, regardless of hormone receptor (HR) status. For patients with HR+\u002FHER2-negative subtype: prior treatment with at least 1 line of CDK4\u002F6 inhibitor plus endocrine therapy is required, and the patient is considered no longer suitable for further endocrine therapy by the investigator.\n\n3.Patients have received 1-4 prior lines of systemic anti-tumor therapy for recurrent or metastatic disease.\n\n1. Line of therapy is defined as a systemic treatment regimen for recurrent or metastatic disease. First-line therapy is the first regimen used in the recurrent\u002Fmetastatic setting; any subsequent regimen that adds a new drug class (e.g., anti-angiogenic, immunotherapy) is considered a new line.\n2. Neoadjuvant or adjuvant therapy is not counted as a treatment line.\n3. Disease recurrence \\>6 months after neoadjuvant therapy is counted as first-line; recurrence ≤6 months is considered continuation of prior therapy and not a new line.\n4. Disease recurrence \\>12 months after adjuvant therapy is counted as first-line; recurrence ≤12 months is considered continuation of prior therapy, and subsequent regimens start at second-line.\n\n4.Prior treatment with taxane is allowed if both criteria are met:\n\n1. Interval from last dose of taxane to first study dose ≥ 4 weeks;\n2. No unresolved taxane-related Grade ≥3 toxicity in the past. 5.Body surface area (BSA): 1.38 m² ≤ BSA ≤ 1.87 m². 6.ECOG performance status 0-1. 7.At least one measurable lesion per RECIST 1.1. 8.Expected survival ≥ 12 weeks. 9.Adequate bone marrow function: ANC ≥ 1.5 × 10⁹\u002FL Platelets ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL 10.Adequate hepatic function: Total bilirubin ≤ 1.5 × ULN ALT\u002FAST ≤ 2.5 × ULN (no liver metastasis) ALT\u002FAST ≤ 5 × ULN (with liver metastasis) 11.Adequate renal function: Serum creatinine ≤ 1.5 mg\u002FdL Or creatinine clearance (Ccr) ≥ 60 mL\u002Fmin (calculated by Cockcroft-Gault formula) if serum creatinine \\>1.5 mg\u002FdL.\n\n12.Pre-existing peripheral neuropathy \\\u003C Grade 2 (CTCAE v6.0). 13.Known CNS metastases are allowed only if all of the following are met:\n\n1. CNS lesions stable for ≥4 weeks before enrollment, per RANO-BM criteria (no new lesions, target lesion volume change \\\u003C20%, no clear progression of non-target lesions on baseline and follow-up MRI).\n2. No corticosteroid use, or current dexamethasone ≤4 mg\u002Fday (or equivalent), with no dose increase within 7 days before enrollment.\n3. For patients with prior local CNS treatment: no imaging progression after treatment completion; neurologic symptoms stable for ≥2 weeks before first study dose; no steroid or ≤4 mg\u002Fday dexamethasone (or equivalent).\n4. No leptomeningeal disease.\n5. Whole-brain radiotherapy completed \\>14 days before enrollment.\n6. Prior stereotactic radiosurgery is allowed.\n7. Prior CNS surgery completed \\>28 days before enrollment with full recovery. 14.Voluntary participation and signed written informed consent.\n\nExclusion Criteria:\n\n1. Patients with suspected major infectious diseases, neurological disorders, or intestinal obstruction.\n2. Patients with a diagnosis of other cancer types (except non-melanoma skin cancer, cervical carcinoma in situ, or other cancers with no recurrence or metastasis for ≥5 years and considered cured).\n3. Patients who have undergone major surgery, including organ resection within 4 weeks before enrollment, or radiotherapy within 2 weeks before enrollment.\n4. Disease progression during prior taxane salvage therapy (at least 2 cycles completed), or recurrence\u002Fmetastasis within 12 months after neoadjuvant\u002Fadjuvant therapy.\n5. Patients requiring long-term concomitant use of P-glycoprotein (P-gp) inhibitors or immunosuppressive agents during the study.\n6. Patients receiving long-term treatment with steroids or other immunosuppressive agents (except oral, topical, or local injection).\n7. Patients with myocardial infarction, congestive heart failure, rapidly changing arrhythmia on ECG, severe or unstable angina pectoris, or other serious heart diseases.\n8. Patients with other severe medical diseases (uncontrolled diabetes mellitus and hypertension, chronic obstructive pulmonary disease (COPD), or dyspnea at rest due to any cause).\n9. Patients with a history of drug or alcohol abuse within the past 3 months.\n10. Pregnant or breastfeeding women, or patients who cannot or will not use effective contraceptive methods.\n11. Patients with or suspected of having bile acid excretion disorders.\n12. Active tendency of gastrointestinal bleeding or use of oral vitamin K antagonists (low-dose warfarin and acetylsalicylic acid are allowed as long as INR ≤2.0).\n13. Patients with severe hypersensitivity to the active ingredients or excipients of the study drugs.\n14. History of HIV seropositivity (HIV testing is not mandatory).\n15. Gastrointestinal dysfunction or diseases that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, poorly controlled nausea, vomiting, diarrhea, malabsorption syndrome), except patients with prior gastrectomy.\n16. Patients receiving enteral feeding (e.g., via nasogastric tube, nasointestinal tube, gastrostomy, or jejunostomy).\n17. Patients with visceral crisis, or patients with excessive tumor burden, rapid disease progression who urgently require rapid tumor shrinkage (e.g., conventional maximum tolerated dose chemotherapy) to relieve severe clinical symptoms per investigator assessment.\n18. Patients considered inappropriate for the clinical trial by the investigator.",{"count":626,"type":21},44,[59],"The goal of this clinical trial is to learn if oral paclitaxel solution (metronomic scheduling) works to treat advanced HER2-negative breast cancer in adults. It will also learn about the safety of oral paclitaxel solution alone and combined with toripalimab.\n\nThe main questions it aims to answer are:\n\nWhat is the optimal tolerated dose (OTD) of metronomic oral paclitaxel solution? Does metronomic oral paclitaxel plus toripalimab improve progression-free survival (PFS)? What medical problems do participants have when taking the study treatments? Researchers will evaluate metronomic oral paclitaxel alone (dose-finding) and metronomic oral paclitaxel plus toripalimab (expansion cohort) to see if the regimens work to treat advanced HER2-negative breast cancer.\n\nParticipants will:\n\nReceive metronomic oral paclitaxel solution (one of two dose levels) once daily or three times weekly After OTD is determined, receive metronomic oral paclitaxel plus toripalimab every 3 weeks Visit the clinic regularly for safety checks, blood tests, and tumor imaging Keep records of treatment compliance and health-related quality of life",[28,604],"2026-05-21",{"date":632,"type":38},"2026-05-22",{"date":634,"type":21},"2026-05-30",{"date":636,"type":21},"2029-05-07",{"name":638,"class":45},"Zhejiang Cancer Hospital",{"id":640,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":641,"targetDuration":4,"studyType":22,"phases":642,"briefSummary":25,"conditions":643,"keywords":644,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":649,"leadSponsor":650,"locationsCount":4},"100639594",{"count":20,"type":21},[24],[27,28],[30,31,32,33],"2026-05-14",{"date":647,"type":38},"2026-05-20",{"date":511,"type":21},{"date":42,"type":21},{"name":44,"class":45},{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":4,"eligibilityCriteria":657,"healthyVolunteers":12,"sex":55,"minAge":18,"maxAge":4,"enrollmentInfo":658,"targetDuration":4,"studyType":22,"phases":659,"briefSummary":660,"conditions":661,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":46},"100503178","rc48-adc-in-her2-low-advanced-breast-cancer-100503178","NCT05831878","RC48-ADC in HER2-low Advanced Breast Cancer","Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer","Inclusion Criteria:\n\n* Female patients aged ≥18 years\n* Expected survival ≥12 weeks\n* ECOG 0-1\n* Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable\n* At least one measurable lesion according to the RECIST 1.1\n* No history of antibody-drug conjugate use\n* Up to one previous chemotherapy for advanced disease\n* Available hormone receptor status. Hormone receptor-positive subjects are allowed to receive no more than two previous endocrine therapy for advanced disease\n* HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test; or HER2-ultralow tumors, defined as incomplete and faint membrane staining in \\>0 but ≤10% of tumor cells\n* Adequate organ function\n\nExclusion Criteria:\n\n* History of thromboembolic events\n* Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc.\n* Active infections requiring systemic treatment\n* Pregnant or lactating\n* Presence of brain metastases and\u002For carcinomatous meningitis",{"count":358,"type":21},[282],"To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.",[28],"2026-05-10",{"date":664,"type":38},"2026-05-13",{"date":666,"type":38},"2023-05-04",{"date":668,"type":21},"2027-12",{"name":670,"class":45},"RenJi Hospital"]