[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2--breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2--breast-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,46,131,156,192,223,244,288,309,322,343,374,400,420,448,475,503,526,553],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"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":19,"type":20},500,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"HER2 + Breast Cancer","Advanced Breast Cancer",[29,30,31,32],"HER2-positive breast cancer","Advanced breast cancer","pyrotinib","Trastuzumab Rezetecan","RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":37},"2026-07-06",{"date":41,"type":20},"2031-12-30",{"name":43,"class":44},"Peking University People's Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":59,"conditions":60,"keywords":91,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":130},"100407463","phase-1-the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463","NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","12 Years",{"count":55,"type":20},300,[57,58],"PHASE1","PHASE2","The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Lung Cancer","Ovarian Cancer","Endometrial Cancer","Prostate Cancer","Colorectal Cancer","Breast Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt","2026-06-24",{"date":122,"type":37},"2026-06-26",{"date":124,"type":37},"2020-10-29",{"date":126,"type":20},"2027-12-31",{"name":128,"class":129},"PMV Pharmaceuticals, Inc","INDUSTRY",77,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":139,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":4},"100644318","circulating-tumor-dna-dynamics-to-optimize-neoadjuvant-therapy-in-her2-positive-and-triple-negative-breast-cancer-100644318","NCT07662252","Circulating Tumor DNA Dynamics to Optimize Neoadjuvant Therapy in HER2-Positive and Triple-Negative Breast Cancer","Evaluation of Circulating Tumor DNA Dynamics for Treatment Optimization in Stage II-III HER2-Positive and Triple-Negative Breast Cancer Candidate to NAT","NEOSHED","Inclusion Criteria:\n\n* Patients with documented stage II-III HER2+ or TNBC and fit candidates for NAT. 2. In TNBC group, confirmed negative ER, PR and HER2 disease by local testing on primary disease specimen: tumor must be negative ER, PR, and HER2 defined by immunohistochemistry (IHC) according to the American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines for hormone receptor testing (Allison et al., 2020; Wolff et al., 2023). 3. In HER2+ group, Confirmed HER2+ disease by local testing on primary disease specimen: tumour must be HER2+ according to ASCO\u002FCAP 2023 guidelines for HER2 testing (Wolff et al., 2023). 4. Patients with measurable disease; Patients with multifocal or multicentric breast cancer with at least one tumor lesion ≥1.0 cm in the longest diameter by ultrasound (reference lesion) are also eligible if the two largest tumor lesions have been histologically confirmed in the clinical evaluation and meet pathological criteria for TNBC and HER2+. 5. No previous treatment of the disease by chemotherapy, hormone therapy, surgery or radiotherapy. 6. Patients with breast cancer are eligible for surgery. 7. Eastern Cooperative Oncology Group (ECOG) performance status≤2.\n\nExclusion Criteria:\n\n* 1\\. Patients with bilateral invasive BC. 2. Patients with metastatic BC (local spread to axillary lymph nodes is permitted (cN1\\_cN2a).\n\n  3\\. Patients with inflammatory BC. 4. Patients with a known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including hepatitis. 5. Patients with a history of invasive BC, ductal carcinoma in situ or lobular carcinoma in situ, and other malignancy within 5 years prior to screening. 6. Patients with a documented history of haemorrhagic diathesis, coagulopathy, or thromboembolism. 7. Patients with known allergy or hypersensitivity to any of the study drugs or any of their excipients. 8. Patients with history of non-compliance to medical regimens. 9. Patients refusing to perform liquid and tissue biopsy. 10. Patients unwilling to or unable to comply with the protocol. 11. Patients having had major surgery within 14 days prior to screening. 12. Pregnant or lactating females prior to treatment. 13. Patients should be excluded if they have a known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).","FEMALE",{"count":141,"type":20},186,"OBSERVATIONAL","The purpose of this non-interventional, observational study is to evaluate the clinical utility of circulating tumor DNA (ctDNA) utility-specifically how quickly tumor DNA disappears from the bloodstream (ctDNA clearance)-to help monitor and predict treatment responses in patients with breast cancer.\n\nThe study focuses on patients diagnosed with Stage II to III HER2-positive or Triple-Negative Breast Cancer (TNBC) who are scheduled to receive standard neoadjuvant therapy (systemic treatment administered before surgery). Because these breast cancer subtypes involve different standard treatment regimens, the study prospectively stratifies patients into three distinct treatment cohorts (Cohorts A, B, and C) to match routine clinical practice and align blood sampling with meaningful clinical milestones.",[70,145,26],"Triple Negative Breast Cancer (TNBC)","NOT_YET_RECRUITING","2026-06-16",{"date":149,"type":37},"2026-06-23",{"date":151,"type":20},"2026-07",{"date":153,"type":20},"2029-06",{"name":155,"class":44},"Federico II University",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":21,"phases":166,"briefSummary":167,"conditions":168,"keywords":176,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":45},"100610025","phase-2-phii-randomized-capecitabine--elacestrant-vs-capecitabine-alone-in-er-breast-cancer-capela-100610025","NCT07222215","PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)","A Phase II Multi-Center Open-label Randomized Study of CAPecitabine in Combination With ELAcestrant Versus Capecitabine Alone in Advanced Estrogen Receptor-Positive Breast Cancer (CAPELA)","CAPELA","Inclusion Criteria:\n\n* Participants must have histologically confirmed estrogen receptor-positive (ER+), HER2-negative metastatic or locally recurrent unresectable (advanced) invasive breast cancer. ER and HER2 measurements should be performed according to institutional guidelines in a CLIA-approved setting. ER must be ≥ 10% on the most recent biopsy in which receptor testing was performed. Cutoff values for positive\u002Fnegative HER2 staining should be in accordance with current ASCO\u002FCAP (American Society of Clinical Oncology\u002FCollege of American Pathologists) guidelines.\n* Participants must have standard of care ctDNA sequencing testing documenting ESR1 and TP53 mutation status. In patients without ESR1 mutation, this result must be from within 3 months.\n\n  * ESR1 mutations that are considered pathogenic are: E380Q, V422del, S436P, L536H, L536P, L536R, Y537C, Y537D, Y537N, Y537S, D538G\n  * TP53 mutations that are considered pathogenic as determined by a CLIA certified laboratory\n* Women or men age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of capecitabine in combination with elacestrant participants \\\u003C18 years of age are excluded from this study\n* Women must be postmenopausal, which is defined as any of the following:\n\n  * Age ≥ 60 years\n  * Age \\\u003C 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range\n  * Premenopausal women who have been on a GnRH agonist for at least three consecutive months prior to study entry are eligible. Women in this group MUST remain on the GnRH agonist for the duration of protocol treatment.\n  * Status-post bilateral oophorectomy or total hysterectomy after adequate healing post-surgery\n* Must have measurable or evaluable disease by RECIST 1.1. Must have progressed on at least one line of endocrine therapy in the metastatic setting or recurred on or within one year of adjuvant endocrine therapy\n* Unrestricted number of prior endocrine therapies (with or without targeted treatment) are allowed in the advanced disease setting. If a patient recurred on or within one year of adjuvant endocrine therapy, it would be counted as one line of treatment.\n* Prior CDK4\u002F6 inhibition is required (in adjuvant or metastatic disease), unless a CDK4\u002F6 inhibitor is contraindicated (CDK4\u002F6 inhibitor in combination with endocrine treatment is considered as one line of endocrine treatment).\n* Participants must have remained on a prior endocrine treatment alone or in combination with a CDK4\u002F6 inhibitor in the metastatic setting without progression for at least 6 months prior to study entry. This regimen does not need to be the most recent regimen prior to study entry. If patients have progressed on adjuvant endocrine treatment and have not received treatment in the metastatic setting, they must have progressed after at least two years of adjuvant endocrine treatments.\n* Prior alpelisib with endocrine treatment is allowed (considered as a line of endocrine treatment).\n* Prior everolimus with endocrine treatment is allowed (considered a line of endocrine treatment).\n* Prior capivasertib with endocrine treatment is allowed (considered a line of endocrine treatment)\n* Prior fulvestrant is permitted. Prior SERM (tamoxifen, lasofoxifene) is permitted. Neither prior oral SERDs nor other next generation oral endocrine therapies (such as PROTACS) are permitted.\n* No prior chemotherapy regimen or ADC is allowed in the metastatic setting.\n* Participants may have received radiotherapy for palliative purposes but must not be experiencing grade \\>1 treatment-related toxicities at study entry and must have completed treatment \\> 14 days prior to registration.\n* ECOG PS 0-1\n* Adequate hematological, liver, and kidney function, as defined below:\n\n  * Absolute neutrophil count \\> 1,500\u002FµL\n  * Platelets \\> 100,000\u002FµL\n  * Hemoglobin \\> 9 g\u002FdL (transfusion is allowed to meet this criterion) Total bilirubin \\\u003C 1.5 x institutional upper limit or normal (ULN) or \\\u003C 3 institutional ULN in the presence of documented Gilbert's syndrome\n  * AST (SGOT)\u002FALT (SGPT) \\\u003C 2.5 x institutional ULN, or ≤ 5 institutional ULN for subjects with documented metastatic disease to the liver\n  * Creatinine clearance \\> 50 mL\u002Fmin\u002F1.73 m2\n* Women of childbearing age, women who are made postmenopausal through use of GNRH agonists, and men must agree to use adequate contraception for the duration of protocol treatment and for at least 6 months after the last dose of capecitabine.\n* Premenopausal women must have a negative serum or urine pregnancy test. Pregnancy testing does not need to be pursued in female participants who are:\n\n  * Age \\> 60 years; or\n  * Age \\\u003C 60 with intact uterus and amenorrhea for 12 consecutive months or more AND estrogen (estradiol) and FSH levels are within postmenopausal range; or\n  * Status-post bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation\n* Participants must be able to swallow and retain oral medication.\n* Ability to understand and the willingness to sign a written informed consent document.\n* HIV-infected participants must have well-controlled HIV on ART, defined as:\n\n  1. Participants on ART must have a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening.\n  2. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening.\n  3. It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n  4. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study. The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors\u002Finducers\u002Fsubstrates.\n\nNote: No HIV testing is required at screening unless mandated by local health Authority.\n\n* Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before allocation.\n\nNote: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.Hepatitis B screening tests are not required unless:\n\n* Known history of HBV infection\n* As mandated by local health authority Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Participants must have completed curative antiviral therapy at least 4 weeks before allocation.\n\nHepatitis C screening tests are not required unless:\n\n* Known history of HCV infection\n* As mandated by local health authority\n\nExclusion Criteria:\n\n* Participants who have had endocrine and\u002For biologic therapy \\\u003C 14 days prior to entering the study or those who have not recovered from any prior treatment-related toxicities (must recover to no more than grade 1; alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 toxicity not constituting a safety risk based on investigator's judgment are acceptable). This is to minimize risk of drug-drug interactions and clarify etiology of future toxicities.\n* Participants who are receiving concurrent therapy with other investigational agents. This is to minimize risk of drug-drug interactions and clarify etiology of future toxicities.\n* Rapidly progressive, symptomatic, visceral spread of disease placing participant at risk of life- threatening complications in the short term. It is likely that these patients will not benefit from this regimen.\n* History of dihydropyrimidine dehydrogenase (DPD) deficiency. Patients with this deficiency are prone to significant toxicity from capecitabine.\n* Participants with active brain metastases. Treated brain metastases that are asymptomatic and do not require systemic steroids for management of symptoms are allowed if they have received SRS (7-day washout) or WBRT (14-day washout) or asymptomatic untreated brain metastases measuring \\\u003C1cm. Patients with leptomeningeal disease are not eligible. It is unlikely that these patients will benefit from this regimen.\n* Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection requiring systemic therapy, clinically significant cardiovascular disease including: cerebral vascular accident\u002Fstroke (\\\u003C 6 months prior to enrollment), myocardial infarction (\\\u003C 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, uncontrolled diabetes mellitus, gastrointestinal disorders potentially affecting the absorption of elacestrant, inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or total gastric resection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements. Active hepatitis B or active hepatitis C infection. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation. This could increase risk of toxicity from treatment and potentially decrease adherence to study protocol.\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances:\n\n  * (1) Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. These cases should be discussed with the sponsor-investigator prior to enrollment.\n  * (2) Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast, cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin. History of prior malignancy puts patients at risk of recurrence from their prior malignancy or progression of a second malignancy which would complicate interpretation of the end points of this trial.\n* Ongoing treatment with drugs that are sensitive substrates of P-glycoprotein (dabigatran, digoxin, fexofenadine) or BRCP (rosuvastatin, sulfasalazine). These drugs have potential drug-drug interactions with the study agents.\n* Treatment with strong CYP3A inhibitors within 2 weeks before first study treatment administration or five elimination half-lives, whichever is longest and cannot be replaced.\n* Medical conditions requiring concomitant administration of medications with a narrow therapeutic window metabolized by CYP3A and for which a dose reduction cannot be considered. See Appendix D for a list of medications that are CYP3A substrates. These drugs have potential drug-drug interactions with the study agents.\n* Female participants lactating or nursing. The safety of these medications in pregnancy or breast feeding patients is unknown.\n\nBoth men and women of all races and ethnic groups are eligible for this trial.",{"count":165,"type":20},297,[58],"The goal of this research study is to compare a combination of two drugs, capecitabine and elacestrant to capecitabine alone as a treatment for advanced estrogen receptor-positive (ER+) breast cancer. This study is designed for participants with cancer that has previously stopped responding to medication in the class of therapy called CDK 4\u002F6 inhibitors, including palbociclib, ribociclib, or abemaciclb.\n\nThe names of the study drugs involved in this study are:\n\n* Elacestrant (a type of selective estrogen receptor degrader)\n* Capecitabine (a type of fluoropyrimidine antimetabolite)",[169,170,70,171,172,87,173,174,175],"Estrogen-receptor-positive Breast Cancer","Metastatic Breast Cancer","Hormone Receptor Positive Breast Cancer","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","ESR1 Gene Mutation","ER Wildtype","Breast Neoplasms",[177,170,178,179,180,87,181,182],"Advanced Estrogen Receptor-Positive Breast Cancer","Breast cancer","Hormone receptor positive breast cancer","Advanced Human Epidermal Growth Factor Receptor 2 negative breast cancer","ESR1 gene mutation","ER wildtype","2026-06-10",{"date":185,"type":37},"2026-06-12",{"date":187,"type":37},"2026-01-16",{"date":189,"type":20},"2030-10-01",{"name":191,"class":44},"Kristina A. Fanucci",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":202,"conditions":203,"keywords":207,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100609178","evaluating-minimal-residual-disease-mrd-through-longitudinal-circulating-tumor-dna-ctdna-profiling-in-breast-malignancies-100609178","NCT07211178","Evaluating Minimal Residual Disease (MRD) Through Longitudinal Circulating Tumor DNA (ctDNA) Profiling in Breast Malignancies","GEMINI Breast","Inclusion Criteria:\n\nAll Cohorts:\n\n1. Willing and able to participate in the research and provide biospecimens\n2. Willing and able to provide informed consent\n3. Must be diagnosed with breast cancer\n\nCohort 1: Neoadjuvant Treatment Cohort 1A: Newly Diagnosed, High Risk HR+,HER2-\n\n1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)\n2. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.\n\nCohort 1B: HER2+ 1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease). Inclusive of HR+ or HR- patients.\n\nCohort 1C: Triple Negative Breast Cancer\n\n1\\. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease).\n\nCohort 2: Adjuvant Therapy \u002F Surveillance Cohort 2A: Newly Diagnosed HR+,HER2-\n\n1. A known or suspected HR+, HER2- breast cancer treated with curative intent (Stage II to III disease)\n2. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.\n3. Have undergone curative intent surgery with no clinical evidence of disease.\n\nCohort 2B: HER2+\n\n1. A known or suspected HER2+ breast cancer treated with curative intent (Stage II to III disease)\n2. Have undergone curative intent surgery with no clinical evidence of disease.\n\nCohort 2C: Triple Negative Breast Cancer\n\n1. A known or suspected triple negative breast cancer treated with curative intent (Stage I to III disease)\n2. Have undergone curative intent surgery with no clinical evidence of disease.\n\nCohort 3: 5-Years Post-Diagnosis Surveillance (NED)\n\n1. A known HR+, HER2- breast cancer treated with curative intent (Stage II to III disease).\n2. No Evidence of Disease (NED) ≥ 5 years from initial diagnosis.\n3. Patients are considered at high risk of recurrence, defined as 4 or more positive axillary lymph nodes (ALNs), or between 1-3 positive ALNs and either grade 3 disease or tumor size of 5 cm or larger.\n\nExclusion Criteria:\n\n1. Not willing or able to adhere with the study procedures\n2. Active secondary malignancy\n3. Diagnosis of a malignancy within 3 years of breast cancer diagnosis Note: Ductal carcinoma in situ (DCIS, ipsilateral or contralateral) within 3 years is not excluded.","99 Years",{"count":201,"type":20},900,"For patients with breast cancer, it's important to find any remaining cancer cells after they've had their main treatment. Even a few cells, called minimal residual disease (MRD), can lead to the cancer coming back later.\n\nA way to find these cells is by looking for tiny bits of cancer DNA that are shed into the blood. This is called circulating tumor DNA (ctDNA). A simple blood test, often called a liquid biopsy, can detect this ctDNA. This research aims to see if finding this cancer DNA in the blood can help predict if a patient's cancer will return. It also may help find out if the treatment is working.\n\nUltimately, the results of this research may help doctors better manage breast cancer and develop new and improved tests and treatments.",[70,204,205,26,206],"TNBC - Triple-Negative Breast Cancer","HR Positive\u002FHER-2 Negative Breast Cancer","Early Stage Breast Cancer",[208,209,210,115,211,206,212,213,214],"Minimal Residual Disease","MRD","Next generation sequencing","ctDNA","TNBC - Triple Negative Breast Cancer","HR positive \u002F HER-2 negative breast cancer","HER2+ breast cancer",{"date":185,"type":37},{"date":217,"type":37},"2025-10-27",{"date":219,"type":20},"2033-12",{"name":221,"class":129},"Tempus AI",14,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":240,"leadSponsor":242,"locationsCount":45},"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":231,"type":20},60,[58],"An Exploratory Study on the Efficacy and Safety of Different Administration Routes of SHR-A1811 in the Treatment of HER2-Positive Advanced Breast Cancer",[235,27,26],"HER2positive","2026-06-09",{"date":238,"type":37},"2026-06-11",{"date":183,"type":20},{"date":241,"type":20},"2029-12-31",{"name":243,"class":44},"Tianjin Medical University Cancer Institute and Hospital",{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":21,"phases":253,"briefSummary":254,"conditions":255,"keywords":266,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":287},"100535595","phase-1-a-phase-11b-study-of-iam1363-in-her2-cancers-100535595","NCT06253871","A Phase 1\u002F1b Study of IAM1363 in HER2 Cancers","A Phase 1\u002F1b Study of IAM1363 in Participants With Advanced Cancers Harboring HER2 Alterations","Key Inclusion Criteria:\n\n* Age ≥ 18 years\n* Have relapsed\u002Frefractory HER2-altered malignancy; for selected cohorts, prospective confirmation of HER2 alteration by central testing is required\n* Have progression of disease after the last systemic therapy, or be intolerant of last systemic therapy\n* Have radiographically measurable disease by RECIST v1.1 and\u002For RANO-BM\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-1\n* Have adequate baseline hematologic, liver and renal function\n* Have left ventricular ejection fraction (LVEF) ≥ 50%\n* Able to swallow oral medication\n\nKey Exclusion Criteria:\n\n* Clinically significant cardiac disease\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Participants with well-controlled HIV (e.g., CD4 \\>350\u002Fmm3 and undetectable viral load) are eligible\n* Current active liver disease including hepatitis A, hepatitis B , or hepatitis C\n* Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption\n* Uncontrolled diabetes\n* History of solid organ transplantation\n* History of Grade ≥2 CNS hemorrhage, or any CNS hemorrhage within 28 days before C1D1\n* Prior history of non-infectious interstitial lung disease (ILD). (Exceptions: participants with prior grade 1 ILD that has completely resolved are eligible)\n* Participants requiring immediate local therapy for brain metastases",{"count":252,"type":20},383,[57],"This is a Phase 1\u002F1b open-label, multi-center dose escalation and dose optimization study designed to evaluate the safety and preliminary efficacy of IAM1363 in participants with advanced cancers that harbor HER2 alterations.",[256,257,88,26,258,259,260,261,79,262,263,264,265],"HER2 Mutation-Related Tumors","HER2","Brain Metastases From Solid Tumors","Brain Metastases From HER2 and Breast Cancer","CNS Metastases","HER2-Positive Solid Tumors","HER2-positive Bladder Cancer","HER2-positive Colorectal Cancer","HER2 + Gastric Cancer","HER2-positive Gastroesophageal Cancer",[267,268,269,270,271,272,273,274,275,276,257,277],"ERBB2 protein, human","Molecular Targeted Therapy","Genes, erbB-2","Receptor, ErbB-2 \u002F antagonists & inhibitors","Neoplasms \u002F drug therapy","HER2 positive","HER2 overexpressing","HER2 altered","Human epidermal growth factor receptor","ErbB Receptors","brain metastases","2026-06-02",{"date":280,"type":37},"2026-06-04",{"date":282,"type":37},"2024-03-25",{"date":284,"type":20},"2028-12",{"name":286,"class":129},"Iambic Therapeutics, Inc",53,{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":21,"phases":297,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":4},"100637806","phase-1-a-study-to-evaluate-the-pharmacokinetics-efficacy-and-safety-of-hlx319-vs-eu-phesgo-in-the-neoadjuvant-therapy-of-her2-positive-early-or-locally-advanced-breast-cancer-100637806","NCT07601620","A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer","A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase I Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Phesgo® Biosimilar HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer","Inclusion Criteria:\n\n* Voluntary participation in the clinical study and signed the Informed Consent Form (ICF).\n* Male or female aged ≥ 18 years old at the time of signing the ICF;\n* Histologically confirmed invasive breast cancer, stage II-IIIC, Human Epidermal Growth Factor Receptor 2 (HER2) positive confirmed by central laboratory.\n* Participants agree to undergo surgery while meeting the criteria for surgery after neoadjuvant therapy.\n* Left ventricular ejection fraction (LVEF) at baseline ≥ 55%.\n* An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1.\n* Adequate major organ functions.\n* Women with child-bearing potential have a negative result of serum pregnancy test at screening period (within 7 days prior to the first dose) or if they are infertile, non- lactating, reproduction-age men and women following highly effective contraceptive measures until 7 months after last dose.\n\nExclusion Criteria:\n\n* Stage IV breast cancer, bilateral breast cancer, or multicentric breast cancer.\n* History of other malignancy within 5 years.\n* Prior systemic therapy for breast cancer treatment or radiotherapy.\n* Patients with a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) who have received systemic therapy or radiotherapy to the ipsilateral breast.\n* Patients who have undergone excision biopsy of the primary tumor and\u002For axillary lymph nodes or lymph node dissection.\n* Have severe heart disease or medical conditions.\n* Participants with viral hepatitis or those with autoimmune hepatitis, sclerosing cholangitis, or liver cirrhosis.\n* Human Immunodeficiency Virus (HIV) infection, HIV antibody positive.\n* Daily use of corticosteroid treatment is required.\n* Sensitivity to any study medications or any of its ingredients or excipients.\n* Participants who underwent any major surgery within 28 days prior to the first dose. Or participants who have received local radiotherapy, radiofrequency ablation, or interventional therapy within 2 weeks prior to the first dose.\n* Received another interventional clinical trial therapy within 4 weeks prior to enrollment in the study, or intentionally participated in another interventional clinical trial during the entire study period.\n* Severe, uncontrolled systemic diseases that may currently interfere with the therapeutic plan.\n* Any other conditions which are inappropriate for the study in the opinion of the investigator.",{"count":296,"type":20},258,[57],"This is a study to compare the similarity in Pharmacokinetics (PK) profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer .",[26],"2026-05-15",{"date":302,"type":37},"2026-05-22",{"date":304,"type":20},"2026-07-03",{"date":306,"type":20},"2027-07-22",{"name":308,"class":129},"Shanghai Henlius Biotech",{"id":310,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":21,"phases":312,"briefSummary":24,"conditions":313,"keywords":314,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":321,"locationsCount":4},"100639594",{"count":19,"type":20},[23],[26,27],[29,30,31,32],"2026-05-14",{"date":317,"type":37},"2026-05-20",{"date":319,"type":20},"2026-06-01",{"date":41,"type":20},{"name":43,"class":44},{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":21,"phases":331,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":45},"100615584","phase-2-a-study-to-evaluate-hlx22-in-combination-with-hlx87-in-patients-with-her2-positive-recurrent-or-metastatic-breast-cancer-100615584","NCT07294508","A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer","An Open-Label, Randomized, Multicenter, Phase II\u002FIII Clinical Study to Evaluate HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With HLX87 (HER2 ADC) as First-Line Treatment in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer","Inclusion Criteria:\n\n* 1\\. Have a full understanding of the study content, and sign the informed consent form (ICF); 2. Aged ≥ 18 years at the time of signing the ICF, male or female; 3. Histopathologically confirmed breast cancer that meets the following criteria:\n\n  1. Advanced or metastatic breast cancer.\n  2. HER2-positive as determined by the central laboratory, defined as IHC 3+, or IHC 2+ and ISH+.\n  3. Positive or negative for hormone receptor HR (including estrogen receptor \\[ER\\] and progesterone receptor \\[PgR\\]) as determined by the central laboratory 4. No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer (1 line of endocrine therapy is allowed).\n\n  5\\. At least one measurable lesion as assessed by central imaging according to RECIST v1.1.\n\n  7\\. Eastern Cooperative Oncology Group performance status score within 7 days prior to the first dose of study drugs: 0-1.\n\n  8\\. Life expectancy ≥ 12 weeks. 9. Adequate organ functions\n\nExclusion Criteria:\n\n* 1\\. History of a second malignancy within 3 years prior to signing the ICF. 2. Previous use of doxorubicin with a concentration of \\> 360 mg\u002Fm2 (or equivalent).\n\n  3\\. Prior treatment with ADCs including exatecan derivatives that contain topoisomerase I inhibitors.\n\n  4\\. Uncontrolled or significant cardiovascular diseases 5. Cerebrovascular accidents within 6 months prior to the first dose of study drugs.\n\n  6\\. ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis or clinically significant lung-specific intercurrent illness .\n\n  7\\. Active infection . 8. Presence of spinal cord compression or clinically symptomatic central nervous system metastases.\n\n  9\\. Residual toxicity from previous anti-tumor therapy that has not resolved to Grade ≤ 1 as per NCI-CTCAE V6.0 or baseline level (except for alopecia).\n\n  10\\. Presence of active tuberculosis. 11. Have received treatment with live attenuated vaccines within 30 days prior to the first dose of study drugs.\n\n  12\\. Known history of severe allergic reaction to macromolecular protein preparations, hypersensitivity to the ingredient of the investigational products, or severe hypersensitivity to any excipient of the study drugs.\n\n  13\\. Known history of abuse of psychotropic drugs or drug addiction. 14. Pregnant or lactating women.",{"count":330,"type":20},706,[58,332],"PHASE3","The study is being conducted to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer",[26],"2026-03-17",{"date":337,"type":37},"2026-03-20",{"date":339,"type":37},"2026-02-27",{"date":341,"type":20},"2030-12-30",{"name":308,"class":129},{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":11,"sex":139,"minAge":17,"maxAge":351,"enrollmentInfo":352,"targetDuration":4,"studyType":21,"phases":354,"briefSummary":355,"conditions":356,"keywords":359,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":45},"100625852","phase-2-pragmatic-study-to-optimize-neoadjuvant-treatment-and-surgical-de-escalation-in-hrher2--early-breast-cancer-using-oncotype-dx-and-abemaciclib-100625852","NCT07428018","Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+\u002FHER2- Early Breast Cancer Using Oncotype DX and Abemaciclib","The VIOLET Trial: A Pragmatic Phase II Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+\u002FHER2- Early Breast Cancer Using Oncotype DX and Abemaciclib","VIOLET","Inclusion Criteria:\n\n* female aged 18 years or older\n* primary, histologically confirmed diagnosis of invasive breast carcinoma,\n* estrogen receptor (ER)-positive tumor, defined as ≥10% by immunohistochemistry and measured as per ASCO\u002FCAP guidelines (Allison et al.2020). Any progesterone receptor expression is acceptable (as per local assessment)\n* documented human epidermal growth factor receptor-2 (HER2)-negative tumor as per ASCO\u002FCAP guidelines, assessed locally,\n* stage II-IIIB as per AJCC TNM classification (8th edition). Absence of distant metastases (with the exception of tumor detected in internal mammary chain nodes by sentinel node procedure),\n* candidate to receive neoadjuvant chemotherapy according to the indication of a multidisciplinary tumor board,\n* not eligible to receive upfront breast conservative surgery (but considered potentially eligible to receive a BCS in case of tumor downstaging) AND\u002FOR not candidate to sentinel lymph node dissection because of clinical node positive disease\n* Eastern Cooperative Oncology Group Performance Status 0-1,\n* The patient is able to swallow oral medications\n* normal hematologic parameters:\n\n  a.) absolute neutrophil count ≥ ≥1500\u002Fmm3 (1.5 × 10 9\u002FL), b) platelets ≥ 100 × 10 9\u002FL, c)hemoglobin ≥ 8 g\u002FdL (≥ 80 g\u002FL)). Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion\n* normal renal function: serum creatinine concentration ≤1.5 ULN or calculated clearance ≥50 mL\u002Fmin according to the Cockcroft-Gault formula,\n* normal liver function:\n\n  a.)serum total bilirubin ≤ 1.5 × upper limit of normal (ULN). Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted., b)AST and ALT ≤ 3 × ULN, c)alkaline phosphatase ≤ 2.5 × ULN,\n* women of child bearing potential must have documented negative pregnancy test within 2 weeks (preferably 7 days) prior to study entry and must agree to effective non-hormonal contraception (barrier method - condoms, diaphragm -also in conjunction with spermicidal jelly, or total abstinence) after the pregnancy test and up to surgery. Oral, injectable, or implant hormonal contraceptives or medicated IUD are not allowed during the trial,\n* willingness to undergo breast surgery after optimal neoadjuvant treatment, and to provide blood and tumor samples for the study purposes, including the submission for central assessment of Oncotype Dx test.\n\nExclusion Criteria:\n\n* presence of distant metastases (stage IV) or stage IIIC disease,\n* inflammatory or locally-advanced, inoperable breast cancer\n* previous invasive ipsilateral breast cancer at any time,\n* previous or concomitant invasive malignancy. The exceptions are patients with the following (and only the following) malignancies (previous or concomitant), if adequately treated:\n\n  1. basal or squamous cell carcinoma of the skin,\n  2. melanoma in situ,\n  3. in situ non-breast carcinoma without invasion,\n  4. contra- or ipsilateral in situ breast carcinoma,\n  5. non-breast invasive malignancy diagnosed at least 5 years ago and without recurrence,\n  6. stage I papillary thyroid cancer,\n  7. stage Ia carcinoma of the cervix,\n  8. stage Ia or b endometrioid endometrial cancer,\n  9. borderline or stage I ovarian cancer\n* known history of uncontrolled or symptomatic angina, uncontrolled hypertension (≥ 180\u002F110 mmHg), uncontrolled diabetes mellitus, dyspnea at rest, chronic therapy with oxygen, a New York Heart Association (NYHA) class III or IV congestive heart failure, syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* females who are pregnant or lactating (lactation has to stop before study entry)\n* the patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea),\n* The patient has had major surgery within 14 days prior to study entry.\n* The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to study entry, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.\n* The patient has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\])\n* contraindications or known hypersensitivity to the trial medication or excipients,\n* use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment","90 Years",{"count":353,"type":20},150,[58],"This is a pragmatic phase 2 study to determine the proportion of patients with ER+ (≥10%)\u002FHER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision and to evaluate the proportion of patients undergoing breast conservative surgery and\u002For sentinel node biopsy",[70,26,357,358],"HR Positive","Neoadjuvant Therapy",[360,361,362,363,364],"breast","oncotype dx","abemaciclib","neoadjuvant treatment","surgical deescalation","2026-03-03",{"date":367,"type":37},"2026-03-05",{"date":369,"type":20},"2026-04-30",{"date":371,"type":20},"2029-04-30",{"name":373,"class":44},"Mario Negri Institute for Pharmacological Research",{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":139,"minAge":17,"maxAge":381,"enrollmentInfo":382,"targetDuration":4,"studyType":21,"phases":384,"briefSummary":385,"conditions":386,"keywords":387,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":45},"100623191","phase-2-neoadjuvant-trastuzumab-deruxtecan-shr-a1811--pertuzumab-in-her2-breast-cancer-100623191","NCT07393425","Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer","Neoadjuvant Therapy With Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab or Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab Sequenced With Paclitaxel-based Regimens + Trastuzumab + Pyrotinib in HER2+ Breast Cancer","Inclusion Criteria:\n\n* Age and Gender: Female patients aged ≥18 years and ≤70 years. Histological Confirmation: Patients must have histologically confirmed invasive breast cancer and must not have received any prior systemic anti-tumor therapy for breast cancer.\n* HER2 Positivity: Histologically confirmed HER2 receptor positivity, following the 2018 ASCO-CAP HER2 positivity judgment guidelines.\n\nConfirmed by pathology laboratory with immunohistochemistry (IHC) score of 3+, or 2+ with positive in situ hybridization (ISH) test (ISH amplification rate ≥2.0).\n\n* Tumor Stage: Patients must have tumor staging conforming to the Stage II-III breast cancer criteria according to the eighth edition of the AJCC breast cancer TNM staging system (T1\\~T4, N1\\~N3, M0).\n* Measurable Target Lesion: At least one measurable target lesion according to RECIST V1.1.\n* ECOG Performance Status: ECOG functional status score of 0\\~1.\n* Organ Function: Adequate organ function levels, with the following requirements (no blood transfusion or use of leukocyte or platelet elevation drugs within 2 weeks prior to screening):\n\n  * Hematology: Absolute neutrophil count (ANC) \\> 1.5 × 109\u002FL; Platelet count (PLT) \\> 75 × 109\u002FL; Hemoglobin (Hb) \\> 90 g\u002FL.\n  * Blood Chemistry: Total bilirubin (TBIL) \\\u003C 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 1.5 × ULN; Alkaline phosphatase \\\u003C 2.5 × ULN; Blood urea nitrogen\u002Furea (BUN\u002FUREA) and creatinine (Cr) \\\u003C 1.5 × ULN.\n  * Cardiac Ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%.\n  * 12-Lead ECG: Fridericia's method corrected QT interval (QTcF) \\\u003C 470 msec.\n* Reproductive Status: For premenopausal women with potential fertility, a pregnancy test must be performed within 7 days before treatment initiation, with negative serum\u002Furine pregnancy results.\n* Patients must not be lactating and must use adequate barrier contraception throughout the treatment cycle and for 6 months after treatment completion.\n\nVoluntary Participation: Voluntary participation in the study with signed informed consent, good compliance, and willingness to cooperate with visit schedules and research-related procedures.\n\nExclusion Criteria:\n\n* Stage IV Breast Cancer: Patients with Stage IV breast cancer. Inflammatory Breast Cancer: Patients with inflammatory breast cancer. Prior Malignancy Treatment: Patients who have received prior anti-tumor therapy or radiotherapy for any malignancy, or have concurrent other malignancies, excluding cured cervical intraepithelial neoplasia, basal cell carcinoma, or squamous cell carcinoma.\n* Concurrent Anti-Tumor Therapy: Patients currently participating in other clinical trials involving anti-tumor therapy, including but not limited to chemotherapy, endocrine therapy, biological therapy, bone modification therapy, or immune checkpoint inhibitor therapy.\n* Recent Surgery: Patients who have undergone major surgery unrelated to breast cancer within 4 weeks prior to the first dose of the study drug, or have not fully recovered from such surgery.\n* Serious Cardiac Disease: Patients with serious cardiac conditions, including but not limited to:\n* History of heart failure or systolic dysfunction (LVEF \\\u003C 50%). Uncontrolled high-risk arrhythmia, such as atrial tachycardia, resting heart rate \\> 100 bpm, significant ventricular arrhythmia, or advanced atrioventricular block (i.e., Mobitz II second-degree or third-degree atrioventricular block).\n* Angina pectoris requiring medication.\n* Clinically significant heart valve disease.\n* ECG showing transmural myocardial infarction.\n* Uncontrolled hypertension (after medication, systolic blood pressure \\> 180 mmHg and\u002For diastolic blood pressure \\> 100 mmHg).\n* Uncontrolled Active Infection: Patients with uncontrolled active infection requiring treatment, or with a history of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n* Allergy to Study Drugs: Patients with a known history of allergy to any component of the study drugs.\n* Pregnant or Lactating Women: Pregnant or lactating women, women of childbearing potential with positive baseline pregnancy test, or those unwilling to use effective contraception during the trial period and for 6 months after the last dose of the study drug.\n* Interstitial Lung Disease: Patients with known or suspected interstitial lung disease; those with other severe pulmonary diseases that may interfere with drug-related pulmonary toxicity detection or management within 3 months prior to the first dose, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia\u002Fobliterative bronchiolitis, pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive\u002Fobstructive lung disease, or any pulmonary autoimmune or inflammatory disease such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis; or those with a history of total pneumonectomy.\n* Severe Concomitant Diseases: Patients with severe concomitant diseases or other conditions that may interfere with the planned treatment, or those deemed unsuitable for the study by the investigator for any other reason.","70 Years",{"count":383,"type":20},50,[58],"Patients with Stage II-III HER2-positive breast cancer will receive three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by imaging assessment. If clinical complete response (cCR) or radiological complete response\u002Fnear radiological complete response (rCR\u002Fnear rCR) is achieved, they will continue to receive an additional three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by surgery.\n\nIf cCR\u002FrCR or near rCR is not achieved, the treatment will be switched to the THPy regimen (paclitaxel-based regimen + Trastuzumab + Pyrotinib) for three cycles.",[26],[388,389,390],"Trastuzumab Deruxtecan","SHR-A1811","neoadjuvant","2026-02-05",{"date":393,"type":37},"2026-02-06",{"date":395,"type":20},"2026-02-02",{"date":397,"type":20},"2032-09-30",{"name":399,"class":44},"Shanghai Jiao Tong University School of Medicine",{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":21,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":4},"100615586","phase-2-a-phase-iiiii-clinical-study-to-evaluate-the-efficacy-and-safety-of-hlx87in-combination-with-hlx22-or-pertuzumab-in-the-neoadjuvant-therapy-of-her2-positive-bresat-cancer-100615586","NCT07294534","A Phase II\u002FIII Clinical Study to Evaluate the Efficacy and Safety of HLX87in Combination With HLX22 or Pertuzumab in the Neoadjuvant Therapy of HER2-Positive Bresat Cancer","An Open-Label, Randomized, Multicenter Phase II\u002FIII Clinical Study to Evaluate the Efficacy and Safety of HLX87 (HER2 ADC) in Combination With HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) or Pertuzumab vs. TCbHP in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer","Inclusion Criteria:\n\n* 1\\. Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements; 2. Aged ≥ 18 years at the time of signing the ICF, male or female; 3. Primary breast cancer meeting the following criteria:\n\n  1. Histologically confirmed invasive breast cancer;\n  2. Clinical stage (assessed by mammography or MRI): T0-4 (including inflammatory breast cancer), N1-3, M0; or ≥ T3, N0, M0 (according to AJCC 8th edition);\n  3. HER2-positive as determined by the central laboratory, defined as IHC 3+ or IHC 2+ and ISH-positive;\n  4. For unifocal and multifocal tumors (i.e., more than one tumor, all confined to the same quadrant as the primary tumor), at least 1 lesion should be sampled and confirmed as HER2-positive by the central laboratory;\n  5. For multi-centric tumors (i.e., multiple tumors involving two or more quadrants of the breast), 1 lesion should be sampled from each affected quadrant and confirmed as HER2-positive by the central laboratory, and all tested quadrants must be confirmed as HER2-positive;\n  6. Positive or negative for hormone receptors HR (including estrogen receptor \\[ER\\] and progesterone receptor \\[PgR\\]) as determined by the central laboratory.\n\nNote: According to ASCO-CAP guidelines, HR-positive is defined as: ER and\u002For PgR ≥ 1% cells have nuclear staining; HR-negative is defined as: ER \\\u003C 1% cells have nuclear staining and PR \\\u003C 1% cells have nuclear staining.\n\nDuring the screening period, unstained tumor sections should be provided to the central laboratory for relevant tests according to the laboratory manual.\n\n4\\. Consent for surgery after neoadjuvant therapy. 5. Baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography (ECHO) or multi-gated acquisition (MUGA) scan (within 28 days prior to the first dose).\n\n6\\. No prior systemic anti-tumor treatment for this current breast cancer (including systemic chemotherapy, molecular targeted drug therapy, biological therapy, and other investigational medicinal products).\n\n7\\. ECOG PS score of 0-1 within 7 days prior to the first dose. 8. Hepatitis B surface antigen (HBsAg) (-) and hepatitis B core antibody (HBcAb) (-). In case of HBsAg (+) or HBcAb (+), hepatitis B virus deoxyribonucleic acid (HBV-DNA) must be \\\u003C 2500 copies\u002FmL or 500 IU\u002FmL or within the reference range of the site.\n\n9\\. HCV antibody (-); subjects with HCV antibody (+) must have a negative HCV-RNA test result to be enrolled. Subjects with HBV\u002FHCV co-infection shall be excluded (positive for HBsAg or HBcAb and positive for HCV antibody) 10. HIV antibody (-). 11. Have adequate organ function as defined by the following criteria (no blood transfusions, or treatment with albumin, recombinant human thrombopoietin or colony-stimulating factor \\[CSF\\] within 14 days prior to the first dose in this study) 12. Female subjects of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first dose. Female subjects of childbearing potential and male subjects with female partners of childbearing potential are required to take a medically approved contraceptive measure (e.g., intra-uterine contraceptive device, contraceptive pills, or condoms) during the study treatment period and for at least 7 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* 1\\. Past medical history of invasive breast carcinoma. 2. Stage IV (metastatic) breast cancer (per AJCC 8th edition). 3. History of any second malignancy within 3 years prior to signing the ICF, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma.\n\n  4\\. With serious heart disease or medical history, including but not limited to the following conditions:\n  1. Any previous and current heart failure or systolic dysfunction meeting the NYHA criteria;\n  2. High-risk uncontrollable arrhythmia: atrial tachycardia with resting heart rate \\> 100 beats\u002Fmin, significant ventricular arrhythmia (such as ventricular tachycardia), or high-grade atrioventricular block (such as Mobitz II second-degree atrioventricular block or third-degree atrioventricular block);\n  3. Unstable angina or angina requiring antianginal medication\n  4. History of transmural myocardial infarction shown by ECG\n  5. Clinically significant cardiac valvular disease;\n  6. Poorly controlled hypertension (with systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg).\n\n  5\\. Cerebrovascular accident within 6 months prior to the first dose. 6. Use of immunosuppressants within 14 days prior to the first dose, except for intranasal and inhaled corticosteroids, systemic corticosteroids with a dose of less than 10 mg\u002Fday of prednisone\u002Fprednisolone or equivalent.\n\n  7\\. Active systemic infection requiring intravenous antibiotics, antivirals, or antifungals within 7 days prior to the first dose.\n\n  8\\. History of (non-infectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, current presence of pneumonitis\u002FILD, or suspected pneumonitis\u002FILD cannot be ruled out by imaging during the screening period.\n\n  9\\. Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary embolism within 3 months prior to dosing, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive pulmonary disease, significant pleural effusion etc.), any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and\u002For prior pulmonary resection.\n\n  10\\. Presence of active tuberculosis. 11. Have received treatment with live attenuated vaccines within 30 days prior to the first dose. Note: If the patient is enrolled, live vaccines should not be administered during the study and within 30 days after the last study treatment.\n\n  12\\. Participation in other clinical studies within 30 days prior to signing the informed consent form. Unless the clinical study is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n\n  13\\. Known history of severe anaphylaxis to macromolecular protein preparations, hypersensitivity to any component in the formulation of the investigational product, or severe hypersensitivity to any excipients of investigational product.\n\n  14\\. Have received major surgery within 28 days prior to the first dose. In this study, a major surgery is defined as any surgery which requires at least 3 weeks of postoperative recovery time before receiving the study treatment. Local radiotherapy, radiofrequency ablation, and interventional therapy (excluding previous diagnostic biopsy) within 2 weeks prior to the first dose.\n\n  15\\. Known history of abuse of psychotropic drugs or drug addiction. 16. Pregnant or lactating women. 17. Other factors, as determined by the investigator, which may result in premature discontinuation of treatment. For example, other serious medical conditions (including mental illnesses) requiring concomitant treatment, serious laboratory abnormalities, family or social factors, and other conditions that may affect the safety of the subjects or the collection of study data.",{"count":408,"type":20},817,[58,332],"The study is being conducted to evaluate the clinical efficacy of HLX87 in combination with HLX22 or pertuzumab vs. TCbHP in the neoadjuvant therapy of HER2-positive early or locally advanced breast cancer.",[26],"2025-12-08",{"date":414,"type":37},"2025-12-19",{"date":416,"type":20},"2026-01-27",{"date":418,"type":20},"2030-02-01",{"name":308,"class":129},{"id":421,"slug":422,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":11,"sex":139,"minAge":17,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":21,"phases":429,"briefSummary":430,"conditions":431,"keywords":432,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":447},"100599212","phase-1-a-first-in-human-phase-1-safety-and-biodistribution-of-177lulu-aby-271-in-subjects-with-her2-positive-metastatic-breast-cancer-100599212","NCT07081555","A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer","A First-in-Human Phase 1, Open-label, Two-stage, Randomized Trial to Assess the Safety, Tolerability, and Biodistribution of [177Lu]Lu-ABY-271 in Tumors and Critical Organs in Subjects With HER2-positive Metastatic Breast Cancer","Inclusion Criteria:\n\n* Subject has unresectable locally advanced or metastatic breast cancer\n* Subject with histologically or cytologically confirmed carcinoma with documented HER2 overexpression (biopsy not older than 2 years): immunohistochemistry (IHC) score 3+; OR 2+ and fluorescence in situ hybridization (ISH) positive\n* At least one known tumor lesion ≥ 15 mm\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n\nPart A only\n\n\\- Subject is in treatment, or planned to start a new line of standard systemic anti-tumor therapy\n\nPart B only\n\n* Subject has progressive disease, documented radiologically in the last three months\n* Subject has received at least 3 lines of standard systemic anti-tumor therapy in the palliative setting\n* Subject has received last dose of previous line of systemic anti-tumor therapy, and has no ongoing treatment related toxicities \\> grade 1 (except alopecia) prior to planned first dose of \\[177Lu\\]Lu-ABY-271\n\nExclusion Criteria:\n\n* Active brain metastases\n* Administration of another IMP within 5 half-lives (for experimental biologics: 6 months or 5 half-lives, whichever is longer) of the planned first dose of \\[177Lu\\]Lu-ABY-271\n* Exposure to any anti-tumor therapy since the last documented progression, including any radiotherapy within 7 days prior to the planned first dose of \\[177Lu\\]Lu-ABY-271",{"count":428,"type":20},21,[57],"This is a FiH phase 1, open-label, two-stage, randomized trial to assess the safety, tolerability, and biodistribution of \\[177Lu\\]Lu-ABY-271 in subjects with HER2 positive metastatic breast cancer.",[170,26],[433,434,435,436,437],"Radiopharmaceutical","Biodistribution","First-in-human","phase 1","safety","2025-09-30",{"date":440,"type":37},"2025-10-01",{"date":442,"type":20},"2025-10-06",{"date":444,"type":20},"2028-06-01",{"name":446,"class":129},"Affibody",3,{"id":449,"slug":450,"hasResults":11,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":454,"eligibilityCriteria":455,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":456,"targetDuration":458,"studyType":142,"phases":4,"briefSummary":459,"conditions":460,"keywords":461,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":474},"100562471","her2-positive-breast-cancer-registry-100562471","NCT06603597","HER2-positive Breast Cancer Registry","Prospective Evaluation of Outcomes for HER2-positive Breast Cancer (PRO-HER2)","PRO-HER2","Inclusion Criteria:\n\n* Stage I-IV HER2-positive breast cancer\n\nExclusion Criteria:\n\n* None",{"count":457,"type":20},1000,"10 Years","The goal of this observational study is to better understand links between patient or tumor characteristics and outcomes in HER2-positive breast cancer.",[26],[462,463,464,272],"breast cancer","registry","HER2+","2025-09-02",{"date":467,"type":37},"2025-09-10",{"date":469,"type":37},"2024-09-27",{"date":471,"type":20},"2044-10",{"name":473,"class":44},"Priyanka Sharma",6,{"id":476,"slug":477,"hasResults":11,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":11,"sex":139,"minAge":17,"maxAge":381,"enrollmentInfo":482,"targetDuration":4,"studyType":21,"phases":484,"briefSummary":485,"conditions":486,"keywords":490,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":4},"100602874","phase-2-shr-a1811-for-her2-positive-breast-cancer-with-suboptimal-neoadjuvant-response-100602874","NCT07129187","SHR-A1811 for HER2-positive Breast Cancer With Suboptimal Neoadjuvant Response","An Open-label, Single-arm, Multicenter Study of SHR-A1811 as Neoadjuvant Therapy in HER2-positive Breast Cancer Patients With Suboptimal Neoadjuvant Response","Inclusion Criteria:\n\n* 1.Female patients with newly diagnosed breast cancer aged 18 to 70 years old;\n* 2.Early or locally advanced HER2-positive invasive breast cancer;\n* 3.Known hormone receptor status;\n* 4.ECOG score of 0-1;\n* 5.Patients who were determined by the researchers to have poor therapeutic effect after 4 cycles of neoadjuvant therapy;\n* 6.Organ function levels must meet the following requirements:\n* 7.Women of childbearing age must undergo a serum pregnancy test within 7 days before enrollment, with a negative result, and be willing to use a medically approved highly effective contraceptive method during the study and within 3 months after the last administration of the study drug.\n* 8.The subjects voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Patients with metastatic or bilateral breast cancer, or inflammatory breast cancer\n* 2\\. Patients with grade 3 or higher thrombocytopenia during previous treatment, or grade 3 or higher nausea and vomiting despite primary prevention\n* 3\\. History of other malignant tumors (except cured carcinoma in situ of the cervix, basal cell carcinoma, etc.) and related treatment history\n* 4\\. Patients who received major non-breast cancer surgery within 4 weeks before enrollment and have not recovered (except biopsy and PICC)\n* 5\\. Autoimmune diseases (except special cases such as hypothyroidism and stable type 1 diabetes)\n* 6\\. Interstitial lung disease, non-infectious pneumonia, uncontrolled systemic diseases\n* 7\\. History of or planned administration of live attenuated vaccines within 28 days\n* 8\\. HIV infection, active hepatitis (hepatitis B, hepatitis C, etc.), autoimmune hepatitis\n* 9\\. Severe infection within 4 weeks, CTCAE grade ≥ 2 active infection within 2 weeks (except neoplastic fever), or evidence of active tuberculosis within 1 year\n* 10\\. History of allogeneic bone marrow or solid organ transplantation\n* 11\\. Peripheral neuropathy of grade ≥ 2\n* 12\\. Severe heart diseases\n* 13\\. Receipt of systemic immunostimulant therapy within 4 weeks\n* 14\\. Receipt of systemic immunosuppressant therapy within 2 weeks (except local or physiological dose of hormones)\n* 15\\. Allergy to study drugs\u002Fexcipients, or history of severe allergic reaction to other monoclonal antibodies\n* 16\\. Pregnant or lactating women; fertile women with positive pregnancy test or unwilling to take effective contraception throughout the trial\n* 17\\. History of neurological\u002Fpsychiatric disorders , or history of substance abuse, alcoholism, or drug addiction\n* 18\\. Other circumstances deemed unsuitable for enrollment by the researcher",{"count":483,"type":20},30,[58],"This is an open-label, single-arm, multicenter clinical study to evaluate the efficacy and safety of SHR-A1811 in early or locally advanced HER2-positive breast cancer patients with suboptimal response to neoadjuvant regimen. Patients who were determined by the researchers to have poor therapeutic effect will switch to SHR-A1811.",[487,26,488,489],"Early Breast Cancer","Stage II Breast Cancer","Stage III Breast Cancer",[491,492,389,493],"neoadjuvant therapy","antibody drug conjugate","suboptimal response","2025-08-20",{"date":496,"type":37},"2025-08-26",{"date":498,"type":20},"2025-10",{"date":500,"type":20},"2030-10",{"name":502,"class":44},"Chuan Wang",{"id":504,"slug":505,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":381,"enrollmentInfo":510,"targetDuration":4,"studyType":21,"phases":512,"briefSummary":513,"conditions":514,"keywords":515,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":45},"100603473","phase-2-efficacy-of-tqb2102-versus-tcbhp-in-neoadjuvant-therapy-for-her2-positive-early-breast-cancer-100603473","NCT07136974","Efficacy of TQB2102 Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer.","Comparing the Efficacy of TQB2102 and TCbHP in Neoadjuvant Treatment for HER2-positive Early Breast Cancer: A Randomized Phase II Clinical Trial.","Inclusion Criteria:\n\n1. 18-70 years,\n2. ECOG performance status 0-1;\n3. Clinical T2-T4, or T1c with axillary lymph node metastasis; Confirmed HER2-positive status (per 2018 ASCO\u002FCAP HER2 Testing Guidelines, defined as IHC 3+ or FISH positive);\n4. Clinically measurable lesion: Lesion measurable by ultrasound, mammography, or optional MRI within 1 month before randomization;\n5. No chemotherapy contraindications based on organ and bone marrow function tests within 1 month prior to chemotherapy: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, Hemoglobin ≥90 g\u002FL, Platelet count ≥100×10⁹\u002FL, Total bilirubin \\\u003C1.5 × ULN (upper limit of normal), Creatinine \\\u003C1.5 × ULN, AST\u002FALT \\\u003C1.5 × ULN, Echocardiography: Left ventricular ejection fraction (LVEF) ≥50%;\n6. For women of childbearing potential: Negative serum pregnancy test within 14 days before randomization;\n7. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Stage IV (metastatic) breast cancer;\n2. Prior treatments received including chemotherapy, endocrine therapy, targeted therapy, or radiotherapy; History of other malignancies within 3 years or concurrent malignancies. Exceptions: Other malignancies treated with surgery alone achieving ≥5-year disease-free survival (DFS) . Cured cervical carcinoma in situ or non-melanoma skin cancer;\n3. Major non-breast cancer-related surgical procedures within 4 weeks prior to enrollment, or incomplete recovery from such procedures;\n4. Significant cardiac disease or conditions including but not limited to: History of heart failure or systolic dysfunction (LVEF \\\u003C50%). Uncontrolled high-risk arrhythmias: Atrial tachycardia, resting heart rate \\>100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or high-grade atrioventricular block (Mobitz II second-degree or third-degree AV block). Angina requiring anti-anginal medication. Clinically significant valvular heart disease. ECG evidence of transmural myocardial infarction. Poorly controlled hypertension (SBP \\>180 mmHg and\u002For DBP \\>100 mmHg);\n5. Contraindications to chemotherapy per investigator's assessment due to severe uncontrolled comorbidities;\n6. Known hypersensitivity to protocol drug components;\n7. History of immunodeficiency disorders (including HIV positivity), other acquired\u002Fcongenital immune deficiencies, or organ transplantation;\n8. Any concurrent condition that in the investigator's judgment would jeopardize patient safety or compromise study completion, or other grounds for ineligibility.",{"count":511,"type":20},280,[58],"The aim of this study is to evaluate the efficacy and safety of TQB2102 compared to TCbHP in the neoadjuvant treatment of HER2-positive breast cancer. Participants will randomly assigned, in a 1:1 ratio, to receive either TQB2102 or TCbHP for 6 cycles. Patients will undergo definitive surgery (breast conservation or mastectomy with sentinel lymph-node evaluation or axillary dissection) 3 to 6 weeks after the last cycle of the neoadjuvant phase. Primary endpoint is pathological complete response, defined as pathological stage ypT0\u002FTis ypN0 at the time of definitive surgery.",[70,26],[272,491],"2025-08-16",{"date":518,"type":37},"2025-08-22",{"date":520,"type":20},"2025-09-01",{"date":522,"type":20},"2030-08-30",{"name":524,"class":525},"Henan Cancer Hospital","OTHER_GOV",{"id":527,"slug":528,"hasResults":11,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":11,"sex":139,"minAge":17,"maxAge":533,"enrollmentInfo":534,"targetDuration":4,"studyType":21,"phases":536,"briefSummary":537,"conditions":538,"keywords":539,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":45},"100597972","phase-2-rc48-plus-bevacizumab-or-pyrotinib-in-her2-positive-metastatic-breast-cancer-after-t-dxd-failure-a-phase-ii-study-100597972","NCT07065435","RC48 Plus Bevacizumab or Pyrotinib in HER2-Positive Metastatic Breast Cancer After T-DXd Failure: A Phase II Study","Efficacy and Safety of Disitamab Vedotin (RC48) in Combination With Bevacizumab or Pyrotinib in Patients With HER2-Positive Metastatic Breast Cancer After Trastuzumab Deruxtecan (T-DXd) Treatment Failure: A Phase II Study","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically or cytologically confirmed HER2-positive (IHC 3+ or IHC 2+ with ISH amplification) advanced or metastatic breast cancer.\n3. Prior treatment with trastuzumab deruxtecan (T-DXd) and documented disease progression during or after therapy.\n4. At least one measurable lesion at baseline as defined by RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Adequate organ and marrow function, including:\n\nAbsolute neutrophil count ≥1.5 × 10⁹\u002FL Platelet count ≥100 × 10⁹\u002FL Hemoglobin ≥9 g\u002FdL ALT and AST ≤2.5 × ULN Total bilirubin ≤1.5 × ULN Creatinine clearance ≥50 mL\u002Fmin Estimated life expectancy of ≥12 weeks. Ability to understand and willingness to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Prior treatment with disitamab vedotin (RC48).\n2. Active infections requiring systemic therapy (bacterial, viral, or fungal).\n3. History of interstitial lung disease or non-infectious pneumonitis requiring corticosteroid therapy.\n4. Uncontrolled cardiovascular disease, including but not limited to: uncontrolled hypertension, recent myocardial infarction (within 6 months), unstable angina, or congestive heart failure.\n5. Pregnant or breastfeeding women.\n6. Concurrent malignancy other than adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix, unless disease-free for ≥5 years.\n7. Participation in another interventional clinical trial with investigational agents not yet completed.\n8. Any condition that, in the opinion of the investigator, would interfere with the subject's ability to comply with study requirements or jeopardize their safety.","75 Years",{"count":535,"type":20},74,[58],"This multicenter, Phase II study (RADIANT-BC01) evaluates the efficacy and safety of Disitamab Vedotin (RC48) in combination with either bevacizumab or pyrotinib in adult patients with HER2-positive metastatic breast cancer whose disease has progressed on prior trastuzumab deruxtecan (T-Dxd) therapy.\n\nEligible participants will be randomized 1:1 to receive RC48 plus bevacizumab (7.5 mg\u002Fkg IV every 2 weeks) or RC48 plus pyrotinib (320 mg orally once daily). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or initiation of new anticancer therapy.\n\nThe primary endpoint is objective response rate (ORR); key secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), overall survival (OS), and safety.\n\nThis study aims to identify new post-T-Dxd treatment options and improve outcomes for patients with advanced HER2-positive breast cancer.",[26],[540,541,542,543],"Disitamab Vedotin (RC48)","Bevacizumab","Pyrotinib","Trastuzumab deruxtecan failure","2025-07-13",{"date":546,"type":37},"2025-07-15",{"date":548,"type":37},"2024-01-01",{"date":550,"type":20},"2026-01-01",{"name":552,"class":44},"The First Affiliated Hospital with Nanjing Medical University",{"id":554,"slug":555,"hasResults":11,"nctId":556,"briefTitle":557,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":561,"conditions":562,"keywords":574,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":578,"lastUpdatePostDateStruct":579,"startDateStruct":581,"completionDateStruct":583,"leadSponsor":585,"locationsCount":45},"100595293","radiomics-to-predict-her2-status-and-t-dxd-efficacy-in-metastatic-breast-cancer-the-radiospher2-study-100595293","NCT07030569","RADIomics to Predict HER2 Status And T-DXd Efficacy in Metastatic Breast Cancer: the RADIOSPHER2 Study","RADIOSPHER2","Inclusion Criteria:\n\n* Patients with metastatic breast cancer underwent a liver, lung, pleural or bone biopsy in the metastatic setting, performed from 01Jan2005 to 01Jan2024.\n\nExclusion Criteria:\n\n* Not available imaging (CT scan and\u002For PET-FdG scan) in the three months before the biopsy or before the last previous treatment interruption;\n* Unknown HER2 status;\n* Node, soft tissue or other visceral as biopsy site.",{"count":19,"type":20},"RADIOSPHER2 study is a monocentric, retrospective, observational study aiming at identifying a radiomics signature able to predict HER2 expression (0 vs low vs overexpression) and trastuzumab deruxtecan efficacy in metastatic breast cancer patients. The study also encompasses translational analyses and inter-modal correlations in order to provide novel insights about HER2 spatial and temporal heterogeneity, at the macroscopic and microscopic levels.",[563,564,565,566,567,175,70,568,569,570,257,26,571,88,572,573],"Radiomic","Radiomics","Breast Cancer Metastatic","Breast Cancer Stage IV","Breast Carcinoma","Breast Cancer With Bone Metastasis","Breast Cancer With Metastatic Bone Disease","Trastuzumab","HER2 Positive Breast Carcinoma","Her2\u002FNeu Positive Advanced Solid Tumors","HER2\u002FNeu-positive Breast Cancer",[564,575,388,576,577],"HER2 expression","Pathomics","HER2 heterogeneity","2025-06-12",{"date":580,"type":37},"2025-06-22",{"date":582,"type":37},"2024-02-01",{"date":584,"type":20},"2027-01-01",{"name":586,"class":44},"Fondazione IRCCS Istituto Nazionale dei Tumori, Milano"]