[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-breast-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,51,80,108,138],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100390210","phase-1-pavement-palbociclib-and-avelumab-in-metastatic-ar-triple-negative-breast-cancer-100390210",false,"NCT04360941","PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer","PAveMenT: Phase Ib Study of Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer","PAveMenT","Inclusion Criteria Part A:\n\n1. Patients with recurrent inoperable locally advanced or metastatic breast cancer.\n2. Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced disease. Patients with ER+ breast cancer must have received at least one prior line of hormone therapy for advanced disease. Patients with HER2+ breast cancer must have received at least one prior line of HER2 directed therapy.\n3. Measurable disease (RECIST 1.1)\n4. Haematological and biochemical indices within the ranges stated in the study protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial.\n5. Women\u002Ffemale patients with child-bearing potential (defined as the fertile status following menarche and until becoming post-menopausal unless permanently sterile by methods that include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n\n   Women\u002Ffemales of child bearing potential or their male partners must use a highly effective method of contraception for 2 weeks before starting the study treatment, throughout the treatment period and for 1 month after discontinuation of treatment with palbociclib and avelumab (women\u002Ffemale patients) or 14 weeks (men\u002Fmale patients). Highly effective methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods, such methods include:\n   * Oral, intra-vaginal or transdermal combined hormonal contraception\n   * Oral, injectable or implantable progesterone-only contraception\n   * Intrauterine device\n   * Intrauterine hormone-releasing system,\n   * Bilateral tubal occlusion\n   * Vasectomised partner\n   * True abstinence:\\* When this is in line with the preferred and usual lifestyle of the subject\n\n   Key: \\* it is only considered highly effective if the patient is refraining from sexual intercourse during the entire period of risk associated with the study treatments\n6. 18 years of age or over.\n7. World Health Organisation (WHO) performance status 0 or 1\n8. Estimated life expectancy of at least 3 months in the opinion of the investigator\n9. Signed and dated informed consent.\n10. Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow up and other procedures\n\nInclusion Criteria Part B:\n\n1. Patients with recurrent inoperable locally advanced or metastatic AR+ triple negative breast cancer with ER, PgR and HER2 status determined locally and AR determined centrally on archival metastatic tissue. Archival tissue from the primary tumour (which must have been ER\u002FPgR negative and collected within 5 years prior to metastatic relapse) may be used for AR testing if no archival metastatic tissue is available.\n2. Previously treated with at least one prior line of chemotherapy for advanced disease, but no more than two prior lines of chemotherapy for advanced disease.\n3. Measurable disease (RECIST 1.1) amenable to fresh biopsy\n4. Haematological and biochemical indices within the ranges stated in the study protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial.\n5. Female patients with child-bearing potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.\n\n   Women\u002Ffemales of child bearing potential or their male partners must use a highly effective method of contraception for 2 weeks before starting the study treatment, throughout the treatment period and for 1 month after discontinuation of treatment with palbociclib and avelumab (women\u002Ffemale patients) or 14 weeks (men\u002Fmale patients). Highly effective methods are defined as methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods, such methods include:\n   * Oral, intra-vaginal or transdermal combined hormonal contraception\n   * Oral, injectable or implantable progesterone-only contraception\n   * Intrauterine device\n   * Intrauterine hormone-releasing system,\n   * Bilateral tubal occlusion\n   * Vasectomised partner\n   * True abstinence:\\* When this is in line with the preferred and usual lifestyle of the subject\n\n   Key: \\* it is only considered highly effective if the patient is refraining from sexual intercourse during the entire period of risk associated with the study treatments\n6. Age 18 years of age or over\n7. World Health Organisation (WHO) performance status 0 or 1\n8. Estimated life expectancy of at least 3 months in the opinion of the investigator\n9. Signed and dated informed consent\n10. Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, follow up, and other procedures\n11. Available archival breast primary tumour tissue (or metastatic tissue if de novo metastatic disease)\n12. Patient willing to undergo a mandatory baseline fresh tumour tissue biopsy procedure (clinical or radiologically-guided)\n\nExclusion Criteria Parts A \\& B:\n\n1. Oral chemotherapy within two weeks, weekly iv chemotherapy within three weeks or any other systemic chemotherapy or investigational medicinal products during the previous four weeks.\n2. Hormonal therapy within 7 days except luteinizing hormone-releasing hormone (LHRH) analogues for ovarian suppression. Bisphosphonates or RANK ligand antagonists are permitted for the management of bone metastases.\n3. Previous exposure to immune checkpoint inhibitors or immune co-stimulatory drugs in the advanced setting. (Note: Patients who have received neoadjuvant and\u002For adjuvant pembrolizumab are eligible if treatment was completed at 6 months prior to metastatic relapse.)\n4. Previous treatment with palbociclib or any agents which inhibit CDK4\u002F6. (Note: Patients who have received adjuvant abemaciclib or ribociclib for early breast cancer are eligible if treatment was completed at least 12 months prior to metastatic relapse.)\n5. Major surgery (excluding minor procedures, e.g. placement of vascular access) within 4 weeks or radiation therapy within 14 days prior to study entry\n6. Patients with known symptomatic brain metastases requiring steroids, untreated brain metastases, leptomeningeal disease or spinal cord compression.\n7. Active infection requiring systemic therapy\n8. Any of the following within 12 months prior to study entry: myocardial infarction, history of myocarditis, uncontrolled angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack.\n9. Uncontrolled hypertension or cardiac dysrhythmia including atrial fibrillation\n10. Active autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.\n11. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n12. Other severe acute or chronic medical conditions including colitis, inflammatory bowel disease, pneumonitis (even if fully resolved), pulmonary fibrosis, end stage renal disease on haemodialysis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behaviour; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n13. Patients on warfarin or direct acting oral anticoagulants. Patients requiring anticoagulation for rate-controlled AF or previous venous thromboembolism should be switched to low-molecular weight heparin.\n14. Known HIV or AIDS-related illness, active infection requiring systemic therapy, or positive HBV or HCV test indicating acute or chronic infection\n15. Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI CTCAE v 5), any history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)\n16. Inability or unwillingness to swallow pills, or receive IV injections.\n17. Persisting toxicity related to prior therapy \\>Grade 1 (except for stable peripheral neuropathy grade ≤2 or alopecia grade ≤2).\n18. Pregnancy or lactation (women\u002Ffemales of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation)\n19. Diagnosis of other malignancy within 3 years, except for previous breast cancer, adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix, or low-grade (Gleason ≤6) prostate cancer\n20. Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable.\n21. Known prior or suspected hypersensitivity to investigational products or to any of the excipients\n22. Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines. Live vaccines must also be avoided for 3 months after the last dose of avelumab.\n23. Any psychiatric condition that would prohibit the understanding or rendering of informed consent\n24. Requirement for continued use of preparations containing St. John's Wort is specifically contraindicated. Other herbal medicinal or natural products that patient is intended to take during the trial must be explored at the beginning and during the course of the trial and discussed with the investigator.\n25. Requirement for continued use of CYP3A inhibitors, inducers or substrates (listed in Appendix 4).\n26. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine as this medicinal product contains lactose.\n27. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.","ALL","18 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This clinical study is aiming to determine the safest doses and schedule for the combination of two drugs named palbociclib and avelumab.\n\nThe study will also be investigating how effective the combination is for a subgroup of breast cancer patients whose cancer expresses the androgen receptor (AR) but not the oestrogen (hormone) or HER2 receptors. Palbociclib is a drug used in routine care for hormone-receptor (HR) positive and HER2 negative advanced breast cancer, the most common subtype of breast cancer.\n\nIt is possible that the combination of palbociclib and avelumab will be a more effective cancer treatment than each drug separately, but this is unknown and this study is needed to establish the best dosage and schedule of each drug as well as how effective the combination is.",[27,28,29,30,31,32],"Triple Negative Breast Cancer","Locally Advanced Breast Cancer","Recurrent Breast Cancer","Metastatic Breast Cancer","ER+ Breast Cancer","HER2-positive Breast Cancer",[34,35,36,37],"Palbociclib","Avelumab","Measurable Disease","Inoperable Disease","RECRUITING","2026-03-31",{"date":41,"type":42},"2026-04-06","ACTUAL",{"date":44,"type":42},"2020-08-11",{"date":46,"type":21},"2026-07-31",{"name":48,"class":49},"Royal Marsden NHS Foundation Trust","OTHER",9,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100544469","phase-2-a-study-of-alisertib-in-combination-with-endocrine-therapy-in-patients-with-hr-positive-her2-negative-recurrent-or-metastatic-breast-cancer-100544469","NCT06369285","A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer","A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer","ALISCA-Breast1","Inclusion Criteria:\n\n* Aged ≥18 years at signing of informed consent.\n* Pathology-confirmed diagnosis of adenocarcinoma of the breast with evidence of recurrent or metastatic disease not amenable to curative therapy.\n* Progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. a. If metastatic disease recurrence occurs during or within six months of discontinuing adjuvant endocrine therapy, then that endocrine therapy will count as one line of prior therapy.\n* Participants must have received a CDK4\u002F6i in combination with endocrine therapy in the recurrent or metastatic setting.\n* HR-positive and HER2-negative tumor status reported per local laboratory testing. HR and HER2 testing must be performed consistent with current American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) or European Society of Medical Oncology (ESMO) guidelines:\n\nExclusion Criteria:\n\n* Treatment with chemotherapy in the recurrent or metastatic setting.\n* Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.\n\nNote: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.",{"count":60,"type":21},150,[62],"PHASE2","PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive\u002FHER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy.",[65,30,29],"Hormone Receptor Positive HER-2 Negative Breast Cancer",[67,68,29,30],"Hormone receptor positive (HR+)","Human epidermal growth factor receptor 2 negative (HER2-)","2025-12-03",{"date":71,"type":42},"2025-12-10",{"date":73,"type":42},"2024-11-19",{"date":75,"type":21},"2028-12-31",{"name":77,"class":78},"Puma Biotechnology, Inc.","INDUSTRY",53,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":88,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100585306","phase-1-bortezomib-plus-cisplatin-in-recurrent-or-metastatic-breast-cancer-100585306","NCT06900647","Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer","Phase I Study to Evaluate the Safety and Preliminary Efficacy of Bortezomib Combined With Cisplatin in Patients With Recurrent or Metastatic Breast Cancer","BOCIS","Inclusion Criteria:\n\n1. Women aged 18 years and above with pathologically confirmed recurrent or metastatic advanced breast cancer ;\n2. The patient has tumor specimens (formalin-fixed, paraffin-embedded or fresh pre-treated recurrent tumor tissue);\n3. Patients who have failed standard treatment in the late stage;\n4. At least one measurable lesion;\n5. ECOG PS : 0-2 points;\n6. Estimated survival period ≥12 weeks;\n7. The function level of major organs meets the following standards:\n\n1\\) The blood routine examination standards must meet: ANC ≥1.5×109\u002FL, PLT ≥75×109\u002FL, Hb ≥85g\u002FL (no blood transfusion and blood products within 14 days, no use of G-CSF and other hematopoietic stimulating factors for correction) 2) Biochemical examinations must meet the following standards: TBIL \\\u003C1.5×ULN, ALT, AST \\\u003C2.5×ULN, ALT, AST \\\u003C5×ULN for patients with liver metastasis, BUN and Cr ≤1×ULN or endogenous creatinine clearance ≥50ml\u002Fmin (Cockcroft-Gault formula); 8. Women of childbearing age must have taken reliable contraceptive measures, or have undergone a pregnancy test (serum or urine) within 7 days before enrollment, with a negative result, and are willing to use appropriate contraceptive methods during the trial and 8 weeks after the last administration of the trial drug.\n\n9\\. The subjects voluntarily join this study, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\nAny of the following will be considered as meeting the exclusion criteria of the study:\n\n1. Patients with acute active hepatitis B or acute active hepatitis C;\n2. Any serious underlying disease, comorbidity and active infection\n3. Currently receiving other anti-tumor treatments;\n4. History of epilepsy or epileptic-induced condition;\n5. Patients who are pregnant or breastfeeding;\n6. Those with poor compliance or unable to undergo normal follow-up;\n7. Allergic to study drugs;\n8. Patients diagnosed with other malignant tumors within 5 years, except for the following: surgically resected non-melanoma skin cancer, adequately treated cervical carcinoma in situ, surgically radically treated ductal carcinoma in situ, or malignant tumors diagnosed 2 years ago with no current evidence of disease and untreated ≤ 2 years before randomization;\n9. The researcher determines other situations that may affect the conduct of the clinical study and the determination of the study results.","FEMALE",{"count":90,"type":21},20,[24],"This a phase 1 study to evaluate the safety and preliminary efficacy of cisplatin combined with bortezomib in patients with recurrent or metastatic breast cancer.",[30,29],[95,96,97],"Breast cancer","Bortezomib","Cisplatin","2025-03-27",{"date":100,"type":42},"2025-04-02",{"date":102,"type":42},"2025-01-01",{"date":104,"type":21},"2028-06-30",{"name":106,"class":49},"Sun Yat-sen University",1,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":107},"100531616","a-study-of-diffusing-alpha-radiation-therapy-for-patients-with-breast-carcinoma-in-frail-or-elderly-patients-100531616","NCT06202118","A Study of Diffusing Alpha Radiation Therapy for Patients With Breast Carcinoma in Frail or Elderly Patients.","A Pilot Feasibility and Safety Trial of Intratumoral Diffusing Alpha-emitter Radiation Therapy (DaRT) for the Treatment of Newly Diagnosed or Recurrent Breast Carcinoma in Frail or Elderly Patients.","Inclusion Criteria:\n\n* Histologically confirmed invasive breast tumor with no involvement of skin within 12 months.\n* Tumor size ≤ 4 centimeters in the longest diameter.\n* Tumor is not deemed as resectable with radical surgery or the patient does not wish to go through surgery\n* De-novo or recurrent lesions.\n* Single lesion per quadrant per subject.\n* Targeted lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds.\n* Interstitial implant indication validated by multidisciplinary team.\n* ECOG Performance Status ≤3.\n* Life expectancy ≥12 months.\n* Women Age ≥65 or younger if unfit for standard of care.\n* Willing and have the ability to provide signed Informed Consent.\n* Blood tests values:\n\n  * Leucocytes ≥3000mm3,\n  * Absolute neutrophil count ≥1500mm3,\n  * Platelets ≥100,000 mm3,\n  * Total bilirubin ≤ 1.5xULN,\n  * AST, SGOT, SGPT ≤2.5xULN, If Alkaline Phosphatase ≤ 4xULN, then transaminases are normal.\n  * Creatinine ≤ 2.0xULN.\n  * INR or Prothrombin time ≤1.5xULN\n\nExclusion Criteria:\n\n* T4 category with skin involvement.\n* Ductal carcinoma in situ.\n* Inflammatory breast carcinoma.\n* Longest tumor diameter \\>4 cm.\n* Patients with prior radiation to the same area within the past 6 months.\n* Has a known additional malignancy that is progressing or requires active treatment.\n* Patients undergoing immunosuppressive and\u002For systemic corticosteroid treatment except for steroid inhalations for treatment of asthma or lung disease\n* Subjects not willing to sign an informed consent.","65 Years","120 Years",{"count":118,"type":21},10,[120],"NA","A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for the treatment of newly diagnosed or Recurrent Breast Carcinoma in frail or elderly patients.",[123,29,124],"Breast Cancer","Breast Carcinoma",[126,95,127,128],"Alpha radiation","Newly Diagnosed Breast Carcinoma","Breast carcinoma","2025-02-06",{"date":131,"type":42},"2025-02-07",{"date":133,"type":42},"2024-02-19",{"date":135,"type":21},"2026-06",{"name":137,"class":78},"Alpha Tau Medical LTD.",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100531627","phase-1-a-study-of-tqb2930-for-injection-monotherapy-or-combination-therapy-in-patients-with-recurrentmetastatic-breast-cancer-100531627","NCT06202261","A Study of TQB2930 for Injection Monotherapy or Combination Therapy in Patients With Recurrent\u002FMetastatic Breast Cancer","A Phase Ib\u002FII Clinical Trial to Evaluate the Safety and Efficacy of TQB2930 for Injection Monotherapy or in Combination for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Recurrent \u002F Metastatic Breast Cancer","Inclusion Criteria:\n\n* Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0\\~1; The expected survival is over 3 months.\n* Phase Ib\n\n  1. Advanced malignancies confirmed by cytology \u002F histopathology, priority given to subjects with HER2 expression or amplification;\n  2. Subjects with malignant tumors who have failed standard treatment or lack effective treatment;\n  3. Confirmed presence of at least one evaluable lesion according to RECIST 1.1 criteria\n* Phase II\n\n  1. Hormone receptor (HR)-negative, HER2-positive breast cancer confirmed by cytology \u002F histopathology, with evidence of local recurrence or distant metastasis, unsuitable for surgery or radiotherapy for curative purposes:\n  2. Have not received systemic antitumor therapy for metastatic stage; Systemic use of endocrine therapy is permitted, but not exceed 2 lines;\n  3. at least one measurable lesion that meets the RECIST 1.1 criteria.\n* Major organs are functioning normally.\n* Female subjects of reproductive age should agree to use contraceptive methods during the study period and until 6 months after the end of the study; Negative serum pregnancy \u002F urine pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; Male subjects should agree to use contraception during the study and until six months after the end of the study.\n\nExclusion Criteria:\n\n* Have occured other malignant tumors within 3 years prior to first dose.\n* Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment;\n* Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the first dose;\n* Long-term unhealed wounds or fractures;\n* Arterial\u002Fvenous thrombosis events occurred within 6 months before the first dose;\n* Have a history of psychotropic drug abuse and can't get rid of it or have mental disorders;\n* Subject with any severe and\u002For uncontrolled disease;\n* Subjects who have been treated with other antitumor agents such as chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first dose, within 5 half-lives of the drug;\n* Have used traditional chinese medicine with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before the first dose;\n* Severe bone injury due to bone metastasis;\n* Subjects with untreated active brain metastases or meningeal metastases or cancerous meningitis;\n* In the course of previous HER2-targeted therapy, Left Ventricular Ejection Fractions (LVEF) decreased to \\\u003C50% or absolute LVEF decreased \\>15%;\n* Cumulative doses of anthracyclines exceeded doxorubicin or doxorubicin liposomes \\>360 mg\u002Fm2;\n* Uncontrolled hypercalcemia or symptomatic hypercalcemia requires continued bisphosphonate therapy\n* Patients with severe hypersensitivity after the use of monoclonal antibodies;\n* Has participated in other antitumor clinical trials within 4 weeks prior to the first dose.","75 Years",{"count":147,"type":21},154,[24,62],"This is a phase Ib\u002FII exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy. After determining the maximum tolerated dose (MTD), a dose expansion study is conducted to observe the safety and efficacy in monotherapy. Phase II study is to further observe the safety and efficacy of TQB2930 combined with albumin-paclitaxel (cohort 3), or chemotherapy selected by investigators (cohort 4).",[30,29,151],"Advanced Malignancies","2024-03-10",{"date":154,"type":42},"2024-03-12",{"date":156,"type":42},"2023-04-13",{"date":158,"type":21},"2027-10",{"name":160,"class":78},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",2]