[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-triple-negative-breast-cancer-tnbc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-triple-negative-breast-cancer-tnbc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100635632","pilot-study-of-bone-mineral-density-changes-during-anti-pd-1-immunotherapy-100635632",false,"NCT07555210","Pilot Study of Bone Mineral Density Changes During Anti-PD-1 Immunotherapy","Pilot Study Assessment of Bone Mineral Density Changes During Treatment With Anti-PD-1 Immunotherapy Agents","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Patients planning to start or within the first four weeks of treatment with anti-PD-1 immune checkpoint inhibitor therapy either alone or in combination with chemotherapy for curative intent for a known cancer diagnosis (use of immunotherapy must be FDA-approved and not experimental).\n3. Life expectancy of at least 12 months per the discretion of the treating physician.\n\nExclusion Criteria:\n\n1. Patients ineligible for anti-PD-1 therapy.\n2. Patients with metastatic disease.\n3. Patients planning treatment with dual immune checkpoint inhibitor therapy.\n4. Bony fractures in the pelvis, bilateral hips\u002Ffemurs, thoracic spine, or lumbar spine.\n5. Known osteoporosis or osteopenia.\n6. Planned or previous treatment with denosumab, zoledronic acid, or other bisphosphonate therapy in the last six months.\n7. Parathyroid gland disorders, rheumatoid arthritis (unless well-controlled off active biologic therapy without chronic steroid use), CKD stage IV\u002FV, or ESRD.\n8. Inability to comply with study procedures.\n9. Inability to lie flat for 20-25 minutes during an imaging session.\n10. Pregnant or breastfeeding patients.\n11. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.","ALL","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"NA","Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment and work by blocking protein interactions that normally prevent the immune system from recognizing and destroying cancer cells. However, these agents, now approved for over 15 types of cancers and for both early-stage and metastatic disease, are capable of causing inflammation in any organ system of the body that can lead to organ damage, dysfunction, and even death in rare cases. Some patients may suffer acute and treatable complications like joint pain, but some may have irreversible complications like hypothyroidism that requires daily, life-long medication. It is therefore important to fully understand the different types of damage ICIs can cause to better monitor patients receiving ICI therapy.\n\nA rising concern from recent reports in the literature is that ICIs may weaken bone and increase the risk of fractures. In this study, the investigators aim to characterize how ICIs impact the bone by examining several factors in patients undergoing curative-intent ICI treatment either alone or in combination with chemotherapy: bone mineral density, bone volume, and markers of bone turnover in the blood. The study will use two imaging techniques to assess bone mineral density and volume. DXA (dual X-ray absorptiometry) imaging uses low-dose X-rays to measure how dense (or strong) bones are and is often used to diagnose or assess the risk of osteoporosis. High-resolution peripheral quantitative computed tomography (HRpQCT) is a 3D imaging technology that can quantify bone structure and volume and offers high resolution that can be used to assess bone in smaller bones of the peripheral skeleton.\n\nThe investigators hypothesize that ICI treatment will weaken bones and increase the risk of fractures. As ICI therapy is relatively new, a rising number of patients may be at risk of fractures or have low bone density that is not being monitored because there are no guidelines in place notifying physicians of this potential risk to patients. This is study will provide important preliminary data that will be the basis for larger studies in the future aiming to better monitor and potentially treat bone weakening in patients treated with ICIs to reduce the pain, inconvenience, and complications from fragility fractures.",[26,27,28,29,30,31,32,33],"Breast Cancer (Triple Negative Breast Cancer (TNBC))","Renal Cell Carcinoma (Kidney Cancer)","Melanoma (Skin Cancer)","Non-Small Cell Lung Cancer","MSI-H\u002FdMMR Rectal Cancer","Squamous Cell Carcinoma Mouth","Invasive Mammary Carcinoma","Classic Hodgkin Lymphoma","RECRUITING","2026-05-04",{"date":37,"type":38},"2026-05-06","ACTUAL",{"date":40,"type":38},"2025-08-25",{"date":42,"type":20},"2028-07-01",{"name":44,"class":45},"Jessica Mezzanotte Sharpe","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":46},"100630426","phase-2-phase-ii-study-of-hlx43-monotherapy-or-combined-with-immune-checkpoint-inhibitors-in-patients-with-locally-advanced-recurrent-or-metastatic-triple-negative-breast-cancer-100630426","NCT07487519","Phase II Study of HLX43 Monotherapy or Combined With Immune Checkpoint Inhibitors in Patients With Locally Advanced, Recurrent, or Metastatic Triple-negative Breast Cancer.","A Phase II Study to Evaluate the Efficacy and Safety of HLX43 (an Anti-PD-L1 ADC) as a Monotherapy or in Combination With Immune Checkpoint Inhibitors in Subjects With Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer (TNBC).","Inclusion Criteria:\n\n1. Voluntary written informed consent obtained before any study procedures.\n2. Age ≥ 18 years at consent; no gender restriction.\n3. Histopathologically confirmed TNBC: ER \\\u003C 1%, PR \\\u003C 1%, HER2 IHC 0\u002F1+\u002F2+ with no FISH amplification.\n\n   * Phase I: Recurrent or metastatic TNBC after ≥1 prior line of standard systemic therapy.\n   * Phase II: Unresectable locally advanced, recurrent, or metastatic TNBC with no prior systemic anti-cancer therapy for this stage (palliative radiotherapy to metastases allowed; neoadjuvant\u002Fadjuvant therapy permitted if completed ≥6 months before recurrence\u002Fmetastasis).\n4. At least one RECIST v1.1-measurable lesion documented within 4 weeks before randomization.\n\n   Note: Target lesions must not be in irradiated fields or the CNS. If only measurable lesion is irradiated, imaging must confirm progression post-radiotherapy.\n5. Archival FFPE tumor tissue (≤6 months old, ≤2 years max) for PD-L1 testing; fresh biopsy acceptable if archival tissue is unavailable or inadequate.\n\n   Note: Specimens must be non-irradiated FFPE blocks\u002Fslides with pathology report confirming malignancy and adequacy.\n6. Washout: ≥3 weeks (or 5 half-lives, whichever is shorter) after major surgery, radiotherapy (except palliative bone RT), chemotherapy, targeted therapy, or immunotherapy; ≥1 week after minor surgery or anti-tumor TCM. All treatment-related AEs resolved to CTCAE v6.0 Grade ≤1 (stable Grade 2 peripheral neuropathy and alopecia exempted).\n7. ECOG PS 0-1, assessed ≤7 days before randomization.\n8. Life expectancy \\>3 months.\n9. Adequate hematologic, hepatic, and renal function per labs ≤7 days before randomization.\n\nExclusion Criteria:\n\n1. Prior topoisomerase I-targeting therapy (e.g., irinotecan, topotecan, or ADCs).\n2. Second primary malignancy within 2 years before randomization (except cured carcinoma in situ or stage I tumors).\n3. Prior grade ≥3 immune-related adverse event during immunotherapy.\n4. Uncontrolled, recurrent malignant pleural, pericardial, or ascitic effusions requiring repeated drainage.\n5. Active CNS metastases, spinal cord compression, or carcinomatous meningitis.\n6. Clinically significant pulmonary impairment.\n7. Uncontrolled cardiovascular or cerebrovascular disease .\n8. Active systemic infection requiring IV antibiotics within 2 weeks before randomization.\n9. Moderate or strong CYP2D6\u002FCYP3A inhibitor or inducer use within 2 weeks before randomization.\n10. Systemic corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressants within 2 weeks before randomization .\n11. Active or suspected autoimmune disease .\n12. Live or attenuated live vaccine within 4 weeks before randomization.\n13. Hypersensitivity to mAbs, large-molecule biologics, or drug formulation excipients.\n14. Active pulmonary tuberculosis.\n15. Known immunodeficiency.\n16. Active HBV , HCV , or HBV\u002FHCV co-infection.\n17. Pregnancy or lactation.\n18. Participation in another interventional trial within 30 days before consent .\n19. Any condition posing unacceptable safety risk or interfering with study conduct per investigator judgment.",{"count":55,"type":20},180,[57],"PHASE2","The study is being conducted to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) as a monotherapy or in combination with immune checkpoint inhibitors in Subjects with locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC).",[26],"NOT_YET_RECRUITING","2026-03-17",{"date":63,"type":38},"2026-03-23",{"date":65,"type":20},"2026-04-25",{"date":67,"type":20},"2028-05-22",{"name":69,"class":70},"Shanghai Henlius Biotech","INDUSTRY"]