[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"invasive-mammary-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:invasive-mammary-carcinoma":32},{"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":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100492563","phase-2-gene-signatures-to-guide-hrmbc-therapy-in-a-diverse-cohort-100492563","NCT05693766","Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort","Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)","INSIGHT","Inclusion Criteria:\n\n* Signed and dated written informed consent.\n* Subjects ≥ 18 years of age.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Clinical stage IV invasive mammary carcinoma or unresectable locoregional recurrence of invasive mammary carcinoma that is:\n\n  * ER (\\>\u002F=1%) and\u002For PR (\\>\u002F= 1%) by IHC and HER2 negative (by IHC or FISH)\n* Previously exposed to an aromatase inhibitor (AI) or a selective estrogenreceptor modulator\u002F downregulator (SERM; SERD) + a CDK4\u002F6 inhibitor.\n* Prior radiation permitted (if completed at least 2 weeks prior to study entry. Patients who have received prior radiotherapy must have recovered from toxicity (≤ grade 1) induced by this treatment (except for alopecia)\n* Patients with brain metastasis secondary to breast cancer and clinically stable for more than 4 weeks from completion of radiation treatment and off steroids\n* Evaluable disease (measurable or non-measurable)\n\n  * Measurable disease, ie, at least 1 measurable lesion as per RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation)\n  * Patients with bone only disease allowed if possible to evaluate on radiological exams (eg.bone scan, PET\u002FCT, CT, MRI) even if lesions are non-measurable according to RECIST1.1.\n* Adequate organ function including:\n\n  * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n  * Platelets ≥ 100 × 10\\^9\u002FL\n  * Hemoglobin ≥ 8\u002Fg\u002FdL (may have been transfused)\n  * Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 2.5 × ULN (or ≤ 5 × ULN if liver metastases are present)\n  * Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50mL\u002Fmin as calculated using the Cockcroft-Gault (CG) equation\n* For randomized patients only: tumors must be diagnosed as non-Luminal A using the Blueprint® and Mammaprint® tests\n\nExclusion Criteria:\n\n* Prior chemotherapy in the metastatic setting\n* Previous malignant disease other than breast cancer within the last 2 years with associated competing risk, with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or low-risk cancers considered curatively treated (i.e. complete remission achieved at least 2 years prior to first dose of study drugs AND additional therapy not required while receiving study treatment).\n* Persisting symptoms related to prior therapy that has not reduced to Grade 1 \\[National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0\\]; however, menopausal symptoms, alopecia, and sensory neuropathy Grade ≤ 2 is acceptable\n* Pregnant or breastfeeding females.",{"count":56,"type":20},64,[58],"PHASE2","This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC)",[32,61],"Metastatic Breast Cancer","2026-01-16",{"date":64,"type":38},"2026-01-20",{"date":66,"type":38},"2023-09-28",{"date":68,"type":20},"2037-08-31",{"name":70,"class":45},"Sonya Reid",3]