[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-neoplasms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-neoplasms":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,139,0,25,[9,44,77,98,118,141,169,195,219,246,270,298,325,361,392,427,451,476,508,535,564,592,622,651,672],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100054274","ultrasound-screening-for-early-detection-of-breast-cancer-in-elderly-women-a-mixed-cluster-individual-rct-100054274",false,"NCT07698366","Ultrasound Screening for Early Detection of Breast Cancer in Elderly Women: A Mixed Cluster-Individual RCT","A Multicenter, Open-label, Mixed Cluster-Individual Randomized Controlled Study on the Efficacy of Breast Cancer Ultrasound Screening","Inclusion Criteria:\n\n\\- Female Age 65-80 years Resident in participating community ≥6 months Signed informed consent\n\nExclusion Criteria:\n\n* History of breast cancer Breast screening within past 2 years Severe comorbid conditions affecting survival Acute breast infection Cognitive impairment affecting participation",true,"FEMALE","65 Years","80 Years",{"count":22,"type":23},82440,"ESTIMATED","INTERVENTIONAL",[26],"NA","This multicenter study aims to evaluate whether active breast ultrasound screening can improve the early diagnosis rate of breast cancer in women aged 65 to 80 years, compared with routine elderly health management. The study uses a mixed cluster-individual randomized design based on community implementation capacity. A subgroup of pilot communities will simultaneously collect ultrasound AI data for research performance analysis only, without affecting clinical diagnosis.",[29,30],"Breast Neoplasms","Early Detection of Cancer","NOT_YET_RECRUITING","2026-07-08",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":23},"2026-07-10",{"date":39,"type":23},"2029-12-31",{"name":41,"class":42},"The First Affiliated Hospital with Nanjing Medical University","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":24,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100590383","phase-3-a-clinical-study-of-sacituzumab-tirumotecan-sac-tmt-mk-2870-in-people-with-breast-cancer-mk-2870-032-100590383","NCT06966700","A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)","A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin\u002FPaclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive\u002FHuman Epidermal Growth Factor Receptor-2 Negative Breast Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and\u002For clinical assessment:\n\n  * cT1c, N1-N2\n  * cT2, N0-N2\n  * cT3, N0-N2\n  * cT4a-d, N0-N2\n* The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+\u002FHER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n* Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).\n* Demonstrates adequate organ function.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement\n* Has received any prior treatment, including radiation, systemic therapy,and\u002For definitive surgery for currently diagnosed breast cancer\n* Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and\u002For axillary sentinel lymph node biopsy prior to study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.\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 coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).\n* Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).\n* Received prior treatment with a topoisomerase I inhibitor-containing ADC.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Uncontrolled systemic disease.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids, has current pneumonitis\u002Finterstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..","ALL","18 Years",{"count":54,"type":23},2400,[56],"PHASE3","Researchers are looking for new ways to treat types of breast cancer that are both:\n\n* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment\n* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive\u002Fhuman epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.\n\nSacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.\n\nThe main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:\n\n* Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy\n* Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy",[29,59,60],"Triple Negative Breast Neoplasms","HR Low-Positive\u002FHER2-Negative Breast Neoplasms",[62,63,64],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","RECRUITING","2026-06-30",{"date":68,"type":35},"2026-07-02",{"date":70,"type":35},"2025-06-30",{"date":72,"type":23},"2034-12-29",{"name":74,"class":75},"Merck Sharp & Dohme LLC","INDUSTRY",310,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":24,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100597616","phase-3-a-clinical-study-of-patritumab-deruxtecan-to-treat-breast-cancer-mk-1022-016-100597616","NCT07060807","A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)","An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of hormone receptor positive (HR+)\u002Fhuman epidermal growth factor receptor 2 (HER2)- invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent\n* Has centrally-confirmed HR+ and HER2- results and human epidermal growth factor receptor 3 (HER3) evaluable results from a biopsy obtained from a distant metastatic site or a locally advanced lesion on or after the most recent line of therapy (with certain exceptions)\n* Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4\u002F6 inhibitor + endocrine therapy (ET) with one of the following:\n\n  * Radiographic disease progression, as assessed by the investigator, on CDK4\u002F6 inhibitor + ET as 1L for treatment of unresectable locally advanced or metastatic HR+\u002FHER2- breast cancer. CDK4\u002F6 inhibitor + ET must be the only line of therapy received in the advanced setting, or\n  * Disease recurrence, either radiographic and\u002For confirmed histologically via biopsy as assessed by the investigator, while on adjuvant ET in combination with a CDK4\u002F6 inhibitor OR within 24 months from the date of last dose of adjuvant CDK4\u002F6 inhibitor\n* Has measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n* Has an Eastern Cooperative Oncology Group performance status of 0 or 1 assessed within 7 days before randomization\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has breast cancer amenable to treatment with curative intent\n* Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator\n* Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) where poly (ADP-ribose) polymerase (PARP) inhibitor(s) is a potential treatment option\n* Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ compromise and\u002For other life-threatening complications\n* Has any of the following: a pulse oximeter reading \\\u003C92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has ≥Grade 2 peripheral neuropathy.\n* Has clinically significant corneal disease\n* Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer\n* Has received prior treatment with an anti-HER3 antibody and\u002For antibody-drug conjugate that consists of a topoisomerase I inhibitor (eg, T-DXd) or any other topoisomerase I inhibitor therapy\n* Has received prior systemic anticancer therapy within 4 weeks (or 5 half-lives, whichever is shorter) before randomization; participants previously treated with ET plus a CDK4\u002F6 inhibitor may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered\n* Has received prior radiotherapy for non-central nervous system disease, or required corticosteroids for radiation-related toxicities, within 14 days of the first dose of study intervention\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, has current pneumonitis\u002Finterstitial lung disease, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at Screening\n* Has severe hypersensitivity (≥Grade 3) to HER3-DXd and\u002For any of its excipients\n* Has severe hypersensitivity (≥Grade 3) to all the available TPC and\u002For any of their excipients",{"count":85,"type":23},1000,[56],"Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+\u002FHER2-) and either unresectable locally advanced or metastatic.\n\n* HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread\n* HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2\n* Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles\n* Metastatic means the cancer has spread to other parts of the body\n\nTreatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing\u002Fspreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.",[29],"2026-06-26",{"date":91,"type":35},"2026-06-29",{"date":93,"type":35},"2025-07-21",{"date":95,"type":23},"2033-07-14",{"name":74,"class":75},184,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":24,"phases":107,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":111,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},"100540079","phase-3-a-study-of-sacituzumab-tirumotecan-mk-2870-as-a-single-agent-and-in-combination-with-pembrolizumab-mk-3475-versus-treatment-of-physicians-choice-in-participants-with-hrher2--unresectable-locally-advanced-or-metastatic-breast-cancer-mk-2870-010-100540079","NCT06312176","A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+\u002FHER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)","An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+\u002FHER2- Unresectable Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Has unresectable locally advanced or metastatic centrally-confirmed hormone receptor positive (HR+)\u002Fhuman epidermal growth factor receptor 2 negative (HER2-) breast cancer\n* Has radiographic disease progression on one or more lines of endocrine therapy for unresectable locally advanced\u002Fmetastatic HR+\u002FHER2- breast cancer, with one in combination with a CDK4\u002F6 inhibitor\n* Is a chemotherapy candidate\n* Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization\n* Has adequate organ function\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load\n* Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n\nExclusion Criteria:\n\n* Has breast cancer amenable to treatment with curative intent\n* Has experienced an early recurrence (\\\u003C6 months after completing adjuvant\u002Fneoadjuvant chemotherapy) and therefore is eligible to receive second-line (2L) treatment\n* Has symptomatic advanced\u002Fmetastatic visceral spread at risk of rapidly evolving into life-threatening complications\n* Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer\n* Active autoimmune disease that has required systemic treatment in the past 2 years\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that requires steroids, or has current pneumonitis\u002Finterstitial lung disease\n* Has an active infection requiring systemic therapy",{"count":106,"type":23},1200,[56],"The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive\u002Fhuman epidermal growth factor receptor-2 negative (HR+\u002FHER2-) unresectable locally advanced, or metastatic, breast cancer.\n\nThe primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.",[29],[62,63,64],{"date":91,"type":35},{"date":113,"type":35},"2024-04-14",{"date":115,"type":23},"2031-04-12",{"name":74,"class":75},259,{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":24,"phases":128,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100615015","phase-2-a-study-of-imlunestrant-ly3484356-in-premenopausal-women-with-estrogen-receptor-positive-er-human-epidermal-growth-factor-receptor-2-negative-her2--early-breast-cancer-100615015","NCT07287098","A Study of Imlunestrant (LY3484356) in Premenopausal Women With Estrogen Receptor-Positive (ER+) Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Early Breast Cancer","preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women With Estrogen Receptor-Positive, HER2-Negative Breast Cancer","preEMBER","Inclusion Criteria:\n\nCohort 1:\n\n* Have histologically confirmed Stage I to III Estrogen Receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) invasive breast carcinoma with Ki-67 at least 10%\n* Be willing and able to provide pre- and on-treatment tumor samples.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Be able to swallow capsules or tablets.\n* Be premenopausal women.\n* If of childbearing potential must use 1 highly effective method of non-hormonal contraception while receiving study treatment and for the duration specified in protocol.\n* Have adequate organ function.\n\nCohort 2:\n\n* Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis\n* Have undergone definitive loco-regional therapy.\n* Have received at least 4.5 years of any adjuvant endocrine therapy (ET), or at least 2 years of adjuvant ET with no additional ovarian suppression planned.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Be able to swallow capsules or tablets.\n* Be premenopausal women\n* If of childbearing potential must use 1 highly effective method of non-hormonal contraception while receiving study treatment and for the duration specified in protocol.\n* Have adequate organ function.\n\nExclusion Criteria:\n\nCohort 1:\n\n* Have bilateral invasive metastatic, occult primary, or inflammatory breast cancer.\n* Have had prior bilateral oophorectomy or ovarian ablation.\n* Have a serious medical condition\n* Had major surgery within 28 days prior to randomization.\n* Have a history of other cancer (except non melanoma skin cancer, Stage I uterine cancer, or carcinoma in situ of the cervix or other in situ cancer), unless in complete remission with no therapy for a minimum of 1 year.\n* Plan to receive concurrent neoadjuvant therapy with any other non-protocol anticancer therapy.\n* Have had any prior therapy for an invasive or non-invasive breast cancer.\n* Have had prior radiotherapy to the ipsilateral chest wall for any malignancy.\n* Have received prior anti-estrogen therapy, including for osteoporosis or prevention of breast cancer.\n* Have had prior treatment with any Gonadotropin-releasing hormone (GnRH) agonist within 12 months prior to randomization.\n* Receiving current exogenous reproductive hormone therapy\n\nCohort 2:\n\n* Have ovarian cyst(s) greater than (\\>) 1 centimeter (cm) at screening.\n* Have metastatic occult primary, or inflammatory breast cancer.\n* Have had prior bilateral oophorectomy or ovarian ablation.\n* Have a serious medical condition\n* Had major surgery within 28 days prior to randomization.\n* Have a history of other cancer (except non melanoma skin cancer or carcinoma in situ of the cervix or other in situ cancer), unless in complete remission with no therapy for a minimum of 1 year.\n* Completed or discontinued prior adjuvant ET \\>6 months prior to screening.\n* Have received prior therapy with any selective estrogen receptor degrader (SERD).\n* Receiving current exogenous reproductive hormone therapy.",{"count":127,"type":23},600,[129],"PHASE2","This study will include two groups of patients: Cohort 1 and Cohort 2.\n\nCohort 1: will help researchers learn how a medicine called imlunestrant (LY3484356) affects a specific type of breast cancer. Some patients will take both imlunestrant and another treatment to suppress their ovarian function. Some will take it without ovarian suppression. Researchers will compare the effects in breast cancer cells to those of another medicine called tamoxifen. All patients in this group will be premenopausal women who have a type of early breast cancer called estrogen receptor-positive, HER2-negative. The treatment in this group will last for up to 29 days.\n\nCohort 2: will help researchers understand how imlunestrant affects the ovaries when it is taken without ovarian suppression. Researchers will compare the effects to those of another medicine called tamoxifen. This group will also include premenopausal women with the same type of breast cancer. The treatment in this group will last for up to 6 months.",[29],"2026-06-25",{"date":89,"type":35},{"date":135,"type":35},"2026-05-13",{"date":137,"type":23},"2029-12",{"name":139,"class":75},"Eli Lilly and Company",71,{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":24,"phases":150,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":168},"100606299","phase-3-rosetta-breast-01-the-effects-and-safety-of-pumitamig-in-patients-with-triple-negative-breast-cancer-100606299","NCT07173751","ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer","A Phase III, Multisite, Randomized, Double-Blind Trial of BNT327 in Combination With Chemotherapy Versus Placebo With Chemotherapy in Patients With Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC Determined Ineligible for PD(L)1 Therapy Based on PD-L1 Negative Disease","Inclusion Criteria:\n\n* Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.\n* Have confirmed locally recurrent inoperable or metastatic TNBC, or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (ER and\u002For progesterone receptor \\[PgR\\]) 1% to 10%, HER2 immunohistochemistry \\[IHC\\] 0, 1+, or 2+ with fluorescence in situ hybridization \\[FISH\\] negative for HER2 gene amplification) documented prior to trial screening as part of standard of care.\n* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.\n* Have provided a tissue sample, archival or fresh, during the screening period (bone biopsies, fine needle aspiration biopsies, and samples from pleural or peritoneal fluid are not acceptable; participants with only one target lesion are not eligible to participate in the trial).\n* Eastern cooperative oncology group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Have received any of the following therapies or drugs prior to the initiation of trial:\n\n  * Have received prior systemic anticancer therapy for advanced disease.\n  * Have received prior treatment with a PD(L)-1\u002Fvascular endothelial growth factor (VEGF) bispecific antibody.\n  * Have received systemic corticosteroids (at a dosage greater than 10 milligrams \\[mg\\]\u002Fday of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of trial treatment. Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\\\u003C= 7 days) of corticosteroids for prophylaxis (for example, prevention of contrast agent allergy) or treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by exposure to allergens).\n  * Have been vaccinated with live attenuated vaccine(s) within 4 weeks prior to initiation of trial treatment.\n  * Have received broad-spectrum intravenous antibiotics therapy within 2 weeks prior to initiation of trial treatment.\n* Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the trial or within 6 months after the last dose of pumitamig or placebo.\n* Have undergone major organ surgery, significant trauma, or invasive dental procedures (such as dental implants) within 28 days prior to the initiation of trial treatment or plan to undergo elective surgery during the trial. Placement of vascular infusion devices is allowed.\n* Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.",{"count":149,"type":23},558,[56],"This is a Phase III trial where participants will be randomized to two treatment groups, which means participants will be assigned by equal chance to a treatment group. This trial will be double-blinded, which means neither the participants nor the trial doctors will know which of the two treatments the participants actually receive. Participants will receive either the trial drug with chemotherapy or placebo (which looks like the trial drug but does not have any drug in it) with chemotherapy.",[29],[154,155,156,157,158,159],"Metastatic TNBC","Bispecific antibody","Programmed death-ligand 1 (PD-L1)","Immunotherapy","Immunotherapy in combination with chemotherapy","Combination with other investigational agents","2026-06-24",{"date":132,"type":35},{"date":163,"type":35},"2025-10-30",{"date":165,"type":23},"2030-09",{"name":167,"class":75},"BioNTech SE",143,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":180,"conditions":181,"keywords":182,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":194},"100598333","screening-tool-artificial-intelligence-based-for-predicting-the-genetic-risk-of-breast-cancer-100598333","NCT07070128","Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer","Screening Tool Artificial Intelligence-based for Predicting the Genetic Risk of BREAST Cancer (STAR-BREAST)","STAR-BREAST","Inclusion Criteria:\n\n* female patients,\n* aged 18 years or older,\n* identified as high genetic risk by breast surgeons,\n* referred to a geneticist, and\n* who agree to participate in the study.\n\nExclusion Criteria:\n\n* male patients,\n* absence of complete information in the medical records,\n* patients unaware of their biological family history, and\n* patients who do not agree to participate in the study.",{"count":178,"type":23},800,"OBSERVATIONAL","It is a retrospective observational study that will include female patients aged 18 years or older, who were treated between 2017 and 2024, in both public and private institutions, and identified as at high genetic risk by breast specialists and referred to a geneticist. The artificial intelligence-based tool to be used in this study is developed by the startup WeConecta, which will collect data via WhatsApp about the patients' family cancer history with the aim of predicting the genetic risk of developing breast cancer.",[29],[183,184,185],"Breast Cancer","Artificial Intelligence","Genetic Risk","2026-06-23",{"date":160,"type":35},{"date":189,"type":35},"2025-08-20",{"date":191,"type":23},"2026-08-11",{"name":193,"class":75},"AstraZeneca",3,{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":24,"phases":205,"briefSummary":206,"conditions":207,"keywords":208,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":43},"100476090","phase-2-neoadjuvant-radiation-in-locally-advanced-breast-cancer-100476090","NCT05479409","Neoadjuvant Radiation in Locally Advanced Breast Cancer","Effect of Neoadjuvant Radiation and Prediction of Response to Treatment in Locally Advanced Breast Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed locally advanced breast carcinoma\n* Inoperable with with 4-6 courses of prior chemotherapy\n* No contradiction of radiation or chemo-radiotherapy\n* Patients should have the ability to understand and the willingness to sign a written informed consent document\n* Signed informed consent must be obtained prior to any study specific procedures\n\nExclusion Criteria:\n\n* Other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or contralateral breast DCIS\n* Coagulation disorders\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia\n* Serious underlying medical illness with life expectancy less than 2 years.\n* Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.","70 Years",{"count":204,"type":23},70,[129],"The purpose of this study is to evaluate the efficacy and safety of neoadjuvant radiation therapy in improving local-regional control and facilitating surgical conversion in patients with inoperable locally advanced breast cancer after 2-6 courses of neoadjuvant chemotherapy. This study will also investigate whether beta-alanine supplementation and spatially fractionated radiotherapy can enhance the therapeutic response to neoadjuvant chemoradiotherapy. In addition, this study aims to explore tumor microenvironmental features and molecular biomarkers associated with treatment response, radioresistance, immune activation, and long-term outcomes.",[29],[209,210,211],"breast cancer","neoadjuvant radiotherapy","biomarkers",{"date":89,"type":35},{"date":214,"type":35},"2021-03-01",{"date":216,"type":23},"2027-12",{"name":218,"class":42},"Fudan University",{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":24,"phases":228,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":7},"100411722","phase-2-a-long-term-treatment-extension-study-of-niraparib-in-participants-who-completed-a-prior-glaxosmithklinetesaro-sponsored-niraparib-study-100411722","NCT04641247","A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline\u002FTESARO-sponsored Niraparib Study","An Open-Label, Multicenter, Long-term Treatment Extension Study in Subjects Who Have Completed a Prior GlaxoSmithKline\u002FTESARO-Sponsored Niraparib Study and Are Judged by the Investigator to Benefit From Continued Treatment With Niraparib","Inclusion Criteria:\n\n* Participant is able to understand the study procedures and agrees to participate in the study by providing written informed consent.\n* Participant is willing and able to comply with scheduled visits, treatment plans, and any other study procedures.\n* Participant is currently receiving treatment with niraparib (as monotherapy or in combination) in a GlaxoSmithKline\u002FTESARO-sponsored study that has fulfilled the requirements for the primary objective.\n* Participant is currently benefiting from treatment with niraparib as assessed by the Investigator according to the parent study protocol requirements.\n* Participants of childbearing potential who are sexually active and their partners must agree to the use of an effective form of contraception throughout their participation during study treatment through 180 days after last dose of study drug.\n\nExclusion Criteria:\n\n* Participant has been permanently discontinued from niraparib treatment in the parent study for any reason.\n* Participant currently has unresolved toxicities for which niraparib dosing has been interrupted in the parent study. Participants meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow niraparib treatment to resume.\n* Participant is pregnant or is expecting to conceive children while receiving study drug or for up to 180 days after the last dose of study drug. Participant is breastfeeding or is expecting to breastfeed within 30 days of receiving the final dose of study drug (women should not breastfeed or store breastmilk for use during niraparib treatment and for 30 days after receiving the final dose of study treatment).",{"count":227,"type":23},37,[129],"This is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within GlaxoSmithKline\u002FTESARO-sponsored studies (NCT01847274, NCT02354586, NCT01905592, NCT03308942, NCT02657889) that has fulfilled the requirements for the primary objective.",[231,29],"Ovarian Neoplasms",[233,234,235,236,237],"Adverse events","Open-label extension","Parent study","Niraparib","Safety","2026-06-22",{"date":160,"type":35},{"date":241,"type":35},"2021-04-16",{"date":243,"type":23},"2026-12-28",{"name":245,"class":75},"GlaxoSmithKline",{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":24,"phases":255,"briefSummary":256,"conditions":257,"keywords":259,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},"100606344","phase-3-a-study-of-tersolisib-ly4064809stx-478-with-other-anti-cancer-treatments-in-participants-with-advanced-breast-cancer-with-a-genetic-change-pik3ca-100606344","NCT07174336","A Study of Tersolisib (LY4064809\u002FSTX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4\u002F6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)","Inclusion Criteria:\n\n* Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* If assigned female at birth, pre-\u002Fperi- and postmenopausal status is allowed. Those with pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist.\n* If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist.\n* Have histologically or cytologically confirmed breast cancer, defined as individuals with\n\n  * locally advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease, and\n  * hormone receptors (HR)+\u002Fhuman epidermal growth factor receptor 2 (HER2)- or HR+\u002FHER low defined by American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) Guidelines\n\n    * HR status: Documented ER+ and\u002For progesterone receptor-positive (PR+) tumor according to ASCO\u002FCAP Guidelines, defined as greater than or equal to (≥)1 percent (%) of tumor cells stained positive based on the most recent tumor biopsy and assessed locally\n    * HER status: immunohistochemistry score of 1+ or score of 2+ with a negative Fluorescence In Situ Hybridization (FISH) based on local results as defined in the ASCO\u002FCAP Guidelines\n* Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.\n* Have measurable disease or non-measurable, evaluable bone disease\n* Part 1:\n\n  * Received 0-2 prior systemic treatments for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.\n  * Up to 1 of these prior systemic treatments may contain chemotherapy\n* Part 2:\n\n  * Received 0 prior systemic treatment for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.\n  * Individuals who are eligible are either\n\n    * Population 1 (P1): Endocrine sensitive\n\n      * newly diagnosed with advanced breast cancer (de novo)\n      * relapsed with documented evidence of progression greater than (\\>)12 months from completion of (neo)adjuvant ET ± cyclin-dependent kinases 4 and 6 (CDK4\u002F6) inhibitor, or\n    * Population 2 (P2): Endocrine resistant\n\n      * relapsed with documented evidence of progression less than or equal to (≤)12 months of completing (neo)adjuvant ET ± CDK4\u002F6 inhibitor.\n      * if a CDK4\u002F6 inhibitor was included as part of neoadjuvant or adjuvant therapy, progression event must be \\>12 months since completion of CDK4\u002F6 inhibitor portion of neoadjuvant or adjuvant therapy.\n\nExclusion Criteria:\n\n* Have an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg\u002FdL) (7.7 millimoles per liter \\[mmol\u002FL\\]), or requiring insulin.\n* Have inflammatory or metaplastic breast cancer.\n* History of leptomeningeal disease or carcinomatous meningitis.\n* Have known and untreated or active central nervous system (CNS) metastases. Exception: Asymptomatic brain or spinal metastases if treated by surgery, surgery plus radiotherapy, or radiotherapy alone with no evidence of radiographic progression or hemorrhage within at least 28 days before randomization and no requirement for anticonvulsants or systemic corticosteroids for at least 28 days before randomization.\n* Have received treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days.\n* Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dose more than 10 milligrams \\[mg\\] daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.\n* Are pregnant, breastfeeding, or intend to become pregnant during the study or within 6 months of the last dose of study intervention and at least 2 years after the last dose of fulvestrant and\u002For CDK4\u002F6 inhibitor after the final administration of study treatment.",{"count":254,"type":23},920,[56],"The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809\u002FSTX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)\u002Fhuman epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.",[29,258],"Neoplasm Metastasis",[260,261],"STX-478","PI3K","2026-06-19",{"date":186,"type":35},{"date":265,"type":35},"2025-12-22",{"date":267,"type":23},"2033-05",{"name":139,"class":75},330,{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":24,"phases":280,"briefSummary":282,"conditions":283,"keywords":289,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":297},"100601754","phase-1-a-study-of-ly4257496-in-participants-with-cancer-omniray-100601754","NCT07114601","A Study of LY4257496 in Participants With Cancer (OMNIRAY)","A Phase 1a\u002Fb Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults With GRPR-Positive Advanced Solid Tumors (OMNIRAY)","OMNIRAY","Inclusion Criteria:\n\n* Must have histologically or cytologically proven diagnosis of locally advanced, unresectable, or metastatic cancer.\n* Must be assessed by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI) to confirm at least 1 of the following:\n\n  * At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n  * If only bone lesions are present without a soft-tissue component, a bone scan or MRI must confirm at least 2 detectable lesions considered to represent active metastases\n* Must have GRPR-positive disease, defined by investigator assessment of GRPR imaging.\n* Must have the following histologically or cytologically confirmed diagnosis:\n\n  * Estrogen receptor (ER+)\u002Fhuman epidermal growth factor receptor 2 (HER2-) breast cancer\n  * ER+\u002FHER2+ breast cancer\n  * Esophageal squamous cell carcinoma\n  * Adenocarcinoma of the stomach, gastroesophageal junction, or esophagus\n  * Colorectal carcinoma\n  * Metastatic castration-resistant prostate cancer\n  * Endometrial carcinoma. Carcinosarcoma is eligible. Uterine leiomyosarcoma, adenosarcoma, or endometrial stromal sarcoma is not eligible.\n  * Low-grade papillary serous ovarian cancer\n  * Other non-Central Nervous System (CNS) primary GRPR-positive solid tumors (Cohorts A1 dose escalation and D1 dose expansion only)\n* For participants with breast cancer diagnosis, where possible, ER and HER2 status should be assessed from the most recent tissue biopsy taken at the time of presentation with recurrent or metastatic disease.\n\n  * To fulfill the requirement for ER+ disease by local testing, a tumor must express the ER immunohistochemistry, as defined in the relevant American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n  * HER2 status should be determined by local testing, as defined in the relevant ASCO\u002FCAP Guidelines.\n* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1.\n* Must be able to comply with outpatient treatment, laboratory monitoring, imaging, and required clinic visits for the duration of trial participation.\n\nExclusion Criteria:\n\n* Phase 1a (Cohort A1 and A2) only: Previously received radiopharmaceutical or radioligand therapy. For participants with prostate cancer, prior ¹⁷⁷Lu-prostate-specific membrane antigen (PSMA) is permitted.\n* Has a history of ongoing acute pancreatitis within 1 year of screening.\n* Previously received any prior hemi-body or whole-body radiotherapy, or prior external beam radiation therapy (EBRT) to greater than 25% of the bone marrow.\n* A bone superscan, defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity.\n* Has evidence of ongoing and untreated urinary tract obstruction or unmanageable urinary incontinence.\n* Have known active hepatitis B virus (HBV). Exception: Individuals with chronic HBV if they:\n\n  * Have positive HBsAg\n  * Are on suppressive antiviral therapy, as allowed per local regulations prior to C1D1\n  * Remain on the same antiviral treatment throughout study, and should follow local standards for continuation of therapy after completion of trial therapy.\n  * Have undetectable HBV DNA ≤14 days of C1D1.\n* Have known active hepatitis C virus (HCV). Exception: Individuals previously treated for HCV if they:\n\n  * Completed curative antiviral therapy.\n  * Have an HCV viral load below the limit of quantification ≤14 days of C1D1 and.\n  * Are positive for anti-HCV antibodies and negative for HCV ribonucleic acid (RNA) before randomization.\n* Have untreated human immunodeficiency virus (HIV) infection. Exception: Individuals who have well-controlled HIV infection\u002Fdisease and they:\n\n  * Are on a stable and permitted antiretroviral therapy (ART) regimen without changes in drug or dose, for at least 4 weeks prior to C1D1\n  * Have a viral load of \\\u003C400 copies\u002FmL ≤14 days of C1D1.\n  * Have a CD4+ T-cell count ≥350 cells\u002FmL ≤14 days of C1D1.\n  * Have not had an opportunistic infection within the past 12 months.\n* Has an active second malignancy unless in remission with life expectancy greater than 2 years.\n* Has known hypersensitivity to any component or excipient of LY4257496.",{"count":279,"type":23},421,[281],"PHASE1","The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.",[29,284,285,286,258,287,288],"Colorectal Neoplasms","Prostate Neoplasm","Endometrial Neoplasms","Stomach Neoplasms","Esophageal Neoplasms",[290],"GRPR-positive",{"date":186,"type":35},{"date":293,"type":35},"2025-08-06",{"date":295,"type":23},"2035-04",{"name":139,"class":75},32,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":18,"minAge":52,"maxAge":19,"enrollmentInfo":306,"targetDuration":4,"studyType":24,"phases":308,"briefSummary":309,"conditions":310,"keywords":311,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":324},"100628913","impact-of-prehabilitation-and-comprehensive-follow-up-in-women-with-breast-cancer-100628913","NCT07467824","Impact of Prehabilitation and Comprehensive Follow-up in Women With Breast Cancer","Impact of Prehabilitation With Exercise and Nutrition, and Comprehensive Follow-up in Women With Breast Cancer: The PREACT Trial","PREACT","Inclusion Criteria:\n\n* Women who have a newly confirmed diagnosis of stage 0-III breast cancer.\n* Age 18 to 65 years old with a body mass index between 18.5 and 35 kg·m-².\n* Have a medical indication for surgery or neoadjuvant systemic treatment (chemotherapy or hormone therapy) or radiotherapy.\n* Be able to perform supervised physical exercise, as determined by prior medical assessment.\n* Understand and voluntarily sign the written informed consent before the start of the study.\n\nExclusion Criteria:\n\n* Women with a diagnosis of metastatic breast cancer.\n* Women with any medical condition that contraindicates physical exercise, such as severe cardiovascular disease, significant respiratory or kidney failure.\n* Women with presence of serious uncontrolled comorbidities, such as decompensated diabetes, severe hypertension or acute psychiatric disorders, among others.\n* Women with severe functional limitations that prevent planned interventions from being performed (e.g., physical disabilities that compromise exercise).\n* Women who are pregnant, breastfeeding, or likely to become pregnant during the trial or who have inability to communicate.",{"count":307,"type":23},66,[26],"Breast cancer (BC) is the most common cancer among women worldwide. Cancer treatments are associated with numerous adverse events that reduce patients' functionality and alter their clinical and molecular profiles. Physical exercise and adherence to nutritional guidelines during treatment and survivorship have been shown to improve recovery prognosis and reduce treatment-related complications. However, the specific effects of prehabilitation, defined as \"the process in the cancer continuum that occurs between diagnosis and the start of treatment,\" remain unknown in BC. A concurrent training program and specific nutritional guidelines during this phase could reduce treatment-related adverse events and improve recovery. Similarly, including a home-based exercise program and nutritional guidelines throughout the cancer treatment continuum could enhance the benefits achieved and improve various aspects of functionality, clinical status, and quality of life. Therefore, the main aim of this randomized controlled trial is to evaluate the impact and effects of a supervised prehabilitation program (combining high-intensity concurrent training and personalized nutritional guidelines) and a supportive care intervention (home-based exercise and personalized nutritional guidelines) on functional, neuromuscular, and cardiorespiratory capacity, quality of life, body composition, and clinical and molecular outcomes in women with BC. In addition, the sustainability of the benefits achieved in the long-term care and the evolution of the outcomes assessed throughout the continuum of cancer treatments will be analyzed.",[183,29],[312,313,314,315],"prehabilitation","exercise","nutrition","training","2026-06-18",{"date":238,"type":35},{"date":319,"type":35},"2026-04-14",{"date":321,"type":23},"2029-05",{"name":323,"class":42},"European University Miguel de Cervantes",2,{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":51,"minAge":332,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":24,"phases":336,"briefSummary":337,"conditions":338,"keywords":343,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":4},"100641936","nudging-preventive-screening-via-message-framing-and-bundling-100641936","NCT07644910","Nudging Preventive Screening Via Message Framing and Bundling","The Effect of Message Framing and Screening Bundling on Preventive Screening Engagement: A Randomized Field Experiment","Inclusion Criteria:\n\n* Has at least one pending cancer screening (breast, colorectal, cervical, or prostate) within the contact window, as determined by the medical institution\n* Aged 21 to 74 years\n* Has a valid phone number on file\n* Eligibility is determined operationally before randomization (ex-ante)\n\nExclusion Criteria:\n\n* Participants whose WhatsApp message was not successfully delivered, as reported by the third-party software used by the medical institution.","21 Years","74 Years",{"count":335,"type":23},235000,[26],"This study is a randomized controlled field experiment embedded in the medical institution Early Diagnosis Program in Chile. Participants with two exams pending (a cancer screening test and a chronic disease test for diabetes and dyslipidemia) will be randomly assigned across a 3 × 3 factorial design: three message framing conditions (Basic, Risk\u002FImportance, Peace of Mind) crossed with three exam-type conditions (cancer screening only, chronic disease test only, or both exams). Participants with only a cancer screening pending will be assigned to the 3 framing conditions and be encouraged to get the cancer screening.\n\nIn both cases, participants are assigned to each experimental arm at twice the rate of an additional arm receiving the standard message currently used by the medical institution. This standard-message arm is included for operational purposes, is not part of the pre-specified analyses, and is thus not described in the \"Arms and Intervention\" section (or counted for \"number of arms\").",[29,339,284,340,341,342],"Uterine Cervical Neoplasms","Prostatic Neoplasms","Diabetes Mellitus","Dyslipidemias",[344,345,346,347,348,349,350,351],"Behavioral science","randomized controlled trial","WhatsApp patient outreach","message framing","information avoidance","cancer screening","chronic disease testing","preventive care","2026-06-15",{"date":354,"type":35},"2026-06-17",{"date":356,"type":23},"2026-06-08",{"date":358,"type":23},"2026-12-08",{"name":360,"class":42},"University of Chile",{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":369,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":24,"phases":372,"briefSummary":373,"conditions":374,"keywords":379,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":43},"100425138","breast-cancer-reasoning-and-activity-intervention-100425138","NCT04816006","Breast Cancer, Reasoning, and Activity Intervention","Enhancing Cognitive Function in Breast Cancer Survivors Through Community-based Exercise Training","BRAIN","Inclusion Criteria\n\n* PRE-REGISTRATION: Age ≥50 years at time of pre-registration visit according to participant report and\u002For clinical determination\n* PRE-REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer according to participant report and\u002For clinical determination\n* PRE-REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and\u002For radiation therapy) 3-36 months prior to registration according to participant report and\u002For clinical determination\n* PRE-REGISTRATION: Sedentary except for casual lifestyle recreation defined as self-reporting no more than 90 minutes per week of moderate-intensity aerobic exercise within the last 6 months\n* PRE-REGISTRATION: Self-reported ability to complete assessments by themselves or with assistance\n* REGISTRATION: Age ≥50 years as confirmed via clinical determination\n* REGISTRATION: Able to provide medical record release to confirm eligibility\n* REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer as confirmed via clinical determination\n* REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and\u002For radiation therapy) 3-36 months prior to pre-registration as confirmed via clinical determination\n* REGISTRATION: No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive status (13-item modified version) (TICS-M; score \\> 21) NOTE: Only individuals who pass the TICS-M during pre-registration will be invited to participate in the urine substudy\n* REGISTRATION: Receive physician's clearance to participate in an exercise program\n\nNOTE: Individuals with conditions\u002Fdiagnoses deemed important by the primary investigator will be required to provide clearance for exercise from their cardiologist. Example conditions include:\n\n* History of major multiple myocardial infarctions (MI)\n* Recent electrocardiogram (ECG) changes or recent MI\n* Resting or unstable angina\n* Significant multivessel coronary occlusion (≥ 70%) on angiography\n* Uncontrolled and\u002For serious arrhythmias\n* 3rd degree heart block\n* Acute congestive heart failure or ejection fraction \\\u003C 30%\n\n  * REGISTRATION: Ability to complete assessments by themselves or with assistance\n\nExclusion Criteria:\n\n* PRE-REGISTRATION: Stage 0 breast cancer diagnosis OR metastatic disease\n* PRE-REGISTRATION: Currently receiving or \\\u003C 3 months since receiving chemotherapy or radiation therapy for cancer, or greater than 36 months post primary treatment\n* PRE-REGISTRATION: Planned surgery during the intervention period\n* PRE-REGISTRATION: Second cancer diagnosis (excluding non-invasive skin cancers or carcinoma-in-situ for any cancer)\n* PRE-REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection\n* PRE-REGISTRATION: Unwilling to return to enrolling institution for follow-up\n* PRE-REGISTRATION: Self-reported inability to walk without assistance or devices\n* REGISTRATION: History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal as confirmed via clinical determination\n* REGISTRATION: Clinically significant TICS-M score (\\\u003C 21) during baseline procedures\n* REGISTRATION: Not able to provide physician re-clearance for exercise if required based upon clinically significant baseline exercise test (as determined by ECG and blood pressure monitoring)\n* REGISTRATION: Contraindications to functional magnetic resonance imaging (fMRI) in accordance with the Mayo Clinic Department of Radiology safety protocols\n* REGISTRATION: Clinically significant MRI scan as determined by physician review in which the following is advised via radiologist overread: remarkable\u002Fabnormal limited diagnostic brain image with recommended medical follow-up\n* REGISTRATION: Enrolled in another physical activity program\n* REGISTRATION: Unable to walk without assistance or devices\n* REGISTRATION: Unwilling to complete study requirements\n* REGISTRATION: Unwilling to be randomized to the exercise group or health education group\n* REGISTRATION: Unable or unwilling to continuously wear and regularly sync\u002Fcharge an activity tracker during the study period\n* REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection\n* REGISTRATION: Unwilling to return to enrolling institution for follow-up","50 Years",{"count":371,"type":23},160,[26],"This phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of life, and long-term health. Aerobic exercise has the potential to improve cognitive function and brain health in older adults and is recommended as a safe, tolerable, and accessible complementary therapy for breast cancer survivors. This study aims to understand the effects of physical activity compared with health education on memory, attention, and brain health in women with breast cancer. Study findings may help researchers design more programs that can improve memory, attention, and brain health in other women with breast cancer.",[183,29,375,376,377,378],"Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Cancer-related Cognitive Dysfunction",[380,313,381,382,209],"physical activity","cognition","brain health","2026-06-11",{"date":385,"type":35},"2026-06-12",{"date":387,"type":35},"2024-02-22",{"date":389,"type":23},"2028-07-31",{"name":391,"class":42},"Mayo Clinic",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":24,"phases":402,"briefSummary":403,"conditions":404,"keywords":412,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":43},"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":401,"type":23},297,[129],"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)",[405,406,183,407,408,409,410,411,29],"Estrogen-receptor-positive Breast Cancer","Metastatic Breast Cancer","Hormone Receptor Positive Breast Cancer","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","HER2- Breast Cancer","ESR1 Gene Mutation","ER Wildtype",[413,406,414,415,416,409,417,418],"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":385,"type":35},{"date":422,"type":35},"2026-01-16",{"date":424,"type":23},"2030-10-01",{"name":426,"class":42},"Kristina A. Fanucci",{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":435,"enrollmentInfo":436,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":450},"100483350","providence---prospective-non-interventional-study-nis-to-examine-patient-reported-outcomes-and-real-world-clinical-data-in-patients-with-her2-positive-her2-low-or-her2-ultralow-unresectable-or-metastatic-breast-cancer-treated-with-trastuzumab-deruxtecan-100483350","NCT05573893","PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan","Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan","PROVIDENCE","Inclusion Criteria:\n\n1. Adults ≥ 18 years old\n2. Patients (irrespective of sex and gender) with pathologically documented breast cancer that:\n\n   * is unresectable or metastatic\n   * has confirmed HER2+, HER2-low or HER2-ultralow tumor status by local pathology\n   * was previously treated with one or more anti-HER2 directed therapy if the tumor is HER2+ OR\n   * was previously treated with at least one endocrine therapy in the metastatic setting and is not considered suitable for endocrine therapy as the next line of treatment if the tumor is HR+, HER2-low or HER2-ultralow OR\n   * was previously treated with prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy if the tumor is HER2-low.\n3. Has documented radiologic progression (during or after most recent treatment)\n4. Patient is eligible for T-DXd treatment in line with the specifications mentioned in the ENHERTU® SmPC and is scheduled for T-DXd treatment \\*\n5. Patient is able to read and understand either German or English\n6. Signed written informed consent\n\n   * The prescription of the medicinal product is clearly separated from the decision to include the patient in this NIS.\n\nExclusion Criteria:\n\n1. Start of T-DXd treatment for more than 30 days before enrolment (eCRF registration date)\n2. Known hypersensitivity to T-DXd or any of the excipients of the drug\n3. Pregnancy or breast feeding\n4. Current or planned participation in an interventional clinical trial\n5. Current or planned systemic treatment of any tumor other than unresectable or metastatic BC\n\nPatients who have never received any T-DXd dose will be discontinued from the study and will be considered as a late screening failure, no further documentation besides reason and date of discontinuation is needed.","130 Years",{"count":178,"type":23},"This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor receptor 2 (HER2)-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer (BC) receiving T-DXd in line with the applicable summary of product characteristics (SmPC) within routine clinical practice in Germany. In addition, patients will be informed about use of digital healthcare application (DiGA).",[29,183,258],[440,441,442,443],"Trastuzumab-Deruxtecan,","Human epidermal growth factor receptor 2 Positive Breast Cancer,","Human epidermal growth factor receptor 2 Low Breast Cancer,","Human epidermal growth factor receptor 2 Ultralow Breast Cancer,",{"date":385,"type":35},{"date":446,"type":35},"2023-09-12",{"date":448,"type":23},"2031-12-31",{"name":193,"class":75},107,{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":24,"phases":460,"briefSummary":461,"conditions":462,"keywords":463,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":475},"100587321","phase-2-a-study-of-izalontamab-brengitecan-versus-chemotherapy-in-participants-with-previously-untreated-locally-advanced-recurrent-inoperable-or-metastatic-triple-negative-breast-cancer-ineligible-for-anti-pdl1-drugs-izabright-breast01-100587321","NCT06926868","A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)","IZABRIGHT-Breast01: A Randomized, Open-label, Inferentially Seamless Phase 2\u002F3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer (TNBC) or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1\u002FPD-L1 Treatment","Inclusion Criteria\n\n* Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER \\\u003C 1%, PgR \\\u003C 1%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and \u002F or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification) per ASCO\u002FCAP criteria, based on the most recently analyzed biopsy or other pathology specimen.\n* Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent.\n* Patients with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 or an anti-PD-L1 due to either one of the following criteria:\n\n  i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC; ii) Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1; iii) Has a severe auto-immune disease or other contraindication.\n* Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.\n* No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting).\n* Measurable disease by CT or MRI as per RECIST v1.1.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":459,"type":23},500,[129,56],"The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.",[29],[464,465,466],"triple-negative breast cancer","antibody-drug conjugate","ER-low\u002FHER2-negative breast cancer","2026-06-09",{"date":419,"type":35},{"date":470,"type":35},"2025-09-11",{"date":472,"type":23},"2030-05-15",{"name":474,"class":75},"Bristol-Myers Squibb",295,{"id":477,"slug":478,"hasResults":12,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":483,"enrollmentInfo":484,"targetDuration":4,"studyType":24,"phases":486,"briefSummary":487,"conditions":488,"keywords":490,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":43},"100601954","phase-1-a-phase-i-study-of-68gaga-dwj155-in-patients-with-breast-and-lung-cancers-100601954","NCT07117214","A Phase I Study of [68Ga]Ga-DWJ155 in Patients With Breast and Lung Cancers","A Phase I, Open Label First in Human Study to Evaluate the Imaging Performance, Safety, Biodistribution and Pharmacokinetics of [68Ga]Ga-DWJ155 in Adult Patients With Advanced Breast Cancer and Advanced NSCLC","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Patients with histologically or cytologically confirmed and documented HR+\u002FHER2- advanced breast cancer (aBC), advanced defined as locoregionally advanced unresectable or metastatic, either untreated or currently receiving first line of systemic therapy OR patients with histologically or cytologically confirmed and documented HER2+ aBC, advanced defined as locoregionally advanced unresectable or metastatic, either untreated or relapsed\u002Frefractory (r\u002Fr) after one or more lines of treatment OR patients with histologically or cytologically confirmed and documented advanced NSCLC (aNSCLC) adenocarcinoma, advanced defined as locoregionally unresectable or metastatic, either untreated or currently receiving first line of systemic therapy.\n* Presence of measurable disease (at least one target lesion) according to RECIST v1.1 assessed by conventional CT scan.\n\nExclusion Criteria:\n\n* Patients having out of range laboratory values for kidney function and blood markers as defined in the study protocol\n* Patients with inadequate hepatic function\n* Unmanageable urinary tract obstruction or urinary incontinence\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":485,"type":23},36,[281],"This is a phase I, open label first in human study to evaluate the imaging performance, safety, biodistribution and pharmacokinetics of \\[68Ga\\]Ga-DWJ155 in patients ≥ 18 years of age with hormone receptor positive\u002FHER2 negative (HR+\u002FHER2-) and HER2 positive (HER2+) advanced breast cancer (aBC) and advanced Non-Small Cell Lung Cancer (aNSCLC) adenocarcinoma.",[29,489],"Carcinoma, Non-Small-Cell Lung",[414,491,492,493,494,495,496,497,498,499,500],"Non-small cell lung cancer","Radioligand imaging","[68Ga]Ga-DWJ155","FKL480","gallium","adenocarcinoma","ductal","lobular","positron emission tomography (PET)","dosimetry",{"date":467,"type":35},{"date":503,"type":23},"2026-06-01",{"date":505,"type":23},"2028-10-31",{"name":507,"class":75},"Novartis Pharmaceuticals",{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":17,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":517,"conditions":518,"keywords":523,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":4},"100643796","non-contrast-breast-mri-diagnosis-and-risk-stratification-using-dwi-generated-synthetic-contrast-enhancement-100643796","NCT07598084","Non-Contrast Breast MRI Diagnosis and Risk Stratification Using DWI-Generated Synthetic Contrast Enhancement","Artificial Intelligence Solution for Simplifying the Diagnostic Workflow of Breast MRI: Development and Clinical Validation of a Diffusion-Weighted Imaging-Based Synthetic Contrast-Enhanced MRI System for Non-Contrast Breast Cancer Diagnosis and Risk Stratification","Inclusion Criteria:\n\n1. Complete breast MRI data;\n2. Negative pathology biopsy results or negative follow-up examinations for at least 12 months for non-cancer cases;\n3. Positive biopsy results that meet the requirements for the pathological subtype of cancer for cancer cases;\n4. Original data that can be used to verify clinical status, including radiological and pathological reports;\n\nExclusion Criteria:\n\n1. Partial mastectomy or puncture biopsy on the diseased side of the breast prior to breast MRI examination;\n2. Poor image quality;\n3. Implants in the affected breast;",{"count":516,"type":23},12000,"This study is conducted under the ethics-approved project titled \"Artificial Intelligence Solution for Simplifying the Diagnostic Workflow of Breast MRI''.The goal of this observational study is to develop an integrated breast MRI system that uses diffusion-weighted imaging (DWI) to create synthetic contrast-enhanced images. This system aims to diagnose and screen for breast cancer without the need for contrast agents, while using a generated risk score to perform imaging-based triage and risk stratification.\n\nParticipants will include people aged 18 and older who require a breast MRI either for evaluation of a suspicious finding or for high-risk screening.\n\nThis study seeks to answer two main questions:\n\n* Can synthetic contrast-enhanced images generated from DWI match real contrast-enhanced images in their ability to distinguish benign from malignant breast lesions?\n* Can the risk score derived from DWI-based synthetic images enable imaging-level risk stratification, allowing people at lower risk to avoid contrast agent injection? Researchers will compare the quality of synthetic images against real contrast-enhanced images and will recruit radiologists to assess how well these images perform for diagnostic and screening tasks. MRI data from participants undergoing breast MRI will be used to train, validate, and test this integrated system.",[29,519,520,521,522],"Artificial Intelligence (AI)","Magnetic Resonance Imaging (MRI)","Diffusion Magnetic Resonance Imaging","Deep Learning",[524,525,184,526],"Breast","Magnetic Resonance Imaging","Deep learning","2026-06-05",{"date":467,"type":35},{"date":530,"type":23},"2026-06",{"date":532,"type":23},"2027-05",{"name":534,"class":42},"Peking University People's Hospital",{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":24,"phases":545,"briefSummary":546,"conditions":547,"keywords":550,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":563},"100609377","phase-1-a-study-of-ly4337713-in-participants-with-fap-positive-solid-tumors-100609377","NCT07213791","A Study of LY4337713 in Participants With FAP-Positive Solid Tumors","A Dose Escalation and Dose Optimization Phase 1a\u002F1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)","FiREBOLT","Inclusion Criteria:\n\n* Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment\n* Must have histologically or cytologically confirmed diagnosis of one of the following:\n\n  * Adenocarcinoma of the pancreas\n  * Hormone receptor (HR)-positive human epidermal growth factor 2 (HER2)-negative breast cancer\n  * HER2-positive breast cancer\n  * Triple negative breast cancer (TNBC)\n  * Platinum-resistant or refractory ovarian cancer (including ovarian carcinosarcoma)\n  * Other solid tumors\n\n    * Gastric cancer (adenocarcinoma)\n    * Colorectal cancer (CRC)\n    * Esophageal cancer (squamous cell carcinoma or adenocarcinoma)\n    * Cholangiocarcinoma\n* Must have received prior treatments as indicated below:\n\n  * Phase 1a\n\n    * Adenocarcinoma of the pancreas: Participants must have received at least 1, but no more than 2 prior regimens for locally advanced unresectable or metastatic disease.\n    * HR-positive HER2-negative breast cancer: Participants must have received less than or equal to (≤)5 prior lines of treatment for advanced or metastatic disease, which must include a cyclin-dependent kinase 4\u002F6 inhibitor.\n    * HER2-positive breast cancer: Participants must have received at least 2 lines of HER2-targeted therapy, which should include at least 1 antibody-drug conjugate (ADC) for metastatic disease (if locally available).\n    * TNBC: Participants must have received at least 2 lines of therapy for metastatic disease.\n    * Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy.\n    * Other solid tumors (gastric cancer, CRC, esophageal and cholangiocarcinoma): Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; including prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.\n  * Phase 1b:\n\n    * Participants must have advanced or metastatic solid tumors and have received ≥1 prior line of therapy.\n* Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.\n* Measured creatinine clearance ≥60 milliliters per minute (mL\u002Fmin)\n\nExclusion Criteria:\n\n* Have known active central nervous system (CNS) metastases or carcinomatous meningitis.\n* Have significant cardiovascular disease\n* Have prolongation of the corrected QTcF \\>470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT\u002F(RR0.33)\n* Have evidence of ongoing and untreated urinary tract obstruction\n* Had previous hemi- or total-body radiation.\n* Had previous adoptive T-cell therapy (e.g., chimeric antigen receptor T-cell \\[CAR-T therapy, T-cell receptor \\[TCR\\] therapy, etc.)\n* Unable to lie flat during, or otherwise tolerate, single photon emission computed tomography (SPECT), positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI).",{"count":544,"type":23},241,[281],"This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.",[231,29,548,284,288,287,549],"Pancreatic Intraductal Neoplasms","Cholangiocarcinoma",[551,552,553,554],"Cancer-associated fibroblasts (CAF)","Lutetium-177","LuFAP","Lu-177-FAP","2026-06-03",{"date":557,"type":35},"2026-06-04",{"date":559,"type":35},"2025-10-22",{"date":561,"type":23},"2033-03",{"name":139,"class":75},30,{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":570,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":24,"phases":574,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":591},"100468924","phase-1-study-of-abemaciclib-and-elacestrant-in-participants-with-brain-metastasis-due-to-erher-2--breast-cancer-100468924","NCT05386108","Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+\u002FHER-2- Breast Cancer","An Open-label Multicenter Phase 1b-2 Study of Elacestrant in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer","ELECTRA","Inclusion Criteria:\n\n1. Participant has the signed informed consent form before any study-related activities according to local guidelines.\n2. Women or men aged ≥18 years, at the time of informed consent signature.\n\n   * Female participants may be either postmenopausal or pre\u002Fperimenopausal. Postmenopausal status is defined by:\n\n     1. Age ≥60 years\n     2. Age \\\u003C60 years and amenorrhea for 12 or more months without an alternative cause) and follicle stimulating hormone and estradiol in postmenopausal ranges per local reference ranges\n     3. Documentation of prior bilateral oophorectomy, at least 1 month before first dose of trial therapy).\n   * Pre-menopausal \u002F peri-menopausal women and men must be concurrently receiving a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 3-4 weeks before the start of trial therapy and is planning to continue LHRH during the study.\n3. Participant must have ER-positive, HER-2 negative tumor status as confirmed by local laboratory testing in the following manner:\n\n   * Documentation of ER positive tumor with ≥ 1% staining by immunohistochemistry (IHC) as defined in the 2010 or 2020 American Society for Clinical Oncology (ASCO) recommendations for ER testing, with or without progesterone receptor (PGR) positivity\n   * HER-2 negative tumor with an IHC result of 0 or 1+ for cellular membrane protein expression or an in situ hybridization negative result as defined in the 2013 or 2018 ASCO recommendations for HER-2 testing\n4. In Phase 2, participants must have at least one active and measurable brain metastasis per RECIST version 1.1.\n\n   * Any of the following qualifies brain metastases as active:\n\n     1. Newly diagnosed brain metastasis in participants who never received prior central nervous system (CNS)-directed therapy.\n     2. Newly diagnosed brain metastasis outside any area that was previously subjected to CNS-directed therapy.\n     3. Brain metastases demonstrating unequivocal progression in the opinion of the treating investigator in an area that has previously been subjected to CNS-directed therapy.\n   * For lesions, including brain metastases, to qualify as measurable, and possibly be selected as target lesions, per RECIST version 1.1, the longest diameter must be ≥10 millimeters \\[mm\\] by computed tomography \\[CT\\] or magnetic resonance imaging \\[MRI\\]).\n   * In Phase 1b, the presence of brain metastases is allowed but not required for eligibility, in this case, at least 1 measurable lesion outside the brain is required.\n5. Participants receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 7 days prior to baseline and not receiving doses higher than 4 mg of dexamethasone per day or equivalent.\n6. Participants have experienced no more than one seizure within 4 weeks prior to starting trial therapy.\n7. Participants' prior therapy received in the metastatic setting includes:\n\n   * At least one endocrine therapy\n   * Up to two chemotherapy regimens\n   * Up to two lines of prior cyclin-dependent kinase (CDK) 4\u002F6 inhibitor, not including abemaciclib\n\n   Note 1: Toxicity from prior therapy must be resolved to NCI CTCAE version 5.0 Grade ≤1, with the exception of alopecia and peripheral sensory neuropathy (Grade ≤2).\n\n   Note 2: Chemotherapy refers to not targeted cytotoxic agents (for example, alkylating agents, taxanes, nucleotide analogs, platinum-based drugs, vinca alkaloids, etc) and antibody drug conjugates (ADCs). Targeted therapies (for example, kinase inhibitors) are not considered chemotherapy for eligibility purposes. Not targeted cytotoxic agents administered for less than 1 cycle will not be counted as a prior chemotherapy regimen.\n8. Participant has documented intracranial and\u002For extracranial radiological progression or recurrence while on or after the most recent therapy.\n9. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2\n10. Participant has a life expectancy ≥ 12 weeks.\n11. Participant has adequate bone marrow and organ function, as defined by the following laboratory values:\n\n    1. Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002Fliter (L)\n    2. Platelets ≥100 × 10\\^9\u002FL\n    3. Hemoglobin ≥9.0 grams (g)\u002Fdeciliter (dL)\n    4. Potassium, sodium, calcium (corrected for serum albumin) and magnesium CTCAE Grade ≤1 (if screening assessments are abnormal, these assessments may be repeated up to 2 times; participants may receive appropriate supplementation or treatment prior to reassessment)\n    5. Creatinine clearance (per Cockcroft-Gault formula) ≥50 mL\u002Fminute\n    6. Serum albumin ≥3.0 g\u002FdL (≥30 g\u002FL)\n    7. Liver function tests:\n\n       In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × upper limit of normal (ULN). If the participant has liver metastases, ALT and AST ≤5.0 × ULN.\n    8. Total serum bilirubin \\\u003C1.5 × ULN except for participants with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN\n12. The participant is willing and able to adhere to the study visit schedule and other protocol requirements.\n\nExclusion Criteria:\n\n1. Immediate CNS-specific treatment is likely to be required, per the treating physician's assessment.\n2. Participant has imminent organ failure and\u002For visceral crisis.\n3. Participant has leptomeningeal metastases, defined as having positive cerebrospinal fluid (CSF) cytology or unequivocal radiologic and clinical evidence of leptomeningeal involvement. Note: Discrete dural metastases are permitted.\n4. Breast cancer treatment-naïve participants (that is, not having received any systemic therapy) in the advanced\u002Fmetastatic setting.\n5. History of pulmonary embolism (PE), cardiovascular accident (CVA), myocardial infarction (MI) in the past 6 months from screening visit.\n6. Prior therapy with abemaciclib in the metastatic setting. Note: Use of abemaciclib in the adjuvant setting is allowed if the last treatment administration was more than 12 months prior to first recurrence.\n7. Prior therapy with elacestrant or other investigational selective estrogen receptor degraders (SERDs), or investigational alike agents such as selective estrogen receptor modulators (SERMs), selective estrogen receptor covalent antagonists (SERCANs), complete estrogen receptor antagonists (CERANs), and proteolysistargeting chimeras (PROTACs) in the metastatic setting.\n8. Participant has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix, or second primary breast cancer; and any other malignancy that is considered in complete remission by the Investigator(s) that is approved by the Medical Monitor.\n9. Currently participating in another breast cancer intervention clinical study. Participants who are being followed for overall survival for another clinical trial with no therapy and study intervention are allowed after the washout period for any prior therapy.\n10. Prior anti-cancer or investigational drug treatment within the following windows:\n\n    * Fulvestrant treatment (last injection) \\\u003C42 days before first dose of study drug\n    * Any other endocrine therapy \\\u003C14 days before first dose of study drug. Note: LHRH agonists should not be counted as endocrine therapy.\n    * Chemotherapy or other anti-cancer therapy \\\u003C14 days before first dose of study drug\n    * Any investigational anti-cancer drug therapy within \\\u003C28 days or \\\u003C5 half lives, whichever is shorter\n    * Bisphosphonates or receptor activator of nuclear factor-κB ligand (RANKL) inhibitors initiated, or dose changed \\\u003C1 month prior to first dose of study drug according to institutional guidelines.\n11. Radiation therapy (including CNS directed) within 7 days before the first dose of study drug or without a full recovery from radiotherapy acute effects.\n12. Uncontrolled significant active infections\n\n    * Participants with hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV) infection must have undetectable viral load (or detected below the lower limit of quantification) during screening\n    * Participants known to be human immunodeficiency virus positive (HIV+) are allowed as long as they have undetectable viral load (viral suppression) at baseline.\n13. Major surgery within 4 weeks of starting trial therapy.\n14. Inability to take oral medication, or history of malabsorption syndrome or any other uncontrolled gastrointestinal condition that may significantly alter the absorption of study drugs.\n15. Females of childbearing potential who do not agree to use a highly effective non-hormonal method of contraception and to abstain from donating ova within 28 days of the first dose of study treatment through 120 days after the last dose of study treatment. Highly effective non-hormonal method of contraception includes any of the following:\n\n    1. Intrauterine device (non-hormonal)\n    2. Sexual abstinence\n    3. Bilateral tubal occlusion\u002Fligation\n    4. Have a vasectomized partner with confirmed azoospermia.\n16. Male participants (including males after a vasectomy) with a pregnant or non-pregnant female of childbearing potential partner who do not agree to use a highly effective barrier contraception method (condoms) within 28 days of the first dose of study treatment until 120 days of the last dose of study treatment. And male participants who do not agree to abstain from freezing or donating sperm within the same period. In addition, female partners of childbearing potential, of male participants (who has not undergone vasectomy) must use highly effective methods of contraception.\n17. Females who are pregnant or breastfeeding. Females should not get pregnant during study treatment and for 120 days after last dose of study treatment. Females should not breastfeed during administration of elacestrant and for 1 week after receiving the last dose.\n18. Known intolerance to either study drug or any of their excipients.\n19. Participants currently receiving or received any of the following medications prior to first dose of trial therapy:\n\n    1. Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 (including foods and herbal preparations) within 14 days or \\\u003C5 half-lives, whichever is shorter)\n    2. Herbal preparations\u002Fmedications (which are not strong or moderate inducers or inhibitors of CYP3A4). These include, but are not limited to, kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng within 7 days prior to initiating trial therapy\n    3. Vaccination, including but not limited to vaccination against coronavirus disease-19 (COVID-19), during the 7 days prior to randomization.\n20. Any severe medical or psychiatric condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study.",{"count":573,"type":23},73,[281,129],"This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.",[29,577,578,579,580,581,582,583],"Brain Neoplasms","Neoplasms by Site","Neoplasms","Breast Diseases","Central Nervous System Neoplasms","Brain Diseases","Central Nervous System Diseases",{"date":557,"type":35},{"date":586,"type":35},"2022-08-31",{"date":588,"type":23},"2026-12",{"name":590,"class":75},"Stemline Therapeutics, Inc.",86,{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":18,"minAge":599,"maxAge":202,"enrollmentInfo":600,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":602,"conditions":603,"keywords":605,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":324},"100250641","acute-and-long-term-cardiovascular-toxicity-after-modern-radiotherapy-for-breast-cancer-100250641","NCT02541435","Acute and Long-term Cardiovascular Toxicity After Modern Radiotherapy for Breast Cancer","Acute and Long-term Cardiovascular Toxicity After Modern Radiotherapy for Breast Cancer - a Prospective Longitudinal Study","Inclusion Criteria:\n\n* diagnosis of breast cancer\n* expected life-expectancy above 10 years\n\nExclusion Criteria:\n\n* Not willing to participate","30 Years",{"count":601,"type":23},1600,"In Europe, breast cancer is by far the most common form of cancer diagnosed in women today, accounting for 29% of all cases. The 5-year survival rate is approximately 90%. Surgery is usually combined with radiotherapy (RT), anthracyclines, aromatase inhibitors and\u002For trastuzumab (Herceptin) which all have improved the life expectancy and survival in breast cancer patients.\n\nUnfortunately, RT is associated with a broad spectrum of cardiovascular diseases, which includes coronary artery disease, valvular dysfunction, congestive heart failure and stroke, and is the most common non-malignancy cause of death. During the last two decades, RT regimens for breast cancer have changed and the doses of radiation to which the heart is exposed are now potentially lower due to new and improved RT techniques. However, there are no data on whether these new regimes decrease the risk of cardiovascular disease.\n\nIn this study the incidence and prevalence of cardiovascular diseases will be estimated 8 and 15 years after both conventional and laser assisted breath controlled RT, and compared with cardiovascular diseases in the general female population. A further aim is to evaluate signs and prevalence of acute cardiotoxicity from RT with the use of cardiac magnetic resonance imaging, coronary fractional flow reserve, ECG and inflammatory and cardiac biomarkers and to investigate whether these signs can predict later cardiovascular disease. The importance of traditional cardiovascular risk factors (age, hypertension, hypercholesterolemia, smoking habits and physical activity, as registered before RT) will also be evaluated.",[29,604],"Cardiovascular Diseases",[606,607,608,609,610,611,612,613],"Radiotherapy","Biological markers","Magnetic resonance imaging","Echocardiography","Tomography, X-Ray Computed","Risk factors","Heart","Quality of Life","2026-06-02",{"date":557,"type":35},{"date":617,"type":35},"2016-11",{"date":619,"type":23},"2036-12",{"name":621,"class":42},"St. Olavs Hospital",{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":483,"enrollmentInfo":630,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":632,"conditions":633,"keywords":634,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":650},"100579932","a-non-interventional-study-for-kisqali-ribociclib-in-combination-with-an-aromatase-inhibitor-for-adjuvant-treatment-in-patients-with-hrher2--early-breast-cancer-at-high-risk-of-recurrence-100579932","NCT06830720","A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+\u002FHER2- Early Breast Cancer at High Risk of Recurrence","A Non-interventional Study for Kisqali (Ribociclib) in Combination With an Aromatase Inhibitor for Adjuvant Treatment in Patients With HR+\u002FHER2- Early Breast Cancer at High Risk of Recurrence to Evaluate Real-world Effectiveness, Safety Profile, Patient Compliance and Quality of Life","CAROLEEN","Inclusion Criteria:\n\n* Histological diagnosis of HR+\u002FHER2- early breast cancer with curative intent\n* Patients must have an indication for a treatment with ribociclib + AI ± LHRH as described in the current SmPC\u002F\"Fachinformation\" of ribociclib (to be included into the cohorts of ribociclib + AI ± LHRH and ET mono ± LHRH) or abemaciclib + ET ± LHRH as described in the current SmPC\u002F\"Fachinformation\" of abemaciclib (to be included into the abemaciclib + ET ± LHRH cohort) in the adjuvant setting\n* Before enrollment the treating physician has made the decision in accordance with the patient to treat the patient with either\n\n  * ribociclib + AI ± LHRH, or\n  * ET mono ± LHRH, or\n  * abemaciclib + ET ± LHRH and baseline is no longer than 2 weeks (14 days) prior to written informed consent for this study.\n\nBaseline = for ribociclib + AI ± LHRH cohort: date of therapy start; for abemaciclib + ET ± LHRH cohort: date of therapy start; for ET mono ± LHRH cohort: within 4 weeks after therapy start or within 4 weeks after last non-endocrine based therapy, whichever is last.\n\n* ≥18 years of age\n* Written informed consent\n\nExclusion Criteria:\n\n\\- Patient is simultaneously participating in any investigational trial or simultaneously participating in another Novartis-sponsored non-interventional study with ribociclib.",{"count":631,"type":23},3250,"This non-interventional observational study evaluates the real-world effectiveness and safety profile of ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+\u002FHER2- early breast cancer at high risk of recurrence, as well as patient compliance and quality of life.",[29],[635,636,209,637,638,639,640,641,642],"Non-interventional study","NIS","early breast cancer","HR+","HER-","ribociclib","real world evidence","adjuvant therapy","2026-05-28",{"date":503,"type":35},{"date":646,"type":35},"2025-02-20",{"date":648,"type":23},"2030-06-30",{"name":507,"class":75},283,{"id":652,"slug":653,"hasResults":12,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":4,"eligibilityCriteria":657,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":658,"targetDuration":4,"studyType":24,"phases":660,"briefSummary":661,"conditions":662,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":671},"100568835","phase-1-study-of-patritumab-deruxtecan-with-other-anticancer-agents-in-participants-with-her2-positive-breast-cancer-that-has-spread-and-cannot-be-surgically-removed-mk-1022-009-100568835","NCT06686394","Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)","HERTHENA-Breast-01: A Phase 1b\u002F2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer\n* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention\n\nArm 1:\n\n* Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting\n* Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment\n\nArm 2:\n\n-Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting\n\nArm 3:\n\n-Has received and had disease progression from T-DXd treatment in any setting and a maximum of 3 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting. T-DXd must be the most recent therapy received before enrollment.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Uncontrolled or significant cardiovascular disease\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has clinically severe respiratory compromise\n* Has any history of or evidence of any current leptomeningeal disease\n* Has clinically significant corneal disease\n* Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection\n* HIV infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Evidence of spinal cord compression or brain metastases\n* Has an active infection requiring systemic therapy\n* Concurrent active HBV and HCV infection\n* Has had major surgical procedure (excluding placement of vascular access) less than 28 days\n\nArm 3 ONLY\n\n\\- Has received prior treatment with tucatinib, lapatinib, or neratinib, or any investigational HER2-targeted tyrosine kinase inhibitors in the locally advanced or metastatic setting",{"count":659,"type":23},81,[281,129],"Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn:\n\n* About the safety and how well people tolerate of patritumab deruxtecan\n* How many people have the cancer respond (get smaller or go away) to treatment",[29,183],"2026-05-20",{"date":665,"type":35},"2026-05-22",{"date":667,"type":35},"2025-02-26",{"date":669,"type":23},"2030-04-18",{"name":74,"class":75},18,{"id":673,"slug":674,"hasResults":12,"nctId":675,"briefTitle":676,"officialTitle":677,"acronym":4,"eligibilityCriteria":678,"healthyVolunteers":12,"sex":51,"minAge":52,"maxAge":4,"enrollmentInfo":679,"targetDuration":4,"studyType":24,"phases":681,"briefSummary":682,"conditions":683,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":684,"lastUpdatePostDateStruct":685,"startDateStruct":686,"completionDateStruct":688,"leadSponsor":690,"locationsCount":691},"100577387","phase-2-study-of-patritumab-deruxtecan-plus-pembrolizumab-with-other-anticancer-agents-in-participants-with-high-risk-early-stage-triple-negative-or-hormone-receptor-low-positiveher-2-negative-breast-cancer-mk-1022-010-herthena-breast-03-100577387","NCT06797635","Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive\u002FHER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)","An Open-label Randomized Phase 2 Study to Evaluate Safety and Efficacy of Patritumab Deruxtecan Plus Pembrolizumab Administered Either Before or After Carboplatin\u002FPaclitaxel Plus Pembrolizumab Compared With Pembrolizumab in Combination With Chemotherapy Followed by Surgery and Adjuvant Pembrolizumab for High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive\u002FHuman Epidermal Growth Factor Receptor-2 Negative Breast Cancer (HERTHENA-Breast03)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has locally advanced, non-metastatic (M0), breast cancer, defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee on Cancer (AJCC) criteria: cT1c, N1-N2; cT2, N0-N2; cT3, N0-N2; or cT4a-d, N0-N2\n* Has centrally confirmed diagnosis of breast cancer that is triple-negative or HR-low+\u002FHER2- breast cancer that will be treated according to the triple-negative breast cancer (TNBC) paradigm\n* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load\n* Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 28 days prior to allocation\u002Frandomization\n* Has left ventricular ejection fraction (LVEF) of ≥50% or ≥ lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigate acquisition scan (MUGA) scan\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has uncontrolled or significant cardiovascular disease before randomization\n* Has any history of or evidence of any current leptomeningeal carcinomatosis.\n* Has clinically significant corneal disease\n* Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcoma and\u002For multicentric Castleman disease\n* Has evidence of ongoing, uncontrolled, systemic bacterial, fungal, or viral infection\n* Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor\n* Has received any prior treatment, including radiation, systemic therapy, and\u002For definitive surgery for currently diagnosed breast cancer\n* Has received prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody and\u002For antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan)\n* Has metastatic (Stage IV) breast cancer or cN3 nodal involvement\n* Has known additional malignancy that is progressing or has required active treatment within the past 5 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, or current or suspected ILD\n* Has an active infection requiring systemic therapy\n* Has concurrent active HBV and HCV infection\n* Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness",{"count":680,"type":23},372,[129],"Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive\u002Fhuman epidermal growth factor receptor-2 (HER2) negative breast cancer. The main goals of this study are to learn:\n\n* About the safety of the study treatments and if people tolerate them\n* If people who receive patritumab deruxtecan, pembrolizumab, and chemotherapy before surgery have fewer cancer cells removed during surgery compared to those who receive only pembrolizumab (pembro) and chemotherapy.",[29,183],"2026-05-19",{"date":663,"type":35},{"date":687,"type":35},"2025-03-20",{"date":689,"type":23},"2034-12-31",{"name":74,"class":75},17]