[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05307705":3,"trial-entities:NCT05307705":518,"trial-summary:NCT05307705":524},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":64,"secondary_outcomes":72,"sex":105,"minimum_age":106,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":107,"std_ages":151,"locations":154,"central_contacts":504,"overall_officials":510,"references":514,"see_also_links":515},"NCT05307705","18394","A Study of LOXO-783 in Patients With Breast Cancer\u002FOther Solid Tumors","A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation","RECRUITING","2026-12","2026-07","2026-07-20","2022-05-11","Eli Lilly and Company","INDUSTRY",false,"The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.",null,[19],"Breast Cancer",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},260,"ESTIMATED",[29,43,47,52,57,60],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":41},"DRUG","LOXO-783","Oral",[34,35,36,37,38,39,40],"Phase 1A: LOXO-783 Monotherapy Dose Escalation","Phase 1B: Part A","Phase 1B: Part B","Phase 1B: Part C","Phase 1B: Part D","Phase 1B: Part E","Phase 1B: Part F",[42],"LY3849524",{"type":30,"name":44,"description":45,"armGroupLabels":46},"Fulvestrant","Intramuscular",[35,36,37,40],{"type":30,"name":48,"description":32,"armGroupLabels":49,"otherNames":50},"Imlunestrant",[35,36],[51],"LY3484356",{"type":30,"name":53,"description":32,"armGroupLabels":54,"otherNames":55},"Abemaciclib",[36],[56],"LY2835219",{"type":30,"name":58,"description":32,"armGroupLabels":59},"Anastrozole, Exemestane, or Letrozole",[35,36],{"type":30,"name":61,"description":62,"armGroupLabels":63},"Paclitaxel","Intravenous",[38],[65,69],{"measure":66,"description":67,"timeFrame":68},"Phase 1 a: To determine the maximum tolerated dose\u002Frecommended phase 2 dose (MTD\u002FRP2D) of LOXO-783: Number of patients with dose-limiting toxicities (DLTs)","Number of patients with DLTs","During the first 28-day cycle of LOXO-783 treatment",{"measure":70,"description":71,"timeFrame":68},"Phase 1 a: To determine the MTD\u002FRP2D of LOXO-783: Number of patients with DLT-equivalent toxicities","Number of patients with DLT-equivalent toxicities",[73,77,80,84,87,90,93,96,99,102],{"measure":74,"description":75,"timeFrame":76},"To assess the pharmacokinetics (PK) of LOXO-783: Area under the concentration versus time curve (AUC)","PK of LOXO-783: AUC","Up to 2 months",{"measure":78,"description":79,"timeFrame":76},"To assess the PK of LOXO-783: Maximum drug concentration (Cmax)","PK of LOXO-783: Cmax",{"measure":81,"description":82,"timeFrame":83},"To evaluate the preliminary antitumor activity of LOXO-783: Overall response rate (ORR)","ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)","Up to approximately 36 months or 3 years",{"measure":85,"description":86,"timeFrame":83},"To evaluate the preliminary antitumor activity of LOXO-783: Best overall response (BOR)","BOR per investigator assessed RECIST 1.1",{"measure":88,"description":89,"timeFrame":83},"To evaluate the preliminary antitumor activity of LOXO-783: Duration of response (DOR)","DOR per investigator assessed RECIST 1.1",{"measure":91,"description":92,"timeFrame":83},"To evaluate the preliminary antitumor activity of LOXO-783: Disease control rate (DCR)","DCR per investigator assessed RECIST 1.1",{"measure":94,"description":95,"timeFrame":83},"To evaluate the preliminary antitumor activity of LOXO-783: Clinical benefit rate (CBR)","CBR per investigator assessed RECIST 1.1",{"measure":97,"description":98,"timeFrame":83},"To evaluate the preliminary antitumor activity of LOXO-783: Time to response (TTR)","TTR per investigator assessed RECIST 1.1",{"measure":100,"description":101,"timeFrame":83},"To evaluate the preliminary antitumor activity of LOXO-783: Progression free survival (PFS)","PFS per investigator assessed RECIST 1.1",{"measure":103,"description":104,"timeFrame":83},"To evaluate the preliminary antitumor activity of LOXO-783: Overall survival (OS)","OS per investigator assessed RECIST 1.1","ALL","18 Years",{"inclusion":108,"exclusion":139,"raw_text":150},[109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,128,131,132,133,134,131,135,121,136,137,128,122,138],"Have advanced breast cancer or another solid tumor with the presence of a phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation)","Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available.","Have stopped all cancer treatment and have recovered from the major side effects","Have adequate organ function, as measured by blood tests","Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale","Patients must have","Measurable disease","Non-measurable bone disease (at least 1 bone lesion in breast cancer patients only)","For patients with an estrogen receptor (ER)+ breast cancer diagnosis:","If female, must be postmenopausal","If male, must agree to use hormone suppression","Phase 1a:","Advanced solid tumor","Patients may have had up to 5 prior regimens for advanced disease","Phase 1b:","Part A:","ER+\u002Fhuman epidermal growth factor receptor 2 (HER2)- advanced breast cancer","Patients may have had up to 5 prior regimens for advanced disease ---- Prior cyclin dependent kinase (CDK)4\u002F6 inhibitor therapy required","Part B:","ER+\u002FHER2- advanced breast cancer","Patients may have had up to 2 prior regimens for advanced disease.","Part C:","Patients may have had up to 5 prior regimens for advanced disease.","Have a diagnosis of diabetes mellitus Type 2","Part D:","Advanced breast cancer","Part E:","Patients may have had up to 3 prior regimens for advanced disease advanced disease","Part F:","Prior cyclin dependent kinase (CDK)4\u002F6 inhibitor therapy required",[140,141,142,143,144,145,146,147,148,149],"Medical Conditions","Colorectal cancer","Endometrial cancers with specific concurrent oncogenic alterations","A history of known active or suspected","Diabetes mellitus Type 1 or","Diabetes mellitus Type 2 requiring antidiabetic medication (Phase 1a and all parts of Phase 1b except Part C).","Serious concomitant systemic disorder","Known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.","Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or other clinically significant active disease process","Prior exposure to phosphatidylinositol 3-kinase\u002Fprotein kinase B\u002Fmammalian target of rapamycin (PI3K\u002FAKT\u002FmTOR) inhibitor(s), except in certain circumstances","Inclusion Criteria:\n\n* Have advanced breast cancer or another solid tumor with the presence of a phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation)\n* Have adequate archival tumor tissue sample available or be approved by the Sponsor for enrollment if no tumor sample is available.\n* Have stopped all cancer treatment and have recovered from the major side effects\n* Have adequate organ function, as measured by blood tests\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale\n* Patients must have\n\n  * Measurable disease\n\n    \\--- Patients with non-breast tumor types must have at least 1 measurable lesion\n  * Non-measurable bone disease (at least 1 bone lesion in breast cancer patients only)\n* For patients with an estrogen receptor (ER)+ breast cancer diagnosis:\n\n  * If female, must be postmenopausal\n  * If male, must agree to use hormone suppression\n* Phase 1a:\n\n  \\-- Dose escalation and backfill patients:\n  * Advanced solid tumor\n  * Patients may have had up to 5 prior regimens for advanced disease\n* Phase 1b:\n\n  * Part A:\n\n    * ER+\u002Fhuman epidermal growth factor receptor 2 (HER2)- advanced breast cancer\n    * Patients may have had up to 5 prior regimens for advanced disease ---- Prior cyclin dependent kinase (CDK)4\u002F6 inhibitor therapy required\n  * Part B:\n\n    * ER+\u002FHER2- advanced breast cancer\n    * Patients may have had up to 2 prior regimens for advanced disease.\n  * Part C:\n\n    * ER+\u002FHER2- advanced breast cancer\n    * Patients may have had up to 5 prior regimens for advanced disease.\n\n      \\---- Prior CDK4\u002F6 inhibitor therapy required.\n    * Have a diagnosis of diabetes mellitus Type 2\n  * Part D:\n\n    * Advanced breast cancer\n    * Patients may have had up to 5 prior regimens for advanced disease.\n  * Part E:\n\n    * Advanced solid tumor\n    * Patients may have had up to 3 prior regimens for advanced disease advanced disease\n  * Part F:\n\n    * ER+\u002FHER2- advanced breast cancer\n    * Patients may have had up to 5 prior regimens for advanced disease\n\n      * Prior cyclin dependent kinase (CDK)4\u002F6 inhibitor therapy required\n\nExclusion Criteria:\n\n* Medical Conditions\n\n  * Colorectal cancer\n  * Endometrial cancers with specific concurrent oncogenic alterations\n  * A history of known active or suspected\n\n    * Diabetes mellitus Type 1 or\n    * Diabetes mellitus Type 2 requiring antidiabetic medication (Phase 1a and all parts of Phase 1b except Part C).\n    * Serious concomitant systemic disorder\n* Known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.\n* Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection, or other clinically significant active disease process\n* Prior exposure to phosphatidylinositol 3-kinase\u002Fprotein kinase B\u002Fmammalian target of rapamycin (PI3K\u002FAKT\u002FmTOR) inhibitor(s), except in certain circumstances",[152,153],"ADULT","OLDER_ADULT",[155,165,174,181,188,196,204,212,216,223,231,238,244,252,260,264,271,278,286,293,300,308,315,323,330,338,345,352,360,367,374,381,388,396,404,411,418,425,432,440,444,452,456,460,467,471,478,485,489,497],{"facility":156,"status":157,"city":158,"state":159,"zip":160,"country":161,"geoPoint":162},"Mayo Clinic of Scottsdale","NOT_YET_RECRUITING","Scottsdale","Arizona","85259","United States",{"lat":163,"lon":164},33.50921,-111.89903,{"facility":166,"status":167,"city":168,"state":169,"zip":170,"country":161,"geoPoint":171},"UCLA Medical Center","COMPLETED","Los Angeles","California","90095",{"lat":172,"lon":173},34.05223,-118.24368,{"facility":175,"status":8,"city":176,"state":169,"zip":177,"country":161,"geoPoint":178},"UCSF Medical Center at Mission Bay","San Francisco","94158",{"lat":179,"lon":180},37.77493,-122.41942,{"facility":182,"status":8,"city":183,"state":169,"zip":184,"country":161,"geoPoint":185},"Stanford University Hospital","Stanford","94305",{"lat":186,"lon":187},37.42411,-122.16608,{"facility":189,"status":157,"city":190,"state":191,"zip":192,"country":161,"geoPoint":193},"Mayo Clinic","Jacksonville","Florida","32224",{"lat":194,"lon":195},30.33218,-81.65565,{"facility":197,"status":167,"city":198,"state":199,"zip":200,"country":161,"geoPoint":201},"Winship Cancer Center Emory University","Atlanta","Georgia","30322",{"lat":202,"lon":203},33.749,-84.38798,{"facility":205,"status":167,"city":206,"state":207,"zip":208,"country":161,"geoPoint":209},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":210,"lon":211},42.35843,-71.05977,{"facility":213,"status":157,"city":206,"state":207,"zip":214,"country":161,"geoPoint":215},"Dana-Farber Cancer Institute","02215",{"lat":210,"lon":211},{"facility":189,"status":8,"city":217,"state":218,"zip":219,"country":161,"geoPoint":220},"Rochester","Minnesota","55905-0002",{"lat":221,"lon":222},44.02163,-92.4699,{"facility":224,"status":8,"city":225,"state":226,"zip":227,"country":161,"geoPoint":228},"Washington University Medical School","St Louis","Missouri","63110",{"lat":229,"lon":230},38.62727,-90.19789,{"facility":232,"status":167,"city":233,"state":233,"zip":234,"country":161,"geoPoint":235},"Memorial Sloan Kettering Cancer Center","New York","10065",{"lat":236,"lon":237},40.71427,-74.00597,{"facility":239,"status":157,"city":217,"state":233,"zip":240,"country":161,"geoPoint":241},"Wilmot Cancer Institute","14642",{"lat":242,"lon":243},43.15478,-77.61556,{"facility":245,"status":167,"city":246,"state":247,"zip":248,"country":161,"geoPoint":249},"Tennessee Oncology PLLC","Nashville","Tennessee","37203",{"lat":250,"lon":251},36.16589,-86.78444,{"facility":253,"status":8,"city":254,"state":255,"zip":256,"country":161,"geoPoint":257},"Texas Oncology-Baylor Charles A. Sammons Cancer Center","Dallas","Texas","75246",{"lat":258,"lon":259},32.78306,-96.80667,{"facility":261,"status":8,"city":254,"state":255,"zip":262,"country":161,"geoPoint":263},"UT Southwestern Medical Center","75390-8884",{"lat":258,"lon":259},{"facility":265,"status":157,"city":266,"state":255,"zip":267,"country":161,"geoPoint":268},"University of Texas MD Anderson Cancer Center","Houston","77030",{"lat":269,"lon":270},29.76328,-95.36327,{"facility":272,"status":157,"city":273,"state":255,"zip":274,"country":161,"geoPoint":275},"South Texas Accelerated Research Therapeutics (START)","San Antonio","78229",{"lat":276,"lon":277},29.42412,-98.49363,{"facility":279,"status":157,"city":280,"zip":281,"country":282,"geoPoint":283},"Cancer Research SA","Adelaide","5000","Australia",{"lat":284,"lon":285},-34.92866,138.59863,{"facility":287,"status":8,"city":288,"zip":289,"country":282,"geoPoint":290},"Peter Maccallum Cancer Institute Erb","East Melbourne","3002",{"lat":291,"lon":292},-37.81667,144.9879,{"facility":294,"status":8,"city":295,"zip":296,"country":282,"geoPoint":297},"St Vincent's Hospital","Sydney","2010",{"lat":298,"lon":299},-33.86785,151.20732,{"facility":301,"status":157,"city":302,"zip":303,"country":304,"geoPoint":305},"Institut Jules Bordet","Anderlecht","1070","Belgium",{"lat":306,"lon":307},50.83619,4.31454,{"facility":309,"status":8,"city":310,"zip":311,"country":304,"geoPoint":312},"Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg","Leuven","3000",{"lat":313,"lon":314},50.87959,4.70093,{"facility":316,"status":8,"city":317,"zip":318,"country":319,"geoPoint":320},"Princess Margaret Hospital (Hong Kong)","Toronto","M5G 2M9","Canada",{"lat":321,"lon":322},43.70643,-79.39864,{"facility":324,"status":8,"city":325,"zip":326,"country":319,"geoPoint":327},"BC Cancer Vancouver","Vancouver","V5Z4E6",{"lat":328,"lon":329},49.24966,-123.11934,{"facility":331,"status":8,"city":332,"zip":333,"country":334,"geoPoint":335},"Beijing Cancer hospital","Beijing","100036","China",{"lat":336,"lon":337},39.9075,116.39723,{"facility":339,"status":8,"city":340,"zip":341,"country":334,"geoPoint":342},"The Third Hospital of Nanchang","Nanchang","330009",{"lat":343,"lon":344},28.68396,115.85306,{"facility":346,"status":8,"city":347,"zip":348,"country":334,"geoPoint":349},"Fudan University Shanghai Cancer Center","Shanghai","200032",{"lat":350,"lon":351},31.22222,121.45806,{"facility":353,"status":8,"city":354,"zip":355,"country":356,"geoPoint":357},"Centre Leon Berard","Lyon","69373","France",{"lat":358,"lon":359},45.74906,4.84789,{"facility":361,"status":157,"city":362,"zip":363,"country":356,"geoPoint":364},"Institut Curie","Paris","75248",{"lat":365,"lon":366},48.85341,2.3488,{"facility":368,"status":8,"city":369,"zip":370,"country":356,"geoPoint":371},"Institut de Cancérologie de l'Ouest","Saint-Herblain","44805",{"lat":372,"lon":373},47.21154,-1.651,{"facility":375,"status":8,"city":376,"zip":377,"country":356,"geoPoint":378},"ICANS_Institut de Cancerologie Strasbourg Europe","Strasbourg","67033",{"lat":379,"lon":380},48.58392,7.74553,{"facility":382,"status":157,"city":383,"zip":384,"country":356,"geoPoint":385},"Gustave Roussy","Villejuif","94805",{"lat":386,"lon":387},48.7939,2.35992,{"facility":389,"status":157,"city":390,"zip":391,"country":392,"geoPoint":393},"Universitätsklinikum Erlangen","Erlangen","91054","Germany",{"lat":394,"lon":395},49.59099,11.00783,{"facility":397,"status":8,"city":398,"zip":399,"country":400,"geoPoint":401},"National Cancer Center Hospital","Chūōku","104-0045","Japan",{"lat":402,"lon":403},33.63867,130.67068,{"facility":405,"status":8,"city":406,"zip":407,"country":400,"geoPoint":408},"The Cancer Institute Hospital of JFCR","Kōtō City","135-8550",{"lat":409,"lon":410},32.77856,130.74537,{"facility":412,"status":157,"city":413,"zip":414,"country":400,"geoPoint":415},"Kyoto University Hospital","Kyoto","606-8507",{"lat":416,"lon":417},35.02107,135.75385,{"facility":419,"status":8,"city":420,"zip":421,"country":400,"geoPoint":422},"Aichi Cancer Center Hospital","Nagoya","464-8681",{"lat":423,"lon":424},35.18147,136.90641,{"facility":426,"status":157,"city":427,"zip":428,"country":427,"geoPoint":429},"National Cancer Centre Singapore","Singapore","169610",{"lat":430,"lon":431},1.28967,103.85007,{"facility":433,"status":157,"city":434,"zip":435,"country":436,"geoPoint":437},"Samsung Medical Center","Seoul","06351","South Korea",{"lat":438,"lon":439},37.566,126.9784,{"facility":441,"status":157,"city":434,"zip":442,"country":436,"geoPoint":443},"Asan Medical Center","5505",{"lat":438,"lon":439},{"facility":445,"status":8,"city":446,"zip":447,"country":448,"geoPoint":449},"Hospital Universitario Quiron Dexeus","Barcelona","08028","Spain",{"lat":450,"lon":451},41.38879,2.15899,{"facility":453,"status":157,"city":446,"zip":454,"country":448,"geoPoint":455},"Hospital Universitari Vall d'Hebron","08035",{"lat":450,"lon":451},{"facility":457,"status":8,"city":446,"zip":458,"country":448,"geoPoint":459},"Hospital Clinic de Barcelona","08036",{"lat":450,"lon":451},{"facility":461,"status":8,"city":462,"zip":463,"country":448,"geoPoint":464},"Hospital General Universitario Gregorio Maranon","Madrid","28007",{"lat":465,"lon":466},40.4165,-3.70256,{"facility":468,"status":157,"city":462,"zip":469,"country":448,"geoPoint":470},"Hospital Universitario 12 de Octubre","28041",{"lat":465,"lon":466},{"facility":472,"status":8,"city":473,"zip":474,"country":448,"geoPoint":475},"Hospital Quironsalud Madrid","Pozuelo de Alarcón","28223",{"lat":476,"lon":477},40.43293,-3.81338,{"facility":479,"status":8,"city":480,"zip":481,"country":448,"geoPoint":482},"Hospital Clinico Universitario de Valencia","Valencia","46010",{"lat":483,"lon":484},39.47391,-0.37966,{"facility":486,"status":8,"city":480,"zip":487,"country":448,"geoPoint":488},"Hospital Arnau de Vilanova Valencia","46015",{"lat":483,"lon":484},{"facility":490,"status":8,"city":491,"zip":492,"country":493,"geoPoint":494},"Royal Marsden NHS Trust","London","SW3 6JJ","United Kingdom",{"lat":495,"lon":496},51.50853,-0.12574,{"facility":498,"status":157,"city":499,"zip":500,"country":493,"geoPoint":501},"Royal Marsden Hospital (Sutton)","Sutton","SM2 5PT",{"lat":502,"lon":503},51.35,-0.2,[505],{"name":506,"role":507,"phone":508,"email":509},"There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or","CONTACT","13176154559","ClinicalTrials.gov@lilly.com",[511],{"name":512,"affiliation":13,"role":513},"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC\u002FGMT - 5 hours, EST)","STUDY_DIRECTOR",[],[516],{"label":6,"url":517},"https:\u002F\u002Ftrials.lilly.com\u002Fen-US\u002Ftrial\u002F338185",{"nct_id":4,"conditions":519,"biomarkers":522},[520,521],"Breast Carcinoma","Solid Neoplasm",[523],"PIK3CA Gene",{"nct_id":4,"found":525,"summary":526,"prompt_version":536},true,{"design":527,"status":528,"heading":529,"summary":530,"follow_up":531,"word_count":532,"commitments":533,"compensation":534,"drugs_mentioned":535},"This is an interventional study, meaning participants will receive specific treatments. It aims to enroll about 260 participants.","completed","LOXO-783 for Breast Cancer and Other Solid Tumors","This study is investigating LOXO-783, a new oral medication, for people with advanced breast cancer or other solid tumors. It's also being studied alongside other approved treatments like Fulvestrant, Imlunestrant, Abemaciclib, Anastrozole, Exemestane, or Letrozole. You might be able to join if your cancer has a specific change in the PIK3CA gene. The main goals are to understand the safety, side effects, and how well LOXO-783 works. Researchers will also look for the highest safe dose of LOXO-783. The study is currently unclear on its recruitment status and plans to enroll about 260 participants. Your participation could last up to three years, or longer if your disease doesn't worsen.","The primary endpoints for safety are measured during the first 28-day cycle of LOXO-783 treatment.",109,"Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.","Not stated in the trial record.",[31,44,48,53,58],"v2"]