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Leállítva2. fázis

Testing the Use of Fulvestrant and Binimetinib Targeted Treatment for NF1 Mutation in Hormone Receptor-Positive Metastatic Breast Cancer (A ComboMATCH Treatment Trial)

Megadott ok: Other - slow accrual

Key facts

Where
Altoona, Anaconda, Ankeny, Ann Arbor, Arroyo Grande, Ashland, Aventura, Baltimore, Barrington, Belpre, Bemidji, Bethesda, Billings, Birmingham, Bismarck, Boise, Boston, Bozeman, Brewer, Brighton, Bryn Mawr, Burlington, Caldwell, Canton, Centerville, Chelsea, Chicago, Chillicothe, City of Saint Peters, Coeur d'Alene, Columbus, Coon Rapids, Coral Gables, Creve Coeur, Crystal Lake, Cudahy, Cumberland, Danville, Dayton, Dearborn, Deer River, Deerfield Beach, DeKalb, Des Moines, Dublin, Duluth, Edina, Edmonds, Effingham, Elgin, Emeryville, Erie, Fargo, Farmington Hills, Flint, Franklin, Fruitland, Geneva, Germantown, Grafton, Great Falls, Green Bay, Greensburg, Greenville, Gulfport, Hazel Crest, Henderson, Hibbing, Houston, Issaquah, Jacksonville, Kalispell, Kenosha, Kettering, Kingman, La Crosse, Lake Forest, Lancaster, Lansing, Las Vegas, Lexington, Libertyville, Livonia, Macomb, Madison, Maplewood, Marietta, Marinette, Martinez, Marysville, Mattoon, Mechanicsburg, Media, Meridian, Miami, Milwaukee, Minneapolis, Missoula, Monroeville, Mount Vernon, Nampa, Newark, Newberg, Oak Lawn, Oklahoma City, Ontario, Orange, Oregon City, Orland Park, Oshkosh, Paoli, Park Ridge, Perrysburg, Philadelphia, Pittsburgh, Plantation, Portland, Portsmouth, Post Falls, Racine, Renton, Richmond, Rochester, Royal Oak, Saginaw, Saint Louis Park, Saint Paul, Sandpoint, Sandstone, Santa Monica, Sheboygan, Shiloh, Sioux Falls, South Hill, Springfield, St Louis, Summit, Tawas City, The Bronx, Toledo, Troy, Twin Falls, Two Rivers, Urbana, Virginia, Walnut Creek, Warrenville, Wauwatosa, West Allis, West Branch, Westerville, Willow Grove, Wynnewood, Yakima, Ypsilanti és Zanesville, Egyesült ÁllamokSee the 192 sites
Phase
2. fázis

Where in Egyesült Államok

  • UPMC AltoonaAltoona, Egyesült ÁllamokNo longer taking part
  • Community Hospital of AnacondaAnaconda, Egyesült ÁllamokNo longer taking part
  • UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, Egyesült ÁllamokNo longer taking part
  • Trinity Health Saint Joseph Mercy Hospital Ann ArborAnn Arbor, Egyesült ÁllamokNo longer taking part
  • PCR OncologyArroyo Grande, Egyesült ÁllamokNo longer taking part
  • Duluth Clinic AshlandAshland, Egyesült ÁllamokNo longer taking part
  • UM Sylvester Comprehensive Cancer Center at AventuraAventura, Egyesült ÁllamokNo longer taking part
  • University of Maryland/Greenebaum Cancer CenterBaltimore, Egyesült ÁllamokNo longer taking part
  • Advocate Good Shepherd HospitalBarrington, Egyesült ÁllamokNo longer taking part
  • Strecker Cancer Center-BelpreBelpre, Egyesült ÁllamokNo longer taking part
  • Sanford Joe Lueken Cancer CenterBemidji, Egyesült ÁllamokNo longer taking part
  • National Institutes of Health Clinical CenterBethesda, Egyesült ÁllamokNo longer taking part
  • Billings Clinic Cancer CenterBillings, Egyesült ÁllamokNo longer taking part
  • University of Alabama at Birmingham Cancer CenterBirmingham, Egyesült ÁllamokNo longer taking part
  • Sanford Bismarck Medical CenterBismarck, Egyesült ÁllamokNo longer taking part
  • Saint Alphonsus Cancer Care Center-BoiseBoise, Egyesült ÁllamokNo longer taking part
  • Saint Luke's Cancer Institute - BoiseBoise, Egyesült ÁllamokNo longer taking part
  • Tufts Medical CenterBoston, Egyesült ÁllamokNo longer taking part
  • Bozeman Health Deaconess HospitalBozeman, Egyesült ÁllamokNo longer taking part
  • Lafayette Family Cancer Center-EMMCBrewer, Egyesült ÁllamokNo longer taking part
  • Trinity Health IHA Medical Group Hematology Oncology - BrightonBrighton, Egyesült ÁllamokNo longer taking part
  • Trinity Health Medical Center - BrightonBrighton, Egyesült ÁllamokNo longer taking part
  • Bryn Mawr HospitalBryn Mawr, Egyesült ÁllamokNo longer taking part
  • Aurora Cancer Care-Southern Lakes VLCCBurlington, Egyesült ÁllamokNo longer taking part
  • Saint Alphonsus Cancer Care Center-CaldwellCaldwell, Egyesült ÁllamokNo longer taking part
  • Aultman Health FoundationCanton, Egyesült ÁllamokNo longer taking part
  • Trinity Health IHA Medical Group Hematology Oncology - CantonCanton, Egyesült ÁllamokNo longer taking part
  • Trinity Health Medical Center - CantonCanton, Egyesült ÁllamokNo longer taking part
  • Miami Valley Hospital SouthCenterville, Egyesült ÁllamokNo longer taking part
  • Chelsea HospitalChelsea, Egyesült ÁllamokNo longer taking part
  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalChelsea, Egyesült ÁllamokNo longer taking part
  • Advocate Illinois Masonic Medical CenterChicago, Egyesült ÁllamokNo longer taking part
  • John H Stroger Jr Hospital of Cook CountyChicago, Egyesült ÁllamokNo longer taking part
  • Northwestern UniversityChicago, Egyesült ÁllamokNo longer taking part
  • Adena Regional Medical CenterChillicothe, Egyesült ÁllamokNo longer taking part
  • Siteman Cancer Center at Saint Peters HospitalCity of Saint Peters, Egyesült ÁllamokNo longer taking part
  • Kootenai Health - Coeur d'AleneCoeur d'Alene, Egyesült ÁllamokNo longer taking part
  • Mount Carmel East HospitalColumbus, Egyesült ÁllamokNo longer taking part
  • Ohio State University Comprehensive Cancer CenterColumbus, Egyesült ÁllamokNo longer taking part
  • The Mark H Zangmeister CenterColumbus, Egyesült ÁllamokNo longer taking part
  • Mercy HospitalCoon Rapids, Egyesült ÁllamokNo longer taking part
  • UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, Egyesült ÁllamokNo longer taking part
  • Siteman Cancer Center at West County HospitalCreve Coeur, Egyesült ÁllamokNo longer taking part
  • AMG Crystal Lake - OncologyCrystal Lake, Egyesült ÁllamokNo longer taking part
  • Aurora Saint Luke's South ShoreCudahy, Egyesült ÁllamokNo longer taking part
  • UPMC Western MarylandCumberland, Egyesült ÁllamokNo longer taking part
  • Carle at The RiverfrontDanville, Egyesült ÁllamokNo longer taking part
  • Dayton Physician LLC - EnglewoodDayton, Egyesült ÁllamokNo longer taking part
  • Miami Valley HospitalDayton, Egyesült ÁllamokNo longer taking part
  • Miami Valley Hospital NorthDayton, Egyesült ÁllamokNo longer taking part
  • Premier Blood and Cancer CenterDayton, Egyesült ÁllamokNo longer taking part
  • Corewell Health Dearborn HospitalDearborn, Egyesült ÁllamokNo longer taking part
  • Essentia Health - Deer River ClinicDeer River, Egyesült ÁllamokNo longer taking part
  • UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, Egyesült ÁllamokNo longer taking part
  • Northwestern Medicine Cancer Center KishwaukeeDeKalb, Egyesült ÁllamokNo longer taking part
  • Mercy Medical Center - Des MoinesDes Moines, Egyesült ÁllamokNo longer taking part
  • UI Health Care Mission Cancer and Blood - Des Moines ClinicDes Moines, Egyesült ÁllamokNo longer taking part
  • Epic Care-DublinDublin, Egyesült ÁllamokNo longer taking part
  • Essentia Health Cancer CenterDuluth, Egyesült ÁllamokNo longer taking part
  • Fairview Southdale HospitalEdina, Egyesült ÁllamokNo longer taking part
  • Swedish Cancer Institute-EdmondsEdmonds, Egyesült ÁllamokNo longer taking part
  • Carle Physician Group-EffinghamEffingham, Egyesült ÁllamokNo longer taking part
  • Advocate Sherman HospitalElgin, Egyesült ÁllamokNo longer taking part
  • Epic Care Partners in Cancer CareEmeryville, Egyesült ÁllamokNo longer taking part
  • UPMC Hillman Cancer Center ErieErie, Egyesült ÁllamokNo longer taking part
  • Sanford Broadway Medical CenterFargo, Egyesült ÁllamokNo longer taking part
  • Sanford Roger Maris Cancer CenterFargo, Egyesült ÁllamokNo longer taking part
  • Corewell Health Farmington Hills HospitalFarmington Hills, Egyesült ÁllamokNo longer taking part
  • Cancer Hematology Centers - FlintFlint, Egyesült ÁllamokNo longer taking part
  • Genesee Hematology Oncology PCFlint, Egyesült ÁllamokNo longer taking part
  • Genesys Hurley Cancer InstituteFlint, Egyesült ÁllamokNo longer taking part
  • Hurley Medical CenterFlint, Egyesült ÁllamokNo longer taking part
  • Atrium Medical Center-Middletown Regional HospitalFranklin, Egyesült ÁllamokNo longer taking part
  • Saint Luke's Cancer Institute - FruitlandFruitland, Egyesült ÁllamokNo longer taking part
  • Northwestern Medicine Cancer Center DelnorGeneva, Egyesült ÁllamokNo longer taking part
  • Aurora Health Care Germantown Health CenterGermantown, Egyesült ÁllamokNo longer taking part
  • Aurora Cancer Care-GraftonGrafton, Egyesült ÁllamokNo longer taking part
  • Benefis Sletten Cancer InstituteGreat Falls, Egyesült ÁllamokNo longer taking part
  • Aurora BayCare Medical CenterGreen Bay, Egyesült ÁllamokNo longer taking part
  • UPMC Cancer Centers - Arnold Palmer PavilionGreensburg, Egyesült ÁllamokNo longer taking part
  • Miami Valley Cancer Care and InfusionGreenville, Egyesült ÁllamokNo longer taking part
  • Gulfport Memorial HospitalGulfport, Egyesült ÁllamokNo longer taking part
  • Advocate South Suburban HospitalHazel Crest, Egyesült ÁllamokNo longer taking part
  • OptumCare Cancer Care at Seven HillsHenderson, Egyesült ÁllamokNo longer taking part
  • Essentia Health Hibbing ClinicHibbing, Egyesült ÁllamokNo longer taking part
  • M D Anderson Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
  • Swedish Cancer Institute-IssaquahIssaquah, Egyesült ÁllamokNo longer taking part
  • Mayo Clinic in FloridaJacksonville, Egyesült ÁllamokNo longer taking part
  • Logan Health Medical CenterKalispell, Egyesült ÁllamokNo longer taking part
  • Aurora Cancer Care-Kenosha SouthKenosha, Egyesült ÁllamokNo longer taking part
  • Kettering Medical CenterKettering, Egyesült ÁllamokNo longer taking part
  • Kingman Regional Medical CenterKingman, Egyesült ÁllamokNo longer taking part
  • Gundersen Lutheran Medical CenterLa Crosse, Egyesült ÁllamokNo longer taking part
  • Northwestern Medicine Lake Forest HospitalLake Forest, Egyesült ÁllamokNo longer taking part
  • Fairfield Medical CenterLancaster, Egyesült ÁllamokNo longer taking part
  • University of Michigan Health - Sparrow LansingLansing, Egyesült ÁllamokNo longer taking part
  • OptumCare Cancer Care at CharlestonLas Vegas, Egyesült ÁllamokNo longer taking part
  • OptumCare Cancer Care at Fort ApacheLas Vegas, Egyesült ÁllamokNo longer taking part
  • University of Kentucky/Markey Cancer CenterLexington, Egyesült ÁllamokNo longer taking part
  • AMG Libertyville - OncologyLibertyville, Egyesült ÁllamokNo longer taking part
  • Condell Memorial HospitalLibertyville, Egyesült ÁllamokNo longer taking part
  • Trinity Health Saint Mary Mercy Livonia HospitalLivonia, Egyesült ÁllamokNo longer taking part
  • Henry Ford Saint John Hospital - Macomb MedicalMacomb, Egyesült ÁllamokNo longer taking part
  • University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterMadison, Egyesült ÁllamokNo longer taking part
  • University of Wisconsin Carbone Cancer Center - University HospitalMadison, Egyesült ÁllamokNo longer taking part
  • Saint John's Hospital - HealtheastMaplewood, Egyesült ÁllamokNo longer taking part
  • Marietta Memorial HospitalMarietta, Egyesült ÁllamokNo longer taking part
  • Aurora Bay Area Medical Group-MarinetteMarinette, Egyesült ÁllamokNo longer taking part
  • Contra Costa Regional Medical CenterMartinez, Egyesült ÁllamokNo longer taking part
  • Memorial HospitalMarysville, Egyesült ÁllamokNo longer taking part
  • Carle Physician Group-Mattoon/CharlestonMattoon, Egyesült ÁllamokNo longer taking part
  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionMechanicsburg, Egyesült ÁllamokNo longer taking part
  • Riddle Memorial HospitalMedia, Egyesült ÁllamokNo longer taking part
  • Saint Luke's Cancer Institute - MeridianMeridian, Egyesült ÁllamokNo longer taking part
  • UM Sylvester Comprehensive Cancer Center at KendallMiami, Egyesült ÁllamokNo longer taking part
  • University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Egyesült ÁllamokNo longer taking part
  • Aurora Cancer Care-MilwaukeeMilwaukee, Egyesült ÁllamokNo longer taking part
  • Aurora Saint Luke's Medical CenterMilwaukee, Egyesült ÁllamokNo longer taking part
  • Aurora Sinai Medical CenterMilwaukee, Egyesült ÁllamokNo longer taking part
  • Abbott-Northwestern HospitalMinneapolis, Egyesült ÁllamokNo longer taking part
  • Community Medical CenterMissoula, Egyesült ÁllamokNo longer taking part
  • UPMC Hillman Cancer Center - MonroevilleMonroeville, Egyesült ÁllamokNo longer taking part
  • Knox Community HospitalMount Vernon, Egyesült ÁllamokNo longer taking part
  • Saint Alphonsus Cancer Care Center-NampaNampa, Egyesült ÁllamokNo longer taking part
  • Saint Luke's Cancer Institute - NampaNampa, Egyesült ÁllamokNo longer taking part
  • Licking Memorial HospitalNewark, Egyesült ÁllamokNo longer taking part
  • Providence Newberg Medical CenterNewberg, Egyesült ÁllamokNo longer taking part
  • Advocate Christ Medical CenterOak Lawn, Egyesült ÁllamokNo longer taking part
  • University of Oklahoma Health Sciences CenterOklahoma City, Egyesült ÁllamokNo longer taking part
  • Saint Alphonsus Cancer Care Center-OntarioOntario, Egyesült ÁllamokNo longer taking part
  • Saint Joseph Hospital - OrangeOrange, Egyesült ÁllamokNo longer taking part
  • Providence Willamette Falls Medical CenterOregon City, Egyesült ÁllamokNo longer taking part
  • Northwestern Medicine Orland ParkOrland Park, Egyesült ÁllamokNo longer taking part
  • Vince Lombardi Cancer Clinic - OshkoshOshkosh, Egyesült ÁllamokNo longer taking part
  • Paoli Memorial HospitalPaoli, Egyesült ÁllamokNo longer taking part
  • Advocate Lutheran General HospitalPark Ridge, Egyesült ÁllamokNo longer taking part
  • Mercy Health - Perrysburg HospitalPerrysburg, Egyesült ÁllamokNo longer taking part
  • Thomas Jefferson University HospitalPhiladelphia, Egyesült ÁllamokNo longer taking part
  • University of Pittsburgh Cancer Institute (UPCI)Pittsburgh, Egyesült ÁllamokNo longer taking part
  • UPMC-Passavant HospitalPittsburgh, Egyesült ÁllamokNo longer taking part
  • UM Sylvester Comprehensive Cancer Center at PlantationPlantation, Egyesült ÁllamokNo longer taking part
  • Providence Portland Medical CenterPortland, Egyesült ÁllamokNo longer taking part
  • Providence Saint Vincent Medical CenterPortland, Egyesült ÁllamokNo longer taking part
  • Southern Ohio Medical CenterPortsmouth, Egyesült ÁllamokNo longer taking part
  • Kootenai Clinic Cancer Services - Post FallsPost Falls, Egyesült ÁllamokNo longer taking part
  • Aurora Cancer Care-RacineRacine, Egyesült ÁllamokNo longer taking part
  • Valley Medical CenterRenton, Egyesült ÁllamokNo longer taking part
  • VCU Massey Cancer Center at Stony PointRichmond, Egyesült ÁllamokNo longer taking part
  • Virginia Cancer InstituteRichmond, Egyesült ÁllamokNo longer taking part
  • Virginia Commonwealth University/Massey Cancer CenterRichmond, Egyesült ÁllamokNo longer taking part
  • Mayo Clinic in RochesterRochester, Egyesült ÁllamokNo longer taking part
  • Corewell Health William Beaumont University HospitalRoyal Oak, Egyesült ÁllamokNo longer taking part
  • MyMichigan Medical Center SaginawSaginaw, Egyesült ÁllamokNo longer taking part
  • Oncology Hematology Associates of Saginaw Valley PCSaginaw, Egyesült ÁllamokNo longer taking part
  • Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Egyesült ÁllamokNo longer taking part
  • Regions HospitalSaint Paul, Egyesült ÁllamokNo longer taking part
  • United HospitalSaint Paul, Egyesült ÁllamokNo longer taking part
  • Kootenai Clinic Cancer Services - SandpointSandpoint, Egyesült ÁllamokNo longer taking part
  • Essentia Health SandstoneSandstone, Egyesült ÁllamokNo longer taking part
  • Saint John's Cancer InstituteSanta Monica, Egyesült ÁllamokNo longer taking part
  • Vince Lombardi Cancer Clinic-SheboyganSheboygan, Egyesült ÁllamokNo longer taking part
  • Memorial Hospital EastShiloh, Egyesült ÁllamokNo longer taking part
  • Sanford Cancer Center Oncology ClinicSioux Falls, Egyesült ÁllamokNo longer taking part
  • Sanford USD Medical Center - Sioux FallsSioux Falls, Egyesült ÁllamokNo longer taking part
  • VCU Community Memorial Health CenterSouth Hill, Egyesült ÁllamokNo longer taking part
  • Springfield Regional Cancer CenterSpringfield, Egyesült ÁllamokNo longer taking part
  • Springfield Regional Medical CenterSpringfield, Egyesült ÁllamokNo longer taking part
  • Siteman Cancer Center at Christian HospitalSt Louis, Egyesült ÁllamokNo longer taking part
  • Siteman Cancer Center-South CountySt Louis, Egyesült ÁllamokNo longer taking part
  • Washington University School of MedicineSt Louis, Egyesült ÁllamokNo longer taking part
  • Aurora Medical Center in SummitSummit, Egyesült ÁllamokNo longer taking part
  • MyMichigan Medical Center TawasTawas City, Egyesült ÁllamokNo longer taking part
  • Montefiore Medical Center-Einstein CampusThe Bronx, Egyesült ÁllamokNo longer taking part
  • Mercy Health - Saint Anne HospitalToledo, Egyesült ÁllamokNo longer taking part
  • Corewell Health Beaumont Troy HospitalTroy, Egyesült ÁllamokNo longer taking part
  • Upper Valley Medical CenterTroy, Egyesült ÁllamokNo longer taking part
  • Saint Luke's Cancer Institute - Twin FallsTwin Falls, Egyesült ÁllamokNo longer taking part
  • Vince Lombardi Cancer Clinic-Two RiversTwo Rivers, Egyesült ÁllamokNo longer taking part
  • Carle Cancer CenterUrbana, Egyesült ÁllamokNo longer taking part
  • Essentia Health Virginia ClinicVirginia, Egyesült ÁllamokNo longer taking part
  • Epic Care Cyberknife CenterWalnut Creek, Egyesült ÁllamokNo longer taking part
  • Northwestern Medicine Cancer Center WarrenvilleWarrenville, Egyesült ÁllamokNo longer taking part
  • Aurora Cancer Care-Milwaukee WestWauwatosa, Egyesült ÁllamokNo longer taking part
  • Aurora West Allis Medical CenterWest Allis, Egyesült ÁllamokNo longer taking part
  • Saint Mary's Oncology/Hematology Associates of West BranchWest Branch, Egyesült ÁllamokNo longer taking part
  • Saint Ann's HospitalWesterville, Egyesült ÁllamokNo longer taking part
  • Asplundh Cancer PavilionWillow Grove, Egyesült ÁllamokNo longer taking part
  • Lankenau Medical CenterWynnewood, Egyesült ÁllamokNo longer taking part
  • North Star Lodge Cancer Center at Yakima Valley Memorial HospitalYakima, Egyesült ÁllamokNo longer taking part
  • Huron Gastroenterology PCYpsilanti, Egyesült ÁllamokNo longer taking part
  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilanti, Egyesült ÁllamokNo longer taking part
  • Genesis Healthcare System Cancer Care CenterZanesville, Egyesült ÁllamokNo longer taking part

Trial details

Who runs it
National Cancer Institute (NCI)
Trial code
NCT05554354
Record updated
2026. március 3.
Original description
This phase II ComboMATCH treatment trial compares the usual treatment alone (fulvestrant) to using binimetinib plus the usual treatment in patients with hormone receptor positive breast cancer that has spread from where it first started to other places in the body (metastatic) and has an NF1 genetic change. Fulvestrant is a hormonal therapy that binds to estrogen receptors in tumor cells, resulting in estrogen receptor destruction and decreased estrogen binding, which may inhibit the growth of estrogen-sensitive tumor cells. Binimetinib is a targeted therapy that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of binimetinib to fulvestrant in breast cancers with an NF1 genetic change could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to fulvestrant alone.Read full original descriptionShow less

Phase 2 Trial of Fulvestrant and Binimetinib in Patients With Hormone Receptor-Positive Metastatic Breast Cancer With Inactivating or Inferred Inactivating NF1 Alterations: A ComboMATCH Treatment Trial

This phase II ComboMATCH treatment trial compares the usual treatment alone (fulvestrant) to using binimetinib plus the usual treatment in patients with hormone receptor positive breast cancer that has spread from where it first started to other places in the body (metastatic) and has an NF1 genetic change. Fulvestrant is a hormonal therapy that binds to estrogen receptors in tumor cells, resulting in estrogen receptor destruction and decreased estrogen binding, which may inhibit the growth of estrogen-sensitive tumor cells. Binimetinib is a targeted therapy that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The addition of binimetinib to fulvestrant in breast cancers with an NF1 genetic change could increase the percentage of tumors that shrink as well as lengthen the time that the tumors remain stable (without progression) as compared to fulvestrant alone.

Inclusion: Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N2 based on the presence of an actionable mutation as defined in EAY191; The patient must be enrolled on the ComboMATCH Master Registration Trial EAY191; Note: Patients must fulfill all eligibility criteria outlined in the ComboMATCH Registration Trial EAY191 at the time of registration to EAY191-N2. This includes submission of next-generation sequencing (NGS) data from one of the National Cancer Institute (NCI) credentialed designated laboratories for all potential patients prior to treatment trial assignment. Copy number and allele frequency cutoff as per the Registration protocol; Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH registration trial (EAY191); Please note the current actionable marker of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trial Support Unit (CTSU) ComboMATCH Registration protocol page; Please note novel/Dynamic aMOI can be submitted for review per the process described in the ComboMATCH Registration protocol; A COMBOMATCH TREATMENT TRIAL EAY191-N2 ELIGIBILITY CRITERIA:; The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information; Age >= 18; Eastern Cooperative Oncology Group (ECOG) performance status 0-2; Histologically or cytologically confirmed invasive breast carcinoma; Confirmed metastatic disease by either imaging or tissue diagnosis; Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and one additional lesion that can be biopsied (primary, metastatic both allowed); Patients must have inactivating or inferred inactivating NF1 alterations detected in tumor as determined by the ComboMATCH screening assessment; The tumor must have been determined to be estrogen receptor (ER) and/or progesterone receptor (PgR) positive assessed by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing. Patients with >= 1% ER or PgR staining by immunohistochemistry (IHC) are considered positive; The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines; Prior use of CDK4/6 inhibitor(i) is required; Prior use of fulvestrant regardless of duration is allowed and will determine treatment assignment; Up to one line of chemotherapy in metastatic setting is allowed; Absolute neutrophil count >= 1,500/mm\^3; Platelet count >= 100,000/ mm\^3; Hemoglobin level >= 10 g/dL; Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula; Total bilirubin level =< institutional upper limit of normal; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be =< 5.0 x ULN; For patients who will be assigned to Cohort 2 (fulvestrant-resistant), a left ventricular ejection fraction (LVEF) assessment must be performed within 12 weeks prior to registration. The LVEF must be >= 50% regardless of the cardiac imaging facility's lower limit of normal. (LVEF assessment performed by echocardiogram is preferred; however, MUGA scan may be substituted based on institutional/situational preferences); Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial; Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial; ELIGIBILITY CRITERIA FOR COHORT 1, TREATMENT REGIMEN 2 PATIENTS WHO MIGRATE TO COHORT 2: Cohort migration: Patients treated with control treatment fulvestrant who experience disease progression may be eligible to migrate to Cohort 2 and receive combination treatment with binimetinib and fulvestrant. Patients who choose to do so must meet laboratory values and performance status requirements below and should begin treatment within 28 days; PATIENTS WHO MIGRATE TO COHORT 2: Patient's willingness to migrate to Cohort 2 affirmed; PATIENTS WHO MIGRATE TO COHORT 2: The patient must have an ECOG performance status of 0-2; PATIENTS WHO MIGRATE TO COHORT 2: Absolute neutrophil count >= 1,500/mm\^3; PATIENTS WHO MIGRATE TO COHORT 2: Platelet count >= 100,000/ mm\^3; PATIENTS WHO MIGRATE TO COHORT 2: Hemoglobin level >= 10 g/dL; PATIENTS WHO MIGRATE TO COHORT 2: Total bilirubin level =< institutional upper limit of normal (ULN); PATIENTS WHO MIGRATE TO COHORT 2: AST and ALT must be =< 5.0 x ULN; PATIENTS WHO MIGRATE TO COHORT 2: Creatinine clearance (CrCL) of ≥30 mL/min by the Cockcroft-Gault formula; PATIENTS WHO MIGRATE TO COHORT 2: A LVEF performed within the last 3 months must be >= 50% regardless of the cardiac imaging facility's lower limit of normal (LVEF assessment performed by echocardiogram is preferred; however, MUGA scan may be substituted based on institutional/situational preferences); PATIENTS WHO MIGRATE TO COHORT 2: Pregnancy test according to institutional standards must be negative (for patients of childbearing potential only).

Exclusion: Concurrent anticancer therapy; Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better; Use of any investigational product within 30 days prior to study entry; Active autoimmune disease requiring systemic treatment within the past 3 months, documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment/central serous, chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration; Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2; Other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results; Patients will be excluded if they currently have the following risk factors for RVO that are documented prior to the enrollment:; Known uncontrolled glaucoma with intra-ocular pressures >= 21 mmHg; Known serum cholesterol >= grade 2; Known hypertriglyceridemia >= grade 2; Known hyperglycemia (fasting) >= grade 2; Patients with baseline QT corrected for heart rate (QTc) > 500 ms, either induced by medication or congenital long QT syndrome will be excluded due to known side effects of binimetinib; Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications; Active brain metastasis. Brain metastases that have been stable for at least 1 month after completion of treatment are not an exclusion criterion; Pregnancy or lactation at the time of registration or intention to become pregnant during the study (Note: Pregnancy testing according to institutional standards for patients of childbearing potential); For binimetinib, highly effective contraception should be used for at least 30 days after the last dose, and patients should not breastfeed for 3 days after the last dose; For fulvestrant, highly effective contraception should be used for 1 year after the last dose, and patients should not breastfeed for 1 year after the last dose; INELIGIBILITY CRITERIA FOR COHORT 1, TREATMENT REGIMEN 2 PATIENTS WHO MIGRATE TO COHORT 2; PATIENTS WHO MIGRATE TO COHORT 2: Not a candidate for binimetinib in the opinion of the treating investigator.

ClinicalTrials.gov NCT05554354