Spots Global Cancer Trial Database for Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
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Trial Identification
Brief Title: Abemaciclib (LY2835219) Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
Official Title: postMONARCH: A Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR+, HER2-, Advanced or Metastatic Breast Cancer Following Progression on a CDK4 & 6 Inhibitor and Endocrine Therapy
Study ID: NCT05169567
Study Description
Brief Summary: This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
Highlands Oncology Group, Springdale, Arkansas, United States
Providence Medical Foundation, Fullerton, California, United States
Cancer and Blood Specialty Clinic, Los Alamitos, California, United States
TRIO-US (Translational Research in Oncology-US), Los Angeles, California, United States
Keck School of Medicine of USC, Los Angeles, California, United States
UCLA Hematology/Oncology - Parkside, Santa Monica, California, United States
Olive View-UCLA Medical Center, Sylmar, California, United States
Torrance Memorial Physician Network / Cancer Care, Torrance, California, United States
PIH Health Hematology Medical Oncology, Whittier, California, United States
Rocky Mountain Cancer Center - Hale Parkway, Denver, Colorado, United States
Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI, Fort Myers, Florida, United States
Millennium Oncology - Hollywood, Hollywood, Florida, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center, Miami, Florida, United States
Woodlands Medical Specialists, PA, Pensacola, Florida, United States
Florida Cancer Specialists SOUTH/Sarah Cannon Research Institute/SCRI, Sarasota, Florida, United States
Florida Cancer Specialists EAST/Sarah Cannon Research Institute/SCRI, West Palm Beach, Florida, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Northeast Georgia Medical Center, Gainesville, Georgia, United States
Central Georgia Cancer Care, Macon, Georgia, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Hematology Oncology Clinic- Baton Rouge/Sarah Cannon Research Institute/SCRI, Baton Rouge, Louisiana, United States
Clinical Trials of SWLA, Lake Charles, Louisiana, United States
Central Maine Medical Center, Lewiston, Maine, United States
Mfsmc-Hjwci, Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A. - Clinton, Clinton, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
MGH Northshore Cancer Center, Danvers, Massachusetts, United States
Southcoast Centers for Cancer Care, Fairhaven, Massachusetts, United States
Dana-Farber Cancer Institute - Foxborough, Foxboro, Massachusetts, United States
Dana Farber Cancer Center Merrimack Valley, Methuen, Massachusetts, United States
Dana Farber Cancer Institute, Milford, Massachusetts, United States
Mass General Cancer Center, Newton, Massachusetts, United States
Dana Farber Cancer Institute, South Weymouth, Massachusetts, United States
Reliant Medical Group, Worcester, Massachusetts, United States
St. Vincent Frontier Cancer Center, Billings, Montana, United States
Dana Farber Cancer Center Londonderry, Londonderry, New Hampshire, United States
University of New Mexico Comprehensive Cancer Center, Albuquerque, New Mexico, United States
Lifespan Cancer Institute, Providence, Rhode Island, United States
Tennessee Oncology-Chattanooga /Sarah Cannon Research Institute/SCRI, Chattanooga, Tennessee, United States
Sarah Cannon Research Institute/SCRI, Nashville, Tennessee, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute/SCRI, Nashville, Tennessee, United States
Texas Oncology - Bedford, Bedford, Texas, United States
Texas Oncology - Denton, Denton, Texas, United States
Texas Oncology, P.A., El Paso, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Texas Oncology - McKinney, McKinney, Texas, United States
Woodlands Medical Specialists, PA, McKinney, Texas, United States
Woodlands Medical Specialists, PA, Mesquite, Texas, United States
Texas Oncology - Plano East, Plano, Texas, United States
Texas Oncology-Plano West, Plano, Texas, United States
Mays Cancer Center, San Antonio, Texas, United States
US Oncology, The Woodlands, Texas, United States
Texas Oncology - Tyler Cancer Center, Tyler, Texas, United States
Intermountain Medical Center, Murray, Utah, United States
Intermountain Healthcare - St. George, Saint George, Utah, United States
The University of Vermont Medical Center Inc., Burlington, Vermont, United States
Shenandoah Oncology, P.C., Winchester, Virginia, United States
Fundación Respirar, Buenos Aires, Buenos Air, Argentina
Centro de Investigaciones Metabólicas (CINME), Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina
Fundación Cenit Para La Investigación En Neurociencias, Caba, Ciudad Autónoma De Buenos Aires, Argentina
Instituto Médico Río Cuarto, Río Cuarto, Córdoba, Argentina
Centro Medico San Roque, San Miguel de Tucumán, Tucumán, Argentina
CER San Juan, San Juan, , Argentina
Algemeen Ziekenhuis klina, Brasschaat, Antwerpen, Belgium
Jessa Ziekenhuis, Hasselt, Limburg, Belgium
CHU UCL Namur/Site Sainte Elisabeth, Namur, , Belgium
Multiscan, Pardubice, Pardubický Kraj, Czechia
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czechia
Herlev and Gentofte Hospital, Copenhagen, Hovedstaden, Denmark
Regionshospitalet Herning, Herning, Midtjylland, Denmark
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest, Bordeaux, Aquitaine, France
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan, Brest, Bretagne, France
Hôpital privé du Confluent SAS, Nantes, Loire-Atlantique, France
CHD Vendee, La Roche-sur-Yon, Vendée, France
University Hospital of Patras, Patras, Achaḯa, Greece
Alexandra Hospital, Athens, Attikí, Greece
University General Hospital of Heraklion, Heraklion, Irakleío, Greece
Euromedica General Clinic of Thessaloniki, Thessaloniki, , Greece
Bacs-Kiskun Varmegyei Oktatokorhaz, Kecskemét, Bács-Kiskun, Hungary
Petz Aladar Egyetemi Oktato Korhaz, Gyor, Győr-Moson-Sopron, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, , Hungary
Országos Onkológiai Intézet, Budapest, , Hungary
Soroka Medical Center, Be'er Sheva, HaDarom, Israel
Meir Medical Center, Kfar Saba, HaMerkaz, Israel
Rabin Medical Center, Petah-Tikva, HaMerkaz, Israel
Sheba Medical Center, Ramat Gan, HaMerkaz, Israel
Sourasky Medical Center, Tel Aviv, Tell Abīb, Israel
Hadassah Medical Center, Jerusalem, Yerushalayim, Israel
Humanitas Istituto Clinico Catanese, Misterbianco, Catania, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Emilia-Romagna, Italy
P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale, Udine, Friuli-Venezia Giulia, Italy
Instituto Tumori Giovanni Paolo II, Bari, , Italy
Ospedale Misericordia di Grosseto, Grosseto, , Italy
Ospedale San Raffaele, Milano, , Italy
ASL Viterbo Ospedale Belcolle, Viterbo, , Italy
Seoul National University Bundang Hospital, Seongnam, Kyǒnggi-do, Korea, Republic of
Korea University Anam Hospital, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Korea University Guro Hospital, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, Taegu-Kwangyǒkshi, Korea, Republic of
Centro de Investigacion en Artritis y Osteoporosis SC, Mexicali, Baja California, Mexico
COI Tijuana - Centro Oncológico Internacional, Tijuana, Baja California, Mexico
Centro Oncológico Internacional (COI), Guadalajara, Jalisco, Mexico
Centro Regiomontano de Investigación, Monterrey, Nuevo León, Mexico
Oncologico Potosino, S.C., San Luis Potosi, San Luis Potosí, Mexico
Europejskie Centrum Zdrowia - Oddzial Onkologii, Otwock, Mazowieckie, Poland
Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego, Opole, Opolskie, Poland
CHUAC-Hospital Teresa Herrera, A Coruña, A Coruña [La Coruña], Spain
Hospital Universitari Son Espases, Palma, Balears [Baleares], Spain
Parc de Salut Mar - Hospital del Mar, Barcelona, Barcelona [Barcelona], Spain
Hospital Clínic de Barcelona, Barcelona, Catalunya [Cataluña], Spain
Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar, Murcia, Región De, Spain
H.R.U Málaga - Hospital Materno-infantil, Malaga, Málaga, Spain
Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
Hospital Universitari Sant Joan de Reus, Reus, Tarragona [Tarragona], Spain
Hospital Universitario Doctor Peset, Valencia, Valenciana, Comunitat, Spain
Hospital Infanta Cristina, Badajoz, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario de Toledo, Toledo, , Spain
Karolinska Universitetssjukhuset Solna, Stockholm, Stockholms, Sweden
Universitetssjukhuset Örebro, Örebro, Örebro Län [se-18], Sweden
Chi Mei Medical Center, Tainan City, Tainan, Taiwan
Kaohsiung Medical University Hospital, Kaohsiung, , Taiwan
Taipei Tzu Chi General Hospital, New Taipei City, , Taiwan
Mackay Memorial Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch, Taoyuan, , Taiwan
Izmir Medical Park Hospital, Karsiyaka, İzmir, Turkey
Necmettin Erbakan Meram Medical Fac., Meram, Konya, Turkey
Adana City Hospital, Adana, , Turkey
Gulhane Egitim Arastirma Hastanesi, Ankara, , Turkey
Memorial Ankara Hastanesi, Ankara, , Turkey
Dicle Üniversitesi, Diyarbakir, , Turkey
Trakya University, Edirne, , Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi, Istanbul, , Turkey
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi, Malatya, , Turkey
Contact Details
Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Affiliation: Eli Lilly and Company
Role: STUDY_DIRECTOR
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