Spots Global Cancer Trial Database for An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
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Trial Identification
Brief Title: An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
Official Title: CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease
Study ID: NCT05952557
Conditions
Study Description
Brief Summary: This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.
Detailed Description: This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Research Site, Fayetteville, Arkansas, United States
Research Site, Duarte, California, United States
Research Site, Fountain Valley, California, United States
Research Site, Greenbrae, California, United States
Research Site, Irvine, California, United States
Research Site, La Jolla, California, United States
Research Site, Los Angeles, California, United States
Research Site, Monterey, California, United States
Research Site, Walnut Creek, California, United States
Research Site, West Hollywood, California, United States
Research Site, Aurora, Colorado, United States
Research Site, Littleton, Colorado, United States
Research Site, Newark, Delaware, United States
Research Site, Fort Myers, Florida, United States
Research Site, Gainesville, Florida, United States
Research Site, Jacksonville, Florida, United States
Research Site, Orlando, Florida, United States
Research Site, Pembroke Pines, Florida, United States
Research Site, Plantation, Florida, United States
Research Site, Plantation, Florida, United States
Research Site, Saint Petersburg, Florida, United States
Research Site, Saint Petersburg, Florida, United States
Research Site, Tallahassee, Florida, United States
Research Site, West Palm Beach, Florida, United States
Research Site, Atlanta, Georgia, United States
Research Site, Atlanta, Georgia, United States
Research Site, Columbus, Georgia, United States
Research Site, Marietta, Georgia, United States
Research Site, Savannah, Georgia, United States
Research Site, Thomasville, Georgia, United States
Research Site, Elmhurst, Illinois, United States
Research Site, Naperville, Illinois, United States
Research Site, Park Ridge, Illinois, United States
Research Site, Plainfield, Illinois, United States
Research Site, Urbana, Illinois, United States
Research Site, Fort Wayne, Indiana, United States
Research Site, Des Moines, Iowa, United States
Research Site, Fairway, Kansas, United States
Research Site, Louisville, Kentucky, United States
Research Site, New Orleans, Louisiana, United States
Research Site, Scarborough, Maine, United States
Research Site, Annapolis, Maryland, United States
Research Site, Baltimore, Maryland, United States
Research Site, Bethesda, Maryland, United States
Research Site, Towson, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Boston, Massachusetts, United States
Research Site, Hyannis, Massachusetts, United States
Research Site, Worcester, Massachusetts, United States
Research Site, Ypsilanti, Michigan, United States
Research Site, Minneapolis, Minnesota, United States
Research Site, Kansas City, Missouri, United States
Research Site, Saint Louis, Missouri, United States
Research Site, Saint Louis, Missouri, United States
Research Site, Lincoln, Nebraska, United States
Research Site, Omaha, Nebraska, United States
Research Site, Hooksett, New Hampshire, United States
Research Site, Lebanon, New Hampshire, United States
Research Site, New Brunswick, New Jersey, United States
Research Site, Farmington, New Mexico, United States
Research Site, East Syracuse, New York, United States
Research Site, New Hyde Park, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, White Plains, New York, United States
Research Site, Charlotte, North Carolina, United States
Research Site, Durham, North Carolina, United States
Research Site, Greensboro, North Carolina, United States
Research Site, Pinehurst, North Carolina, United States
Research Site, Raleigh, North Carolina, United States
Research Site, Blue Ash, Ohio, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Cleveland, Ohio, United States
Research Site, Columbus, Ohio, United States
Research Site, Toledo, Ohio, United States
Research Site, Youngstown, Ohio, United States
Research Site, Hershey, Pennsylvania, United States
Research Site, Philadelphia, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Sayre, Pennsylvania, United States
Research Site, York, Pennsylvania, United States
Research Site, Greenville, South Carolina, United States
Research Site, Rock Hill, South Carolina, United States
Research Site, Spartanburg, South Carolina, United States
Research Site, Sioux Falls, South Dakota, United States
Research Site, Chattanooga, Tennessee, United States
Research Site, Knoxville, Tennessee, United States
Research Site, Knoxville, Tennessee, United States
Research Site, Memphis, Tennessee, United States
Research Site, Nashville, Tennessee, United States
Research Site, Nashville, Tennessee, United States
Research Site, Austin, Texas, United States
Research Site, Bedford, Texas, United States
Research Site, Dallas, Texas, United States
Research Site, Dallas, Texas, United States
Research Site, Dallas, Texas, United States
Research Site, El Paso, Texas, United States
Research Site, Flower Mound, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Plano, Texas, United States
Research Site, San Antonio, Texas, United States
Research Site, Tyler, Texas, United States
Research Site, Salt Lake City, Utah, United States
Research Site, Fairfax, Virginia, United States
Research Site, Midlothian, Virginia, United States
Research Site, Norfolk, Virginia, United States
Research Site, Richmond, Virginia, United States
Research Site, Roanoke, Virginia, United States
Research Site, Winchester, Virginia, United States
Research Site, Puyallup, Washington, United States
Research Site, Spokane, Washington, United States
Research Site, Vancouver, Washington, United States
Research Site, Charleston, West Virginia, United States
Research Site, Morgantown, West Virginia, United States
Research Site, Appleton, Wisconsin, United States
Research Site, Milwaukee, Wisconsin, United States
Research Site, Caba, , Argentina
Research Site, Capital Federal, , Argentina
Research Site, Ciudad Autonoma de Buenos Aires, , Argentina
Research Site, San Juan, , Argentina
Research Site, Bankstown, , Australia
Research Site, Bowral, , Australia
Research Site, Brighton, , Australia
Research Site, Clayton, , Australia
Research Site, Fitzroy, , Australia
Research Site, Murdoch, , Australia
Research Site, Richmond, , Australia
Research Site, South Brisbane, , Australia
Research Site, St Leonards, , Australia
Research Site, Subiaco, , Australia
Research Site, Graz, , Austria
Research Site, Innsbruck, , Austria
Research Site, Klagenfurt, , Austria
Research Site, Linz, , Austria
Research Site, Salzburg, , Austria
Research Site, St. Veit an der Glan, , Austria
Research Site, Steyr, , Austria
Research Site, Wels, , Austria
Research Site, Wien, , Austria
Research Site, Wien, , Austria
Research Site, Wien, , Austria
Research Site, Wien, , Austria
Research Site, Anderlecht, , Belgium
Research Site, Brasschaat, , Belgium
Research Site, Bruxelles, , Belgium
Research Site, Charleroi, , Belgium
Research Site, Edegem, , Belgium
Research Site, Leuven, , Belgium
Research Site, Namur, , Belgium
Research Site, Wilrijk, , Belgium
Research Site, Alfenas, , Brazil
Research Site, Belo Horizonte, , Brazil
Research Site, Blumenau, , Brazil
Research Site, Curitiba, , Brazil
Research Site, Fortaleza, , Brazil
Research Site, Goiânia, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Velho, , Brazil
Research Site, Pouso Alegre, , Brazil
Research Site, Ribeirão Preto, , Brazil
Research Site, Rio De Janeiro, , Brazil
Research Site, Salvador, , Brazil
Research Site, Santo André, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Tres Lagoas, , Brazil
Research Site, Vitória, , Brazil
Research Site, Dobrich, , Bulgaria
Research Site, Haskovo, , Bulgaria
Research Site, Plovdiv, , Bulgaria
Research Site, Plovdiv, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Varna, , Bulgaria
Research Site, Vratsa, , Bulgaria
Research Site, Calgary, Alberta, Canada
Research Site, Edmonton, Alberta, Canada
Research Site, Kelowna, British Columbia, Canada
Research Site, North Vancouver, British Columbia, Canada
Research Site, Halifax, Nova Scotia, Canada
Research Site, Barrie, Ontario, Canada
Research Site, Kingston, Ontario, Canada
Research Site, Sault Ste. Marie, Ontario, Canada
Research Site, Sudbury, Ontario, Canada
Research Site, Thunder Bay, Ontario, Canada
Research Site, Windsor, Ontario, Canada
Research Site, Chicoutimi, Quebec, Canada
Research Site, Levis, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Saskatoon, Saskatchewan, Canada
Research Site, Quebec, , Canada
Research Site, Providencia, , Chile
Research Site, Santiago, , Chile
Research Site, Santiago, , Chile
Research Site, Temuco, , Chile
Research Site, Baoding, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Beijing, , China
Research Site, Bengbu, , China
Research Site, Binzhou, , China
Research Site, Cangzhou, , China
Research Site, Changchun, , China
Research Site, Changsha, , China
Research Site, Chengdu, , China
Research Site, Chengdu, , China
Research Site, Chifeng, , China
Research Site, Dalian, , China
Research Site, Foshan, , China
Research Site, Fuzhou, , China
Research Site, Guangzhou, , China
Research Site, Guangzhou, , China
Research Site, Haikou, , China
Research Site, Hangzhou, , China
Research Site, Hangzhou, , China
Research Site, Hangzhou, , China
Research Site, Hangzhou, , China
Research Site, Hefei, , China
Research Site, Hefei, , China
Research Site, Hefei, , China
Research Site, Hohhot, , China
Research Site, Huizhou, , China
Research Site, Jinzhou, , China
Research Site, Liuzhou, , China
Research Site, Nanchang, , China
Research Site, Nanjing, , China
Research Site, Nanning, , China
Research Site, Neijiang, , China
Research Site, Shantou, , China
Research Site, Shaoguan Shi, , China
Research Site, Shenyang, , China
Research Site, Shijiahzhuang, , China
Research Site, Suining Shi, , China
Research Site, Suzhou, , China
Research Site, Suzhou, , China
Research Site, Taizhou, , China
Research Site, WeiFang, , China
Research Site, Wuhan, , China
Research Site, Wuhan, , China
Research Site, Xiangfan, , China
Research Site, Xian, , China
Research Site, Xinxiang, , China
Research Site, Xuzhou, , China
Research Site, Cali, , Colombia
Research Site, Medellin, , Colombia
Research Site, Valledupar, , Colombia
Research Site, Rijeka, , Croatia
Research Site, Zadar, , Croatia
Research Site, Zagreb, , Croatia
Research Site, Pardubice, , Czechia
Research Site, Tallinn, , Estonia
Research Site, Tallin, , Estonia
Research Site, Bordeaux, , France
Research Site, Caen cedex 05, , France
Research Site, Clermont-Ferrand, , France
Research Site, Dijon, , France
Research Site, Epagny Metz-Tessy, , France
Research Site, Lille, , France
Research Site, Montpellier, , France
Research Site, Nimes, , France
Research Site, Plerin SUR MER, , France
Research Site, Rennes, , France
Research Site, Rouen, , France
Research Site, Saint Herblain, , France
Research Site, Saint-Priest-En-Jarez, , France
Research Site, Strasbourg, , France
Research Site, Toulouse Cedex 09, , France
Research Site, Vandoeuvre les Nancy, , France
Research Site, Tbilisi, , Georgia
Research Site, Tbilisi, , Georgia
Research Site, Tbilisi, , Georgia
Research Site, Tbilisi, , Georgia
Research Site, Aachen, , Germany
Research Site, Düsseldorf, , Germany
Research Site, Essen, , Germany
Research Site, Freudenstadt, , Germany
Research Site, Hamburg, , Germany
Research Site, Hanau, , Germany
Research Site, Hannover, , Germany
Research Site, Hannover, , Germany
Research Site, Heidelberg, , Germany
Research Site, Karlsruhe, , Germany
Research Site, Koblenz, , Germany
Research Site, Köln, , Germany
Research Site, Mainz, , Germany
Research Site, Nurtingen, , Germany
Research Site, Offenburg, , Germany
Research Site, Rostock, , Germany
Research Site, Saarbrücken, , Germany
Research Site, Schweinfurt, , Germany
Research Site, Wiesbaden, , Germany
Research Site, Wiesbaden, , Germany
Research Site, Witten, , Germany
Research Site, Worms, , Germany
Research Site, Wuppertal, , Germany
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Heraklion, , Greece
Research Site, Ioannina, , Greece
Research Site, Larissa, , Greece
Research Site, Thessaloniki, , Greece
Research Site, Thessaloniki, , Greece
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Gyula, , Hungary
Research Site, Győr, , Hungary
Research Site, Kaposvár, , Hungary
Research Site, Kecskemét, , Hungary
Research Site, Miskolc, , Hungary
Research Site, Nyíregyháza, , Hungary
Research Site, Salgotarjan, , Hungary
Research Site, Szekszárd, , Hungary
Research Site, Zalaegerszeg, , Hungary
Research Site, Ansari Nagar, , India
Research Site, Bangalore, , India
Research Site, Belgavi, , India
Research Site, Delhi, , India
Research Site, Dhanvantari Nagar, , India
Research Site, Gurgaon, , India
Research Site, Kanpur, , India
Research Site, Kolkata, , India
Research Site, Mysuru, , India
Research Site, Nagpur, , India
Research Site, Nashik, , India
Research Site, Nashik, , India
Research Site, New Delhi, , India
Research Site, New Delhi, , India
Research Site, Dublin, , Ireland
Research Site, Dublin, , Ireland
Research Site, Beer Sheva, , Israel
Research Site, Haifa, , Israel
Research Site, Jerusalem, , Israel
Research Site, Kfar Saba, , Israel
Research Site, Nahariya, , Israel
Research Site, Bologna, , Italy
Research Site, Brindisi, , Italy
Research Site, Firenze, , Italy
Research Site, Genoa, , Italy
Research Site, Milano, , Italy
Research Site, Milan, , Italy
Research Site, Misterbianco, , Italy
Research Site, Modena, , Italy
Research Site, Monza, , Italy
Research Site, Napoli, , Italy
Research Site, Novara, , Italy
Research Site, Padova, , Italy
Research Site, Roma, , Italy
Research Site, Roma, , Italy
Research Site, Rozzano, , Italy
Research Site, Torino, , Italy
Research Site, Trento, , Italy
Research Site, Chiba-shi, , Japan
Research Site, Fukuoka-shi, , Japan
Research Site, Fukushima-shi, , Japan
Research Site, Hirakata-shi, , Japan
Research Site, Hiroshima-shi, , Japan
Research Site, Iruma-Gun, , Japan
Research Site, Isehara-shi, , Japan
Research Site, Kagoshima-shi, , Japan
Research Site, Kashiwa, , Japan
Research Site, Koto-ku, , Japan
Research Site, Kumamoto-shi, , Japan
Research Site, Kurume-shi, , Japan
Research Site, Kyoto-shi, , Japan
Research Site, Matsuyama-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Niigata-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Ota-shi, , Japan
Research Site, Sapporo-shi, , Japan
Research Site, Sapporo-shi, , Japan
Research Site, Sendai-shi, , Japan
Research Site, Shinagawa-ku, , Japan
Research Site, Suita-shi, , Japan
Research Site, Sunto-gun, , Japan
Research Site, Takasaki-shi, , Japan
Research Site, Tsu-shi, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Cheonan-si, , Korea, Republic of
Research Site, Daegu, , Korea, Republic of
Research Site, Goyang-si, , Korea, Republic of
Research Site, Seongnam-si, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Johor Bahru, , Malaysia
Research Site, Kota Bharu, , Malaysia
Research Site, Kuala Lumpur, , Malaysia
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Research Site, Kuching, , Malaysia
Research Site, Melaka, , Malaysia
Research Site, Pulau Pinang, , Malaysia
Research Site, Alc. Cuauhtémoc, , Mexico
Research Site, Cancún, , Mexico
Research Site, Colonia Lindavista, , Mexico
Research Site, Monterrey, , Mexico
Research Site, San Luis Potosí, , Mexico
Research Site, Tuxtla Gutiérrez, , Mexico
Research Site, Veracruz, , Mexico
Research Site, Palmerston North, , New Zealand
Research Site, Arequipa, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Bacolod, , Philippines
Research Site, Iloilo City, , Philippines
Research Site, Quezon, , Philippines
Research Site, Białystok, , Poland
Research Site, Bydgoszcz, , Poland
Research Site, Gdańsk, , Poland
Research Site, Gdynia, , Poland
Research Site, Grudziadz, , Poland
Research Site, Koszalin, , Poland
Research Site, Kraków, , Poland
Research Site, Lublin, , Poland
Research Site, Lublin, , Poland
Research Site, Opole, , Poland
Research Site, Poznań, , Poland
Research Site, Racibórz, , Poland
Research Site, Rzeszow, , Poland
Research Site, Rzeszów, , Poland
Research Site, Szczecin, , Poland
Research Site, Tomaszów Mazowiecki, , Poland
Research Site, Warszawa, , Poland
Research Site, Wroclaw, , Poland
Research Site, Łódź, , Poland
Research Site, Amadora, , Portugal
Research Site, Lisboa, , Portugal
Research Site, Porto, , Portugal
Research Site, Viana do Castelo, , Portugal
Research Site, Vila Nova de Gaia, , Portugal
Research Site, Bucuresti, , Romania
Research Site, Cluj-Napoca, , Romania
Research Site, Craiova, , Romania
Research Site, Iasi, , Romania
Research Site, Oradea, , Romania
Research Site, Ovidiu, , Romania
Research Site, Pitesti, , Romania
Research Site, Sibiu, , Romania
Research Site, Timisoara, , Romania
Research Site, Riyadh/MENA, , Saudi Arabia
Research Site, Belgrade, , Serbia
Research Site, Beograd, , Serbia
Research Site, Nis, , Serbia
Research Site, Novi Sad, , Serbia
Research Site, Valjevo, , Serbia
Research Site, Zrenjanin, , Serbia
Research Site, Johannesburg, , South Africa
Research Site, A Coruña, , Spain
Research Site, Albacete, , Spain
Research Site, Barakaldo, , Spain
Research Site, Barcelona, , Spain
Research Site, Barcelona, , Spain
Research Site, Burgos, , Spain
Research Site, Cordoba, , Spain
Research Site, El Palmar, , Spain
Research Site, Elche(Alicante), , Spain
Research Site, Fuenlabrada, , Spain
Research Site, Granada, , Spain
Research Site, La Coruña, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Malaga, , Spain
Research Site, Manresa, , Spain
Research Site, Murcia, , Spain
Research Site, Palma de Mallorca, , Spain
Research Site, San Sebastian, , Spain
Research Site, Sevilla, , Spain
Research Site, Valencia, , Spain
Research Site, Zaragoza, , Spain
Research Site, Basel, , Switzerland
Research Site, Bellinzona, , Switzerland
Research Site, Chur, , Switzerland
Research Site, Luzern, , Switzerland
Research Site, Zürich, , Switzerland
Research Site, Hsinchu, , Taiwan
Research Site, Kaohsiung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
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Research Site, Yong Kang City, , Taiwan
Research Site, Bangkok, , Thailand
Research Site, Bangkok, , Thailand
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Research Site, Hat Yai, , Thailand
Research Site, Khon Kaen, , Thailand
Research Site, Ankara, , Turkey
Research Site, Ankara, , Turkey
Research Site, Cigli, , Turkey
Research Site, Edirne, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Istanbul, , Turkey
Research Site, İstanbul, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Abu Dhabi, , United Arab Emirates
Research Site, Al Ain, , United Arab Emirates
Research Site, Dubai, , United Arab Emirates
Research Site, Dubai, , United Arab Emirates
Research Site, Aberdeen, , United Kingdom
Research Site, Bath, , United Kingdom
Research Site, Brighton, , United Kingdom
Research Site, Guilford, , United Kingdom
Research Site, Lancaster, , United Kingdom
Research Site, Leeds, , United Kingdom
Research Site, Leicester, , United Kingdom
Research Site, London, , United Kingdom
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Research Site, Manchester, , United Kingdom
Research Site, Northampton, , United Kingdom
Research Site, Oxford, , United Kingdom
Research Site, Stockton, , United Kingdom
Research Site, Sutton In Ashfield, , United Kingdom
Research Site, Taunton, , United Kingdom
Research Site, Warwick, , United Kingdom
Research Site, Whitchurch, , United Kingdom
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