Spots Global Cancer Trial Database for Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)
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Trial Identification
Brief Title: Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women With Early-Stage Breast Cancer at High Risk of Recurrence (D-CARE)
Study ID: NCT01077154
Conditions
Study Description
Brief Summary: This randomized phase 3 trial is studying the effect of denosumab to see if it can prevent disease recurrence in the bone or in any other part of the body, when it is given as adjuvant therapy for women with early-stage breast cancer, who are at high risk of disease recurrence.
Detailed Description: Eligible participants were randomized in a 1:1 ratio to receive denosumab 120 mg or placebo subcutaneously (SC) for up to 5 years. Randomization was stratified based on: 1. Breast cancer therapy/lymph node (LN) status: neoadjuvant therapy/any LN status versus adjuvant therapy/LN negative (based on axillary LN dissection, or based on sentinel node status) versus adjuvant therapy/LN positive 2. Hormone receptor (estrogen receptor \[ER\]/progesterone receptor \[PR\]) status: ER and/or PR positive versus ER and PR negative 3. Human epidermal growth factor receptor 2 (HER-2) status: HER-2 positive versus HER-2 negative 4. Age: \< 50 years versus ≥ 50 years 5. Geographic Region: Japan versus Other regions. The primary analysis was conducted after all enrolled participants had the opportunity to complete 5 years of treatment from study day 1.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Research Site, Birmingham, Alabama, United States
Research Site, Tucson, Arizona, United States
Research Site, Jonesboro, Arkansas, United States
Research Site, Alhambra, California, United States
Research Site, Anaheim, California, United States
Research Site, Beverly Hills, California, United States
Research Site, Campbell, California, United States
Research Site, Fresno, California, United States
Research Site, Fullerton, California, United States
Research Site, La Verne, California, United States
Research Site, Lancaster, California, United States
Research Site, Long Beach, California, United States
Research Site, Los Angeles, California, United States
Research Site, Los Angeles, California, United States
Research Site, Los Angeles, California, United States
Research Site, Northridge, California, United States
Research Site, Redondo Beach, California, United States
Research Site, Santa Barbara, California, United States
Research Site, Santa Maria, California, United States
Research Site, Torrance, California, United States
Research Site, Denver, Colorado, United States
Research Site, Grand Junction, Colorado, United States
Research Site, New Haven, Connecticut, United States
Research Site, Boynton Beach, Florida, United States
Research Site, Coral Springs, Florida, United States
Research Site, Fort Lauderdale, Florida, United States
Research Site, Hollywood, Florida, United States
Research Site, Jacksonville, Florida, United States
Research Site, Melbourne, Florida, United States
Research Site, Athens, Georgia, United States
Research Site, Niles, Illinois, United States
Research Site, Indianapolis, Indiana, United States
Research Site, Cedar Rapids, Iowa, United States
Research Site, Hutchinson, Kansas, United States
Research Site, Wichita, Kansas, United States
Research Site, Paducah, Kentucky, United States
Research Site, Annapolis, Maryland, United States
Research Site, Baltimore, Maryland, United States
Research Site, Bethesda, Maryland, United States
Research Site, Columbia, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Danvers, Massachusetts, United States
Research Site, Ann Arbor, Michigan, United States
Research Site, Detroit, Michigan, United States
Research Site, Edina, Minnesota, United States
Research Site, Minneapolis, Minnesota, United States
Research Site, Saint Louis Park, Minnesota, United States
Research Site, Jackson, Mississippi, United States
Research Site, Jefferson City, Missouri, United States
Research Site, Lincoln, Nebraska, United States
Research Site, Henderson, Nevada, United States
Research Site, Lebanon, New Hampshire, United States
Research Site, Denville, New Jersey, United States
Research Site, Hackensack, New Jersey, United States
Research Site, East Setauket, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, Nyack, New York, United States
Research Site, Asheville, North Carolina, United States
Research Site, High Point, North Carolina, United States
Research Site, Cincinnati, Ohio, United States
Research Site, Columbus, Ohio, United States
Research Site, Tulsa, Oklahoma, United States
Research Site, Hershey, Pennsylvania, United States
Research Site, Pittsburgh, Pennsylvania, United States
Research Site, Pawtucket, Rhode Island, United States
Research Site, Charleston, South Carolina, United States
Research Site, Columbia, South Carolina, United States
Research Site, Hilton Head Island, South Carolina, United States
Research Site, Sioux Falls, South Dakota, United States
Research Site, Chattanooga, Tennessee, United States
Research Site, Germantown, Tennessee, United States
Research Site, Nashville, Tennessee, United States
Research Site, Abilene, Texas, United States
Research Site, Corpus Christi, 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, Garland, 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, San Antonio, Texas, United States
Research Site, Tyler, Texas, United States
Research Site, Richlands, Virginia, United States
Research Site, Richmond, Virginia, United States
Research Site, Roanoke, Virginia, United States
Research Site, Seattle, Washington, United States
Research Site, Seattle, Washington, United States
Research Site, Tacoma, Washington, United States
Research Site, Quilmes, Buenos Aires, Argentina
Research Site, Quilmes, Buenos Aires, Argentina
Research Site, San Martin, Buenos Aires, Argentina
Research Site, Neuquen, Neuquén, Argentina
Research Site, Provincia De Santa Fe, Santa Fe, Argentina
Research Site, San Miguel de Tucuman, Tucuman, Argentina
Research Site, Camperdown, New South Wales, Australia
Research Site, Caringbah, New South Wales, Australia
Research Site, Kogarah, New South Wales, Australia
Research Site, Tweed Heads, New South Wales, Australia
Research Site, Wahroonga, New South Wales, Australia
Research Site, Bedford Park, South Australia, Australia
Research Site, Bentleigh East, Victoria, Australia
Research Site, East Melbourne, Victoria, Australia
Research Site, Fitzroy, Victoria, Australia
Research Site, Footscray, Victoria, Australia
Research Site, Frankston, Victoria, Australia
Research Site, Heidelberg, Victoria, Australia
Research Site, Malvern, Victoria, Australia
Research Site, Parkville, Victoria, Australia
Research Site, Richmond, Victoria, Australia
Research Site, Ringwood East, Victoria, Australia
Research Site, Warrnambool, Victoria, Australia
Research Site, Wodonga, Victoria, Australia
Research Site, Perth, Western Australia, Australia
Research Site, Subiaco, Western Australia, Australia
Research Site, Antwerpen, , Belgium
Research Site, Bonheiden, , Belgium
Research Site, Brugge, , Belgium
Research Site, Brussel, , Belgium
Research Site, Bruxelles, , Belgium
Research Site, Bruxelles, , Belgium
Research Site, Edegem, , Belgium
Research Site, Gent, , Belgium
Research Site, Hasselt, , Belgium
Research Site, Kortrijk, , Belgium
Research Site, Leuven, , Belgium
Research Site, Libramont, , Belgium
Research Site, Liège, , Belgium
Research Site, Namur, , Belgium
Research Site, Oostende, , Belgium
Research Site, Ottignies, , Belgium
Research Site, Sint-Niklaas, , Belgium
Research Site, Tournai, , Belgium
Research Site, Wilrijk, , Belgium
Research Site, Yvoir, , Belgium
Research Site, Salvador, Bahia, Brazil
Research Site, Salvador, Bahia, Brazil
Research Site, Curitiba, Paraná, Brazil
Research Site, Londrina, Paraná, Brazil
Research Site, Porto Alegre, Rio Grande Do Sul, Brazil
Research Site, Porto Alegre, Rio Grande Do Sul, Brazil
Research Site, Porto Alegre, Rio Grande Do Sul, Brazil
Research Site, ItajaÃ-, Santa Catarina, Brazil
Research Site, Barretos, São Paulo, Brazil
Research Site, Santo Andre, São Paulo, Brazil
Research Site, Sao Paulo, São Paulo, Brazil
Research Site, São Paulo, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Plovdiv, , Bulgaria
Research Site, Rousse, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Sofia, , Bulgaria
Research Site, Stara Zagora, , Bulgaria
Research Site, Varna, , Bulgaria
Research Site, Veliko Tarnovo, , Bulgaria
Research Site, Calgary, Alberta, Canada
Research Site, Edmonton, Alberta, Canada
Research Site, Kelowna, British Columbia, Canada
Research Site, Victoria, British Columbia, Canada
Research Site, Moncton, New Brunswick, Canada
Research Site, St. John's, Newfoundland and Labrador, Canada
Research Site, Sydney, Nova Scotia, Canada
Research Site, Barrie, Ontario, Canada
Research Site, Brampton, Ontario, Canada
Research Site, Kingston, Ontario, Canada
Research Site, Kitchener, Ontario, Canada
Research Site, Ottawa, Ontario, Canada
Research Site, Sault Ste. Marie, Ontario, Canada
Research Site, Sudbury, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Greenfield Park, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Sherbrooke, Quebec, Canada
Research Site, Quebec, , Canada
Research Site, Temuco, CautÃ-n, Chile
Research Site, Vina del Mar, ValparaÃ-so, Chile
Research Site, Santiago, , Chile
Research Site, Brno, , Czechia
Research Site, Brno, , Czechia
Research Site, Chomutov, , Czechia
Research Site, Horovice, , Czechia
Research Site, Hradec Kralove, , Czechia
Research Site, Olomouc, , Czechia
Research Site, Praha 10, , Czechia
Research Site, Praha 10, , Czechia
Research Site, Praha 4, , Czechia
Research Site, Praha 5, , Czechia
Research Site, Praha 8, , Czechia
Research Site, Herning, , Denmark
Research Site, Vejle, , Denmark
Research Site, Viborg, , Denmark
Research Site, Ã…rhus C, , Denmark
Research Site, Angers, , France
Research Site, Bordeaux Cedex, , France
Research Site, Dijon, , France
Research Site, Grenoble, , France
Research Site, Hyères, , France
Research Site, Le Mans, , France
Research Site, Lille, , France
Research Site, Monaco, , France
Research Site, Nantes Cedex 2, , France
Research Site, Paris, , France
Research Site, Pierre-Benite, , France
Research Site, Saint Priest en Jarez Cedex, , France
Research Site, Strasbourg cedex, , France
Research Site, Villejuif cedex, , France
Research Site, Berlin, , Germany
Research Site, Berlin, , Germany
Research Site, Bonn, , Germany
Research Site, Bottrop, , Germany
Research Site, Erlangen, , Germany
Research Site, Frankfurt, , Germany
Research Site, Kiel, , Germany
Research Site, Koblenz, , Germany
Research Site, Mannheim, , Germany
Research Site, München, , Germany
Research Site, München, , Germany
Research Site, München, , Germany
Research Site, Recklinghausen, , Germany
Research Site, Rostock, , Germany
Research Site, Trier, , Germany
Research Site, Tübingen, , Germany
Research Site, Athens, , Greece
Research Site, Athens, , Greece
Research Site, Heraklion, , Greece
Research Site, Patra, , Greece
Research Site, Thessaloniki, , Greece
Research Site, Thessaloniki, , Greece
Research Site, Hong Kong, , Hong Kong
Research Site, New Territories, , Hong Kong
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Budapest, , Hungary
Research Site, Debrecen, , Hungary
Research Site, Gyor, , Hungary
Research Site, Nyiregyhaza, , Hungary
Research Site, Pecs, , Hungary
Research Site, Szeged, , Hungary
Research Site, Szekesfehervar, , Hungary
Research Site, Szolnok, , Hungary
Research Site, Zalaegerszeg, , Hungary
Research Site, Hyderabad, Andhra Pradesh, India
Research Site, Bangalore, Karnataka, India
Research Site, Ahmednagar, Maharashtra, India
Research Site, Aurangabad, Maharashtra, India
Research Site, Miraj, Maharashtra, India
Research Site, Mumbai, Maharashtra, India
Research Site, Mumbai, Maharashtra, India
Research Site, Nashik, Maharashtra, India
Research Site, Nashik, Maharashtra, India
Research Site, Pune, Maharashtra, India
Research Site, Jaipur, Rajasthan, India
Research Site, Chennai, Tamil Nadu, India
Research Site, Madurai, Tamil Nadu, India
Research Site, Cork, , Ireland
Research Site, Dublin, , Ireland
Research Site, Dublin, , Ireland
Research Site, Dublin, , Ireland
Research Site, Limerick, , Ireland
Research Site, Waterford, , Ireland
Research Site, Ashkelon, , Israel
Research Site, Haifa, , Israel
Research Site, Jerusalem, , Israel
Research Site, Kfar Sava, , Israel
Research Site, Petah Tikva, , Israel
Research Site, Poria Eylit, , Israel
Research Site, Rehovot, , Israel
Research Site, Tel Aviv, , Israel
Research Site, Tel Aviv, , Israel
Research Site, Ancona, , Italy
Research Site, Bari, , Italy
Research Site, Brescia, , Italy
Research Site, Meldola FC, , Italy
Research Site, Milano, , Italy
Research Site, Monza (MB), , Italy
Research Site, Palermo, , Italy
Research Site, Parma, , Italy
Research Site, San Giovanni Rotondo FG, , Italy
Research Site, Treviglio (BG), , Italy
Research Site, Varese, , Italy
Research Site, Nagoya-shi, Aichi, Japan
Research Site, Nagoya-shi, Aichi, Japan
Research Site, Matsuyama-shi, Ehime, Japan
Research Site, Fukuoka-shi, Fukuoka, Japan
Research Site, Kitakyushu-shi, Fukuoka, Japan
Research Site, Kurume-shi, Fukuoka, Japan
Research Site, Kure-shi, Hiroshima, Japan
Research Site, Akashi-shi, Hyogo, Japan
Research Site, Kagoshima-shi, Kagoshima, Japan
Research Site, Isehara-shi, Kanagawa, Japan
Research Site, Kumamoto-shi, Kumamoto, Japan
Research Site, Kyoto-shi, Kyoto, Japan
Research Site, Miyazaki-shi, Miyazaki, Japan
Research Site, Niigata-shi, Niigata, Japan
Research Site, Kurashiki-shi, Okayama, Japan
Research Site, Osaka-shi, Osaka, Japan
Research Site, Osaka-shi, Osaka, Japan
Research Site, Suita-shi, Osaka, Japan
Research Site, Hidaka-Shi, Saitama, Japan
Research Site, Kitaadachi-gun, Saitama, Japan
Research Site, Suntou-gun, Shizuoka, Japan
Research Site, Shimotsuke-shi, Tochigi, Japan
Research Site, Utsunomiya-shi, Tochigi, Japan
Research Site, Chuo-ku, Tokyo, Japan
Research Site, Tokyo, , Japan
Research Site, Tokyo, , Japan
Research Site, Tokyo, , Japan
Research Site, Tokyo, , Japan
Research Site, Goyang-si, Gyeonggi-do, , Korea, Republic of
Research Site, Incheon, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Daugavpils, , Latvia
Research Site, Liepaja, , Latvia
Research Site, Riga, , Latvia
Research Site, Kota Bharu, Kelantan, Malaysia
Research Site, Subang Jaya, Selangor (incl. Putrajaya), Malaysia
Research Site, Kuala Lumpur, Wilayah Persekutuan, Malaysia
Research Site, Kuala Lumpur, Wilayah Persekutuan, Malaysia
Research Site, Mexico City, Distrito Federal, Mexico
Research Site, Mexico City, Distrito Federal, Mexico
Research Site, Mexico, Distrito Federal, Mexico
Research Site, Leon, Guanajuato, Mexico
Research Site, Pachuca de Soto, Hidalgo, Mexico
Research Site, Monterrey, Nuevo León, Mexico
Research Site, Queretaro, Querétaro, Mexico
Research Site, San Luis Potosi, San Luis PotosÃ-, Mexico
Research Site, Colima, , Mexico
Research Site, Distrito Federal, , Mexico
Research Site, Durango, , Mexico
Research Site, Toluca, , Mexico
Research Site, Amsterdam, , Netherlands
Research Site, Bergen op Zoom, , Netherlands
Research Site, Breda, , Netherlands
Research Site, Capelle aan den ijssel, , Netherlands
Research Site, Den Haag, , Netherlands
Research Site, Dordrecht, , Netherlands
Research Site, Hoofddorp, , Netherlands
Research Site, Leiden, , Netherlands
Research Site, Nieuwegein, , Netherlands
Research Site, Rotterdam, , Netherlands
Research Site, Rotterdam, , Netherlands
Research Site, Schiedam, , Netherlands
Research Site, Sittard-Geleen, , Netherlands
Research Site, Tiel, , Netherlands
Research Site, Tilburg, , Netherlands
Research Site, Venlo, , Netherlands
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Lima, , Peru
Research Site, Cebu City, , Philippines
Research Site, Manila, , Philippines
Research Site, Manila, , Philippines
Research Site, Metro Manila, , Philippines
Research Site, Quezon City, , Philippines
Research Site, Gdansk, , Poland
Research Site, Gdansk, , Poland
Research Site, Krakow, , Poland
Research Site, Olsztyn, , Poland
Research Site, Poznan, , Poland
Research Site, Rzeszow, , Poland
Research Site, Szczecin, , Poland
Research Site, Lisboa, , Portugal
Research Site, Lisboa, , Portugal
Research Site, Porto, , Portugal
Research Site, Porto, , Portugal
Research Site, Santa Maria da Feira, , Portugal
Research Site, Bucharest, , Romania
Research Site, Craiova, , Romania
Research Site, Sibiu, , Romania
Research Site, Suceava, , Romania
Research Site, Timisoara, , Romania
Research Site, Barnaul, , Russian Federation
Research Site, Chelyabinsk, , Russian Federation
Research Site, Ivanovo, , Russian Federation
Research Site, Kazan, , Russian Federation
Research Site, Moscow, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Saint Petersburg, , Russian Federation
Research Site, Belgrade, , Serbia
Research Site, Nis, , Serbia
Research Site, Bardejov, , Slovakia
Research Site, Kosice, , Slovakia
Research Site, Michalovce, , Slovakia
Research Site, Poprad, , Slovakia
Research Site, Presov, , Slovakia
Research Site, Spisska Nova Ves, , Slovakia
Research Site, Trebisov, , Slovakia
Research Site, Ljublijana, , Slovenia
Research Site, Maribor, , Slovenia
Research Site, Groenkloof, Gauteng, South Africa
Research Site, Johannesburg, Gauteng, South Africa
Research Site, Cape Town, , South Africa
Research Site, Pietermaritzburg, , South Africa
Research Site, Port Elizabeth, , South Africa
Research Site, Pretoria, , South Africa
Research Site, Pretoria, , South Africa
Research Site, Cádiz, AndalucÃ-a, Spain
Research Site, Córdoba, AndalucÃ-a, Spain
Research Site, Jaén, AndalucÃ-a, Spain
Research Site, Málaga, AndalucÃ-a, Spain
Research Site, Sevilla, AndalucÃ-a, Spain
Research Site, Zaragoza, Aragón, Spain
Research Site, Santander, Cantabria, Spain
Research Site, Badalona, Cataluña, Spain
Research Site, Barcelona, Cataluña, Spain
Research Site, Barcelona, Cataluña, Spain
Research Site, Barcelona, Cataluña, Spain
Research Site, Barcelona, Cataluña, Spain
Research Site, Girona, Cataluña, Spain
Research Site, Lleida, Cataluña, Spain
Research Site, Sabadell, Cataluña, Spain
Research Site, Elche, Comunidad Valenciana, Spain
Research Site, Valencia, Comunidad Valenciana, Spain
Research Site, Valencia, Comunidad Valenciana, Spain
Research Site, A Coruña, Galicia, Spain
Research Site, A Coruña, Galicia, Spain
Research Site, Alcorcón, Madrid, Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Putzu City, Chiayi, Taiwan
Research Site, Keelung City, Keelung, Taiwan
Research Site, Tainan, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Ankara, , Turkey
Research Site, Ankara, , Turkey
Research Site, Bornova-Izmir, , Turkey
Research Site, Ä°zmir, , Turkey
Research Site, Bebington, , United Kingdom
Research Site, Birmingham, , United Kingdom
Research Site, Brighton, , United Kingdom
Research Site, Bristol, , United Kingdom
Research Site, Cambridge, , United Kingdom
Research Site, Dorset, , United Kingdom
Research Site, Guildford, , United Kingdom
Research Site, Leeds, , United Kingdom
Research Site, London, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Newcastle, , United Kingdom
Research Site, Peterborough, , United Kingdom
Research Site, Plymouth, , United Kingdom
Research Site, Poole, , United Kingdom
Research Site, Portsmouth, , United Kingdom
Research Site, Sheffield, , United Kingdom
Research Site, Truro, , United Kingdom
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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