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Spots Global Cancer Trial Database for Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer

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Trial Identification

Brief Title: Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study Comparing GW572016 and Letrozole Versus Letrozole in Subjects With Estrogen/Progesterone Receptor- Positive Advanced or Metastatic Breast Cancer

Study ID: NCT00073528

Study Description

Brief Summary: This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or metastatic disease.

Detailed Description: Subjects were randomly assigned to receive either lapatinib (1500 mg once daily orally) with letrozole (2.5 mg once daily orally), or letrozole (2.5 mg once daily orally) with placebo (which matched with lapatinib tablet). Randomization was stratified by site of disease (i.e., soft tissue/visceral disease versus bone only disease) and time since prior adjuvant endocrine therapy (\<6 months or ≥ 6 months from discontinuation of adjuvant anti-estrogen therapy (e.g. tamoxifen or raloxifene) or no prior adjuvant antiestrogen therapy). Study therapy was administered daily until disease progression (objective or symptomatic) or withdrawal from therapy (e.g., due to unacceptable toxicity, withdrawal of consent, or other reason). All subjects were to be followed for survival information until death. On 13 Apr 2015, after the introduction of the Long Term Follow UP (LTFU) phase (per protocol amendment 07), subjects receiving study treatment with lapatinib plus letrozole, or letrozole plus placebo had continued access to this study treatment until the occurrence of one of the following criteria: * Disease progression (as determined by the Investigator), * Intercurrent illness that prevented further administration of study treatment * Drug related AE which was considered by the investigator to warrant permanent discontinuation of study treatment * The subject decided to withdraw from the study. Investigators collected AEs and/or SAEs related to study participation, until 30 days following study treatment discontinuation. Subjects who were being followed-up for OS but were not taking study medication, were withdrawn from the study. The study was terminated on 22-Mar-2018 (last subject last visit).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Novartis Investigative Site, Tucson, Arizona, United States

Novartis Investigative Site, Hot Springs, Arkansas, United States

Novartis Investigative Site, Jonesboro, Arkansas, United States

Novartis Investigative Site, Alhambra, California, United States

Novartis Investigative Site, Bakersfield, California, United States

Novartis Investigative Site, Duarte, California, United States

Novartis Investigative Site, Fountain Valley, California, United States

Novartis Investigative Site, Fresno, California, United States

Novartis Investigative Site, Fullerton, California, United States

Novartis Investigative Site, La Jolla, California, United States

Novartis Investigative Site, Long Beach, California, United States

Novartis Investigative Site, Los Angeles, California, United States

Novartis Investigative Site, Montebello, California, United States

Novartis Investigative Site, Northridge, California, United States

Novartis Investigative Site, Oxnard, California, United States

Novartis Investigative Site, Pleasant Hill, California, United States

Novartis Investigative Site, Porterville, California, United States

Novartis Investigative Site, Redondo Beach, California, United States

Novartis Investigative Site, San Diego, California, United States

Novartis Investigative Site, Santa Barbara, California, United States

Novartis Investigative Site, Santa Maria, California, United States

Novartis Investigative Site, Vallejo, California, United States

Novartis Investigative Site, Vista, California, United States

Novartis Investigative Site, Aurora, Colorado, United States

Novartis Investigative Site, Denver, Colorado, United States

Novartis Investigative Site, Longmont, Colorado, United States

Novartis Investigative Site, Wheat Ridge, Colorado, United States

Novartis Investigative Site, New Haven, Connecticut, United States

Novartis Investigative Site, Boca Raton, Florida, United States

Novartis Investigative Site, Boca Raton, Florida, United States

Novartis Investigative Site, Gainesville, Florida, United States

Novartis Investigative Site, Gainesville, Florida, United States

Novartis Investigative Site, Hollywood, Florida, United States

Novartis Investigative Site, Lakeland, Florida, United States

Novartis Investigative Site, Miami, Florida, United States

Novartis Investigative Site, Orlando, Florida, United States

Novartis Investigative Site, Port Saint Lucie, Florida, United States

Novartis Investigative Site, West Palm Beach, Florida, United States

Novartis Investigative Site, Atlanta, Georgia, United States

Novartis Investigative Site, Marietta, Georgia, United States

Novartis Investigative Site, Savannah, Georgia, United States

Novartis Investigative Site, Peoria, Illinois, United States

Novartis Investigative Site, Skokie, Illinois, United States

Novartis Investigative Site, Indianapolis, Indiana, United States

Novartis Investigative Site, Bettendorf, Iowa, United States

Novartis Investigative Site, Louisville, Kentucky, United States

Novartis Investigative Site, Metairie, Louisiana, United States

Novartis Investigative Site, New Orleans, Louisiana, United States

Novartis Investigative Site, Worcester, Massachusetts, United States

Novartis Investigative Site, Duluth, Minnesota, United States

Novartis Investigative Site, Minneapolis, Minnesota, United States

Novartis Investigative Site, Robbinsdale, Minnesota, United States

Novartis Investigative Site, Saint Louis Park, Minnesota, United States

Novartis Investigative Site, Saint Charles, Missouri, United States

Novartis Investigative Site, Saint Louis, Missouri, United States

Novartis Investigative Site, Omaha, Nebraska, United States

Novartis Investigative Site, Las Vegas, Nevada, United States

Novartis Investigative Site, Voorhees, New Jersey, United States

Novartis Investigative Site, Santa Fe, New Mexico, United States

Novartis Investigative Site, Manhasset, New York, United States

Novartis Investigative Site, Rochester, New York, United States

Novartis Investigative Site, Chapel Hill, North Carolina, United States

Novartis Investigative Site, Greenville, North Carolina, United States

Novartis Investigative Site, Fargo, North Dakota, United States

Novartis Investigative Site, Canton, Ohio, United States

Novartis Investigative Site, Hershey, Pennsylvania, United States

Novartis Investigative Site, Philadelphia, Pennsylvania, United States

Novartis Investigative Site, Pittsburgh, Pennsylvania, United States

Novartis Investigative Site, West Columbia, South Carolina, United States

Novartis Investigative Site, Germantown, Tennessee, United States

Novartis Investigative Site, Knoxville, Tennessee, United States

Novartis Investigative Site, Amarillo, Texas, United States

Novartis Investigative Site, Dallas, Texas, United States

Novartis Investigative Site, Dallas, Texas, United States

Novartis Investigative Site, Houston, Texas, United States

Novartis Investigative Site, Irving, Texas, United States

Novartis Investigative Site, Ogden, Utah, United States

Novartis Investigative Site, Salt Lake City, Utah, United States

Novartis Investigative Site, Burlington, Vermont, United States

Novartis Investigative Site, Danville, Virginia, United States

Novartis Investigative Site, Richmond, Virginia, United States

Novartis Investigative Site, Seattle, Washington, United States

Novartis Investigative Site, Tacoma, Washington, United States

Novartis Investigative Site, Charleston, West Virginia, United States

Novartis Investigative Site, Capital Federal, Buenos Aires, Argentina

Novartis Investigative Site, Buenos Aires, , Argentina

Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, , Argentina

Novartis Investigative Site, Garran, Australian Capital Territory, Australia

Novartis Investigative Site, Douglas, Queensland, Australia

Novartis Investigative Site, Herston, Queensland, Australia

Novartis Investigative Site, Redcliffe, Queensland, Australia

Novartis Investigative Site, Adelaide, South Australia, Australia

Novartis Investigative Site, Salvador, Bahía, Brazil

Novartis Investigative Site, Rio de Janeiro, , Brazil

Novartis Investigative Site, Plovdiv, , Bulgaria

Novartis Investigative Site, Sofia, , Bulgaria

Novartis Investigative Site, Sofia, , Bulgaria

Novartis Investigative Site, Winnipeg, Manitoba, Canada

Novartis Investigative Site, London, Ontario, Canada

Novartis Investigative Site, Mississauga, Ontario, Canada

Novartis Investigative Site, Oshawa, Ontario, Canada

Novartis Investigative Site, Sudbury, Ontario, Canada

Novartis Investigative Site, Toronto, Ontario, Canada

Novartis Investigative Site, Montreal, Quebec, Canada

Novartis Investigative Site, Montreal, Quebec, Canada

Novartis Investigative Site, Montreal, Quebec, Canada

Novartis Investigative Site, Montreal, Quebec, Canada

Novartis Investigative Site, Sherbrooke, Quebec, Canada

Novartis Investigative Site, Quebec, , Canada

Novartis Investigative Site, Santiago, Región Metro De Santiago, Chile

Novartis Investigative Site, Santiago, Región Metro De Santiago, Chile

Novartis Investigative Site, Bogota, , Colombia

Novartis Investigative Site, Osijek, , Croatia

Novartis Investigative Site, Pula, , Croatia

Novartis Investigative Site, Split, , Croatia

Novartis Investigative Site, Brno, , Czechia

Novartis Investigative Site, Ceske Budejovice, , Czechia

Novartis Investigative Site, Praha 8, , Czechia

Novartis Investigative Site, Aalborg, , Denmark

Novartis Investigative Site, Hillerod, , Denmark

Novartis Investigative Site, Koebenhavn Oe, , Denmark

Novartis Investigative Site, Naestved, , Denmark

Novartis Investigative Site, Odense C, , Denmark

Novartis Investigative Site, Roskilde, , Denmark

Novartis Investigative Site, Vejle, , Denmark

Novartis Investigative Site, Angers Cedex 01, , France

Novartis Investigative Site, Besancon, , France

Novartis Investigative Site, Grenoble Cedex 9, , France

Novartis Investigative Site, Lille Cedex, , France

Novartis Investigative Site, Montpellier, , France

Novartis Investigative Site, Paris Cedex 5, , France

Novartis Investigative Site, Pierre Benite Cedex, , France

Novartis Investigative Site, Toulouse Cedex9, , France

Novartis Investigative Site, Villejuif Cedex, , France

Novartis Investigative Site, Aalen, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Freiburg, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Heidelberg, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Heidenheim, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Schwetzingen, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Stuttgart, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Ulm, Baden-Wuerttemberg, Germany

Novartis Investigative Site, Augsburg, Bayern, Germany

Novartis Investigative Site, Bayreuth, Bayern, Germany

Novartis Investigative Site, Erlangen, Bayern, Germany

Novartis Investigative Site, Muenchen, Bayern, Germany

Novartis Investigative Site, Muenchen, Bayern, Germany

Novartis Investigative Site, Muenchen, Bayern, Germany

Novartis Investigative Site, Regensburg, Bayern, Germany

Novartis Investigative Site, Rehling, Bayern, Germany

Novartis Investigative Site, Rosenheim, Bayern, Germany

Novartis Investigative Site, Frankfurt am Main, Hessen, Germany

Novartis Investigative Site, Frankfurt, Hessen, Germany

Novartis Investigative Site, Wiesbaden, Hessen, Germany

Novartis Investigative Site, Wiesbaden, Hessen, Germany

Novartis Investigative Site, Goslar, Niedersachsen, Germany

Novartis Investigative Site, Leer, Niedersachsen, Germany

Novartis Investigative Site, Bonn, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Coesfeld, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Duesseldorf, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Ibbenbueren, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Muenster, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Troisdorf, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Velbert, Nordrhein-Westfalen, Germany

Novartis Investigative Site, Altenkirchen, Rheinland-Pfalz, Germany

Novartis Investigative Site, Chemnitz, Sachsen, Germany

Novartis Investigative Site, Dresden, Sachsen, Germany

Novartis Investigative Site, Kiel, Schleswig-Holstein, Germany

Novartis Investigative Site, Kiel, Schleswig-Holstein, Germany

Novartis Investigative Site, Pinneberg, Schleswig-Holstein, Germany

Novartis Investigative Site, Jena, Thueringen, Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Berlin, , Germany

Novartis Investigative Site, Hamburg, , Germany

Novartis Investigative Site, Hamburg, , Germany

Novartis Investigative Site, Hamburg, , Germany

Novartis Investigative Site, Hamburg, , Germany

Novartis Investigative Site, Hamburg, , Germany

Novartis Investigative Site, Budapest, , Hungary

Novartis Investigative Site, Budapest, , Hungary

Novartis Investigative Site, Budapest, , Hungary

Novartis Investigative Site, Kecskemet, , Hungary

Novartis Investigative Site, Kistarcsa, , Hungary

Novartis Investigative Site, Szeged, , Hungary

Novartis Investigative Site, Tatabanya, , Hungary

Novartis Investigative Site, Cork, , Ireland

Novartis Investigative Site, Dooradoyle, , Ireland

Novartis Investigative Site, Dublin, , Ireland

Novartis Investigative Site, Dublin, , Ireland

Novartis Investigative Site, Dublin, , Ireland

Novartis Investigative Site, Galway, , Ireland

Novartis Investigative Site, Tallaght, Dublin, , Ireland

Novartis Investigative Site, Wilton, Cork, , Ireland

Novartis Investigative Site, Bologna, Emilia-Romagna, Italy

Novartis Investigative Site, Parma, Emilia-Romagna, Italy

Novartis Investigative Site, Roma, Lazio, Italy

Novartis Investigative Site, Roma, Lazio, Italy

Novartis Investigative Site, Genova, Liguria, Italy

Novartis Investigative Site, Genova, Liguria, Italy

Novartis Investigative Site, Crema, Lombardia, Italy

Novartis Investigative Site, Milano, Lombardia, Italy

Novartis Investigative Site, Gyeonggi-do, , Korea, Republic of

Novartis Investigative Site, Seodaemun-gu, Seoul, , Korea, Republic of

Novartis Investigative Site, Seoul, , Korea, Republic of

Novartis Investigative Site, Acapulco, Guerrero, Mexico

Novartis Investigative Site, Colima, , Mexico

Novartis Investigative Site, Durango, , Mexico

Novartis Investigative Site, Durango, , Mexico

Novartis Investigative Site, Mexico, D.F., , Mexico

Novartis Investigative Site, Amersfoort, , Netherlands

Novartis Investigative Site, Delft, , Netherlands

Novartis Investigative Site, Den Haag, , Netherlands

Novartis Investigative Site, Den Haag, , Netherlands

Novartis Investigative Site, Doetinchem, , Netherlands

Novartis Investigative Site, Eindhoven, , Netherlands

Novartis Investigative Site, Heerlen, , Netherlands

Novartis Investigative Site, Leidschendam, , Netherlands

Novartis Investigative Site, Maastricht, , Netherlands

Novartis Investigative Site, Nieuwegein, , Netherlands

Novartis Investigative Site, Sittard-geleen, , Netherlands

Novartis Investigative Site, Utrecht, , Netherlands

Novartis Investigative Site, Utrecht, , Netherlands

Novartis Investigative Site, Christchurch, , New Zealand

Novartis Investigative Site, Lahore, , Pakistan

Novartis Investigative Site, Lahore, , Pakistan

Novartis Investigative Site, Rawalpindi, , Pakistan

Novartis Investigative Site, Callao, , Peru

Novartis Investigative Site, Lima, , Peru

Novartis Investigative Site, Bydogoszcz, , Poland

Novartis Investigative Site, Krakow, , Poland

Novartis Investigative Site, Poznan, , Poland

Novartis Investigative Site, Warszawa, , Poland

Novartis Investigative Site, Wroclaw, , Poland

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, Moscow, , Russian Federation

Novartis Investigative Site, St. Petersburg, , Russian Federation

Novartis Investigative Site, St. Petersburg, , Russian Federation

Novartis Investigative Site, Capital Park, , South Africa

Novartis Investigative Site, Panorama, , South Africa

Novartis Investigative Site, Parktown, , South Africa

Novartis Investigative Site, Port Elizabeth, , South Africa

Novartis Investigative Site, Alcala De Henares (Madrid), , Spain

Novartis Investigative Site, Badalona, , Spain

Novartis Investigative Site, Barcelona, , Spain

Novartis Investigative Site, Elche, , Spain

Novartis Investigative Site, Girona, , Spain

Novartis Investigative Site, Leganes, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Madrid, , Spain

Novartis Investigative Site, Malaga, , Spain

Novartis Investigative Site, Mostoles, , Spain

Novartis Investigative Site, Oviedo, , Spain

Novartis Investigative Site, Palma de Mallorca, , Spain

Novartis Investigative Site, San Sebastian, , Spain

Novartis Investigative Site, Valencia, , Spain

Novartis Investigative Site, Vigo ( Pontevedra), , Spain

Novartis Investigative Site, Zaragoza, , Spain

Novartis Investigative Site, Sfax, , Tunisia

Novartis Investigative Site, Sousse, , Tunisia

Novartis Investigative Site, Tunis, , Tunisia

Novartis Investigative Site, Tunis, , Tunisia

Novartis Investigative Site, Ankara, , Turkey

Novartis Investigative Site, Istanbul, , Turkey

Novartis Investigative Site, Istanbul, , Turkey

Novartis Investigative Site, Chelmsford, Essex, United Kingdom

Novartis Investigative Site, Manchester, Lancashire, United Kingdom

Novartis Investigative Site, Northwood, Middlesex, United Kingdom

Novartis Investigative Site, Sutton, Surrey, United Kingdom

Novartis Investigative Site, Birmingham, West Midlands, United Kingdom

Novartis Investigative Site, Huddersfield, , United Kingdom

Novartis Investigative Site, London, , United Kingdom

Novartis Investigative Site, London, , United Kingdom

Novartis Investigative Site, London, , United Kingdom

Novartis Investigative Site, Sheffield, , United Kingdom

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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