Spots Global Cancer Trial Database for A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer
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Trial Identification
Brief Title: A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer
Official Title: A Phase III Trial to Compare the Safety and Efficacy of Lapatinib Plus Trastuzumab Plus an Aromatase Inhibitor (AI) vs. Trastuzumab Plus an AI vs. Lapatinib Plus an AI as 1st- or 2nd- Line Therapy in Postmenopausal Subjects With Hormone Receptor+, HER2-positive Metastatic Breast Cancer (MBC) Who Received Prior Trastuzumab and Endocrine Therapies
Study ID: NCT01160211
Conditions
Study Description
Brief Summary: A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).
Detailed Description: This was a Phase III, randomized, open-label, multi-center, three arm study of lapatinib plus trastuzumab plus an aromatase inhibitor (AI), trastuzumab plus an AI, or lapatinib plus an AI to evaluate the efficacy and safety of these regimens as first- or second-line therapy in postmenopausal subjects with hormone receptor positive (HR+), HER2-positive metastatic breast cancer (MBC) who have received prior trastuzumab and endocrine therapies. Eligible subjects was postmenopausal; had tumors that are ER and/or PgR positive and HER2-positive; had Stage IV metastatic breast cancer. The primary objective was to demonstrate superiority of lapatinib/trastuzumab/AI combination versus (vs.) trastuzumab/AI combination for progression free survival. The secondary objectives were to evaluate progression free survival in trastuzumab/AI vs. lapatinib/AI and trastuzumab/lapatinib/AI vs. lapatinib/AI, overall survival, overall response rate, clinical benefit rate, the safety and tolerability of all three treatment groups (lapatinib plus trastuzumab plus an AI, trastuzumab plus an AI, or lapatinib plus an AI), and quality of life status relative to baseline.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Novartis Investigative Site, La Jolla, California, United States
Novartis Investigative Site, Pleasant Hill, California, United States
Novartis Investigative Site, Hollywood, Florida, United States
Novartis Investigative Site, Miami, Florida, United States
Novartis Investigative Site, Augusta, Georgia, United States
Novartis Investigative Site, Lawrenceville, Georgia, United States
Novartis Investigative Site, Chicago, Illinois, United States
Novartis Investigative Site, Goshen, Indiana, United States
Novartis Investigative Site, Waterloo, Iowa, United States
Novartis Investigative Site, Grand Rapids, Michigan, United States
Novartis Investigative Site, Minneapolis, Minnesota, United States
Novartis Investigative Site, Billings, Montana, United States
Novartis Investigative Site, Omaha, Nebraska, United States
Novartis Investigative Site, Albuquerque, New Mexico, United States
Novartis Investigative Site, Albuquerque, New Mexico, United States
Novartis Investigative Site, Cary, North Carolina, United States
Novartis Investigative Site, Dayton, Ohio, United States
Novartis Investigative Site, Germantown, Tennessee, United States
Novartis Investigative Site, Houston, Texas, United States
Novartis Investigative Site, Tacoma, Washington, United States
Novartis Investigative Site, Milwaukee, Wisconsin, United States
Novartis Investigative Site, Berazategui, Buenos Aires, Argentina
Novartis Investigative Site, Capital Federal, Buenos Aires, Argentina
Novartis Investigative Site, Ciudad Aut6noma de Buenos Aires, Buenos Aires, Argentina
Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Novartis Investigative Site, La Plata, Buenos Aires, Argentina
Novartis Investigative Site, Viedma, Río Negro, Argentina
Novartis Investigative Site, Rosario, Santa Fe, Argentina
Novartis Investigative Site, Ciudad Autonoma de Buenos Aires, , Argentina
Novartis Investigative Site, Cordoba, , Argentina
Novartis Investigative Site, La Rioja, , Argentina
Novartis Investigative Site, Quilmes, , Argentina
Novartis Investigative Site, San Miguel de Tucuman, , Argentina
Novartis Investigative Site, Box Hill, Victoria, Australia
Novartis Investigative Site, Wodonga, Victoria, Australia
Novartis Investigative Site, Adelaide, , Australia
Novartis Investigative Site, Douglas, , Australia
Novartis Investigative Site, Ringwood East, , Australia
Novartis Investigative Site, Tweed Heads, , Australia
Novartis Investigative Site, Leuven, , Belgium
Novartis Investigative Site, Liege, , Belgium
Novartis Investigative Site, Namur, , Belgium
Novartis Investigative Site, Fortaleza, Ceará, Brazil
Novartis Investigative Site, Goiania, Goiás, Brazil
Novartis Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil
Novartis Investigative Site, Porto Alegre, Rio Grande Do Sul, Brazil
Novartis Investigative Site, Barretos, São Paulo, Brazil
Novartis Investigative Site, Sao Paulo, São Paulo, Brazil
Novartis Investigative Site, Sao Paulo, São Paulo, Brazil
Novartis Investigative Site, Sao Paulo, São Paulo, Brazil
Novartis Investigative Site, Sao Paulo, São Paulo, 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, Sofia, , Bulgaria
Novartis Investigative Site, Varna, , Bulgaria
Novartis Investigative Site, Calgary, Alberta, Canada
Novartis Investigative Site, Fuzhou, Fujian, China
Novartis Investigative Site, Guangzhou, Guangdong, China
Novartis Investigative Site, Changchun, Jilin, China
Novartis Investigative Site, Harbin, , China
Novartis Investigative Site, Shanghai, , China
Novartis Investigative Site, Monteria, , Colombia
Novartis Investigative Site, Osijek, , Croatia
Novartis Investigative Site, Pula, , Croatia
Novartis Investigative Site, Zagreb, , Croatia
Novartis Investigative Site, Besancon, , France
Novartis Investigative Site, Le Mans, , France
Novartis Investigative Site, Lille, , France
Novartis Investigative Site, Montpellier Cedex 5, , France
Novartis Investigative Site, Nancy, , France
Novartis Investigative Site, Paris Cedex 20, , France
Novartis Investigative Site, Heidelberg, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Tuebingen, Baden-Wuerttemberg, Germany
Novartis Investigative Site, Muenchen, Bayern, Germany
Novartis Investigative Site, Muenchen, Bayern, Germany
Novartis Investigative Site, Regensburg, Bayern, Germany
Novartis Investigative Site, Rosenheim, Bayern, Germany
Novartis Investigative Site, Fuerstenwalde, Brandenburg, Germany
Novartis Investigative Site, Rostock, Mecklenburg-Vorpommern, Germany
Novartis Investigative Site, Goslar, Niedersachsen, Germany
Novartis Investigative Site, Hannover, Niedersachsen, Germany
Novartis Investigative Site, Aachen, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Bottrop, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Troisdorf, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Velbert, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Halle, Sachsen-Anhalt, Germany
Novartis Investigative Site, Kiel, Schleswig-Holstein, 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, Athens, , Greece
Novartis Investigative Site, Chania, , Greece
Novartis Investigative Site, Heraklion, , Greece
Novartis Investigative Site, Perioxi Dragana, Alexandroupolis, , Greece
Novartis Investigative Site, Hong Kong, , Hong Kong
Novartis Investigative Site, Kowloon, , Hong Kong
Novartis Investigative Site, Pokfulam, , Hong Kong
Novartis Investigative Site, Tuen Mun, , Hong Kong
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Budapest, , Hungary
Novartis Investigative Site, Debrecen, , Hungary
Novartis Investigative Site, Gyor, , Hungary
Novartis Investigative Site, Gyula, , Hungary
Novartis Investigative Site, Kaposvar, , Hungary
Novartis Investigative Site, Miskolc, , Hungary
Novartis Investigative Site, Nyiregyhaza, , Hungary
Novartis Investigative Site, Pecs, , Hungary
Novartis Investigative Site, Szeged, , Hungary
Novartis Investigative Site, Szolnok, , Hungary
Novartis Investigative Site, Veszprem, , Hungary
Novartis Investigative Site, Zalaegerszeg, , Hungary
Novartis Investigative Site, Bangalore, , India
Novartis Investigative Site, Chennai, , India
Novartis Investigative Site, Delhi, , India
Novartis Investigative Site, Nagpur, , India
Novartis Investigative Site, New Delhi, , India
Novartis Investigative Site, Pune, , India
Novartis Investigative Site, Surat, , India
Novartis Investigative Site, Dublin 7, , Ireland
Novartis Investigative Site, Dublin, , Ireland
Novartis Investigative Site, Dublin, , Ireland
Novartis Investigative Site, Dublin, , Ireland
Novartis Investigative Site, Galway, , Ireland
Novartis Investigative Site, Haifa, , Israel
Novartis Investigative Site, Jerusalem, , Israel
Novartis Investigative Site, Petah-Tikva, , Israel
Novartis Investigative Site, Ramat Gan, , Israel
Novartis Investigative Site, Rehovot, , Israel
Novartis Investigative Site, Tel Aviv, , Israel
Novartis Investigative Site, Parma, Emilia-Romagna, Italy
Novartis Investigative Site, Piacenza, Emilia-Romagna, Italy
Novartis Investigative Site, Monza, Lombardia, Italy
Novartis Investigative Site, Pavia, Lombardia, Italy
Novartis Investigative Site, Rozzano (MI), Lombardia, Italy
Novartis Investigative Site, San Giovanni Rotondo, , Italy
Novartis Investigative Site, Aichi, , Japan
Novartis Investigative Site, Chiba, , Japan
Novartis Investigative Site, Ehime, , Japan
Novartis Investigative Site, Kagoshima, , Japan
Novartis Investigative Site, Osaka, , Japan
Novartis Investigative Site, Osaka, , Japan
Novartis Investigative Site, Saitama, , Japan
Novartis Investigative Site, Saitama, , Japan
Novartis Investigative Site, Shizuoka, , Japan
Novartis Investigative Site, Tokyo, , Japan
Novartis Investigative Site, Tokyo, , Japan
Novartis Investigative Site, Tokyo, , Japan
Novartis Investigative Site, Gyeonggi-do, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Vilnius, , Lithuania
Novartis Investigative Site, Lorenskog, , Norway
Novartis Investigative Site, Miraflores, Lima, Peru
Novartis Investigative Site, San Borja, Lima, Peru
Novartis Investigative Site, San Isidro, Lima, Peru
Novartis Investigative Site, Arequipa, , Peru
Novartis Investigative Site, Lima, , Peru
Novartis Investigative Site, Trujillo, , Peru
Novartis Investigative Site, Makati City, , Philippines
Novartis Investigative Site, Quezon City, , Philippines
Novartis Investigative Site, Konin, , Poland
Novartis Investigative Site, Lubin, , Poland
Novartis Investigative Site, Otwock, , Poland
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Wieliszew, , Poland
Novartis Investigative Site, Wroclaw, , Poland
Novartis Investigative Site, Coimbra, , Portugal
Novartis Investigative Site, Evora, , Portugal
Novartis Investigative Site, Lisboa, , Portugal
Novartis Investigative Site, Lisbon, , Portugal
Novartis Investigative Site, Porto, , Portugal
Novartis Investigative Site, San Juan, , Puerto Rico
Novartis Investigative Site, San Juan, , Puerto Rico
Novartis Investigative Site, Bucharest, , Romania
Novartis Investigative Site, Bucuresti, , Romania
Novartis Investigative Site, Timisoara, , Romania
Novartis Investigative Site, Arkhangelsk, , Russian Federation
Novartis Investigative Site, Kazan, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Moscow, , Russian Federation
Novartis Investigative Site, Ryazan, , Russian Federation
Novartis Investigative Site, St. Petersburg, , Russian Federation
Novartis Investigative Site, St. Petersburg, , Russian Federation
Novartis Investigative Site, Tver, , Russian Federation
Novartis Investigative Site, Belgrade, , Serbia
Novartis Investigative Site, Kragujevac, , Serbia
Novartis Investigative Site, Sremska Kamenica, , Serbia
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Cape Town, , South Africa
Novartis Investigative Site, Durban, , South Africa
Novartis Investigative Site, Port Elizabeth, , South Africa
Novartis Investigative Site, Pretoria, , South Africa
Novartis Investigative Site, Saxonwold, Johannesburg, , South Africa
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, Castellon, , Spain
Novartis Investigative Site, Cordoba, , Spain
Novartis Investigative Site, La Coruna, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Santa Cruz de Tenerife, , Spain
Novartis Investigative Site, Changhua, , Taiwan
Novartis Investigative Site, Kaohsiung Hsien, , Taiwan
Novartis Investigative Site, Taipei City, , Taiwan
Novartis Investigative Site, Ankara, , Turkey
Novartis Investigative Site, Izmir, , Turkey
Novartis Investigative Site, Chernivtsi, , Ukraine
Novartis Investigative Site, Dnipropetrovsk, , Ukraine
Novartis Investigative Site, Kharkiv, , Ukraine
Novartis Investigative Site, Khmelnytskyi, , Ukraine
Novartis Investigative Site, Lyutizh, , Ukraine
Novartis Investigative Site, Sumy, , Ukraine
Novartis Investigative Site, Uzhgorod, , Ukraine
Novartis Investigative Site, Vinnitsia, , Ukraine
Novartis Investigative Site, Chelmsford, Essex, 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, Maidstone, , United Kingdom
Novartis Investigative Site, Manchester, , United Kingdom
Novartis Investigative Site, Nottingham, , United Kingdom
Novartis Investigative Site, Peterborough, , United Kingdom
Novartis Investigative Site, Sutton, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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