Breast Cancer Clinical Trial
Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
Summary
This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.
Eligibility Criteria
Inclusion Criteria:
ErbB-2 positive locally recurrent or metastatic breast cancer
Eastern Cooperative Oncology Group (ECOG) 0-2
Measurable disease
Availability of tumor tissue for HER2 status confirmation
Exclusion Criteria:
Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease
Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting
Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy
History of heart disease
History of gastrointestinal disease
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There are 188 Locations for this study
Oxnard California, 93030, United States
Santa Rosa California, 95403, United States
Plainville Connecticut, 06062, United States
Boynton Beach Florida, 33435, United States
Deerfield Beach Florida, 33064, United States
Fort Lauderdale Florida, 33316, United States
Orange City Florida, 32763, United States
Plantation Florida, 33324, United States
Port Saint Lucie Florida, 34952, United States
Albany Georgia, 31701, United States
Dublin Georgia, 31021, United States
Skokie Illinois, 60077, United States
Skokie Illinois, 60077, United States
Springfield Illinois, 62703, United States
Alexandria Louisiana, 71301, United States
Metairie Louisiana, 70006, United States
Saint Louis Park Minnesota, 55426, United States
Columbia Missouri, 65201, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65807, United States
Paramus New Jersey, 07652, United States
Gastonia North Carolina, 28054, United States
Akron Ohio, 44304, United States
Tulsa Oklahoma, 74104, United States
Corvallis Oregon, 97330, United States
Pawtucket Rhode Island, 02860, United States
Charleston South Carolina, 29425, United States
Sumter South Carolina, 29150, United States
Knoxville Tennessee, 37909, United States
Memphis Tennessee, 38120, United States
Bedford Texas, 76022, United States
El Paso Texas, 79902, United States
Midland Texas, 79701, United States
Southlake Texas, 76092, United States
Salt Lake City Utah, 84106, United States
Charleston West Virginia, 25304, United States
North Adelaide South Australia, 5011, Australia
Parkville Victoria, 3050, Australia
Nassau CB, 13932, Bahamas
Lesnoy Minsk Region, 22304, Belarus
Gomel , 24601, Belarus
Grodno , 23001, Belarus
Vitebsk , 21060, Belarus
Brussels , 1000, Belgium
Plovdiv , 4004, Bulgaria
Sofia , 1233, Bulgaria
Sofia , 1756, Bulgaria
Greenfield Park Quebec, J4V 2, Canada
Trois-Rivieres Quebec, G8Z 3, Canada
Guangzhou Guangdong, 51006, China
Guangzhou Guangdong, 51051, China
Hangzhou Zhejiang, 31002, China
Beijing , 10002, China
Beijing , 10003, China
Beijing , 10007, China
Beijing , 10085, China
Shanghai , 20003, China
Tian Jin , 30006, China
Osijek , 31000, Croatia
Zagreb , 10000, Croatia
Copenhagen , 2100, Denmark
Creteil , 94010, France
Lyon , 69373, France
Montpellier , 34298, France
Paris , 75181, France
Paris , 75651, France
Paris , 75674, France
Perigueux , 24004, France
St. Brieuc , 22015, France
Strasbourg , 67000, France
Strasbourg , 67091, France
Tours , 37044, France
Bamberg , 96049, Germany
Chai Wan , , Hong Kong
Hong Kong , , Hong Kong
Wanchai , , Hong Kong
Budapest , 1082, Hungary
Budapest , 1115, Hungary
Budapest , 1122, Hungary
Kaposvar , 7400, Hungary
Kecskemet , 6000, Hungary
Miskolc , 3526, Hungary
Szeged , 6720, Hungary
New Delhi Delhi, 11002, India
Bhopal Madhya Pradesh, 46200, India
Mumbai Maharashtra, 40001, India
Nagpur Maharashtra, 44001, India
Nashik Maharashtra, 42200, India
Nashilk Maharashtra, 42200, India
Pune Maharashtra, 41100, India
Jaipur Rajasthan, 30201, India
Madurai Tamil Nadu, 62510, India
Kolkata West Bengal, 70005, India
Rehovot , 76101, Israel
Tel Aviv , 64239, Israel
Zerifin , 60930, Israel
Modena , 41100, Italy
Pavia , 27100, Italy
Roma , 00128, Italy
Roma , 00189, Italy
Torino , 10126, Italy
Hyogo Akashi-shi, 673-8, Japan
Oita Beppu-shi, 874-0, Japan
Tokyo Bunkyo-ku, 113-8, Japan
Chiba Chiba-shi, 260-8, Japan
Fukuoka Fukuoka-shi, 811-1, Japan
Ibaraki Higashiibaraki-gun, 311-3, Japan
Hiroshima Hiroshima-shi, 734-8, Japan
Kagoshima Kagoshima-city, 892-0, Japan
Chiba Kashiwa-shi, 277-8, Japan
Saitama Kitaadachi-gun, 362-0, Japan
Kumamoto Kumamoto-city, 862-8, Japan
Fukuoka Kurume-Shi, 830-0, Japan
Ehime Matsuyama-city, 791-0, Japan
Iwate Morioka-shi, 020-8, Japan
Aichi Nagoya-shi, 464-8, Japan
Aichi Nagoya, 460-0, Japan
Niigata Niigata-shi, 951-8, Japan
Osaka Osaka-shi, 537-8, Japan
Osaka Osaka-shi, 540-0, Japan
Hokkaido Sapporo-shi, 003-0, Japan
Miyagi Sendai-city, 980-8, Japan
Nara Tenri-shi, 632-8, Japan
Kanagawa Yokohama-City, 241-0, Japan
Hiroshima , 730-8, Japan
Hiroshima , 737-0, Japan
Hyogo , 650-0, Japan
Hyogo , 651-0, Japan
Kumamoto , 860-8, Japan
Osaka , 530-8, Japan
Osaka , 565-0, Japan
Tochigi , 329-0, Japan
Tokyo , 105-8, Japan
Tokyo , 152-8, Japan
Goyang-si Gyeonggi-do, 410-7, Korea, Republic of
Seoul Korea, 135-7, Korea, Republic of
Seoul Korea, 138-7, Korea, Republic of
Seoul Korea, 152-7, Korea, Republic of
Seoul Seoul/Korea, 120-7, Korea, Republic of
Liepaja , LV-34, Latvia
Riga , LV - , Latvia
Riga , LV-10, Latvia
Kaunas , LT 45, Lithuania
Vilnius , LT-08, Lithuania
Kuala Lumpur , 59100, Malaysia
Floriana , VLT 1, Malta
Jelenia Gora Dolnoslaskie, 58-50, Poland
Warszawa Mazowieckie, 04125, Poland
Opole Opolskie, 45061, Poland
Olsztyn Warminsko-Mazurskie, 10228, Poland
Bialystok , 15027, Poland
Lisboa , 1500-, Portugal
Cluj-Napoca Cluj, 40001, Romania
Craiova Dolj, 20038, Romania
Bucuresti , 05009, Romania
Belgrade , 11000, Serbia
Nis , 18000, Serbia
Singapore , 11908, Singapore
Singapore , 16961, Singapore
Port Elizabeth Eastern Cape, 6045, South Africa
Johannesburg Gauteng, 2196, South Africa
Johannesburg Gauteng, 2197, South Africa
Johannesburg Gauteng, 2199, South Africa
Pretoria Gauteng, 0081, South Africa
Durban KwaZulu Natal, 4001, South Africa
Kraaifontein Western Cape, 7570, South Africa
Lleida Cataluna, 25198, Spain
Santiago de Compostela Galicia, 15706, Spain
Palma Illes Balears, 07198, Spain
Alcorcon Madrid, 28922, Spain
Majadahonda Madrid, 28222, Spain
Parla Madrid, 28981, Spain
Sanchinarro Madrid, 28050, Spain
Marbella Malaga, 29603, Spain
Baracaldo Vizcaya, 48903, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
Madrid , 28041, Spain
Aarau , 5000, Switzerland
Thun , 3600, Switzerland
Winterthur , 8401, Switzerland
Taoyuan , 333, Taiwan
Bornova Izmir, 35040, Turkey
Cherkassy , 18009, Ukraine
Chernivtsi , 58013, Ukraine
Dnipropetrovsk , 49102, Ukraine
Donetsk , 83092, Ukraine
Kharkiv , 61024, Ukraine
Kyiv , 03022, Ukraine
Lutsk , 63000, Ukraine
Lviv , 79031, Ukraine
Mariupil , 87500, Ukraine
Sumy , 40005, Ukraine
London , SE1 9, United Kingdom
Nottingham , NG5 1, United Kingdom
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