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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

479

Study ID:

NCT00915018

Recruitment Status:

Completed

Sponsor:

Puma Biotechnology, Inc.

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There are 188 Locations for this study

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Ventura County Hematology-Oncology Specialists
Oxnard California, 93030, United States
Redwood Regional Medical Group
Santa Rosa California, 95403, United States
Cancer Center of Central Connecticut
Plainville Connecticut, 06062, United States
Palm Beach Institute of Hematology and Oncology
Boynton Beach Florida, 33435, United States
North Broward Medical Center Cancer Center
Deerfield Beach Florida, 33064, United States
Broward General Medical Center
Fort Lauderdale Florida, 33316, United States
Mid Florida Cancer Centers
Orange City Florida, 32763, United States
Florida Cancer Research Institute
Plantation Florida, 33324, United States
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie Florida, 34952, United States
Phoebe Cancer Center
Albany Georgia, 31701, United States
Dublin Hematology and Oncology Care
Dublin Georgia, 31021, United States
Clintell
Skokie Illinois, 60077, United States
Presence Hematology and Oncology
Skokie Illinois, 60077, United States
Springfield Clinic
Springfield Illinois, 62703, United States
CHRISTUS St. Frances Cabrini Hospital
Alexandria Louisiana, 71301, United States
Hematology Oncology Services
Metairie Louisiana, 70006, United States
Park Nicollet Institute
Saint Louis Park Minnesota, 55426, United States
Missouri Cancer Associates
Columbia Missouri, 65201, United States
Washington University School of Medicine Siteman Cancer Center
Saint Louis Missouri, 63110, United States
St. John's Medical Research Institute
Springfield Missouri, 65807, United States
The Valley Hospital, Luckow Pavilion Office of Oncology Clinical Trials
Paramus New Jersey, 07652, United States
Gaston Hematology and Oncology Associates
Gastonia North Carolina, 28054, United States
Summa Health System Hospitals
Akron Ohio, 44304, United States
Warren Cancer Research Foundation
Tulsa Oklahoma, 74104, United States
Samaritan Hematology and Oncology Consultants
Corvallis Oregon, 97330, United States
Pawtucket Memorial Hospital
Pawtucket Rhode Island, 02860, United States
Medical University of South Carolina Hollings Cancer Center
Charleston South Carolina, 29425, United States
Santee Hematology Oncology
Sumter South Carolina, 29150, United States
Tenessee Cancer Specialists
Knoxville Tennessee, 37909, United States
Family Cancer Care
Memphis Tennessee, 38120, United States
Texas Oncology
Bedford Texas, 76022, United States
El Paso Cancer Treatment Center
El Paso Texas, 79902, United States
Texas Oncology-Allison Cancer Center
Midland Texas, 79701, United States
Southlake Oncology
Southlake Texas, 76092, United States
Utah Cancer Specialists
Salt Lake City Utah, 84106, United States
Charleston Area Medical Center, Health, Education, and Research Institute
Charleston West Virginia, 25304, United States
The Queen Elizabeth Hospital
North Adelaide South Australia, 5011, Australia
Royal Melbourne Hospital
Parkville Victoria, 3050, Australia
Affinity Research Limited
Nassau CB, 13932, Bahamas
N.N. Aleksandrov National Cancer Center of Belarus
Lesnoy Minsk Region, 22304, Belarus
Institution Gomel Regional Clinical Oncology Dispensary
Gomel , 24601, Belarus
Institution of Healthcare Grodno Regional Clinical Hospital
Grodno , 23001, Belarus
Healthcare Institution Vitebsk Regional Clinical Oncology Dispensary
Vitebsk , 21060, Belarus
Institut Jules Bordet
Brussels , 1000, Belgium
District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD
Plovdiv , 4004, Bulgaria
District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD
Sofia , 1233, Bulgaria
Specialised Hospital of ActiveTreatment in Oncology, Clinic of Chemotherapy
Sofia , 1756, Bulgaria
Hopital Charles, LeMoyne Le Centre Intégré de Cancérologie de la Montérégie
Greenfield Park Quebec, J4V 2, Canada
Centre Hospitalier Régional de Trois-Rivières
Trois-Rivieres Quebec, G8Z 3, Canada
Sun Yat-Sen University Cancer Center
Guangzhou Guangdong, 51006, China
Southern Medical University Nanfang Hospital
Guangzhou Guangdong, 51051, China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31002, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing , 10002, China
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Beijing , 10003, China
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
Beijing , 10007, China
Chinese People's Liberation Army General Hospital
Beijing , 10085, China
Fudan University Shanghai Cancer Center
Shanghai , 20003, China
Tianjin Cancer Hospital
Tian Jin , 30006, China
Clinical Hospital Osijek, Department of Radiotherapy and Oncology
Osijek , 31000, Croatia
University Hospital For Tumors
Zagreb , 10000, Croatia
Rigshospitalet, Copenhagen, Onkologisk Klinik
Copenhagen , 2100, Denmark
Hôpital Henri-Mondor
Creteil , 94010, France
Centre Leon Berard Departement de Cancerologie Medicale
Lyon , 69373, France
Centre Val d'Aurelle
Montpellier , 34298, France
Hopital Hotel Dieu, Service d'Oncologie Medicale, Bat B2, 5ieme
Paris , 75181, France
Hopital La Pitie-Salpetriere
Paris , 75651, France
Groupe Hospitalier Paris Saint Joseph, Oncologie medicale
Paris , 75674, France
Service d'Oncologie et de Radiotherapie, Polyclinique Francheville
Perigueux , 24004, France
Clinique Armoricaine de Radiologie
St. Brieuc , 22015, France
Centre de Radiothérapie, Clinique Sainte Anne, Service d'Oncologie Libérale
Strasbourg , 67000, France
CHU Strasbourg Departement Oncologie & Hematologie Hopital Civil
Strasbourg , 67091, France
CHU Bretonneau, Centre Henry Kaplan
Tours , 37044, France
Sozialstiftung Bamberg Klinik fuer Haematologie und internistische Onkologie
Bamberg , 96049, Germany
Pamela Youde Nethersole Eastern Hospital
Chai Wan , , Hong Kong
Queen Mary Hospital
Hong Kong , , Hong Kong
UNIMED Medical Institute, Comprehensive Centre for Breast Diseases
Wanchai , , Hong Kong
Semmelweis Egyetem Radiologiai és Onkoterapias Klinika
Budapest , 1082, Hungary
Fovarosi Onkormanyzat Szent Imre Korhaz Klinikai Onkologiai Profil
Budapest , 1115, Hungary
Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly
Budapest , 1122, Hungary
Kaposi Mor Oktato Korhoz Onkologiai Centrum
Kaposvar , 7400, Hungary
Bacs-Kiskun Megyei Onkormanyzat Korhaza Onkoradiologiai Kozpont
Kecskemet , 6000, Hungary
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
Miskolc , 3526, Hungary
Szegedi Tudomanyegyetem Onkoterapias Klinika
Szeged , 6720, Hungary
Institute Rotary Cancer Hospital, AIIMS
New Delhi Delhi, 11002, India
Jawaharlal Nehru Cancer Hospital
Bhopal Madhya Pradesh, 46200, India
Tata Memorial Centre
Mumbai Maharashtra, 40001, India
Central India Cancer Research Institute
Nagpur Maharashtra, 44001, India
Curie Manavata Cancer Centre
Nashik Maharashtra, 42200, India
Shatabdi Super Speciality Hospital
Nashilk Maharashtra, 42200, India
Deenanath Mangeshkar Hospital and Research Centre
Pune Maharashtra, 41100, India
Searoc Cancer Center
Jaipur Rajasthan, 30201, India
Meenakshi Mission Hospital and Research Centre
Madurai Tamil Nadu, 62510, India
B P Poddar and Medical Research Ltd.
Kolkata West Bengal, 70005, India
Kaplan Medical Center
Rehovot , 76101, Israel
Sourasky Medical Center
Tel Aviv , 64239, Israel
Assaf Harofeh Medical Center
Zerifin , 60930, Israel
Policlinico di Modena Oncologia ed Ematologia
Modena , 41100, Italy
Fondazione Salvatore Maugeri
Pavia , 27100, Italy
Policlinico Universitario Campus Bio-Medico
Roma , 00128, Italy
Ospedale San Pietro Fatebenefratelli
Roma , 00189, Italy
Ospedale San Giovanni Battista-Molinette
Torino , 10126, Italy
Hyogo Cancer Center
Hyogo Akashi-shi, 673-8, Japan
National Hospital Organization Beppu Medical Center
Oita Beppu-shi, 874-0, Japan
Tokyo Metropolitan Cancer and Infectious Disease Center, Komagome Hospital
Tokyo Bunkyo-ku, 113-8, Japan
Chiba Cancer Center
Chiba Chiba-shi, 260-8, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka Fukuoka-shi, 811-1, Japan
National Hospital Organization Mito Medical Center
Ibaraki Higashiibaraki-gun, 311-3, Japan
Hiroshima University Hospital
Hiroshima Hiroshima-shi, 734-8, Japan
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima Kagoshima-city, 892-0, Japan
National Cancer Center Hospital East
Chiba Kashiwa-shi, 277-8, Japan
Saitama Cancer Center
Saitama Kitaadachi-gun, 362-0, Japan
Kumamoto Municipal Hospital
Kumamoto Kumamoto-city, 862-8, Japan
Kurume Daiichi Social Insurance Hospital
Fukuoka Kurume-Shi, 830-0, Japan
National Hospital Organization Shikoku Cancer Center
Ehime Matsuyama-city, 791-0, Japan
Iwate Medical University Hospital
Iwate Morioka-shi, 020-8, Japan
Aichi Cancer Center
Aichi Nagoya-shi, 464-8, Japan
National Hospital Organization Nagoya Medical Center
Aichi Nagoya, 460-0, Japan
Niigata Cancer Center Hospital
Niigata Niigata-shi, 951-8, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka Osaka-shi, 537-8, Japan
National Hospital Organization Osaka National Hospital
Osaka Osaka-shi, 540-0, Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido Sapporo-shi, 003-0, Japan
Tohoku University Hospital
Miyagi Sendai-city, 980-8, Japan
Tenri Hospital
Nara Tenri-shi, 632-8, Japan
Kanagawa Cancer Center
Kanagawa Yokohama-City, 241-0, Japan
Hiroshima City Hospital
Hiroshima , 730-8, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Hiroshima , 737-0, Japan
Kobe City Medical Center General Hospital
Hyogo , 650-0, Japan
Shinko Hospital
Hyogo , 651-0, Japan
Kumamoto University Hospital
Kumamoto , 860-8, Japan
Tazuke Kofukai Medical Research Institute Kitano Hospital
Osaka , 530-8, Japan
Osaka University Hospital
Osaka , 565-0, Japan
Jichi Medical University Hospital
Tochigi , 329-0, Japan
Toranomon Hospital
Tokyo , 105-8, Japan
National Hospital Organization Tokyo Medical Center
Tokyo , 152-8, Japan
National Cancer Center, Center for Breast Cancer
Goyang-si Gyeonggi-do, 410-7, Korea, Republic of
Samsung Medical Center
Seoul Korea, 135-7, Korea, Republic of
Asan Medical Center
Seoul Korea, 138-7, Korea, Republic of
Korea University Guro Hospital
Seoul Korea, 152-7, Korea, Republic of
Yonsei University Health System Severance Hospital
Seoul Seoul/Korea, 120-7, Korea, Republic of
Piejuras Hospital, Liepajas Oncological Clinic
Liepaja , LV-34, Latvia
Pauls Stradiņš Clinical University Hospital
Riga , LV - , Latvia
Riga Eastern University Hospital
Riga , LV-10, Latvia
Hospital of Lithuanian University of Health sciences
Kaunas , LT 45, Lithuania
Nacionalinis Vezio Institutas, Vilniaus Universiteto Onkologijos Institutas
Vilnius , LT-08, Lithuania
University Malaya Medical Centre
Kuala Lumpur , 59100, Malaysia
Sir Anthony Oncology Center
Floriana , VLT 1, Malta
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial
Jelenia Gora Dolnoslaskie, 58-50, Poland
Magodent
Warszawa Mazowieckie, 04125, Poland
Opolskie Centrum Onkologii
Opole Opolskie, 45061, Poland
Zakład Opieki Zdrowotnej MSW z Warmińsko, Mazurskim Centrum Onkologii
Olsztyn Warminsko-Mazurskie, 10228, Poland
Białostockie Centrum Onkologii
Bialystok , 15027, Poland
Hospital da Luz Servico de Oncologia Medica
Lisboa , 1500-, Portugal
Institutul Oncologic Prof. Dr. Ion Chiricuţă
Cluj-Napoca Cluj, 40001, Romania
SC Oncolab S.R.L.
Craiova Dolj, 20038, Romania
Spitalul Universitar de Urgenta Bucuresti
Bucuresti , 05009, Romania
Institute of Oncology and Radiology of Serbia
Belgrade , 11000, Serbia
Clinical centre Nis Clinic of Oncology
Nis , 18000, Serbia
National University Hospital, National Cancer Institute
Singapore , 11908, Singapore
National Cancer Centre Singapore
Singapore , 16961, Singapore
GVI Oncology
Port Elizabeth Eastern Cape, 6045, South Africa
The Medical Oncology Centre of Rosebank
Johannesburg Gauteng, 2196, South Africa
University of Witwatersrand Oncology, Donald Gordon Medical Centre
Johannesburg Gauteng, 2197, South Africa
Sandton Oncology Centre
Johannesburg Gauteng, 2199, South Africa
Eastleigh Breast Care Centre
Pretoria Gauteng, 0081, South Africa
Westridge Medical Centre
Durban KwaZulu Natal, 4001, South Africa
GVI Oncology
Kraaifontein Western Cape, 7570, South Africa
Hospital Universitari Arnau de Vilanova
Lleida Cataluna, 25198, Spain
Complejo Hospitalario Universitario Santiago de Compostela
Santiago de Compostela Galicia, 15706, Spain
Hospital Son Llàtzer
Palma Illes Balears, 07198, Spain
Hospital Universitario Fundación Alcorcón
Alcorcon Madrid, 28922, Spain
Hospital Puerta De Hierro
Majadahonda Madrid, 28222, Spain
Hospital Universitario Infanta Cristina
Parla Madrid, 28981, Spain
Hospital Madrid Norte Sanchinarro Centro Integral Oncológico Clara Campal Ensayos Clínicos
Sanchinarro Madrid, 28050, Spain
Hospital Costa del Sol
Marbella Malaga, 29603, Spain
Hospital de Cruces
Baracaldo Vizcaya, 48903, Spain
Centro Oncologico MD Anderson
Madrid , 28033, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Tumor Center Hirslanden Medical Center
Aarau , 5000, Switzerland
Spital STS AG Onkologiezentrum Thun - Berner Oberland
Thun , 3600, Switzerland
Kantonsspital Winterthur Medizinische Onkologie
Winterthur , 8401, Switzerland
Chang Gung Medical Foundation, Linkou Branch
Taoyuan , 333, Taiwan
Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi
Bornova Izmir, 35040, Turkey
Komunalnyy Zaklad Cherkasskyy Oblasnyy Onkologichnyy Dyspanser
Cherkassy , 18009, Ukraine
Chernivtsi Regional Oncology Centre Outpatient Department Bukovynian State Medical University Department of Oncology and Radiology
Chernivtsi , 58013, Ukraine
City Multifield Clinical Hospital
Dnipropetrovsk , 49102, Ukraine
Donetsk Regional Antitumor Center Department of Pretumor Diseases and Tumor Treatment
Donetsk , 83092, Ukraine
S.P. Grigoreva Institute of Medical Radiology Department of Chemotherapy
Kharkiv , 61024, Ukraine
National Institute of Cancer Department of Conseravtive Methods of Treatment
Kyiv , 03022, Ukraine
Volyn Regional Oncological Center
Lutsk , 63000, Ukraine
State Oncological Regional Treatment and Diagnostic Center
Lviv , 79031, Ukraine
Mariupil Oncological Center
Mariupil , 87500, Ukraine
Sumy Regional Clinical Oncology Centre
Sumy , 40005, Ukraine
Guy's and St Thomas NHS Foundation Trust Management Offices 4th Floor Bermondsey Wing Guy's Hospital
London , SE1 9, United Kingdom
Nottingham University Hospital
Nottingham , NG5 1, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

479

Study ID:

NCT00915018

Recruitment Status:

Completed

Sponsor:


Puma Biotechnology, Inc.

How clear is this clinincal trial information?

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