Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00915018
- Lead Sponsor
- Puma Biotechnology, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 479
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description neratinib plus paclitaxel Neratinib - trastuzumab plus paclitaxel Trastuzumab - neratinib plus paclitaxel Paclitaxel - trastuzumab plus paclitaxel Paclitaxel -
- Primary Outcome Measures
Name Time Method Progression-Free Survival From randomization to disease progression or death, assessed up to 5.3 years Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy.
- Secondary Outcome Measures
Name Time Method Objective Response Rate From randomization to disease progression or last tumor assessment, assessed up to 5.3 years Defined as the percentage of subjects who achieved confirmed tumor response (complete or partial response) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-Progressive Disease for non-target lesions, and no new lesions.
Duration of Response From first response to first PD or death, assessed up to 5.3 years after first subject randomized Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, disease progression (PD), or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Clinical Benefit Rate From randomization to disease progression or death, assessed up to 5.3 years Defined as the proportion of patients who achieved overall tumor response (CR or PR) or SD for at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Symptomatic or Progressive Central Nervous System (CNS) Lesions From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 years Defined as the time interval from the date of randomization until the first date of CNS symptoms, the imaging examination shows CNS progression or is censored at the last assessable evaluation on study or prior to new anti-cancer therapy, if applicable.
If median time to Symptomatic or Progressive CNS Lesions is not estimable, cumulative incidence will be reported instead.
Trial Locations
- Locations (194)
Service d'Oncologie et de Radiotherapie, Polyclinique Francheville
🇫🇷Perigueux, France
Institutul Oncologic Prof. Dr. Ion Chiricuţă
🇷🇴Cluj-Napoca, Cluj, Romania
Hospital Universitario Fundación Alcorcón
🇪🇸Alcorcon, Madrid, Spain
Meenakshi Mission Hospital and Research Centre
🇮🇳Madurai, Tamil Nadu, India
Institution of Healthcare Grodno Regional Clinical Hospital
🇧🇾Grodno, Belarus
Hopital Charles, LeMoyne Le Centre Intégré de Cancérologie de la Montérégie
🇨🇦Greenfield Park, Quebec, Canada
National Hospital Organization Hokkaido Cancer Center
🇯🇵Hokkaido, Sapporo-shi, Japan
Tohoku University Hospital
🇯🇵Miyagi, Sendai-city, Japan
National Institute of Cancer Department of Conseravtive Methods of Treatment
🇺🇦Kyiv, Ukraine
Assaf Harofeh Medical Center
🇮🇱Zerifin, Israel
Tokyo Metropolitan Cancer and Infectious Disease Center, Komagome Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Fukuoka-shi, Japan
Tenessee Cancer Specialists
🇺🇸Knoxville, Tennessee, United States
Medical University of South Carolina Hollings Cancer Center
🇺🇸Charleston, South Carolina, United States
Healthcare Institution Vitebsk Regional Clinical Oncology Dispensary
🇧🇾Vitebsk, Belarus
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Kumamoto Municipal Hospital
🇯🇵Kumamoto, Kumamoto-city, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata, Niigata-shi, Japan
CHRISTUS St. Frances Cabrini Hospital
🇺🇸Alexandria, Louisiana, United States
Jawaharlal Nehru Cancer Hospital
🇮🇳Bhopal, Madhya Pradesh, India
Fovarosi Onkormanyzat Szent Imre Korhaz Klinikai Onkologiai Profil
🇭🇺Budapest, Hungary
UNIMED Medical Institute, Comprehensive Centre for Breast Diseases
🇭🇰Wanchai, Hong Kong
National Hospital Organization Shikoku Cancer Center
🇯🇵Ehime, Matsuyama-city, Japan
Tazuke Kofukai Medical Research Institute Kitano Hospital
🇯🇵Osaka, Japan
Zakład Opieki Zdrowotnej MSW z Warmińsko, Mazurskim Centrum Onkologii
🇵🇱Olsztyn, Warminsko-Mazurskie, Poland
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD
🇧🇬Sofia, Bulgaria
National Hospital Organization Mito Medical Center
🇯🇵Ibaraki, Higashiibaraki-gun, Japan
Aichi Cancer Center
🇯🇵Aichi, Nagoya-shi, Japan
Kumamoto University Hospital
🇯🇵Kumamoto, Japan
City Multifield Clinical Hospital
🇺🇦Dnipropetrovsk, Ukraine
State Oncological Regional Treatment and Diagnostic Center
🇺🇦Lviv, Ukraine
Hematology Oncology Services
🇺🇸Metairie, Louisiana, United States
Santee Hematology Oncology
🇺🇸Sumter, South Carolina, United States
National Hospital Organization Osaka National Hospital
🇯🇵Osaka, Osaka-shi, Japan
Shinko Hospital
🇯🇵Hyogo, Japan
Piejuras Hospital, Liepajas Oncological Clinic
🇱🇻Liepaja, Latvia
Chang Gung Medical Foundation, Linkou Branch
🇨🇳Taoyuan, Taiwan
Kanagawa Cancer Center
🇯🇵Kanagawa, Yokohama-City, Japan
National Hospital Organization Tokyo Medical Center
🇯🇵Tokyo, Japan
Institute of Oncology and Radiology of Serbia
🇷🇸Belgrade, Serbia
Tianjin Cancer Hospital
🇨🇳Tian Jin, China
Cancer Center of Central Connecticut
🇺🇸Plainville, Connecticut, United States
Broward General Medical Center
🇺🇸Fort Lauderdale, Florida, United States
Hematology Oncology Associates of Treasure Coast
🇺🇸Port Saint Lucie, Florida, United States
Samaritan Hematology and Oncology Consultants
🇺🇸Corvallis, Oregon, United States
Pawtucket Memorial Hospital
🇺🇸Pawtucket, Rhode Island, United States
Warren Cancer Research Foundation
🇺🇸Tulsa, Oklahoma, United States
Institution Gomel Regional Clinical Oncology Dispensary
🇧🇾Gomel, Belarus
Specialised Hospital of ActiveTreatment in Oncology, Clinic of Chemotherapy
🇧🇬Sofia, Bulgaria
Texas Oncology
🇺🇸Bedford, Texas, United States
Centre Hospitalier Régional de Trois-Rivières
🇨🇦Trois-Rivieres, Quebec, Canada
Charleston Area Medical Center, Health, Education, and Research Institute
🇺🇸Charleston, West Virginia, United States
Affinity Research Limited
🇧🇸Nassau, CB, Bahamas
N.N. Aleksandrov National Cancer Center of Belarus
🇧🇾Lesnoy, Minsk Region, Belarus
Institut Jules Bordet
🇧🇪Brussels, Belgium
District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD
🇧🇬Plovdiv, Bulgaria
Chinese People's Liberation Army General Hospital
🇨🇳Beijing, China
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Southern Medical University Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, China
The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
🇨🇳Beijing, China
Clinical Hospital Osijek, Department of Radiotherapy and Oncology
🇭🇷Osijek, Croatia
Centre Leon Berard Departement de Cancerologie Medicale
🇫🇷Lyon, France
Szegedi Tudomanyegyetem Onkoterapias Klinika
🇭🇺Szeged, Hungary
Semmelweis Egyetem Radiologiai és Onkoterapias Klinika
🇭🇺Budapest, Hungary
Sozialstiftung Bamberg Klinik fuer Haematologie und internistische Onkologie
🇩🇪Bamberg, Germany
Hopital La Pitie-Salpetriere
🇫🇷Paris, France
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, China
Groupe Hospitalier Paris Saint Joseph, Oncologie medicale
🇫🇷Paris, France
University Hospital For Tumors
🇭🇷Zagreb, Croatia
Centre Val d'Aurelle
🇫🇷Montpellier, France
Rigshospitalet, Copenhagen, Onkologisk Klinik
🇩🇰Copenhagen, Denmark
Pamela Youde Nethersole Eastern Hospital
🇭🇰Chai Wan, Hong Kong
Hopital Hotel Dieu, Service d'Oncologie Medicale, Bat B2, 5ieme
🇫🇷Paris, France
Clinique Armoricaine de Radiologie
🇫🇷St. Brieuc, France
Central India Cancer Research Institute
🇮🇳Nagpur, Maharashtra, India
Tata Memorial Centre
🇮🇳Mumbai, Maharashtra, India
Curie Manavata Cancer Centre
🇮🇳Nashik, Maharashtra, India
Kaposi Mor Oktato Korhoz Onkologiai Centrum
🇭🇺Kaposvar, Hungary
Bacs-Kiskun Megyei Onkormanyzat Korhaza Onkoradiologiai Kozpont
🇭🇺Kecskemet, Hungary
Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
🇭🇺Miskolc, Hungary
Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly
🇭🇺Budapest, Hungary
Searoc Cancer Center
🇮🇳Jaipur, Rajasthan, India
Institute Rotary Cancer Hospital, AIIMS
🇮🇳New Delhi, Delhi, India
Deenanath Mangeshkar Hospital and Research Centre
🇮🇳Pune, Maharashtra, India
Chiba Cancer Center
🇯🇵Chiba, Chiba-shi, Japan
Policlinico di Modena Oncologia ed Ematologia
🇮🇹Modena, Italy
Fondazione Salvatore Maugeri
🇮🇹Pavia, Italy
Ospedale San Giovanni Battista-Molinette
🇮🇹Torino, Italy
Hyogo Cancer Center
🇯🇵Hyogo, Akashi-shi, Japan
Hakuaikai Medical Corporation Sagara Hospital
🇯🇵Kagoshima, Kagoshima-city, Japan
National Cancer Center Hospital East
🇯🇵Chiba, Kashiwa-shi, Japan
Saitama Cancer Center
🇯🇵Saitama, Kitaadachi-gun, Japan
National Hospital Organization Nagoya Medical Center
🇯🇵Aichi, Nagoya, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Hiroshima-shi, Japan
Kurume Daiichi Social Insurance Hospital
🇯🇵Fukuoka, Kurume-Shi, Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases
🇯🇵Osaka, Osaka-shi, Japan
Tenri Hospital
🇯🇵Nara, Tenri-shi, Japan
Hiroshima City Hospital
🇯🇵Hiroshima, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
🇯🇵Hiroshima, Japan
Asan Medical Center
🇰🇷Seoul, Korea, Korea, Republic of
Nacionalinis Vezio Institutas, Vilniaus Universiteto Onkologijos Institutas
🇱🇹Vilnius, Lithuania
Pauls Stradiņš Clinical University Hospital
🇱🇻Riga, Latvia
National University Hospital, National Cancer Institute
🇸🇬Singapore, Singapore
Korea University Guro Hospital
🇰🇷Seoul, Korea, Korea, Republic of
Hospital of Lithuanian University of Health sciences
🇱🇹Kaunas, Lithuania
Riga Eastern University Hospital
🇱🇻Riga, Latvia
Sir Anthony Oncology Center
🇲🇹Floriana, Malta
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial
🇵🇱Jelenia Gora, Dolnoslaskie, Poland
Magodent
🇵🇱Warszawa, Mazowieckie, Poland
Opolskie Centrum Onkologii
🇵🇱Opole, Opolskie, Poland
Clinical centre Nis Clinic of Oncology
🇷🇸Nis, Serbia
Sandton Oncology Centre
🇿🇦Johannesburg, Gauteng, South Africa
Westridge Medical Centre
🇿🇦Durban, KwaZulu Natal, South Africa
Białostockie Centrum Onkologii
🇵🇱Bialystok, Poland
Hospital da Luz Servico de Oncologia Medica
🇵🇹Lisboa, Portugal
SC Oncolab S.R.L.
🇷🇴Craiova, Dolj, Romania
Spitalul Universitar de Urgenta Bucuresti
🇷🇴Bucuresti, Romania
National Cancer Centre Singapore
🇸🇬Singapore, Singapore
GVI Oncology
🇿🇦Kraaifontein, Western Cape, South Africa
Hospital Universitari Arnau de Vilanova
🇪🇸Lleida, Cataluna, Spain
Spital STS AG Onkologiezentrum Thun - Berner Oberland
🇨🇭Thun, Switzerland
Kantonsspital Winterthur Medizinische Onkologie
🇨🇭Winterthur, Switzerland
Komunalnyy Zaklad Cherkasskyy Oblasnyy Onkologichnyy Dyspanser
🇺🇦Cherkassy, Ukraine
Centro Oncologico MD Anderson
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi
🇹🇷Bornova, Izmir, Turkey
Donetsk Regional Antitumor Center Department of Pretumor Diseases and Tumor Treatment
🇺🇦Donetsk, Ukraine
Chernivtsi Regional Oncology Centre Outpatient Department Bukovynian State Medical University Department of Oncology and Radiology
🇺🇦Chernivtsi, Ukraine
Mariupil Oncological Center
🇺🇦Mariupil, Ukraine
Guy's and St Thomas NHS Foundation Trust Management Offices 4th Floor Bermondsey Wing Guy's Hospital
🇬🇧London, United Kingdom
Sumy Regional Clinical Oncology Centre
🇺🇦Sumy, Ukraine
Hôpital Henri-Mondor
🇫🇷Creteil, France
Centre de Radiothérapie, Clinique Sainte Anne, Service d'Oncologie Libérale
🇫🇷Strasbourg, France
CHU Strasbourg Departement Oncologie & Hematologie Hopital Civil
🇫🇷Strasbourg, France
Hospital Son Llàtzer
🇪🇸Palma, Illes Balears, Spain
Complejo Hospitalario Universitario Santiago de Compostela
🇪🇸Santiago de Compostela, Galicia, Spain
Florida Cancer Research Institute
🇺🇸Plantation, Florida, United States
Mid Florida Cancer Centers
🇺🇸Orange City, Florida, United States
Park Nicollet Institute
🇺🇸Saint Louis Park, Minnesota, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
St. John's Medical Research Institute
🇺🇸Springfield, Missouri, United States
Ventura County Hematology-Oncology Specialists
🇺🇸Oxnard, California, United States
North Broward Medical Center Cancer Center
🇺🇸Deerfield Beach, Florida, United States
Palm Beach Institute of Hematology and Oncology
🇺🇸Boynton Beach, Florida, United States
Dublin Hematology and Oncology Care
🇺🇸Dublin, Georgia, United States
Phoebe Cancer Center
🇺🇸Albany, Georgia, United States
Clintell
🇺🇸Skokie, Illinois, United States
Presence Hematology and Oncology
🇺🇸Skokie, Illinois, United States
Springfield Clinic
🇺🇸Springfield, Illinois, United States
Washington University School of Medicine Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
The Valley Hospital, Luckow Pavilion Office of Oncology Clinical Trials
🇺🇸Paramus, New Jersey, United States
Summa Health System Hospitals
🇺🇸Akron, Ohio, United States
Gaston Hematology and Oncology Associates
🇺🇸Gastonia, North Carolina, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Texas Oncology-Allison Cancer Center
🇺🇸Midland, Texas, United States
Southlake Oncology
🇺🇸Southlake, Texas, United States
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
🇨🇳Beijing, China
CHU Bretonneau, Centre Henry Kaplan
🇫🇷Tours, France
B P Poddar and Medical Research Ltd.
🇮🇳Kolkata, West Bengal, India
Shatabdi Super Speciality Hospital
🇮🇳Nashilk, Maharashtra, India
Kaplan Medical Center
🇮🇱Rehovot, Israel
Policlinico Universitario Campus Bio-Medico
🇮🇹Roma, Italy
Ospedale San Pietro Fatebenefratelli
🇮🇹Roma, Italy
National Hospital Organization Beppu Medical Center
🇯🇵Oita, Beppu-shi, Japan
Iwate Medical University Hospital
🇯🇵Iwate, Morioka-shi, Japan
Kobe City Medical Center General Hospital
🇯🇵Hyogo, Japan
Osaka University Hospital
🇯🇵Osaka, Japan
Jichi Medical University Hospital
🇯🇵Tochigi, Japan
Toranomon Hospital
🇯🇵Tokyo, Japan
National Cancer Center, Center for Breast Cancer
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Korea, Republic of
Yonsei University Health System Severance Hospital
🇰🇷Seoul, Seoul/Korea, Korea, Republic of
University Malaya Medical Centre
🇲🇾Kuala Lumpur, Malaysia
The Medical Oncology Centre of Rosebank
🇿🇦Johannesburg, Gauteng, South Africa
Eastleigh Breast Care Centre
🇿🇦Pretoria, Gauteng, South Africa
University of Witwatersrand Oncology, Donald Gordon Medical Centre
🇿🇦Johannesburg, Gauteng, South Africa
Hospital Puerta De Hierro
🇪🇸Majadahonda, Madrid, Spain
Hospital Madrid Norte Sanchinarro Centro Integral Oncológico Clara Campal Ensayos Clínicos
🇪🇸Sanchinarro, Madrid, Spain
Hospital Universitario Infanta Cristina
🇪🇸Parla, Madrid, Spain
Hospital Costa del Sol
🇪🇸Marbella, Malaga, Spain
Hospital de Cruces
🇪🇸Baracaldo, Vizcaya, Spain
Tumor Center Hirslanden Medical Center
🇨🇭Aarau, Switzerland
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
S.P. Grigoreva Institute of Medical Radiology Department of Chemotherapy
🇺🇦Kharkiv, Ukraine
Nottingham University Hospital
🇬🇧Nottingham, United Kingdom
Volyn Regional Oncological Center
🇺🇦Lutsk, Ukraine
Family Cancer Care
🇺🇸Memphis, Tennessee, United States
Redwood Regional Medical Group
🇺🇸Santa Rosa, California, United States
El Paso Cancer Treatment Center
🇺🇸El Paso, Texas, United States
The Queen Elizabeth Hospital
🇦🇺North Adelaide, South Australia, Australia