Clinical trial NCT00915018: Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
Official title: A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: ErbB-2 positive advanced breast cancer
HKI-272
Neratinib
Nerlynx
HER2
PB-272
metastatic breast cancer
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-05
Enrollment: 479
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression-Free Survival
timeFrame: From randomization to disease progression or death, assessed up to 5.3 years
Secondary outcomes:
measure: Objective Response Rate
timeFrame: From randomization to disease progression or last tumor assessment, assessed up to 5.3 years
measure: Duration of Response
timeFrame: From first response to first PD or death, assessed up to 5.3 years after first subject randomized
measure: Clinical Benefit Rate
timeFrame: From randomization to disease progression or death, assessed up to 5.3 years
measure: Symptomatic or Progressive Central Nervous System (CNS) Lesions
timeFrame: From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 years
Other outcomes:
Locations:
city: Oxnard
country: United States
facility: Ventura County Hematology-Oncology Specialists
state: California
city: Santa Rosa
country: United States
facility: Redwood Regional Medical Group
state: California
city: Plainville
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Boynton Beach
country: United States
facility: Palm Beach Institute of Hematology and Oncology
state: Florida
city: Deerfield Beach
country: United States
facility: North Broward Medical Center Cancer Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward General Medical Center
state: Florida
city: Orange City
country: United States
facility: Mid Florida Cancer Centers
state: Florida
city: Plantation
country: United States
facility: Florida Cancer Research Institute
state: Florida
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates of Treasure Coast
state: Florida
city: Albany
country: United States
facility: Phoebe Cancer Center
state: Georgia
city: Dublin
country: United States
facility: Dublin Hematology and Oncology Care
state: Georgia
city: Skokie
country: United States
facility: Clintell
state: Illinois
city: Skokie
country: United States
facility: Presence Hematology and Oncology
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Alexandria
country: United States
facility: CHRISTUS St. Frances Cabrini Hospital
state: Louisiana
city: Metairie
country: United States
facility: Hematology Oncology Services
state: Louisiana
city: Saint Louis Park
country: United States
facility: Park Nicollet Institute
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine Siteman Cancer Center
state: Missouri
city: Springfield
country: United States
facility: St. John's Medical Research Institute
state: Missouri
city: Paramus
country: United States
facility: The Valley Hospital, Luckow Pavilion Office of Oncology Clinical Trials
state: New Jersey
city: Gastonia
country: United States
facility: Gaston Hematology and Oncology Associates
state: North Carolina
city: Akron
country: United States
facility: Summa Health System Hospitals
state: Ohio
city: Tulsa
country: United States
facility: Warren Cancer Research Foundation
state: Oklahoma
city: Corvallis
country: United States
facility: Samaritan Hematology and Oncology Consultants
state: Oregon
city: Pawtucket
country: United States
facility: Pawtucket Memorial Hospital
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina Hollings Cancer Center
state: South Carolina
city: Sumter
country: United States
facility: Santee Hematology Oncology
state: South Carolina
city: Knoxville
country: United States
facility: Tenessee Cancer Specialists
state: Tennessee
city: Memphis
country: United States
facility: Family Cancer Care
state: Tennessee
city: Bedford
country: United States
facility: Texas Oncology
state: Texas
city: El Paso
country: United States
facility: El Paso Cancer Treatment Center
state: Texas
city: Midland
country: United States
facility: Texas Oncology-Allison Cancer Center
state: Texas
city: Southlake
country: United States
facility: Southlake Oncology
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Charleston
country: United States
facility: Charleston Area Medical Center, Health, Education, and Research Institute
state: West Virginia
city: North Adelaide
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Nassau
country: Bahamas
facility: Affinity Research Limited
state: CB
city: Lesnoy
country: Belarus
facility: N.N. Aleksandrov National Cancer Center of Belarus
state: Minsk Region
city: Gomel
country: Belarus
facility: Institution Gomel Regional Clinical Oncology Dispensary
city: Grodno
country: Belarus
facility: Institution of Healthcare Grodno Regional Clinical Hospital
city: Vitebsk
country: Belarus
facility: Healthcare Institution Vitebsk Regional Clinical Oncology Dispensary
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Plovdiv
country: Bulgaria
facility: District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD
city: Sofia
country: Bulgaria
facility: District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD
city: Sofia
country: Bulgaria
facility: Specialised Hospital of ActiveTreatment in Oncology, Clinic of Chemotherapy
city: Greenfield Park
country: Canada
facility: Hopital Charles, LeMoyne Le Centre Intégré de Cancérologie de la Montérégie
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Centre Hospitalier Régional de Trois-Rivières
state: Quebec
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: The Hospital Affiliated Academy Military Medical Science, Chinese People's Liberation Army
city: Beijing
country: China
facility: Chinese People's Liberation Army General Hospital
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Tian Jin
country: China
facility: Tianjin Cancer Hospital
city: Osijek
country: Croatia
facility: Clinical Hospital Osijek, Department of Radiotherapy and Oncology
city: Zagreb
country: Croatia
facility: University Hospital For Tumors
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Copenhagen, Onkologisk Klinik
city: Creteil
country: France
facility: Hôpital Henri-Mondor
city: Lyon
country: France
facility: Centre Leon Berard Departement de Cancerologie Medicale
city: Montpellier
country: France
facility: Centre Val d'Aurelle
city: Paris
country: France
facility: Hopital Hotel Dieu, Service d'Oncologie Medicale, Bat B2, 5ieme
city: Paris
country: France
facility: Hopital La Pitie-Salpetriere
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph, Oncologie medicale
city: Perigueux
country: France
facility: Service d'Oncologie et de Radiotherapie, Polyclinique Francheville
city: St. Brieuc
country: France
facility: Clinique Armoricaine de Radiologie
city: Strasbourg
country: France
facility: Centre de Radiothérapie, Clinique Sainte Anne, Service d'Oncologie Libérale
city: Strasbourg
country: France
facility: CHU Strasbourg Departement Oncologie & Hematologie Hopital Civil
city: Tours
country: France
facility: CHU Bretonneau, Centre Henry Kaplan
city: Bamberg
country: Germany
facility: Sozialstiftung Bamberg Klinik fuer Haematologie und internistische Onkologie
city: Chai Wan
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Wanchai
country: Hong Kong
facility: UNIMED Medical Institute, Comprehensive Centre for Breast Diseases
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Radiologiai és Onkoterapias Klinika
city: Budapest
country: Hungary
facility: Fovarosi Onkormanyzat Szent Imre Korhaz Klinikai Onkologiai Profil
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly
city: Kaposvar
country: Hungary
facility: Kaposi Mor Oktato Korhoz Onkologiai Centrum
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Onkormanyzat Korhaza Onkoradiologiai Kozpont
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Kórház és Egyetemi Oktató Kórház
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Onkoterapias Klinika
city: New Delhi
country: India
facility: Institute Rotary Cancer Hospital, AIIMS
state: Delhi
city: Bhopal
country: India
facility: Jawaharlal Nehru Cancer Hospital
state: Madhya Pradesh
city: Mumbai
country: India
facility: Tata Memorial Centre
state: Maharashtra
city: Nagpur
country: India
facility: Central India Cancer Research Institute
state: Maharashtra
city: Nashik
country: India
facility: Curie Manavata Cancer Centre
state: Maharashtra
city: Nashilk
country: India
facility: Shatabdi Super Speciality Hospital
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
state: Maharashtra
city: Jaipur
country: India
facility: Searoc Cancer Center
state: Rajasthan
city: Madurai
country: India
facility: Meenakshi Mission Hospital and Research Centre
state: Tamil Nadu
city: Kolkata
country: India
facility: B P Poddar and Medical Research Ltd.
state: West Bengal
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Modena
country: Italy
facility: Policlinico di Modena Oncologia ed Ematologia
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Roma
country: Italy
facility: Ospedale San Pietro Fatebenefratelli
city: Torino
country: Italy
facility: Ospedale San Giovanni Battista-Molinette
city: Hyogo
country: Japan
facility: Hyogo Cancer Center
state: Akashi-shi
city: Oita
country: Japan
facility: National Hospital Organization Beppu Medical Center
state: Beppu-shi
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious Disease Center, Komagome Hospital
state: Bunkyo-ku
city: Chiba
country: Japan
facility: Chiba Cancer Center
state: Chiba-shi
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
state: Fukuoka-shi
city: Ibaraki
country: Japan
facility: National Hospital Organization Mito Medical Center
state: Higashiibaraki-gun
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
state: Hiroshima-shi
city: Kagoshima
country: Japan
facility: Hakuaikai Medical Corporation Sagara Hospital
state: Kagoshima-city
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
state: Kashiwa-shi
city: Saitama
country: Japan
facility: Saitama Cancer Center
state: Kitaadachi-gun
city: Kumamoto
country: Japan
facility: Kumamoto Municipal Hospital
state: Kumamoto-city
city: Fukuoka
country: Japan
facility: Kurume Daiichi Social Insurance Hospital
state: Kurume-Shi
city: Ehime
country: Japan
facility: National Hospital Organization Shikoku Cancer Center
state: Matsuyama-city
city: Iwate
country: Japan
facility: Iwate Medical University Hospital
state: Morioka-shi
city: Aichi
country: Japan
facility: Aichi Cancer Center
state: Nagoya-shi
city: Aichi
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Nagoya
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
state: Niigata-shi
city: Osaka
country: Japan
facility: Osaka Medical Center for Cancer and Cardiovascular Diseases
state: Osaka-shi
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
state: Osaka-shi
city: Hokkaido
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Sapporo-shi
city: Miyagi
country: Japan
facility: Tohoku University Hospital
state: Sendai-city
city: Nara
country: Japan
facility: Tenri Hospital
state: Tenri-shi
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
state: Yokohama-City
city: Hiroshima
country: Japan
facility: Hiroshima City Hospital
city: Hiroshima
country: Japan
facility: National Hospital Organization Kure Medical Center and Chugoku Cancer Center
city: Hyogo
country: Japan
facility: Kobe City Medical Center General Hospital
city: Hyogo
country: Japan
facility: Shinko Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Osaka
country: Japan
facility: Tazuke Kofukai Medical Research Institute Kitano Hospital
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tokyo
country: Japan
facility: National Hospital Organization Tokyo Medical Center
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center, Center for Breast Cancer
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Korea
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Korea
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital
state: Seoul/Korea
city: Liepaja
country: Latvia
facility: Piejuras Hospital, Liepajas Oncological Clinic
city: Riga
country: Latvia
facility: Pauls Stradiņš Clinical University Hospital
city: Riga
country: Latvia
facility: Riga Eastern University Hospital
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health sciences
city: Vilnius
country: Lithuania
facility: Nacionalinis Vezio Institutas, Vilniaus Universiteto Onkologijos Institutas
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Floriana
country: Malta
facility: Sir Anthony Oncology Center
city: Jelenia Gora
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial
state: Dolnoslaskie
city: Warszawa
country: Poland
facility: Magodent
state: Mazowieckie
city: Opole
country: Poland
facility: Opolskie Centrum Onkologii
state: Opolskie
city: Olsztyn
country: Poland
facility: Zakład Opieki Zdrowotnej MSW z Warmińsko, Mazurskim Centrum Onkologii
state: Warminsko-Mazurskie
city: Bialystok
country: Poland
facility: Białostockie Centrum Onkologii
city: Lisboa
country: Portugal
facility: Hospital da Luz Servico de Oncologia Medica
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof. Dr. Ion Chiricuţă
state: Cluj
city: Craiova
country: Romania
facility: SC Oncolab S.R.L.
state: Dolj
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
city: Belgrade
country: Serbia
facility: Institute of Oncology and Radiology of Serbia
city: Nis
country: Serbia
facility: Clinical centre Nis Clinic of Oncology
city: Singapore
country: Singapore
facility: National University Hospital, National Cancer Institute
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Port Elizabeth
country: South Africa
facility: GVI Oncology
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: The Medical Oncology Centre of Rosebank
state: Gauteng
city: Johannesburg
country: South Africa
facility: University of Witwatersrand Oncology, Donald Gordon Medical Centre
state: Gauteng
city: Johannesburg
country: South Africa
facility: Sandton Oncology Centre
state: Gauteng
city: Pretoria
country: South Africa
facility: Eastleigh Breast Care Centre
state: Gauteng
city: Durban
country: South Africa
facility: Westridge Medical Centre
state: KwaZulu Natal
city: Kraaifontein
country: South Africa
facility: GVI Oncology
state: Western Cape
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova
state: Cataluna
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario Santiago de Compostela
state: Galicia
city: Palma
country: Spain
facility: Hospital Son Llàtzer
state: Illes Balears
city: Alcorcon
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Puerta De Hierro
state: Madrid
city: Parla
country: Spain
facility: Hospital Universitario Infanta Cristina
state: Madrid
city: Sanchinarro
country: Spain
facility: Hospital Madrid Norte Sanchinarro Centro Integral Oncológico Clara Campal Ensayos Clínicos
state: Madrid
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Malaga
city: Baracaldo
country: Spain
facility: Hospital de Cruces
state: Vizcaya
city: Madrid
country: Spain
facility: Centro Oncologico MD Anderson
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Aarau
country: Switzerland
facility: Tumor Center Hirslanden Medical Center
city: Thun
country: Switzerland
facility: Spital STS AG Onkologiezentrum Thun - Berner Oberland
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur Medizinische Onkologie
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation, Linkou Branch
city: Bornova
country: Turkey
facility: Ege Universitesi Tip Fakultesi Tulay Aktas Onkoloji Hastanesi
state: Izmir
city: Cherkassy
country: Ukraine
facility: Komunalnyy Zaklad Cherkasskyy Oblasnyy Onkologichnyy Dyspanser
city: Chernivtsi
country: Ukraine
facility: Chernivtsi Regional Oncology Centre Outpatient Department Bukovynian State Medical University Department of Oncology and Radiology
city: Dnipropetrovsk
country: Ukraine
facility: City Multifield Clinical Hospital
city: Donetsk
country: Ukraine
facility: Donetsk Regional Antitumor Center Department of Pretumor Diseases and Tumor Treatment
city: Kharkiv
country: Ukraine
facility: S.P. Grigoreva Institute of Medical Radiology Department of Chemotherapy
city: Kyiv
country: Ukraine
facility: National Institute of Cancer Department of Conseravtive Methods of Treatment
city: Lutsk
country: Ukraine
facility: Volyn Regional Oncological Center
city: Lviv
country: Ukraine
facility: State Oncological Regional Treatment and Diagnostic Center
city: Mariupil
country: Ukraine
facility: Mariupil Oncological Center
city: Sumy
country: Ukraine
facility: Sumy Regional Clinical Oncology Centre
city: London
country: United Kingdom
facility: Guy's and St Thomas NHS Foundation Trust Management Offices 4th Floor Bermondsey Wing Guy's Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
Study officials:
affiliation: Biotechnology
name: Puma
role: STUDY_DIRECTOR
References:
citation: Awada A, Colomer R, Inoue K, Bondarenko I, Badwe RA, Demetriou G, Lee SC, Mehta AO, Kim SB, Bachelot T, Goswami C, Deo S, Bose R, Wong A, Xu F, Yao B, Bryce R, Carey LA. Neratinib Plus Paclitaxel vs Trastuzumab Plus Paclitaxel in Previously Untreated Metastatic ERBB2-Positive Breast Cancer: The NEfERT-T Randomized Clinical Trial. JAMA Oncol. 2016 Dec 1;2(12):1557-1564. doi: 10.1001/jamaoncol.2016.0237.