Clinical trial NCT00777101: Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer
Official title: A Phase 2 Randomized Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine For The Treatment Of ErbB-2 Positive Locally Advanced Or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Breast Cancer
Breast Cancer
Keywords: HER2
ErbB2
metastatic
neratinib
lapatinib
capecitabine
HKI-272
Nerlynx
PB-272
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-22
Enrollment: 233
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 is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and to compare quality of life of patients taking the two regimens.


Eligibility criteria: Inclusion Criteria:

* Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
* Prior use of Herceptin (trastuzumab), and a taxane
* Adequate cardiac and renal function

Exclusion Criteria:

* More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) \[Tyverb\]
* Bone as the only site of disease
* Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
* Significant gastrointestinal disorder with diarrhea as major symptom

Primary outcomes:
measure: Progression Free Survival
timeFrame: From randomization date to progression or death, assessed up to 69 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization date to death, assessed up to 69 months
measure: Objective Response Rate (ORR).
timeFrame: From randomization date to progression or last tumor assessment, assessed up to 69 months
measure: Clinical Benefit Rate
timeFrame: From randomization date to progression or last tumor assessment, assessed up to 69 months
measure: Duration of Response
timeFrame: From start date of response to first PD, assessed up to 69 months after the first subject was randomized.
measure: Frequency of CNS Metastases (Frequency)
timeFrame: From randomization date to first CNS symptom or lesions
measure: Time to CNS Metastases
timeFrame: From randomization date to first CNS symptom or lesions
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates HOPE
state: Arizona
city: Murrieta
country: United States
facility: Southwest Cancer Care
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center
state: California
city: Palm Springs
country: United States
facility: Aptium Oncology/Comprehensive Cancer Center at Desert Regional Medical Center
state: California
city: Santa Rosa
country: United States
facility: Redwood Regional Medical Group, Inc.
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Stamford
country: United States
facility: Hematology Oncology Associates, P.C.
state: Connecticut
city: Boynton Beach
country: United States
facility: Palm Beach Institute of Hematology & Oncology
state: Florida
city: Gainesville
country: United States
facility: Robert R. Carroll, MD, PA
state: Florida
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Loxahatchee Groves
country: United States
facility: Hematology Oncology Associates
state: Florida
city: Miami
country: United States
facility: Mercy Research Institute
state: Florida
city: Orlando
country: United States
facility: Cancer Centers of Florida
state: Florida
city: Port Saint Lucie
country: United States
facility: Hematology Oncology Associates of the Treasure Coast
state: Florida
city: Decatur
country: United States
facility: Cancer Care Specialists Of Central Illinois
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists, SC
state: Illinois
city: Zion
country: United States
facility: Midwestern Regional Medical Center
state: Illinois
city: Fishers
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Indianapolis
country: United States
facility: Hematology Oncology of Indiana
state: Indiana
city: New Albany
country: United States
facility: Floyd Memorial Cancer Center of Indiana
state: Indiana
city: Ashland
country: United States
facility: Ashland-Bellefonte Cancer Center
state: Kentucky
city: Louisville
country: United States
facility: Owsley Brown Frazier Cancer Center (OBFCC)
state: Kentucky
city: Paducah
country: United States
facility: Purchase Cancer Group
state: Kentucky
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Jefferson City
country: United States
facility: Capitol Comprehensive Cancer Care Clinic
state: Missouri
city: Lake Success
country: United States
facility: Arena Oncology Associates, PC
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College New York-Presbyterian Hospital Weill, Cornell Breast Center
state: New York
city: Troy
country: United States
facility: New York Oncology Hematolgy, PC
state: New York
city: Cincinnati
country: United States
facility: Oncology Partners Network
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center, Cancer Care Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center Dept. of Hematology Oncology
state: Oklahoma
city: Portland
country: United States
facility: Northwest Cancer Specialists, PC
state: Oregon
city: Lancaster
country: United States
facility: Lancaster Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital Allegheny Cancer Center
state: Pennsylvania
city: Cookeville
country: United States
facility: Cookeville Regional Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: Center for Biomedical Research
state: Tennessee
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center Thompson Oncology Group
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Cancer Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: El Paso
country: United States
facility: El Paso Cancer Treatment Center - West
state: Texas
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Richardson
country: United States
facility: HOPE Oncology
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Network of South Texas-HOAST
state: Texas
city: Tyler
country: United States
facility: East Texas Medical Center Cancer Institute, Tyler Hematology Oncology
state: Texas
city: South Brisbane
country: Australia
facility: Mater Private Centre for HOCA
state: Queensland
city: Adelaide
country: Australia
facility: Medical Oncology Royal Adelaide Hospital
state: South Australia
city: Footscray
country: Australia
facility: Western Hospital
state: Victoria
city: West Perth
country: Australia
facility: Mount Hospital
city: Wien
country: Austria
facility: AKH Wien Universitaetsklinik fuer Innere Medizin I Klinische Abteilung für Onkologie
city: Brussels
country: Belgium
facility: Institut Jules Bordet Unite du Chimiotherapie
city: Sofia
country: Bulgaria
facility: District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD, Dept. of Chemotherapy
city: Sofia
country: Bulgaria
facility: UMHAT Tzaritza Yoanna
city: Varna
country: Bulgaria
facility: Interdistrict Dispensary for Oncology Diseases -Internal Unit- Department Oncotherapy and Palliative Care
city: Vancouver
country: Canada
facility: BC Cancer Agency - Vancouver Centre
state: British Columbia
city: Quebec
country: Canada
facility: Centre Hospitalier Affilie Universitaire de Quebec Hopital du St-Sacrement
city: Varazdin
country: Croatia
facility: General Hospital Varazdin
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
city: Zagreb
country: Croatia
facility: University Hospital Sestre Milosrdnice
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc Klinika onkologie
city: Lille
country: France
facility: Centre Oscar Lambret Departement de senologie
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU de Poitiers Service d'oncologie medicale
city: Villejuif
country: France
facility: Institut Gustave ROUSSY Service de Pathologie mammaire
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf Klinik und Poliklinik fuer Gynaekologie
city: Heidelberg
country: Germany
facility: Nationales Centrum fuer Tumorerkrankungen Sektion Gynaekologische Onkologie
city: Thessaloníki
country: Greece
facility: Theagenio Anticancer Hospital of Thessaloniki
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Oncology, Tuen Mun Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: UNIMED Medical Institute, Comprehensive Centre for Breast Diseases
city: Budapest
country: Hungary
facility: Fovarosi Onkormanyzat Szent Janos Korhaza es Eszak-budai Egyesitett Korhazai, Onkologia
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont
city: Nyiregyhaza
country: Hungary
facility: Josa Andras Oktatokorhaz / Onkoradiologiai Osztaly
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Onkoterapias Klinika
city: Veszprem
country: Hungary
facility: Hospital of County Veszprem
city: Prato
country: Italy
facility: Ospedale Misericordia e Dolce c/o UO Oncologia Medica
city: Roma
country: Italy
facility: Istituto Regina Elena, Struttura Complessa Oncologia Medica A
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center
state: Hokkaido
city: Tsukiji
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Aichi
country: Japan
facility: Aichi Cancer Center
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Hiroshima
country: Japan
facility: Hiroshima City Hospital
city: Hyogo
country: Japan
facility: Hyogo Cancer Center
city: Kagoshima
country: Japan
facility: Hakuaikai Medical Corporation Sagara Hospital
city: Kanagawa
country: Japan
facility: Tokai University Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Municipal Hospital
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Saitama
country: Japan
facility: Saitama Cancer Center
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokyo
country: Japan
facility: St. Luke's International Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research Department of Medical Oncology
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Cancer&Infectious disease Ctr Komagome Hp
city: Amman
country: Jordan
facility: King Hussein Cancer Centre
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Korea
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System - Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Monterrey
country: Mexico
facility: Oca Hospital / Monterrey International Research Center
state: Nuevo Leon
city: Bialystok
country: Poland
facility: Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie w Bialymstoku Specjalistyczny Szpital Onkologiczn
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne w Gdansku Klinika Onkologii i Radioterapii
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie Oddzial KIiniczny Kliniki Onkologii
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej im. SW. Jana z Dukli
city: San Juan
country: Puerto Rico
facility: Metropolitan Oncology Center
city: Bucuresti
country: Romania
facility: Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta
city: Iasi
country: Romania
facility: Centrul de Oncologie Medicala
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean
city: Pesochny
country: Russian Federation
facility: Scientific Research Institute of Oncology N.N. Petrov
state: Saint Petersburg
city: Moscow
country: Russian Federation
facility: Russian Oncology Research Centre of RAMS
city: Perm
country: Russian Federation
facility: GUZ Perm Regional Oncology Dispensary
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University I.P.Pavlov of Federal Agency in Healthcare and Social Development
city: Saint Petersburg
country: Russian Federation
facility: SIH Leningrad Regional Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: GUZ City Clinical Oncology Dispensary
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Medical University I.P.Pavlov of Roszdrav
city: Sochi
country: Russian Federation
facility: SIH Oncology Dispensary # 2 Of Department of Public Health
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Ministry of Healthcare of Bashkortostan Republic
city: Belgrade
country: Serbia
facility: Institute of Oncology and Radiology of Serbia
city: Belgrade
country: Serbia
facility: Klinicko Bolnicki Centar (KBC) Bezanijska Kosa (Medical Centre ''Bezanijska Kosa'' (MCBK))
city: Singapore
country: Singapore
facility: Johns Hopkins Singapore International Medical Centre
city: Ljubljana
country: Slovenia
facility: Institute for Oncology Department for Medical Oncology
city: Johannesburg
country: South Africa
facility: The Medical Oncology Centre of Rosebank
state: Gauteng
city: Lynnwood
country: South Africa
facility: Eastleigh Breast Care Centre
state: Gauteng
city: Durban
country: South Africa
facility: Hopelands Oncology Centre
state: KwaZulu Natal
city: Kraaifontein
country: South Africa
facility: GVI Oncology Trial Unit Room 110 Panorama Medical Centre
state: Western Cape Province
city: Oviedo
country: Spain
facility: Hospital Central de Asturias Servicio de Oncologia, Planta Baja Oeste, Edificio Principal
state: Asturias
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol Servicio de Oncologia
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli Servicio de Oncologia
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa Servicio de Oncologia
state: Barcelona
city: A Coruña
country: Spain
facility: Complejo Hospitalario U. de A Coruña Hospital Teresa Herrera Servicio de Oncologia
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante Servicio de Oncologia
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara Servicio de Oncologia
city: Cordoba
country: Spain
facility: Hospital Provincial (Reina Sofia) Servicio de Oncologia
city: Gerona
country: Spain
facility: Hospital Universitario Dr. Josep Trueta Servicio de Oncologia
city: Jaen
country: Spain
facility: Centro Hospitalario de Jaen Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon Servicio de Oncologia
city: Madrid
country: Spain
facility: Centro Oncologico M.D. Anderson Internacional
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia Servicio de Hematologia y Oncologia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet Servicio de Oncologia
city: Lausanne
country: Switzerland
facility: University of Lausanne Hospitals CHUV
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur Medizinische Onkologie
city: Zuerich
country: Switzerland
facility: Abteilung fuer Onkologie Departement für Innere
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Bangkok-noi
country: Thailand
facility: Division of Medical Oncology, Department of Medicine
state: Bangkok
city: Chelmsford
country: United Kingdom
facility: Broomfield Hospital
state: Essex
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust & Institute of Cancer Research
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust & Institute of Cancer Research
Study officials:
affiliation: Biotechnology
name: Puma
role: STUDY_DIRECTOR
References:
citation: Martin M, Bonneterre J, Geyer CE Jr, Ito Y, Ro J, Lang I, Kim SB, Germa C, Vermette J, Wang K, Wang K, Awada A. A phase two randomised trial of neratinib monotherapy versus lapatinib plus capecitabine combination therapy in patients with HER2+ advanced breast cancer. Eur J Cancer. 2013 Dec;49(18):3763-72. doi: 10.1016/j.ejca.2013.07.142. Epub 2013 Aug 15.