Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer
- Conditions
- Advanced Breast CancerBreast Cancer
- Interventions
- Registration Number
- NCT00777101
- Lead Sponsor
- Puma Biotechnology, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 233
- Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
- Prior use of Herceptin (trastuzumab), and a taxane
- Adequate cardiac and renal function
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neratinib Neratinib - Lapatinib plus Capecitabine Lapatinib - Lapatinib plus Capecitabine Capecitabine -
- Primary Outcome Measures
Name Time Method Progression Free Survival From randomization date to progression or death, assessed up to 69 months Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) From randomization date to death, assessed up to 69 months Overall Survival (OS) was defined as the time from randomization to death due to any cause. Subjects last known to be alive were censored at the last date of last contact or the data cutoff employed for the analysis, whichever was earlier.
Clinical Benefit Rate From randomization date to progression or last tumor assessment, assessed up to 69 months Clinical benefit rate (CR, PR, or SD = 24 weeks) for women For ErbB2 Positive Advanced Breast Cancer. Clinical benefit rate was the percentage of subjects who achieved overall tumor 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; 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.
Clinical Benefit (CB) = CR + PR + SD \>= 24 weeks.Objective Response Rate (ORR). From randomization date to progression or last tumor assessment, assessed up to 69 months Objective Response Rate, investigator assessment. The ORR was defined as the percentage of participants demonstrating a confirmed objective response, either Complete Response (CR) or Partial Response (PR) during the study per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: 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.
Duration of Response From start date of response to first PD, assessed up to 69 months after the first subject was randomized. Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death. For subjects without death or progression, censorship was at the last valid tumor assessment 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.
Time to CNS Metastases From randomization date to first CNS symptom or lesions Time to symptomatic or progressive Central nervous system (CNS) lesions. Time to symptomatic or progressive CNS lesions was the time from the date of randomization until the date of progressive disease (PD) considering CNS lesions only (ie, appearance of newly diagnosed CNS lesions or progressive CNS lesions).
Frequency of CNS Metastases (Frequency) From randomization date to first CNS symptom or lesions The percent of patients with symptomatic or progressive CNS lesions was the proportion of subjects who had PD considering CNS lesions only, according to RECIST criteria.
Trial Locations
- Locations (152)
The Medical Oncology Centre of Rosebank
🇿🇦Johannesburg, Gauteng, South Africa
Division of Medical Oncology, Department of Medicine
🇹ðŸ‡Bangkok-noi, Bangkok, Thailand
Broomfield Hospital
🇬🇧Chelmsford, Essex, United Kingdom
University of Florida
🇺🇸Jacksonville, Florida, United States
Mercy Research Institute
🇺🇸Miami, Florida, United States
Oncology Partners Network
🇺🇸Cincinnati, Ohio, United States
Oca Hospital / Monterrey International Research Center
🇲🇽Monterrey, Nuevo Leon, Mexico
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
AKH Wien Universitaetsklinik fuer Innere Medizin I Klinische Abteilung für Onkologie
🇦🇹Wien, Austria
BC Cancer Agency - Vancouver Centre
🇨🇦Vancouver, British Columbia, Canada
University of Oklahoma Health Sciences Center Dept. of Hematology Oncology
🇺🇸Oklahoma City, Oklahoma, United States
Northwest Cancer Specialists, PC
🇺🇸Portland, Oregon, United States
Hakuaikai Medical Corporation Sagara Hospital
🇯🇵Kagoshima, Japan
Purchase Cancer Group
🇺🇸Paducah, Kentucky, United States
Ashland-Bellefonte Cancer Center
🇺🇸Ashland, Kentucky, United States
MetroHealth Medical Center, Cancer Care Center
🇺🇸Cleveland, Ohio, United States
HOPE Oncology
🇺🇸Richardson, Texas, United States
The Center for Cancer and Blood Disorders
🇺🇸Fort Worth, Texas, United States
Hematology Oncology Associates, P.C.
🇺🇸Stamford, Connecticut, United States
Redwood Regional Medical Group, Inc.
🇺🇸Santa Rosa, California, United States
Hematology Oncology Associates
🇺🇸Loxahatchee Groves, Florida, United States
Hematology Oncology Associates of the Treasure Coast
🇺🇸Port Saint Lucie, Florida, United States
Cancer Centers of Florida
🇺🇸Orlando, Florida, United States
Cancer Care Specialists Of Central Illinois
🇺🇸Decatur, Illinois, United States
Oncology Specialists, SC
🇺🇸Park Ridge, Illinois, United States
Floyd Memorial Cancer Center of Indiana
🇺🇸New Albany, Indiana, United States
Weill Cornell Medical College New York-Presbyterian Hospital Weill, Cornell Breast Center
🇺🇸New York, New York, United States
Hematology Oncology of Indiana
🇺🇸Indianapolis, Indiana, United States
New York Oncology Hematolgy, PC
🇺🇸Troy, New York, United States
Lancaster Cancer Center
🇺🇸Lancaster, Pennsylvania, United States
Cookeville Regional Medical Center
🇺🇸Cookeville, Tennessee, United States
Center for Biomedical Research
🇺🇸Knoxville, Tennessee, United States
Thompson Cancer Survival Center Thompson Oncology Group
🇺🇸Knoxville, Tennessee, United States
Texas Oncology, P.A.
🇺🇸Austin, Texas, United States
University of Tennessee Cancer Institute
🇺🇸Memphis, Tennessee, United States
Cancer Care Network of South Texas-HOAST
🇺🇸San Antonio, Texas, United States
Medical Oncology Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
UMHAT Tzaritza Yoanna
🇧🇬Sofia, Bulgaria
District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD, Dept. of Chemotherapy
🇧🇬Sofia, Bulgaria
Mount Hospital
🇦🇺West Perth, Australia
Institut Jules Bordet Unite du Chimiotherapie
🇧🇪Brussels, Belgium
Interdistrict Dispensary for Oncology Diseases -Internal Unit- Department Oncotherapy and Palliative Care
🇧🇬Varna, Bulgaria
University Hospital Center Zagreb
ðŸ‡ðŸ‡·Zagreb, Croatia
Centre Hospitalier Affilie Universitaire de Quebec Hopital du St-Sacrement
🇨🇦Quebec, Canada
General Hospital Varazdin
ðŸ‡ðŸ‡·Varazdin, Croatia
University Hospital Sestre Milosrdnice
ðŸ‡ðŸ‡·Zagreb, Croatia
Fakultni nemocnice Olomouc Klinika onkologie
🇨🇿Olomouc, Czechia
Centre Oscar Lambret Departement de senologie
🇫🇷Lille, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Nationales Centrum fuer Tumorerkrankungen Sektion Gynaekologische Onkologie
🇩🇪Heidelberg, Germany
CHU de Poitiers Service d'oncologie medicale
🇫🇷Poitiers, France
Institut Gustave ROUSSY Service de Pathologie mammaire
🇫🇷Villejuif, France
Universitaetsklinikum Hamburg-Eppendorf Klinik und Poliklinik fuer Gynaekologie
🇩🇪Hamburg, Germany
Theagenio Anticancer Hospital of Thessaloniki
🇬🇷ThessalonÃki, Greece
Department of Clinical Oncology, Tuen Mun Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Josa Andras Oktatokorhaz / Onkoradiologiai Osztaly
ðŸ‡ðŸ‡ºNyiregyhaza, Hungary
Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont
ðŸ‡ðŸ‡ºKecskemet, Hungary
Fovarosi Onkormanyzat Szent Janos Korhaza es Eszak-budai Egyesitett Korhazai, Onkologia
ðŸ‡ðŸ‡ºBudapest, Hungary
Istituto Regina Elena, Struttura Complessa Oncologia Medica A
🇮🇹Roma, Italy
Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly
ðŸ‡ðŸ‡ºBudapest, Hungary
Szegedi Tudomanyegyetem Onkoterapias Klinika
ðŸ‡ðŸ‡ºSzeged, Hungary
Aichi Cancer Center
🇯🇵Aichi, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵Sapporo, Hokkaido, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Hiroshima City Hospital
🇯🇵Hiroshima, Japan
National Cancer Center Hospital
🇯🇵Tsukiji, Tokyo, Japan
Chiba Cancer Center
🇯🇵Chiba, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
National Cancer Center Hospital East
🇯🇵Chiba, Japan
Saitama Cancer Center
🇯🇵Saitama, Japan
Jichi Medical University Hospital
🇯🇵Tochigi, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Osaka, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata, Japan
St. Luke's International Hospital
🇯🇵Tokyo, Japan
King Hussein Cancer Centre
🇯🇴Amman, Jordan
Yonsei University Health System - Severance Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie w Bialymstoku Specjalistyczny Szpital Onkologiczn
🇵🇱Bialystok, Poland
Uniwersyteckie Centrum Kliniczne w Gdansku Klinika Onkologii i Radioterapii
🇵🇱Gdansk, Poland
Szpital Uniwersytecki w Krakowie Oddzial KIiniczny Kliniki Onkologii
🇵🇱Krakow, Poland
Centrum Onkologii Ziemi Lubelskiej im. SW. Jana z Dukli
🇵🇱Lublin, Poland
Metropolitan Oncology Center
🇵🇷San Juan, Puerto Rico
Institutul Oncologic "Prof. Dr. Alex. Trestioreanu"
🇷🇴Bucuresti, Romania
Spitalul Universitar de Urgenta
🇷🇴Bucuresti, Romania
Scientific Research Institute of Oncology N.N. Petrov
🇷🇺Pesochny, Saint Petersburg, Russian Federation
Spitalul Clinic Judetean
🇷🇴Sibiu, Romania
GUZ Perm Regional Oncology Dispensary
🇷🇺Perm, Russian Federation
SIH Leningrad Regional Oncology Dispensary
🇷🇺Saint Petersburg, Russian Federation
Klinicko Bolnicki Centar (KBC) Bezanijska Kosa (Medical Centre ''Bezanijska Kosa'' (MCBK))
🇷🇸Belgrade, Serbia
SIH Oncology Dispensary # 2 Of Department of Public Health
🇷🇺Sochi, Russian Federation
St. Petersburg State Medical University I.P.Pavlov of Roszdrav
🇷🇺Saint Petersburg, Russian Federation
Eastleigh Breast Care Centre
🇿🇦Lynnwood, Gauteng, South Africa
Corporacio Sanitaria Parc Tauli Servicio de Oncologia
🇪🇸Sabadell, Barcelona, Spain
Hospital Mutua de Terrassa Servicio de Oncologia
🇪🇸Terrassa, Barcelona, Spain
Hospital Clinico Universitario de Valencia Servicio de Hematologia y Oncologia
🇪🇸Valencia, Spain
Abteilung fuer Onkologie Departement für Innere
🇨ðŸ‡Zuerich, Switzerland
Royal Marsden NHS Foundation Trust & Institute of Cancer Research
🇬🇧London, United Kingdom
The Royal Marsden NHS Foundation Trust & Institute of Cancer Research
🇬🇧London, United Kingdom
UC Irvine Medical Center
🇺🇸Orange, California, United States
Arizona Oncology Associates HOPE
🇺🇸Tucson, Arizona, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
Centro Oncologico M.D. Anderson Internacional
🇪🇸Madrid, Spain
Palm Beach Institute of Hematology & Oncology
🇺🇸Boynton Beach, Florida, United States
Centro Hospitalario de Jaen Servicio de Oncologia
🇪🇸Jaen, Spain
Central Indiana Cancer Centers
🇺🇸Fishers, Indiana, United States
Owsley Brown Frazier Cancer Center (OBFCC)
🇺🇸Louisville, Kentucky, United States
Mater Private Centre for HOCA
🇦🇺South Brisbane, Queensland, Australia
Western Hospital
🇦🇺Footscray, Victoria, Australia
Hospital of County Veszprem
ðŸ‡ðŸ‡ºVeszprem, Hungary
Ospedale Misericordia e Dolce c/o UO Oncologia Medica
🇮🇹Prato, Italy
Hyogo Cancer Center
🇯🇵Hyogo, Japan
Kumamoto Municipal Hospital
🇯🇵Kumamoto, Japan
Tokai University Hospital
🇯🇵Kanagawa, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Japan
The Cancer Institute Hospital of Japanese Foundation for Cancer Research Department of Medical Oncology
🇯🇵Tokyo, Japan
Tokyo Metropolitan Cancer&Infectious disease Ctr Komagome Hp
🇯🇵Tokyo, Japan
Centrul de Oncologie Medicala
🇷🇴Iasi, Romania
Ryazan State Medical University I.P.Pavlov of Federal Agency in Healthcare and Social Development
🇷🇺Ryazan, Russian Federation
Russian Oncology Research Centre of RAMS
🇷🇺Moscow, Russian Federation
GUZ City Clinical Oncology Dispensary
🇷🇺Saint Petersburg, Russian Federation
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Bashkortostan Republic
🇷🇺Ufa, Russian Federation
Institute of Oncology and Radiology of Serbia
🇷🇸Belgrade, Serbia
Johns Hopkins Singapore International Medical Centre
🇸🇬Singapore, Singapore
Institute for Oncology Department for Medical Oncology
🇸🇮Ljubljana, Slovenia
Hospital Central de Asturias Servicio de Oncologia, Planta Baja Oeste, Edificio Principal
🇪🇸Oviedo, Asturias, Spain
GVI Oncology Trial Unit Room 110 Panorama Medical Centre
🇿🇦Kraaifontein, Western Cape Province, South Africa
Hospital San Pedro de Alcantara Servicio de Oncologia
🇪🇸Caceres, Spain
Complejo Hospitalario U. de A Coruña Hospital Teresa Herrera Servicio de Oncologia
🇪🇸A Coruña, Spain
Hospital General Universitario de Alicante Servicio de Oncologia
🇪🇸Alicante, Spain
Hospital Provincial (Reina Sofia) Servicio de Oncologia
🇪🇸Cordoba, Spain
Hospital Universitario Dr. Josep Trueta Servicio de Oncologia
🇪🇸Gerona, Spain
Hospital Universitario Miguel Servet Servicio de Oncologia
🇪🇸Zaragoza, Spain
Instituto Valenciano de Oncologia Servicio de Oncologia
🇪🇸Valencia, Spain
University of Lausanne Hospitals CHUV
🇨ðŸ‡Lausanne, Switzerland
Kantonsspital Winterthur Medizinische Onkologie
🇨ðŸ‡Winterthur, Switzerland
Aptium Oncology/Comprehensive Cancer Center at Desert Regional Medical Center
🇺🇸Palm Springs, California, United States
Robert R. Carroll, MD, PA
🇺🇸Gainesville, Florida, United States
Allegheny General Hospital Allegheny Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Southwest Cancer Care
🇺🇸Murrieta, California, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Midwestern Regional Medical Center
🇺🇸Zion, Illinois, United States
Arena Oncology Associates, PC
🇺🇸Lake Success, New York, United States
Capitol Comprehensive Cancer Care Clinic
🇺🇸Jefferson City, Missouri, United States
El Paso Cancer Treatment Center - West
🇺🇸El Paso, Texas, United States
Hopelands Oncology Centre
🇿🇦Durban, KwaZulu Natal, South Africa
East Texas Medical Center Cancer Institute, Tyler Hematology Oncology
🇺🇸Tyler, Texas, United States
Hospital Gregorio Marañon Servicio de Oncologia
🇪🇸Madrid, Spain
National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Korea, Republic of
Hospital Germans Trias i Pujol Servicio de Oncologia
🇪🇸Badalona, Barcelona, Spain
Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
UNIMED Medical Institute, Comprehensive Centre for Breast Diseases
ðŸ‡ðŸ‡°Hong Kong, Hong Kong