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A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting (NALA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Puma Biotechnology, Inc.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT01808573
First received: March 4, 2013
Last updated: April 24, 2015
Last verified: February 2015
  Purpose

This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.


Condition Intervention Phase
HER2+ Metastatic Breast Cancer (MBC)
Drug: neratinib
Drug: capecitabine
Drug: lapatinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

Resource links provided by NLM:


Further study details as provided by Puma Biotechnology, Inc.:

Primary Outcome Measures:
  • Independently assessed Progression Free Survival [ Time Frame: Estimated 10 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: Estimated 28 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator Assessed Progression Free Survival [ Time Frame: Estimated 10 months ] [ Designated as safety issue: No ]
  • Objective Response Rate (ORR) [ Time Frame: Estimated 10 months ] [ Designated as safety issue: No ]
  • Clinical Benefit Rate (CBR) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    CBR is defined as Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for ≥ 24 weeks.

  • Duration of Response (DOR) [ Time Frame: Estimated 10 months ] [ Designated as safety issue: No ]
  • Time to intervention for symptomatic metastatic central nervous system disease [ Time Frame: Estimated 10 months ] [ Designated as safety issue: No ]
  • Safety (Adverse Events [AEs] and Serious Adverse Events [SAEs]) [ Time Frame: From consent through 30 days following treatment completion (estimated 11 months) ] [ Designated as safety issue: Yes ]
  • Health Outcomes Assessments [ Time Frame: Estimated 10 months ] [ Designated as safety issue: No ]
    Validated Quality of Life Questionnaires; EORTC QLQ-C30, EORTC QLQ-BR23, and EQ-5D-5L


Other Outcome Measures:
  • Population pharmacokinetics [ Time Frame: 1 month following enrollment ] [ Designated as safety issue: No ]
    To assess the variability of neratinib concentration when administered in combination with capecitabine among individuals in the target population.


Estimated Enrollment: 600
Study Start Date: March 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: neratinib plus capecitabine Drug: neratinib
240 mg orally, once daily with food, continuously in 21 day cycles
Drug: capecitabine
1500 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal. Taken on days 1 to 14 of each 21 day cycle.
Other Name: Xeloda
Active Comparator: lapatinib plus capecitabine Drug: lapatinib
1250 mg orally, once daily, continuously in 21 day cycles
Other Names:
  • Tykerb
  • Tyverb
Drug: capecitabine
2000 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal. Taken on days 1 to 14 of each 21 day cycle.
Other Name: Xeloda

Detailed Description:

This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting. Patients will be randomized in a 1:1 ratio to one of the following treatment arms:

  • Arm A: neratinib (240 mg once daily) + capecitabine (1500 mg/m^2 daily, 750 mg/m^2 twice daily [BID])
  • Arm B: lapatinib (1250 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)

Patients will receive either neratinib plus capecitabine combination or lapatinib plus capecitabine combination until the occurrence of death, disease progression, unacceptable toxicity, or other specified withdrawal criterion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged ≥18 years at signing of informed consent.
  • Histologically confirmed MBC, current stage IV.
  • Documented HER2 overexpression or gene-amplified tumor (immunohistochemistry [IHC] 3+ or IHC 2+ with confirmatory fluorescence in situ hybridization [FISH]+).
  • Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.

Exclusion Criteria:

  • Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.

Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808573

Contacts
Contact: Puma Biotechnology Clinical Operations 424-248-6500 clinicaltrials@pumabiotechnology.com

  Hide Study Locations
Locations
United States, Arizona
Ironwood Cancer and Research Centers Recruiting
Chandler, Arizona, United States, 85224
Desert Oncology Associates Recruiting
Gilbert, Arizona, United States, 85297
Desert Oncology Associates Recruiting
Mesa, Arizona, United States, 85202
Ironwood Cancer and Research Centers Recruiting
Mesa, Arizona, United States, 85206
Ironwood Cancer and Research Centers Recruiting
Phoenix, Arizona, United States, 85028
United States, California
UCLA Hematology/Oncology Recruiting
Alhambra, California, United States, 91801
Innovative Clinical Research Institute Recruiting
Anaheim, California, United States, 92801
Comprehensive Blood and Cancer Center Recruiting
Bakersfield, California, United States, 93309
East Valley Hematology Oncology Med Group Recruiting
Burbank, California, United States
Compassionate Cancer Care Medical Group Recruiting
Corona, California, United States, 92879
Innovative Clinical Research Institute Recruiting
Downey, California, United States, 90241
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Compassionate Cancer Care Medical Group Inc Recruiting
Fountain Valley, California, United States, 92708
St. Jude Heritage Medical Group Recruiting
Fullerton, California, United States, 92834
St. Jude Heritage Medical Group Recruiting
Fullerton, California, United States, 92835
Innovative Clinical Research Institute Recruiting
Glendale, California, United States, 91204
Marin Cancer Care Inc Recruiting
Greenbrae, California, United States, 94904
Beaver Medical Group Recruiting
Highland, California, United States, 92346
UCLA Hematology/Oncology Recruiting
Irvine, California, United States, 92604
University of California San Diego Recruiting
La Jolla, California, United States, 92093-0698
University of California San Diego Medical Center Recruiting
La Jolla, California, United States, 92037
City of Hope National Medical Center Recruiting
Lancaster, California, United States, 93534
Innovative Clinical Research Institute Recruiting
Long Beach, California, United States, 90805
Oncology Institute of Hope and Innovation Recruiting
Lynwood, California, United States, 90262
Innovative Clinical Research Institute Recruiting
Montebello, California, United States, 90640
Breastlink Medical Group Recruiting
Orange, California, United States, 92868
UCLA Hematology/Oncology Recruiting
Porter Ranch, California, United States, 91326
Redlands Community Hospital Recruiting
Redlands, California, United States, 92373
Cancer Care Associates Medical Group, Inc Recruiting
Redondo Beach, California, United States, 90277
Compassionate Cancer Care Medical Group Recruiting
Riverside, California, United States, 92501
University of California San Diego Medical Center Recruiting
San Diego, California, United States, 92103
Global Cancer Research Institute (GCRI), Inc. Recruiting
San Jose, California, United States, 95124
Coastal Integrative Cancer Care Recruiting
San Luis Obispo, California, United States, 93401
Innovative Clinical Research Institute Recruiting
Santa Ana, California, United States, 92705
Breastlink Medical Group, Inc. Recruiting
Santa Ana, California, United States, 92705
Cancer Center of Santa Barbara Recruiting
Santa Barbara, California, United States, 93105
Sansum Clinica Recruiting
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology Recruiting
Santa Maria, California, United States, 93454
UCLA Hematology Oncology Santa Monica Recruiting
Santa Monica, California, United States, 90404
Cancer Center of Santa Barbara Recruiting
Solvang, California, United States, 93463
City of Hope Medical Group Recruiting
South Pasadena, California, United States, 91030
Innovative Clinical Research Institute Recruiting
Torrance, California, United States, 90503
UCLA Healthcare Santa Clarita Oncology Recruiting
Valencia, California, United States, 91355
UCLA Hematology/Oncology Recruiting
Westlake Village, California, United States, 91361
East Valley Hematology and Oncology Medical Group Recruiting
Whittier, California, United States, 90603
Innovative Clinical Research Institute Recruiting
Whittier, California, United States
United States, Colorado
Poudre Valley Hospital/Oncology Clinical Research Recruiting
Fort Collins, Colorado, United States, 80528
Cancer Center of the Rockies Recruiting
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital Recruiting
Fort Collins, Colorado, United States, 80524
Front Range Cancer Specialists Recruiting
Fort Collins, Colorado, United States, 80528
Greeley Medical Clinic Recruiting
Greeley, Colorado, United States, 80631
Medical Clinic at Centerra PC Recruiting
Loveland, Colorado, United States, 80538
United States, District of Columbia
Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
United States, Florida
Florida Cancer Research Institute Recruiting
Boca Raton, Florida, United States, 33428
Lynn Cancer Institute Recruiting
Boca Raton, Florida, United States, 33486
Memorial Cancer Institute Recruiting
Hollywood, Florida, United States, 33021
Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Orlando Health, Inc Recruiting
Orlando, Florida, United States, 32806
Memorial Cancer Institute Recruiting
Pembroke Pines, Florida, United States, 33028
Florida Cancer Research Institute Recruiting
Plantation, Florida, United States, 33324
United States, Georgia
Emory Clinic Recruiting
Atlanta, Georgia, United States, 30322
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Winship Cancer Institute, Emory Recruiting
Atlanta, Georgia, United States, 30322
United States, Hawaii
OnCare Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital Recruiting
Honolulu, Hawaii, United States, 96813
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
United States, Illinois
Northwestern Medical Faculty Foundation Recruiting
Chicago, Illinois, United States, 60611
Resurrection Medical Group Recruiting
Chicago, Illinois, United States, 60057
North Shore Oncology-Hematology Associates, Ltd. Recruiting
Crystal Lake, Illinois, United States, 60014
Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Primary Healthcare Associates, SC Recruiting
Harvey, Illinois, United States, 60426
North Shore Hematology Oncology Recruiting
Highland Park, Illinois, United States, 60035
North Shore Oncology-Hematology Associates, Ltd. Recruiting
Libertyville, Illinois, United States, 60048
Orchard Healthcare Research Inc Recruiting
Skokie, Illinois, United States, 60077
Primary Healthcare Associates, SC Recruiting
Tinley Park, Illinois, United States, 60477
Midwestern Regional Medical Center Recruiting
Zion, Illinois, United States, 60099
United States, Indiana
Hematology Oncology Associates Recruiting
Avon, Indiana, United States, 46123
Fayette Regional Health System Recruiting
Connersville, Indiana, United States, 47331
Hematology Oncology Associates Recruiting
Crawfordsville, Indiana, United States, 47933
Hematology Oncology of IN Recruiting
Danville, Indiana, United States, 46122
Primary Health Oncology Recruiting
Hobart, Indiana, United States, 46342
St Mary Medical Center Recruiting
Hobart, Indiana, United States, 46342
Investigative Clinical Research of Indiana, LLC Recruiting
Indianapolis, Indiana, United States, 46260
Hematology Oncology of IN Recruiting
Indianapolis, Indiana, United States, 46260
St. Joseph Cancer Center Recruiting
Kokomo, Indiana, United States, 46901
Hematology Oncology Associates Recruiting
Mooresville, Indiana, United States, 46158
Community Hospital Recruiting
Munster, Indiana, United States, 46321
United States, Kentucky
Baptist Health Cancer Care Recruiting
Corbin, Kentucky, United States, 40701
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Norton Cancer Institute - Audubon Recruiting
Louisville, Kentucky, United States, 40217
Norton Cancer Institute - Pavilion Recruiting
Louisville, Kentucky, United States, 40202
Norton Cancer Institute - Suburban Recruiting
Louisville, Kentucky, United States, 40207
Norton Healthcare Recruiting
Louisville, Kentucky, United States, 40241
West Kentucky Hematology and Oncology Group Recruiting
Paducah, Kentucky, United States, 42003
Central Baptist Hospital Recruiting
Richmond, Kentucky, United States, 40425
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21231
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
Sidney Kimmel Comprehensive Cancer Center at John Hopkins at Greenspring Station Recruiting
Lutherville, Maryland, United States, 21093
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Mississippi
Jackson Oncology Associates Recruiting
Jackson, Mississippi, United States, 39202
Jackson Oncology Associates Recruiting
Jackson, Mississippi, United States, 39216
Mississippi Baptist Medical Center Recruiting
Jackson, Mississippi, United States, 39202
United States, Missouri
Mercy Clinic - Cancer Hematology Recruiting
Branson, Missouri, United States, 65616
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Mercy Medical Research Institute Recruiting
Springfield, Missouri, United States, 65807
Barnes Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Siteman Cancer Center - South County Recruiting
St. Louis, Missouri, United States, 63129
Siteman Cancer Center - West County Recruiting
St. Louis, Missouri, United States, 63141
Siteman Cancer Center - St. Peters Recruiting
St. Peters, Missouri, United States, 63376
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Henderson, Nevada, United States, 89014
Comprehensive Cancer Centers of Nevada Recruiting
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada Recruiting
Henderson, Nevada, United States, 89074
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Kenneth Nahum, DO Recruiting
Howell, New Jersey, United States, 07731
Atlantic Hematology Oncology Associates LLC Recruiting
Manasquan, New Jersey, United States, 08736
Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08901
United States, New Mexico
New Mexico Cancer Care Alliance Recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
North Shore Hematology Oncology Association PC Recruiting
East Setauket, New York, United States, 11733
CR Wood Cancer Center Recruiting
Glens Falls, New York, United States, 12801
Clinical Research Alliance, Inc. Recruiting
Lake Success, New York, United States, 11042
Drs. Tamao, Marino & McNeis PC Lab Recruiting
Lake Success, New York, United States, 11042
NYU Langone Medical Center Recruiting
Lake Success, New York, United States, 11042
Clinical Research Alliance, Inc. Recruiting
New York, New York, United States, 10021
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Lynn H. Ratner MD PLLC Recruiting
New York, New York, United States, 10028
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Abraham Mittelman MD LLC Recruiting
Purchase, New York, United States, 10577
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
United States, North Carolina
Hope A Womens Cancer Center Recruiting
Asheville, North Carolina, United States, 28806
Mission Hospitals Recruiting
Asheville, North Carolina, United States, 28806
United States, Ohio
University Hospitals Case Medical Center Recruiting
Cleveland, Ohio, United States, 44106
University Hospitals Case Medical Center Recruiting
Orange Village, Ohio, United States, 44122
United States, Pennsylvania
UPMC Cancer Pavillion Recruiting
Greensburg, Pennsylvania, United States, 15601
St. Mary Medical Center Recruiting
Langhorne, Pennsylvania, United States, 19047
UPMC Cancer Pavillion Recruiting
Monroeville, Pennsylvania, United States, 15146
Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Magee Women's Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
UPMC Cancer Pavillion Recruiting
Pittsburgh, Pennsylvania, United States, 15215
UPMC Cancer Pavillion Recruiting
Pittsburgh, Pennsylvania, United States, 15237
UPMC Cancer Pavillion Recruiting
Uniontown, Pennsylvania, United States, 15401
UPMC Cancer Pavillion Recruiting
West Mifflin, Pennsylvania, United States, 15122
United States, Rhode Island
Memorial Hospital of RI Recruiting
Pawtucket, Rhode Island, United States, 02860
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
UT Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75235
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Houston Cancer Institute Recruiting
Houston, Texas, United States, 77055
Smith Clinic Recruiting
Houston, Texas, United States, 77054
University of Texas Health Center at Tyler Recruiting
Tyler, Texas, United States, 75708
United States, Utah
Utah Cancer Specialists Recruiting
American Fork, Utah, United States, 84003
Utah Cancer Specialists Recruiting
Bountiful, Utah, United States, 84010
Utah Cancer Specialists Recruiting
Layton, Utah, United States, 84041
Utah Cancer Specialists Recruiting
Murray, Utah, United States, 84157
Utah Cancer Specialists Recruiting
Provo, Utah, United States, 84604
Utah Cancer Specialists Recruiting
Salt Lake City, Utah, United States, 84102
Utah Cancer Specialists Recruiting
Salt Lake City, Utah, United States, 84106
Utah Cancer Specialists Recruiting
West Jordan, Utah, United States, 84088
United States, Vermont
Rutland Regional Medical Center Recruiting
Rutland, Vermont, United States, 05701
United States, West Virginia
W VA University Mary Babb Randolph Cancer Center Recruiting
Morgantown, West Virginia, United States, 26506-8110
United States, Wisconsin
Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311
Australia
Bankstown-Lidcombe Hospital Recruiting
Bankstown, Australia, NSW 2200
St. George Hospital, Clinical Research Unit, Division of Cancer Services Recruiting
Kogarah, Australia, NSW 2217
Box Hill Hospital, Oncology Department Recruiting
Melbourne, Australia, 3128
Maroondah Hospital, Maroondah Breast Clinic Recruiting
Melbourne, Australia, 3135
Nambour General Hospital Recruiting
Nambour, Australia, QLD 4560
Liverpool Hospital Recruiting
Sydney, Australia, NSW 2170
Tweed Hospital, Cancer Care Centre Recruiting
Tweed Heads, Australia
Sydney Adventist Hospital Recruiting
Wahroonga, Australia, 8833
Austria
University Hospital Innsbruck - Tyrolean Hospital, Department of Gynecology Recruiting
Innsbruck, Austria, 6020
Hospital of the Sisters of Mercy Linz, Department of Internal Medicine I, Medical Oncology, Hematology and Gastroenterology Recruiting
Linz, Austria, 4010
Salzburg Regional Hospital Recruiting
Salzburg, Austria, 5020
Vienna General Hospital, University Clinic of Internal Medicine I, Clinical Department of Oncology Recruiting
Vienna, Austria, 1090
Belgium
Our Dear Lady Hospital, Aalst Campus Recruiting
Aalst, Belgium
Saint Luc University Hospital Recruiting
Brussels, Belgium, 1200
Antwerp University Hospital Recruiting
Edegem, Belgium, B-2650
General Hospital Groeninge Recruiting
Kortrijk, Belgium
Leuven University Hospitals Recruiting
Leuven, Belgium, 3000
Clinic Saint-Joseph Recruiting
Liege, Belgium, 4000
St. Elizabeth Maternity Clinic Recruiting
Namur, Belgium, B-5000
AZ Damiaan General Hospital, Sint-Jozef Oncology Center Recruiting
Ostend, Belgium
St. Augustinus Hospital Recruiting
Wilrijk, Belgium, 2610
Canada, Ontario
Ottawa Hospital, Cancer Center Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Toronto East General Hospital Recruiting
Toronto, Ontario, Canada, M4C 3E7
Sunnybrook Health Sciences Center, Odette Cancer Center Recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
CHUM Notre Dame Hospital Recruiting
Montreal, Quebec, Canada, H2L 4M1
Czech Republic
Masaryk Memorial Cancer Institute Recruiting
Brno, Czech Republic
University Hospital Hradec Kralove, Clinic of Oncology and Radiotherapy Recruiting
Hradec Kralove, Czech Republic
Hospital Novy Jicin Recruiting
Novy Jicin, Czech Republic, 741 01
University Hospital Olomouc, Clinic of Oncology Recruiting
Olomouc, Czech Republic
Multiscan, Ltd., Center for Oncology Recruiting
Pardubice, Czech Republic, 530 01
Hospital Na Bulovce, Clinic of Oncology and Radiation Therapy Withdrawn
Prague, Czech Republic
University Hospital Motol, Comprehensive Oncology Center Recruiting
Prague, Czech Republic, 150 06
Finland
Docrates Cancer Center Recruiting
Helsinki, Finland, FI-00180
Helsinki University Central Hospital, Department of Oncology Recruiting
Helsinki, Finland, 00029
Tampere University Hospital, Department of Oncology Recruiting
Tampere, Finland, 33520
France
South Lyon Hospital Center, Department of Clinical Hematology and Medical Oncology Recruiting
Pierre-Benite, Lyon, France, 69495
Hospital Jean Minjoz, Department of Medical Oncology Recruiting
Besancon, France, 25030
Center Jean Perrin Recruiting
Clermont-Ferrand, France, 63011
Hospital Albert Michalon Recruiting
Grenoble, France, 38034
Saint Joseph Foundation Hospital Recruiting
Paris, France, 75014
Saint-Louis Hospital Recruiting
Paris, France, 75010
Clinic Sainte Anne, Center for Radiotherapy Recruiting
Strasbourg, France, 67000
Gustave Roussy Oncology Institute, Department of Medicine Recruiting
Villejuif, France, 94805
Germany
Hematology-Oncology Practice Recruiting
Augsburg, Germany, 86150
Practice for Oncology Bielefeld Recruiting
Bielefeld, Germany, 33604
University Hospital Erlangen, Gynecology Clinic Recruiting
Erlangen, Germany, 91054
University Hospital Schleswig-Holstein, Breast Cancer Center, Department of Gynecology and Obstetrics Recruiting
Luebeck, Germany, 23538
Otto von Guericke University of Magdeburg Recruiting
Magdeburg, Germany, D-39106
Gynecology Practice in Rodgau Withdrawn
Rodgau, Germany, 63110
Hanse Hospital Stralsund GmbH, Department of Gynecology and Obstetrics Recruiting
Stralsund, Germany, 18435
Hospital Mutterhaus der Borromaeerinnen gGmbH, Center for Breast Cancer Withdrawn
Trier, Germany, 54290
University Hospital Tuebingen, Women's Care Clinic Recruiting
Tuebingen, Germany, 72076
University Hospital Ulm, Department of Gynecology and Obstetrics Recruiting
Ulm, Germany, 89075
Hong Kong
Queen Mary Hospital, Department of Clinical Oncology Recruiting
Hong Kong, Hong Kong
Queen Mary Hospital, Department of Oncology Recruiting
Hong Kong, Hong Kong
Queen Mary Hospital, Department of Surgery Recruiting
Hong Kong, Hong Kong
Tuen Mun Hospital Recruiting
Hong Kong, Hong Kong
UNIMED Medical Institute Comprehensive Center for Breast Diseases Recruiting
Hong Kong, Hong Kong
Israel
Soroka University Medical Center, Department of Oncology Recruiting
Beer-Sheva, Israel
Rambam Medical Center Recruiting
Haifa, Israel
Edith Wolfson Medical Center Recruiting
Holon, Israel, 58100
Hadassah Medical Center Recruiting
Jerusalem, Israel, 91120
Meir Medical Center Recruiting
Kfar-Saba, Israel, 44281
Rabin Medical Center, Belinson Hospital Recruiting
Petah-Tikva, Israel, 49100
Kaplan Medical Center, Department of Oncology Recruiting
Rehovot, Israel
Chaim Sheba Medical Center, Institute of Oncology Recruiting
Tel Hashomer, Israel, 52621
Sourasky Medical Center, Department of Oncology Recruiting
Tel-Aviv, Israel, 64239
Italy
Hospital San Giuseppe Moscati Recruiting
Avellino, Italy, 83100
Institute of Oncology of the Mediterranean Recruiting
Catania, Italy, 95020
Foundation for Research and Treatment of Cancer T. Campanella Recruiting
Catanzaro, Italy, 88100
Hospital Cervesi di Cattolica, Department of Oncology Recruiting
Cattolica, Italy, 47841
Hospital Desio and Vimercate, Department of Medical Oncology Recruiting
Desio, Italy
Scientific Institute of Romagna of the Study and Treatment of Cancer Recruiting
Forli, Italy, 47014
European Institute of Oncology Recruiting
Milan, Italy, 20141
Hospital San Gerardo, Complex Structure of Medical Oncology Recruiting
Monza, Italy, 20900
Hospital Antonio Cardarelli Recruiting
Naples, Italy, 80131
National Cancer Institute - IRCCS "Fondazione G. Pascale" Recruiting
Naples, Italy, 80131
Hospital Bianchi Melacrino Morelli Recruiting
Reggio Calabria, Italy, 89100
Hospital Infermi Rimini, Unit of Oncology Recruiting
Rimini, Italy, 47900
University Hospital Campus Bio-Medico Recruiting
Rome, Italy, 00128
National Cancer Institute Regina Elena IRCCS, Department of Medical Oncology A Recruiting
Rome, Italy, 00144
Institute of Cancer Research and Treatment Recruiting
Torino, Italy, 10060
Hospital Desio and Vimercate, Department of Medical Oncology Recruiting
Vimercate, Italy, 20871
Hospital Belcolle Viterbo Recruiting
Viterbo, Italy, 01100
Korea, Republic of
National Cancer Center Recruiting
Gyeonggi-do, Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 152-703
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Singapore
Gleneagles Medical Center Recruiting
Singapore, Singapore, 258500
Gleneagles Medical Centre, Center for Medical Oncology Recruiting
Singapore, Singapore, 258500
Johns Hopkins Singapore International Medical Center Recruiting
Singapore, Singapore, 308433
National Cancer Centre Singapore, Department of Medical Oncology Recruiting
Singapore, Singapore, 169610
National University Hospital Recruiting
Singapore, Singapore, 119228
Parkway Cancer Centre Recruiting
Singapore, Singapore, 258500
Raffles Hospital Recruiting
Singapore, Singapore, 188770
Spain
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Consorcio Hospitalario Provincial de Castellon, Servicio de Oncologia Recruiting
Castellon de la Plana, Spain, 12002
Hospital Universitari de Girona Dr. Josep Trueta (ICO Girona), Servicio de Oncologia Recruiting
Girona, Spain, 17007
Complejo Hospitalario de Jaen Recruiting
Jaen, Spain, 23007
Complejo Hospitalario Universitario Insular-Materno Infantil Recruiting
Las Palmas de Gran Canaria, Spain, 35016
Hospital Universitari Arnau de Vilanova de Lleida Recruiting
Lerida, Spain, 25198
Centro Oncologico MD Anderson International España Recruiting
Madrid, Spain, 28033
Centro Integral Oncologico Clara Campal Recruiting
Madrid, Spain, 28050
University Hospital 12 de Octubre, Servicio de Oncologia - Edificio Maternidad, 2ª planta Recruiting
Madrid, Spain, 28041
University Hospital Clinic San Carlos, Servicio de Oncologia Medica Recruiting
Madrid, Spain, 28040
Hospital Universitario Puerta de Hierro Majadahonda, Servicio de Oncologia- Consultas Externas, 2ª planta Recruiting
Majadahonda, Spain, 28222
Hospital Universitario Virgen de la Arrixaca, Servicio de Oncologia Recruiting
Murcia, Spain, 30120
Hospital Son Llatzer, Servicio de Oncologia Recruiting
Palma de Mallorca, Spain, 07198
Hospital Universitario Son Espases, Servicio de Oncologia Recruiting
Palma de Mallorca, Spain, 07010
University Hospital Virgen del Rocio, Servicio de Oncologia Recruiting
Sevilla, Spain, 41013
Hospital Universitario Virgen Macarena, Servicio de Oncologia. Consultas Externas, planta sotano Recruiting
Sevilla, Spain, 41009
Hospital Universitario Sant Joan de Reus, Servicio de Oncologia - Nivel 1 - Pasillo Q Recruiting
Tarragona, Spain, 43204
Hospital Clinico Universitario de Valencia, Servicio de Oncologia Recruiting
Valencia, Spain, 46010
Hospital Clinico Universitario Lozano Blesa, Servicio de Oncologia Recruiting
Zaragoza, Spain, 50009
Sweden
Malarsjukhuset, Department of Oncology Recruiting
Eskilstuna, Sweden
Orebro University Hospital, Department of Oncology Recruiting
Orebro, Sweden
Uppsala University Hospital, Department of Oncology Recruiting
Uppsala, Sweden
Switzerland
Hospital Engeried Recruiting
Bern, Switzerland, CH-3012
University Hospital of Geneva Recruiting
Geneva, Switzerland, CH-1211
Canton Hospital Winterthur Recruiting
Winterthur, Switzerland
Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Province of China, Taiwan, 83301
China Medical University Hospital Recruiting
Taichung, Province of China, Taiwan, 40447
Taichung Veterans General Hospital, Breast Center Recruiting
Taichung, Province of China, Taiwan, 40705
Chi Mei Medical Center - LiouYing Branch Recruiting
Tainan, Province of China, Taiwan
Chi Mei Medical Center - YK Branch Recruiting
Tainan, Province of China, Taiwan, 71004
National Cheng Kung University Hospital Recruiting
Tainan, Province of China, Taiwan, 70403
Tri-Service General Hospital Recruiting
Taipei, Province of China, Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Province of China, Taiwan, 10449
United Kingdom
Velindre Cancer Centre Recruiting
Cardiff, United Kingdom, CF14 2TL
Calderdale Royal Hospital, Macmillan Unit Recruiting
Halifax, United Kingdom, HX3 0PW
Huddersfield Royal Infirmary Recruiting
Huddersfield, United Kingdom, HD3 3EA
Nottingham City Hospital Campus, Department of Oncology Recruiting
Nottingham, United Kingdom, NG5 1PB
Churchill Hospital, Hematology and Oncology Center Recruiting
Oxford, United Kingdom, OX3 7LJ
Poole Hospital Recruiting
Poole, United Kingdom, BH15 2JB
Great Western Hospital Recruiting
Swindon, United Kingdom, SN3 6BB
Sponsors and Collaborators
Puma Biotechnology, Inc.
  More Information

No publications provided

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT01808573     History of Changes
Other Study ID Numbers: PUMA-NER-1301, 2012-004492-38, UTN U1111-1161-1603
Study First Received: March 4, 2013
Last Updated: April 24, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Capecitabine
Fluorouracil
Lapatinib
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on July 30, 2015