Trial record 1 of 1 for:    PUMA-NER-1301
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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 April 2014 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 15, 2014
Last verified: April 2014
  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
Innovative Clinical Research Institute/American Institute of Research Recruiting
Anaheim, California, United States, 92801
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/American Institute of Research Recruiting
Downey, California, United States, 90241
Compassionate Cancer Care Medical Center Recruiting
Fountain Valley, California, United States, 92708
Innovative Clinical Research Institute/American Institute of Research Recruiting
Glendale, California, United States, 91204
California Cancer Care Recruiting
Greenbrae, California, United States, 94904
Beaver Medical Group Recruiting
Highland, California, United States, 92346
Beaver Medical Group Recruiting
Highland, California, United States
UCLA Hematology Oncology Irvine Recruiting
Irvine, California, United States, 92604
Breastlink Medical Group, Inc. Recruiting
Long Beach, California, United States, 90806
Innovative Clinical Research Institute/American Institute of Research Recruiting
Long Beach, California, United States, 90805
Oncology Institute of Hope and Innovation Recruiting
Lynwood, California, United States, 90262
Marin General Hospital - Marin Cancer Institute Recruiting
Marin, California, United States
Innovative Clinical Research Institute/American Institute of Research Recruiting
Montebello, California, United States, 90640
Breastlink Medical Group, Inc. Recruiting
Orange, California, United States, 92868
UCLA Hematology Oncology Porter Ranch Recruiting
Porter Ranch, California, United States, 91326
Breastlink Medical Group, Inc. Recruiting
Rancho Mirage, California, United States, 92270
Compassionate Cancer Care Medical Group Recruiting
Riverside, California, United States, 92501
Global Cancer Research Institute Recruiting
San Jose, California, United States, 95124
Innovative Clinical Research Institute/American Institute of Research Recruiting
Santa Ana, California, United States, 92705
UCLA Hematology Oncology Santa Monica Recruiting
Santa Monica, California, United States, 90404
Innovative Clinical Research Institute/American Institute of Research Recruiting
Torrance, California, United States, 90503
Innovative Clinical Research Institute Recruiting
Whittier, California, United States
United States, Colorado
Front Range Cancer Specialists 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
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 Hospital Recruiting
Washington, District of Columbia, United States, 20016
United States, Florida
Florida Cancer Research Institute Recruiting
Boca Raton, Florida, United States, 33428
Florida Cancer Research Institute Recruiting
Plantation, Florida, United States, 33324
United States, Georgia
Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Winship Cancer Institute Midtown Campus Recruiting
Atlanta, Georgia, United States, 30308
United States, Illinois
Resurrection Medical Group Recruiting
Chicago, Illinois, United States, 60057
North Shore Oncology-Hematology Associates, Ltd. Recruiting
Crystal Lake, Illinois, United States, 60014
Monroe Medical Associates Recruiting
Harvey, Illinois, United States, 60426
Ingalls Memorial Hospital 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
North Shore Hematology Oncology Recruiting
Skokie, Illinois, United States, 60077
Orchard Research Healthcare Recruiting
Skokie, Illinois, United States
Monroe Medical Associates Recruiting
Tinley Park, Illinois, United States, 60477
Cancer Treatment Centers of America Recruiting
Zion, Illinois, United States, 60099
United States, Indiana
Hematology Oncology Associates Recruiting
Avon, Indiana, United States, 46123
Fayette Regional Health Systems Recruiting
Cornnersville, Indiana, United States, 47331
Hematology Oncology Associates Recruiting
Crawfordsville, Indiana, United States, 47933
Hematology Oncology Associates Recruiting
Danville, Indiana, United States, 46122
Hematology Oncology Associates Recruiting
Indianapolis, Indiana, United States, 46260
Investigative Clinical Research of Indiana, LLC 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
Monroe Medical Associates Recruiting
Munster, Indiana, United States, 46321
Community Hospital Recruiting
Munster, Indiana, United States, 46321
United States, Kentucky
Baptist Health Cancer Care Recruiting
Corbin, Kentucky, United States, 40701
Central Baptist Hospital Recruiting
Lexington, Kentucky, United States, 40503
Central Baptist Medical Plaza - Brannon Crossing Recruiting
Nicholasville, Kentucky, United States
Western Kentucky Hematology and Oncology Group Recruiting
Paducah, Kentucky, United States, 42003
Central Baptist Medical Plaza - Richmond Recruiting
Richmond, Kentucky, United States
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21231
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21231
Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
United States, Mississippi
Mississippi Baptist Medical Center Recruiting
Jackson, Mississippi, United States, 39202
Jackson Oncology Associates, PLLC Recruiting
Jackson, Mississippi, United States, 39216
Jackson Oncology Associates, PLLC Recruiting
Jackson, Mississippi, United States, 39202
United States, Missouri
Mercy Branson Cancer and Hematology Recruiting
Branson, Missouri, United States, 65616
Mercy Medical Research Institute Recruiting
Springfield, Missouri, United States, 65804
United States, Nebraska
Nebraska Methodist Hospital Recruiting
Omaha, Nebraska, United States, 68114
United States, New Jersey
Kenneth Nahum, DO Recruiting
Howell, New Jersey, United States, 07731
Atlantic Hematology Oncology Associates Recruiting
Manasquan, New Jersey, United States, 08736
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
United States, New Mexico
New Mexico Cancer Care Alliance Recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
North Shore Hematology Oncology Associates Recruiting
East Setauket, New York, United States, 11733
Glens Falls Hospital, 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
Clinical Research Alliance, Inc. Recruiting
New York, New York, United States, 10021
Lynn H. Ratner MD PLLC Recruiting
New York, New York, United States, 10028
NYU Langone Medical Center Recruiting
New York, New York, United States, 10016
Abraham Mittelman MD LLC Recruiting
Purchase, New York, United States, 10577
Stony Brook University Recruiting
Stony Brook, New York, United States, 11794
United States, Pennsylvania
St. Mary Medical Center Recruiting
Langhorne, Pennsylvania, United States, 19047
United States, Rhode Island
Memorial Hospital of Rhode Island Recruiting
Pawtucket, Rhode Island, United States, 02860
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Houston Cancer Institute Recruiting
Houston, Texas, United States, 77055
The University of Texas Health Center at Tyler Recruiting
Tyler, Texas, United States, 75708
United States, Utah
Utah Cancer Specialists Cancer Center Bountiful Recruiting
Bountiful, Utah, United States, 84010
Utah Cancer Specialists Cancer Center Layton Recruiting
Layton, Utah, United States, 84041
Utah Cancer Specialists Cancer Center Cottonwood Recruiting
Murray, Utah, United States, 84157
Utah Cancer Specialists Cancer Center Provo Recruiting
Provo, Utah, United States, 84604
Utah Cancer Specialists Cancer Center Recruiting
Salt Lake City, Utah, United States, 84106
Utah Cancer Specialists Cancer Center Salt Lake Recruiting
Salt Lake City, Utah, United States, 84102
Utah Cancer Specialists Cancer Center Jordan Valley Recruiting
West Jordan, Utah, United States, 84088
United States, Vermont
Rutland Regional Medical Center Recruiting
Rutland, Vermont, United States, 05701
United States, West Virginia
Mary Babb Randolph Cancer Center Recruiting
Morgantown, West Virginia, United States, 26506
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
Nambour General Hospital Recruiting
Nambour, Australia, QLD 4560
Liverpool Hospital Recruiting
Sydney, Australia, NSW 2170
Austria
University Hospital Innsbruck, Department of Gynecology Recruiting
Innsbruck, Austria, 6020
Hospital of the Sisters of Mercy Linz 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
University Hospital Saint Luc Recruiting
Brussels, Belgium
University Hospital Antwerp Recruiting
Edegem, Belgium, B-2650
General Hospital Groeninge Recruiting
Kortrijk, Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, B-3000
Saint-Joseph Clinic 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
Sunnybrook Health Sciences Center, Odette Cancer Center Recruiting
Toronto, Ontario, Canada, M4N 3M5
Toronto East General Hospital Recruiting
Toronto, Ontario, Canada, M4C 3E7
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 Recruiting
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
Center Jean Perrin Recruiting
Clermont-Ferrand, France, 63011
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
Hanse Hospital Stralsund GmbH, Department of Gynecology and Obstetrics Recruiting
Stralsund, Germany, 18435
Borromaerinnen Hospital, Center for Breast Cancer Recruiting
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 Surgery Recruiting
Hong Kong, Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Queen Mary Hospital, Department of Oncology Recruiting
Hong Kong, Hong Kong
Tuen Mun Hospital Recruiting
Tuen Mun, Hong Kong
UNIMED Medical Institute Comprehensive Center for Breast Diseases Recruiting
Wan Chai, 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 Hospital Recruiting
Kfar-Saba, Israel
Rabin Medical Center, Belinson Hospital Recruiting
Petah-Tikva, Israel, 49100
Kaplan Medical Center, Department of Oncology Recruiting
Rehovot, Israel
Sheba Medical Center, Tel Hashomer, Institute of Oncology Recruiting
Tel Hashomer, Israel, 52621
Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 64239
Korea, Republic of
National Cancer Center Recruiting
Gyeonggi-do, Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Severance Hospital Recruiting
Seoul, Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 152-703
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Singapore
National University Cancer Institute Recruiting
Singapore, Singapore, 119228
Raffles Hospital Recruiting
Singapore, Singapore, 188770
Gleneagles Medical Center Recruiting
Singapore, Singapore, 258500
Parkway Cancer Centre Recruiting
Singapore, Singapore, 258500
Spain
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Consorcio Hospitalario Provincial de Castellon Recruiting
Castellon de la Plana, Spain, 12002
Hospital Universitari de Girona 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 Integral Oncologico Clara Campal Recruiting
Madrid, Spain, 28050
Hospital Universitario Puerta de Hierro Recruiting
Madrid, Spain, 28222
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Centro Oncologico MD Anderson International España Recruiting
Madrid, Spain, 28033
Centro Oncologico MD Anderson International España, Servicio de Oncologia Recruiting
Madrid, Spain, 28033
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Hospital Universitario Virgen de la Arrixaca, Servicio de Oncologia Recruiting
Murcia, Spain, 30120
Hospital Universitario Son Espases Recruiting
Palma de Mallorca, Spain, 07010
Hospital Son Llatzer Recruiting
Palma de Mallorca, Spain, 07198
Virgen Macarena University Hospital Recruiting
Sevilla, Spain, 41009
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Hospital Universitario Sant Joan de Reus, Servicio de Oncologia - Nivel 1 - Pasillo Q Recruiting
Tarragona, Spain, 43204
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Hospital Clinico Universitario Lozano Blesa Recruiting
Zaragoza, Spain, 50009
Switzerland
Hospital Engeried Recruiting
Bern, Switzerland, CH-3012
Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Province of China, Taiwan, 83301
Taichung Veterans General Hospital, Breast Center Recruiting
Taichung, Province of China, Taiwan, 40705
Chi Mei Medical Center Recruiting
Tainan, Province of China, Taiwan, 71004
Chang Gung Memorial Hospital Linkou Branch Recruiting
Tainan, Province of China, Taiwan, 70403
National Cheng Kung University Hospital Recruiting
Tainan, Province of China, Taiwan, 70403
Mackay Memorial Hospital Recruiting
Taipei, Province of China, Taiwan, 10449
United Kingdom
Velindre Cancer Centre Recruiting
Cardiff, United Kingdom, CF14 2TL
Calderdale Royal Hospital 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
Study First Received: March 4, 2013
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014