Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer (ExteNET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00878709
Recruitment Status : Active, not recruiting
First Posted : April 9, 2009
Results First Posted : October 9, 2017
Last Update Posted : August 7, 2018
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Brief Summary:
The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: neratinib Other: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer
Actual Study Start Date : July 9, 2009
Actual Primary Completion Date : August 21, 2014
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Neratinib
240 mg orally daily for one year
Drug: neratinib
Other Names:
  • HKI-272
  • Nerlynx

Placebo Comparator: Placebo
orally daily for one year
Other: placebo

Primary Outcome Measures :
  1. Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm [ Time Frame: From randomization until time of event up to 2 years ]
    Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.

  2. Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms [ Time Frame: From randomization until time of event up to 2 years ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: From time of randomization to death ]
    Overall survival is defined as the time from randomization to death from any cause

  2. Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm [ Time Frame: From randomization until time of event up to 2 years ]
    Disease-free survival including DCIS time is defined as the time from date of randomization until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any.

  3. Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms [ Time Frame: From randomization until time of event up to 2 years ]
  4. Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm [ Time Frame: From randomization until time of event up to 2 years ]
    Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause.

  5. Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms [ Time Frame: From randomization until time of event up to 2 years ]
  6. Time to Distant Recurrence (TTDR) in Neratinib Arm Compared to Placebo Arm [ Time Frame: From randomization until time of event up to 2 years ]
    Time to distant recurrence is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer.

  7. Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms [ Time Frame: From randomization until time of event up to 2 years ]
  8. Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm [ Time Frame: From randomization until time of event up to 2 years ]
    CNS recurrence is defined as the time from randomization to CNS as the first distant recurrence. Competing events include distant recurrence at other sites as the first distant recurrence and death from any cause prior to distant recurrence.

  9. Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2 [ Time Frame: From randomization until time of event up to 2 years ]
    Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
  • Been treated for early breast cancer with standard of care duration of trastuzumab.
  • Could have been treated neoadjuvantly but have not reached pathologic complete response.

Exclusion Criteria:

  • Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
  • History of heart disease.
  • QTc interval >0.45 seconds
  • History of gastrointestinal disease with diarrhea as the major symptom.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00878709

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United States, Alabama
Anniston Oncology
Anniston, Alabama, United States, 36207
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, United States, 35205
United States, Arizona
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, United States, 85016
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, United States, 86336
Arizona Oncology Associates
Tucson, Arizona, United States, 85704-7891
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States, 72401
United States, California
Cedars-Sinai Medical Group
Beverly Hills, California, United States, 90211
Ronald Yanagihara, M.D.
Gilroy, California, United States, 95020
Glendale Adventist Medical Center Cancer Services
Glendale, California, United States, 91206
California Cancer Care
Greenbrae, California, United States, 94904
Beaver Medical Group, L.P.
Highland, California, United States, 92346
Breastlink Medical Group
Long Beach, California, United States, 90806
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Facey Medical Group
Mission Hills, California, United States, 91345
Gynecologic Oncology Associates
Newport Beach, California, United States, 92663
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States, 93030
Desert Hematology Oncology Medical Group, Inc
Rancho Mirage, California, United States, 92270
Helen Diller Family University of California San Francisco Comprehensive Cancer Center
San Francisco, California, United States, 94115
San Francisco Oncology Associates
San Francisco, California, United States, 94115
Redwood Regional Medical Group
Santa Rosa, California, United States, 95403
The Cancer Prevention and Treatment Center
Soquel, California, United States, 95073
United States, Connecticut
Cancer Center of Central Connecticut
Southington, Connecticut, United States, 06489
Hematology Oncology, PC
Stamford, Connecticut, United States, 06902
Connecticut Oncology and Hematology
Torrington, Connecticut, United States, 06790
United States, District of Columbia
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Innovative Medical Research of South Florida, Inc.
Aventura, Florida, United States, 33180
University Cancer Institute, LLC
Boynton Beach, Florida, United States, 33426
North Broward Medical Center
Deerfield Beach, Florida, United States, 33064
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
Florida Cancer Specialists and Research Institute
Gainesville, Florida, United States, 32605
Lakeland Regional Cancer Center
Lakeland, Florida, United States, 33805
Hematology Oncology Associates
Loxahatchee Groves, Florida, United States, 33470
Florida Cancer Affiliates-Ocala
Ocala, Florida, United States, 34471
Mid-Florida Hematology & Oncology Centers, PA
Orange City, Florida, United States, 32763-8316
Cancer Centers of Florida
Orlando, Florida, United States, 32806
M.D. Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
Florida Cancer Research Institute
Plantation, Florida, United States, 33324
Hematology Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, United States, 34592
Florida Cancer Specialists, P.L.
Saint Petersburg, Florida, United States, 33705
Oncology and Hematology of West Broward
Tamarac, Florida, United States, 33321
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States, 33542
United States, Georgia
Phoebe Cancer Center
Albany, Georgia, United States, 31701
Piedmont Cancer Institute
Atlanta, Georgia, United States, 30318
Augusta Oncology Associates (ACORN), P.C.
Augusta, Georgia, United States, 30909
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, United States, 30905-5650
United States, Hawaii
Straub Clinic & Hospital
Honolulu, Hawaii, United States, 96813-3083
United States, Idaho
Portneuf Medical Center
Pocatello, Idaho, United States, 83201
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Cancer Care Specialists of Illinois, Decatur Memorial Hospital Clinical Research
Decatur, Illinois, United States, 62526
Midwest Center for Hematology/Oncology
Joliet, Illinois, United States, 60432
Medical Arts Associates, Ltd
Moline, Illinois, United States, 61265
Advocate Medical Group
Niles, Illinois, United States, 60714
Cancer Care & Hematology Specialists of Chicagoland
Niles, Illinois, United States, 60714
Quincy Medical Group, Cancer Center at Blessing Hospital
Quincy, Illinois, United States, 62301
North Shore Cancer Research Associates
Skokie, Illinois, United States, 60076
Orchard Healthcare Research, Inc.
Skokie, Illinois, United States, 60076
Orchard Research, LLC
Skokie, Illinois, United States, 60076
Simmons Cancer Institute
Springfield, Illinois, United States, 62702
Springfield Clinic, LLP
Springfield, Illinois, United States, 62703
Midwestern Regional Medical Center
Zion, Illinois, United States, 60099
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Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
Hematology Oncology of Indiana
Indianapolis, Indiana, United States, 46260-2082
Community Hospital
Munster, Indiana, United States, 46321
United States, Kentucky
Ashland-Bellefonte Cancer Center
Ashland, Kentucky, United States, 41101-7016
Purchase Cancer Group
Paducah, Kentucky, United States, 42001
United States, Louisiana
Hematology-Oncology Clinic
Baton Rouge, Louisiana, United States, 70809
Crescent City Research Consortium, LLC
Marrero, Louisiana, United States, 70072
United States, Maine
Central Maine Healthcare Corp
Lewiston, Maine, United States, 04240
Mercy Hospital Oncology/Hematology Center
Portland, Maine, United States, 04102
Mercy Hospital
Portland, Maine, United States, 04102
York Hospital Oncology Treatment Center
York, Maine, United States, 03909
United States, Maryland
Medical Oncology & Hematology Mercy Medical Center
Baltimore, Maryland, United States, 21202
Harry and Jeanette Weinberg Cancer Center
Baltimore, Maryland, United States, 21237
Alliance Hematology Oncology, PA Carroll County Cancer Center
Westminster, Maryland, United States, 21157
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-2013
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States, 49503
Medical Specialty Associates
Grand Rapids, Michigan, United States, 49503
Northern Michigan Hematology/Oncology
Petoskey, Michigan, United States, 49770
United States, Minnesota
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, United States, 55404
Park Nicollet Institute
Saint Louis Park, Minnesota, United States, 55426
United States, Mississippi
North Mississippi Hematology and Oncology Associates, Ltd.
Tupelo, Mississippi, United States, 38801
United States, Missouri
Capitol Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States, 65109
St. Joseph's Oncology
Saint Joseph, Missouri, United States, 64507
Washington University School of Medicine Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
Mercy Medical Research Institute
Springfield, Missouri, United States, 65807
United States, Montana
Montana Cancer Specialists
Missoula, Montana, United States, 59802
United States, Nebraska
Southeast Nebraska Hematology & Oncology Consultants, PC
Lincoln, Nebraska, United States, 68510
Great Plains Regional Medical Center
North Platte, Nebraska, United States, 69101
United States, New Jersey
The Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States, 08003
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, United States, 07207
Saint Barnabas Health Care System
Livingston, New Jersey, United States, 07039
Summit Medical Group
Morristown, New Jersey, United States, 07960
Oncology and Hematology Specialist
Mountain Lakes, New Jersey, United States, 07046
Jersey Shore University Medical Center
Neptune, New Jersey, United States, 07754
The Valley Hospital, Luckow Pavilion
Paramus, New Jersey, United States, 07652
Cooper University Hospital
Voorhees, New Jersey, United States, 08043-4689
United States, New York
Eastchester Center for Cancer Care
Bronx, New York, United States, 10469
ProHealth Care Associates
Lake Success, New York, United States, 11042
NYU Clinical Cancer Center
New York, New York, United States, 10016
Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
United States, North Carolina
NorthEast Oncology Associates Carolinas Medical Center NorthEast
Concord, North Carolina, United States, 28025
Duke University Medical Center Medical Oncology
Durham, North Carolina, United States, 27710
Raleigh Hematology Oncology Associates Cancer Centers of North Carolina
Raleigh, North Carolina, United States, 27607
Hanover Medical Specialists, PA
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
United States, Ohio
The Christ Hospital Cancer Center
Cincinnati, Ohio, United States, 45219
University of Cincinnati
Cincinnati, Ohio, United States, 45267
University Hospitals, Cleveland Medical Center
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Signal Point Hematology/Oncology, Inc.
Middletown, Ohio, United States, 45042
United States, Oklahoma
Mercy Physicians of Oklahoma
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Bend Memorial Clinic
Bend, Oregon, United States, 97701
Samaritan Hematology & Oncology Consultants
Corvallis, Oregon, United States, 97330
Northwest Cancer Specialist, P.C.
Portland, Oregon, United States, 97213
Providence Cancer Center Oncology and Hematology Care - Westside
Portland, Oregon, United States, 97213
Kaiser Permanente Northwest Region Oncology Hematology
Portland, Oregon, United States, 97227-1110
Oregon Health and Science University
Portland, Oregon, United States, 97239
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Oncology-Hematology of Lehigh Valley, PC
Bethlehem, Pennsylvania, United States, 18015
Gettysburg Cancer Center
Gettysburg, Pennsylvania, United States, 17325
Pinnacle Health Cancer Center Community Campus
Harrisburg, Pennsylvania, United States, 17109
Sweeney-Melenyser Pavillion
Monongahela, Pennsylvania, United States, 15063
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Guthrie Clinic, Limited
Sayre, Pennsylvania, United States, 18840
Abington Hematology Oncology Associates, Inc
Willow Grove, Pennsylvania, United States, 19090-1137
United States, Rhode Island
Pawtuket Memorial Hospital
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States, 29414
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Francisco Gonzalez MD PA
Columbia, South Carolina, United States, 29203
McLeod Oncology and Hematology Associates
Florence, South Carolina, United States, 29506
South Carolina Cancer Specialists
Hilton Head Island, South Carolina, United States, 29926
Santee Hematology Oncology
Sumter, South Carolina, United States, 29150
United States, South Dakota
Avera Medical Oncology and Hematology - Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
University Hematology/Oncology Associates PLLC
Chattanooga, Tennessee, United States, 37403
Cookeville Regional Cancer Center
Cookeville, Tennessee, United States, 38501
The Jones Clinic, PC
Germantown, Tennessee, United States, 38138
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
Nashville Breast Center
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Oncology, P.A.
Austin, Texas, United States, 78731
Texas Oncology, P.A.
Bedford, Texas, United States, 76022
Coastal Bend Cancer Center
Corpus Christi, Texas, United States, 78404
South Texas Institute of Cancer
Corpus Christi, Texas, United States, 78405
Cancer Specialists of South Texas, P.A.
Corpus Christi, Texas, United States, 78412
Center for Oncology Research
Dallas, Texas, United States, 75230
Texas Oncology, P.A.
Dallas, Texas, United States, 75231-4400
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
University of Texas Southwestern Medical Center Simmons Cancer Center
Dallas, Texas, United States, 75390
Texas Oncology, P.A.
Denton, Texas, United States, 76210
El Paso Cancer Treatment Center - West
El Paso, Texas, United States, 79902
Center for Integrative Cancer Medicine, PA
El Paso, Texas, United States, 79912
Texas Oncology
Fort Worth, Texas, United States, 76104
Texas Oncology, P.A.
Garland, Texas, United States, 75042
Texas Oncology - Memorial City
Houston, Texas, United States, 77024
The Methodist Hospital Breast Center
Houston, Texas, United States, 77030
Medicus Alliance Clinical Research Org., Inc.
Houston, Texas, United States, 77055
Jabboury Foundation for Cancer Research, Inc.
Houston, Texas, United States, 77082
Texas Oncology, P.A.
Paris, Texas, United States, 75460
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78217
South Texas Oncology & Hematology
San Antonio, Texas, United States, 78229
Texas Oncology P.A.
Sugar Land, Texas, United States, 77479
East Texas Medical Center Cancer Institute
Tyler, Texas, United States, 75701
Texas Oncology
Tyler, Texas, United States, 75702
Texas Oncology Cancer Care and Research Center
Waco, Texas, United States, 76712
United States, Utah
North Utah Associates
Ogden, Utah, United States, 84403
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
United States, Vermont
Southwestern Vermont Regional Cancer Center
Bennington, Vermont, United States, 05201
Rutland Regional Medical Center
Rutland, Vermont, United States, 05701
United States, Virginia
Medical Oncology & Hematology Associates of Northern Virginia, LTD
Fairfax, Virginia, United States, 22031
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
Cascade Cancer Center
Kirkland, Washington, United States, 98034
Cancer Care Northwest-North
Spokane, Washington, United States, 99202
Northwest Medical Specialties PLLC
Tacoma, Washington, United States, 98405
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, West Virginia
West Virginia University Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506
Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Wheaton Franciscan Cancer Care-All Saints
Racine, Wisconsin, United States, 53405
Australia, New South Wales
Sydney West Cancer Trials Centre
Sydney, New South Wales, Australia, 2145
Australia, Queensland
Iron Cancer Care South Brisbane
South Brisbane, Queensland, Australia, 4101
Australia, South Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia, 5011
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia, 5037
North Adelaide Oncology Calvary Hospital North Adelaide
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
The Western Hospital
Melbourne, Victoria, Australia, 3050
Australia, Western Australia
Hollywood Private Hospital
Nedlands, Western Australia, Australia, 6009
Affinity Research Limited
Nassau, Bahamas, 13932
OLVZ Medische Oncologie
Aalst, Belgium, 9300
Az. St. Jan
Brugge, Belgium, 8000
Cliniques Universitaires de Bruxelles
Bruxelles, Belgium, 1070
VZW Jesseziekenhuis - Campus Virga Jesse
Hasselt, Belgium, 3500
Jan Yperman Ziekenhuis
Ieper, Belgium, 8900
AZ Groeninge ampus Maria's Voorzienigheid (MV) Oncologisch Centrum
Kortrijk, Belgium, 8500
Centre Hospitalier Regional de La Citadelle
Liege, Belgium, 4000
C.H.U. Ambroise Paré
Mons, Belgium, 7000
AZ Damiaan - Site Sint-Jozef
Oostende, Belgium, 8400
AZ Zusters van Barmhartigheid
Ronse, Belgium, 9600
AZ Nikolaas
Sint Niklaas, Belgium, 9100
Turnhout, Belgium, 2300
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, RS, Brazil, 90610-000
District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD, Ist
Plovdiv, Bulgaria, 4004
District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD, Second
Plovdiv, Bulgaria, 4004
District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD
Sofia, Bulgaria, 1233
Specialised Hospital of ActiveTreatment in Oncology
Sofia, Bulgaria, 1756
Interdistrict Dispensary for Oncology Diseases
Varna, Bulgaria, 9000
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Jack Ady Cancer Centre
Lethbridge, Alberta, Canada, T1J 1W5
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Stronach Regional Cancer Centre at Southlake
Newmarket, Ontario, Canada, L3Y 2P9
R.S. McLaughlin Durham Regional Cancer Centre
Oshawa, Ontario, Canada, L1G 2B9
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Humber River Regional Hospital - Church Street Site
Weston, Ontario, Canada, M9N 1N8
Canada, Quebec
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
C.H.U.M. - Hopital Notre-Dame, Departement d'Oncologie
Montreal, Quebec, Canada, H2L 4M1
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Centre Hospitalier Affilie Universitaire de Quebec Hopital du St-Sacrement
Quebec, Canada, G1S 4L8
CSSS Alphonse-Desjardins
Quebec, Canada, G6V 3Z1
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
Beijing, China, 100032
The Hospital Affiliated Academy Military Medical Science, Chinese People's
Beijing, China, 100071
Chinese People's Liberation Army General Hospital
Beijing, China, 100853
Sun Yat-Sen University Cancer Center
Guangzhou, China, 510060
Southern Medical University Nanfang Hospital
Guangzhou, China, 510515
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Tianjin Cancer Hospital
Tianjin, China, 300060
Oncomedica S.A. IMAT
Monteria, Cordoba, Colombia
Oncologos del Occidente
Pereira, Risaralda, Colombia
Administradora Country S.A-Clinica del Country
Bogota, Colombia
University Hospital Centre Osijek, Department of Radiotherapy and Oncology
Osijek, Croatia, 31000
General Hospital Varazdin
Varazdin, Croatia, 42000
University Hospital Center Zagreb
Zagreb, Croatia, 10000
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Masarykuv Onkologicky ustav
Brno, Czechia, 65653
Nemocnice Jihlava
Jihlava, Czechia, 58633
Institut Onkologie a Reahabilitace na Plesi
Nova Ves pod Plesi, Czechia, 26204
Multiscan s. r. o.
Pardubice, Czechia, 53003
Fakultni Nemocnice v Motole
Praha, Czechia, 15006
Aalborg Sygehus
Aalborg, Denmark, 9000
Aarhus University Hospital
Aarhus C, Denmark, 8000
Copenhagen, Denmark, 2100
Sydvestjysk Sygehus
Esbjerg, Denmark, 6700
Herlev Hospital
Herlev, Denmark, 2730
Hillerod Hospital
Hillerod, Denmark, 3400
Næstved Sygehus
Naestved, Denmark, 4700
Odense Universitetshospital
Odense C, Denmark, 5000
Roskilde University Hospital
Roskilde, Denmark, 4000
Sygehus Sonderjylland
Sonderborg, Denmark, 6400
Vejle Sygehus
Vejle, Denmark, 7100
Regionshospital Viborg
Viborg, Denmark, 8800
Centre Rene Gauducheau
Saint Herblain, Cedex, France, 44805
C.H.U. De Bordeaux Saint Andre
Bordeaux, Cedex, France, 33000
Centre François Baclesse
Caen, France, 14076
Centre Hospitalier de Montluçon
Clermont-Ferrand, France, 63011
Centre Georges Francois Leclerc
Dijon, France, 21034
Oncologie department, Hopital albert Michalon
Grenoble, France, 38043
Hopital de Versailles
Le Chesnay, France, 78157
Centre Oscar Lambret
Lille, France, 59020
Hopital Saint Louis
Paris Cedex 10, France, 75475
Hopital La Pitie-Salpetriere
Paris cedex 13, France, 75651
Institut Curie, Département d'Oncologie Médicale
Paris, France, 75248
Service d'Oncologie et de Radiotherapie, Polyclinique Francheville, 38
Perigueux, France, 24000
Centre Henri Becquerel
Rouen, Cedex 1, France, 76038
Institute de Cancerologie de la Loire
Saint Priest en Jarez, France, 42470
Pole Hospitalier Mutualiste
Saint-Nazaire, France, 44600
Clinique Sainte Anne Centre de Radiothérapie
Strasbourg, France, 67010
CHU Strasbourg
Strasbourg, France, 67091
CHU Bretonneau Centre Henry Kaplan
Tours, France, 37044
Institut Gustave Roussy
Villejuif, France, 94800
CHU Paul Brousse
Villejuif, France, 94804
Aachen, Germany, 52066
Onkologische Praxis
Augsburg, Germany, 86150
Sozialstiftung Bamberg Klinik fuer Haematologie und Internistische Onkologie
Bamberg, Germany, 96049
Onkologische Schwerpunktpraxis
Berlin, Germany, 10317
Praxisklinik Krebsheilkunde fuer Frauen
Berlin, Germany, 10367
Onkologische Schwerpunktpraxis
Berlin, Germany, 10707
Berlin, Germany, 14169
Universitaetsklinikum Duesseldorf, Frauenklinik
Duesseldorf, Germany, 40225
Duesseldorf, Germany, 40235
Facharzt fuer Frauenheilkunde und Geburtshilfe
Erfurt, Germany, 99084
Onkologische Gemeinschaftspraxis Frankfurt
Frankfurt am Main, Germany, 60389
Frauenklinik der J.W. Goethe-Universitaet
Frankfurt am Main, Germany, 60590
Staedtische Kliniken Frankfurt am Main-Hoechst Frauenklinik
Frankfurt am Main, Germany, 65929
Praxis für interdisziplinaere Onkologie & Haematologie GbR
Freiburg, Germany, 79106
Klinikum St. Georg/Franziskus, Abteilung fuer Senologie
Georgsmarienhuette, Germany, 49124
Kreiskrankenhaus Hameln, Onkologische Ambulanz
Hameln, Germany, 31785
Facharzt fuer Frauenheilkunde
Hannover, Germany, 30177
Onkologische Schwerpunktpraxis
Heidelberg, Germany, 69115
Nationales Centrum fuer Tumorerkrankungen
Heidelberg, Germany, 69120
Klinikum Kempten - Oberallgaeu
Kempten, Germany, 87439
MTV Abts & Partner Kiel
Kiel, Germany, 24103
Universitaetsfrauenklinikum Schleswig-Holstein
Luebeck, Germany, 23538
Universitaetsklinikum Magdeburg A.oe.R.
Magdeburg, Germany, 39108
Klinikum der Johannes-Gutenberg-Universitaet
Mainz, Germany, 55131
Fachpraxis fuer Innere Medizin
Muenchen, Germany, 80335
Klinik und Poliklinik fuer
Muenchen, Germany, 80337
Praxis Gynaekologie Arabella Muenchen
Muenchen, Germany, 81925
Klinik fuer Gynaekologie und Geburtshilfe
Offenbach, Germany, 63069
Pius-Hospital Oldenburg
Oldenburg, Germany, 26121
Klinikum Oldenburg GmbH
Oldenburg, Germany, 26133
Oncologianova GmbH
Recklinghausen, Germany, 45657
Universitaetsfrauenklinik Tuebingen
Tuebingen, Germany, 72076
St. Marienhospital Vechta
Vechta, Germany, 49377
Gemeinschaftspraxis fuer Haematologie und Onkologie
Westerstede, Germany, 26655
Klinik für Gynaekologie und gyn. Onkologie
Wiesbaden, Germany, 65199
Marienhospital Witten
Witten, Germany, 58452
University Hospital of Heraklion
Heraklion, Creete, Greece, 71110
General Hospital of Chania Ag. Georgios
Chania, Crete, Greece, 73300
University General Hospital of Alexandroupoli, Department of Medical Oncology
Alexandroúpoli, Greece, 68100
Hippokratio General Hospital of Athens
Athens, Greece, 11527
Hippokration Hospital Athens
Athens, Greece, 11527
University General Hospital of Larissa
Larissa, Greece, 41110
University Hospital of Patras
Rio Patras, Greece, 26500
Euromedica General Clinic
Thessaloniki, Greece, 54645
Hong Kong
UNIMED Medical Institute, Comprehensive Centre for Breast Diseases
Hong Kong, Wanchai, Hong Kong
Department of Clinical Oncology, Tuen Mun Hospital
Hong Kong, Hong Kong
Queen Mary Hospital, Department of Clinical Oncology, Professorial Block
Hong Kong, Hong Kong
Queen Mary Hospital, Department of Medicine, Blk K
Hong Kong, Hong Kong
Queen Mary Hospital, Department of Medicine
Hong Kong, Hong Kong
Queen Mary Hospital, Profesional Block
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
UNIMED Medical Institute, Comprehensive Centre for Breast Diseases, 10/F., Luk Kwok Centre
Hong Kong, Hong Kong
Semmelweis Egyetem Radiologiai és Onkoterapias Klinika
Budapest, Hungary, 1082
Fovarosi Onkormanyzat Szent Imre Korhaz
Budapest, Hungary, 1115
Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly
Budapest, Hungary, 1122
Bekes M. Kepviselotest. Pandy Kalman Korhaz, Megyei Onkol. Kp., Klin. Onkol. es Sugartherapias Oszt.
Gyula, Hungary, 5700
Kaposi Mor Oktato Korhaz, Onkologiai Centrum
Kaposvar, Hungary, 7400
Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont
Kecskemet, Hungary, 6000
Borsod-Abauj-Zemplen M. Korhaz es Egyetemi Okt. K., Klin. Onk., Sugarterapias es Kozp. Szuro Centrum
Miskolc, Hungary, 3526
Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft. / Onkoradiologiai Osztaly
Nyiregyhaza, Hungary, 4400
Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.
Veszprem, Hungary, 8200
Soroka University MC, Department of Oncology
Beer Sheva, Israel, 84101
Rambam Health care campus, Oncology institute
Haifa, Israel, 31096
Kaplan Medical Center, Department of Oncology
Rehovot, Israel, 76100
Sheba Medical Center, Oncology Institute Tel Hashomer
Tel Hashomer, Israel, 52621
Azienda Ospedaliera San Giuseppe Moscati
Avellino, Italy, 83100
Presidio Ospedaliero di Summa - Antonio Perrino
Brindisi, Italy, 72100
Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele"
Catania, Italy, 95123
Fondazione per la Ricerca e la Cura dei Tumori Tommaso Campanella
Catanzaro, Italy, 88100
Azienda Ospedaliera San Gerardo
Monza, Italy, 20052
Fondazione Giovanni Pascale
Napoli, Italy, 80131
Unita' Operativa Complessa Oncologia Medica, A.O.R.N. "Cardarelli"
Napoli, Italy, 80131
Azienda Ospedaliera San Luigi Gonzaga
Orbassano (TO), Italy, 10043
IRCCS Istituto Oncologico Veneto di Padova
Padova, Italy, 35131
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy, 56126
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Calabria, Italy, 89124
Universita Campus Bio-Medico
Roma, Italy, 00128
Oncologia Medica A, Istituti Fisioterapici Ospitalieri
Roma, Italy, 00144
Ospedale San Pietro Fatebenefratelli
Roma, Italy, 00189
Ospedale SS Trinita
Sora (FR), Italy, 03039
Azienda Ospedaliera S. Maria
Terni, Italy, 05100
Ospedale Treviglio e Caravaggio, UO Oncologia Medica
Treviglio, BG, Italy, 24047
Istituto Oncologico del Mediterraneo
Viagrande (CT), Italy, 95029
Ospedale Belcolle Viterbo
Viterbo, Italy, 01100
Aichi Cancer Center
Aichi, Japan, 464-8681
Chiba Cancer Center
Chiba, Japan, 260-8717
National Cancer Center Hospital East
Chiba, Japan, 277-8577
National Hospital Organization Shikoku Cancer Center
Ehime, Japan, 791-0280
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Kurume Daiichi Social Insurance Hospital
Fukuoka, Japan, 830-0013
Hiroshima City Hospital
Hiroshima, Japan, 730-8518
National Hospital Organization Hokkaido Cancer Center
Hokkaido, Japan, 003-0804
Hyogo Cancer Center
Hyogo, Japan, 673-8558
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima, Japan, 892-0833
Kanagawa Cancer Center
Kanagawa, Japan, 241-0815
Tokai University Hospital
Kanagawa, Japan, 259-1193
Kumamoto Municipal Hospital
Kumamoto, Japan, 862-8505
Kyoto University Hospital
Kyoto, Japan, 606-8507
Niigata Cancer Center Hospital 2-15-3
Niigata, Japan, 951-8566
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka, Japan, 537-8511
National Hospital Organization Osaka National Hospital
Osaka, Japan, 540-0006
Osaka University Hospital
Osaka, Japan, 565-0871
Saitama Cancer Center
Saitama, Japan, 362-0806
Shizuoka Cancer Center
Shizuoka, Japan, 411-8777
Jichi Medical University Hospital
Tochigi, Japan, 329-0498
Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hp
Tokyo, Japan, 113-8677
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Tokyo, Japan, 135-8550
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Korea, Republic of, 135-710
National Cancer Center, Center for Breast Cancer
Gyeonggi-do, Korea, Republic of, 410-769
Seoul National University Hospital, Department of Internal Medicine
Seoul, Korea, Republic of, 110-744
Korea University Anam Hospital, Department of Oncology/Hematology
Seoul, Korea, Republic of, 136-705
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Kaunas University of Medicine Hospital
Kaunas, Lithuania, LT-50009
Oncology Institute of Vilnius University
Vilnius, Lithuania, LT-08661
Macedonia, The Former Yugoslav Republic of
University Clinic for Radiotherapy and Oncology
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
University Malaya Medical Centre
Kuala Lumpur, Malaysia, 59100
Sir Paul Boffa Hospital
Floriana, Malta, VLT 14
Nucleo de Especialidades Oncológicas
Guadalajara, Jalisco, Mexico, 44670
Ziekenhuis Amstelland
Amstelveen, Netherlands, 1186 AM
Gelre ZH
Apeldoorn, Netherlands, 7334 DZ
Amphia Ziekenhuis - Interne Geneeskunde
Breda, Netherlands, 4819 EV
Haga Ziekenhuis
Den Haag, Netherlands, 2545 CH
Maxima Medisch Centrum
Eindhoven, Netherlands, 5631 BM
Vlietland Ziekenhuis
Schiedam, Netherlands, 3118 JH
Orbis Medisch Centrum
Sittard-Geleen, Netherlands, 6162 BG
New Zealand
Auckland Hospital
Auckland, New Zealand, 1023
Clínica Vista Alegre / Unidad de Investigacion
Surco, Lima, Peru, 33
Bialostockie Centrum Onkologii im. M. Sklodowskiej- Curie w Bialymstoku
Bialystok, Poland, 15027
Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"
Bydgoszcz, Poland, 85796
Uniwersyteckie Centrum Kliniczne w Gdansku
Gdansk, Poland, 80952
Szpital Morski im. PCK Gdynskie Centrum Onkologii Oddzial Chemioterapii
Gdynia, Poland, 81519
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial
Jelenia Gora, Poland, 58506
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w
Krakow, Poland, 31531
Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w
Olsztyn, Poland, 10228
Olsztynski Osrodek Onkologiczny Kopernik Sp. z o.o.
Olsztyn, Poland, 10513
Szpital Wojewodzki im. Sw. Lukasza Samodzielny Publiczny Zaklad Opieki
Tarnow, Poland, 33100
Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"
Warszawa, Poland, 04125
Institutul Oncologic "Prof. Dr. Ion Chiricuta"
Cluj-Napoca, Cluj, Romania, 400015
SC Oncolab S.R.L.
Craiova, Dolj, Romania, 200385
Spitalul Universitar de Urgenta Bucuresti
Bucuresti, Romania, 050098
Institute of Oncology and Radiology of Serbia
Belgrade, Serbia, 11000
Clinical centre Nis
Nis, Serbia, 18000
National Cancer Centre Singapore
Singapore, Singapore, 169610
Interna onkologicka klinika
Bratislava, Slovakia, 81250
Oddelenie radioterapie a onkologie
Kosice, Slovakia, 04191
Poliklinika ADUS
Poprad, Slovakia, 05801
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Hospital de Torrevieja
Torrevieja, Alicante, Spain, 03186
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
ICO de Barcelona - Hospital Duran i Reynals, Hospitalet de Llobregat Consorci Sanitari de Terrassa
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221
Hospital de Barbastro
Barbastro, Huesca, Spain, 22300
Hospital Universitari Son Espases
Palma de Mallorca, Islas Baleares, Spain, 07010
Hospital Universitario Fundacion de Alcorcon
Alcorcon, Madrid, Spain, 28922
Hospital Puerta de Hierro-Majadahonda
Majadahonda, Madrid, Spain, 28222
Hospital Universitario de Canarias
La Laguna, Santa Cruz De Tenerife, Spain, 38320
Hospital De Basurto
Bilbao, Vizcaya, Spain, 48013
Centro Oncologico de Galicia
A Coruna, Spain, 15009
Hospital Universitario Vall D´Hebron
Barcelona, Spain, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital San Pedro de Alcantara
Caceres, Spain, 10003
Hospital Universitario Puerta del Mar
Cadiz, Spain, 11009
Consorcio Hospitalario Provincial de Castellon
Castellon, Spain, 12002
Hospital Universitario Reina Sofia
Cordoba, Spain, 14004
ICO de Girona - Hospital Universitario de Girona Dr. Josep Trueta
Girona, Spain, 17007
Hospital Universitario de Guadalajara
Guadalajara, Spain, 19002
Complejo Hospitalario de Jaen
Jaen, Spain, 23007
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria, Spain, 35016
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Spain, 25198
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Madrid Norte Sanchinarro. Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050
Hospital Clinico Universitario Virgen de La Victoria
Malaga, Spain, 14004
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain, 38010
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Hospital Virgen de la Salud
Toledo, Spain, 45004
Fundacion Instituto Valenciano de Oncologia
Valencia, Spain, 46010
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Hospital Provincial de Zamora
Zamora, Spain, 49021
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Onkologiska Kliniken
Lund, Sweden, 22185
Skanes Onkologiska Kliniken
Lund, Sweden, 22185
Hirslanden Medical Center Tumor Center
Aarau, Switzerland, 5000
Kantonsspital Baden
Baden, Switzerland, 5404
Kantonsspital Olten-Medizinische Onkologie
Olten, Switzerland, 4600
Spital STS AG
Thun, Switzerland, 3600
Kaohsiung Medical University Chung-Ho memorial Hospital
Kaohsiung, Taiwan, 807
Chang Gung Medical Foundation, Linkou Branch
Kwei-Shan, Taoyuan, Taiwan, 333
National Taiwan University Hospital
Taipei TOC, Taiwan, 100
Gazi Universitesi Tip Fakultesi
Besevler/Ankara, Turkey, 06500
Ege Universitesi Tip Fakultesi
Bornova/Izmir, Turkey, 35100
Istanbul Universitesi Istanbul Tip Fakultesi
Capa/Istanbul, Turkey, 34390
Istanbul Universitesi Cerrahpasa Tip Fakultesi, Ic Hastaliklari Anabilim Dali
Cerrahpasa/Istanbul, Turkey, 34098
Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi
Demetevler/Ankara, Turkey, 06200
Uludag Universitesi Tip Fakultesi
Gorukle/Bursa, Turkey, 16059
Dokuz Eylul Universitesi Tip Fakultesi
Inciralti/Izmir, Turkey, 35340
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul, Turkey, 34890
Gaziantep Universitesi
Sehitkamil/Gaziantep, Turkey, 27310
Hacettepe Universitesi Tip Fakultesi
Sihhiye/Ankara, Turkey, 06100
United Kingdom
Berkshire Cancer Centre
Reading, Berkshire, United Kingdom, RG1 5AN
North West Cancer Treatment Centre
Bodelwydan, Denbighshire, United Kingdom, LL18 5UJ
Queens Hospital
Burton-on-Trent, Staffs, United Kingdom, DE13 0RB
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
University Hospitals of Leicester
Leicester, United Kingdom, LE1 5WW
St. Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Guy's and St Thomas NHS Foundation Cancer Management Offices
London, United Kingdom, SE1 9RT
Charing Cross Hospital, Department Of Medical Oncology
London, United Kingdom, W6 8RF
Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Norfolk & Norwich University Hospitals
Norwich, United Kingdom, NR4 7UY
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Weston Park Hospital
Sheffield, United Kingdom, S10 2SJ
South West Wales Cancer Institute-Singleton Hospital
Swansea, United Kingdom, SA2-8QA
Southend University Hospital
Westcliffe-on-Sea, United Kingdom, SS0 0RY
Sponsors and Collaborators
Puma Biotechnology, Inc.
Study Director: Puma Biotechnology

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Puma Biotechnology, Inc. Identifier: NCT00878709     History of Changes
Other Study ID Numbers: 3144A2-3004 / B1891004
First Posted: April 9, 2009    Key Record Dates
Results First Posted: October 9, 2017
Last Update Posted: August 7, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Puma Biotechnology, Inc.:
HER-2/erbB-2 positive breast cancer
breast cancer
adjuvant therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents