Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer (ExteNET)
This study is ongoing, but not recruiting participants.
Sponsor:
Puma Biotechnology, Inc.
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00878709
First received: April 8, 2009
Last updated: May 7, 2012
Last verified: May 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: neratinib Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Trastuzumab
U.S. FDA Resources
Further study details as provided by Puma Biotechnology, Inc.:
Primary Outcome Measures:
- disease free survival (DFS) [ Time Frame: Two years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to Distant Recurrence (TTDR) [ Time Frame: Two Years ] [ Designated as safety issue: No ]The time between randomization and the date of the first distant recurrence, or death from breast cancer
- Disease free survival including ductal carcinoma in situ (DFS-DCIS) [ Time Frame: Two years ] [ Designated as safety issue: No ]The time from randomization to the first occurrence of any DFS event or DCIS
- Distant disease free survival (DDFS) [ Time Frame: Two years ] [ Designated as safety issue: No ]The time from randomization to the first distant recurrence or death from any cause.
- Incidence of central nervous system recurrence [ Time Frame: Two years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Two years ] [ Designated as safety issue: No ]
- Short and long term safety of neratinib [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
| Enrollment: | 2842 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: neratinib
240 mg orally daily for 1 year
Other Name: HKI-272
|
| Placebo Comparator: 2 |
Other: placebo
orally daily for 1 year
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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 pCR.
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00878709
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| Austin, Texas, United States, 78745 | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78705 | |
| Pfizer Investigational Site | |
| Bedford, Texas, United States, 76022 | |
| Pfizer Investigational Site | |
| Cedar Park, Texas, United States, 78613 | |
| Pfizer Investigational Site | |
| Corpus Christi, Texas, United States, 78410 | |
| Pfizer Investigational Site | |
| Corpus Christi, Texas, United States, 78404 | |
| Pfizer Investigational Site | |
| Corpus Christi, Texas, United States, 78412 | |
| Pfizer Investigational Site | |
| Corpus Christi, Texas, United States, 78405 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75246 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75235 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75390-9015 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75390 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75231-4400 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75230 | |
| Pfizer Investigational Site | |
| Denton, Texas, United States, 76210 | |
| Pfizer Investigational Site | |
| El Paso, Texas, United States, 79915 | |
| Pfizer Investigational Site | |
| El Paso, Texas, United States, 79912 | |
| Pfizer Investigational Site | |
| El Paso, Texas, United States, 79902 | |
| Pfizer Investigational Site | |
| Fort Worth, Texas, United States, 76132 | |
| Pfizer Investigational Site | |
| Fort Worth, Texas, United States, 76117 | |
| Pfizer Investigational Site | |
| Fort Worth, Texas, United States, 76104 | |
| Pfizer Investigational Site | |
| Fort Worth, Texas, United States, 76177 | |
| Pfizer Investigational Site | |
| Garland, Texas, United States, 75042 | |
| Pfizer Investigational Site | |
| Grapevine, Texas, United States, 76051 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77082 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77030 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77024 | |
| Pfizer Investigational Site | |
| Jacksonville, Texas, United States, 75766 | |
| Pfizer Investigational Site | |
| Kerrville, Texas, United States, 78028- | |
| Pfizer Investigational Site | |
| Kyle, Texas, United States, 78640 | |
| Pfizer Investigational Site | |
| Paris, Texas, United States, 75460 | |
| Pfizer Investigational Site | |
| Plano, Texas, United States, 75093 | |
| Pfizer Investigational Site | |
| Round Rock, Texas, United States, 78681 | |
| Pfizer Investigational Site | |
| Round Rock, Texas, United States, 78665 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78207 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78217 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78258-3912 | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78258 | |
| Pfizer Investigational Site | |
| San Marcos, Texas, United States, 78666 | |
| Pfizer Investigational Site | |
| Sugar Land, Texas, United States, 77479 | |
| Pfizer Investigational Site | |
| Tyler, Texas, United States, 75702 | |
| Pfizer Investigational Site | |
| Tyler, Texas, United States, 75701 | |
| Pfizer Investigational Site | |
| Waco, Texas, United States, 76712 | |
| United States, Utah | |
| Pfizer Investigational Site | |
| Layton, Utah, United States, 84041 | |
| Pfizer Investigational Site | |
| Murray, Utah, United States, 84157 | |
| Pfizer Investigational Site | |
| Ogden, Utah, United States, 84405 | |
| Pfizer Investigational Site | |
| Ogden, Utah, United States, 84403 | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84106 | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84102 | |
| Pfizer Investigational Site | |
| West Valley City, Utah, United States, 84120 | |
| United States, Vermont | |
| Pfizer Investigational Site | |
| Bennington, Vermont, United States, 05201 | |
| Pfizer Investigational Site | |
| Rutland, Vermont, United States, 05701 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Arlington, Virginia, United States, 22205 | |
| Pfizer Investigational Site | |
| Fairfax, Virginia, United States, 22031 | |
| Pfizer Investigational Site | |
| Gainesville, Virginia, United States, 20155 | |
| Pfizer Investigational Site | |
| Leesburg, Virginia, United States, 20176 | |
| Pfizer Investigational Site | |
| Norfolk, Virginia, United States, 23502 | |
| Pfizer Investigational Site | |
| Reston, Virginia, United States, 20190 | |
| Pfizer Investigational Site | |
| Winchester, Virginia, United States, 22601 | |
| Pfizer Investigational Site | |
| Woodbridge, Virginia, United States, 22191 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Federal Way, Washington, United States, 98003 | |
| Pfizer Investigational Site | |
| Gig Harbor, Washington, United States, 98332 | |
| Pfizer Investigational Site | |
| Kirkland, Washington, United States, 98034 | |
| Pfizer Investigational Site | |
| Lakewood, Washington, United States, 98499 | |
| Pfizer Investigational Site | |
| Puyallup, Washington, United States, 98372 | |
| Pfizer Investigational Site | |
| Spokane, Washington, United States, 99218 | |
| Pfizer Investigational Site | |
| Spokane, Washington, United States, 99216 | |
| Pfizer Investigational Site | |
| Spokane, Washington, United States, 99202 | |
| Pfizer Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| Pfizer Investigational Site | |
| Vancouver, Washington, United States, 98686 | |
| Pfizer Investigational Site | |
| Vancouver, Washington, United States, 98684 | |
| Pfizer Investigational Site | |
| Wenatchee, Washington, United States, 98801 | |
| United States, West Virginia | |
| Pfizer Investigational Site | |
| Morgantown, West Virginia, United States, 26506 | |
| Pfizer Investigational Site | |
| Wheeling, West Virginia, United States, 26003 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Green Bay, Wisconsin, United States, 54311 | |
| Pfizer Investigational Site | |
| Racine, Wisconsin, United States, 53405 | |
| Australia, New South Wales | |
| Pfizer Investigational Site | |
| Sydney, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Pfizer Investigational Site | |
| Auchenflower, Queensland, Australia, 4101 | |
| Pfizer Investigational Site | |
| Chermside, Queensland, Australia, 4032 | |
| Pfizer Investigational Site | |
| South Brisbane, Queensland, Australia | |
| Australia, South Australia | |
| Pfizer Investigational Site | |
| Adelaide, South Australia, Australia, 5037 | |
| Pfizer Investigational Site | |
| Adelaide, South Australia, Australia, 5067 | |
| Pfizer Investigational Site | |
| Adelaide, South Australia, Australia, 5011 | |
| Pfizer Investigational Site | |
| Elizabeth Vale, South Australia, Australia, 5112 | |
| Pfizer Investigational Site | |
| North Adelaide, South Australia, Australia, 5006 | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| Melbourne, Victoria, Australia, 3011 | |
| Pfizer Investigational Site | |
| Melbourne, Victoria, Australia, 3050 | |
| Australia | |
| Pfizer Investigational Site | |
| Queensland, Australia, 4101 | |
| Pfizer Investigational Site | |
| West Perth, Australia, 6000 | |
| Bahamas | |
| Pfizer Investigational Site | |
| Nassau, Bahamas | |
| Belgium | |
| Pfizer Investigational Site | |
| Aalst, Belgium, 9300 | |
| Pfizer Investigational Site | |
| Brugge, Belgium, 8000 | |
| Pfizer Investigational Site | |
| Bruxelles, Belgium, 1070 | |
| Pfizer Investigational Site | |
| Hasselt, Belgium, 3500 | |
| Pfizer Investigational Site | |
| Ieper, Belgium, 8900 | |
| Pfizer Investigational Site | |
| Kortrijk, Belgium, 8500 | |
| Pfizer Investigational Site | |
| Liege, Belgium, 4000 | |
| Pfizer Investigational Site | |
| Mons, Belgium, 7000 | |
| Pfizer Investigational Site | |
| Oostende, Belgium, 8400 | |
| Pfizer Investigational Site | |
| Ronse, Belgium, 9600 | |
| Pfizer Investigational Site | |
| Sint Niklaas, Belgium, 9100 | |
| Pfizer Investigational Site | |
| Turnhout, Belgium, 2300 | |
| Brazil | |
| Pfizer Investigational Site | |
| Porto Alegre, RS, Brazil, 90610-000 | |
| Bulgaria | |
| Pfizer Investigational Site | |
| Plovdiv, Bulgaria, 4000 | |
| Pfizer Investigational Site | |
| Plovdiv, Bulgaria, 4004 | |
| Pfizer Investigational Site | |
| Sofia, Bulgaria, 1756 | |
| Pfizer Investigational Site | |
| Sofia, Bulgaria, 1784 | |
| Pfizer Investigational Site | |
| Sofia, Bulgaria, 1233 | |
| Pfizer Investigational Site | |
| Sofia, Bulgaria, 1407 | |
| Pfizer Investigational Site | |
| Varna, Bulgaria, 9003 | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Pfizer Investigational Site | |
| Lethbridge, Alberta, Canada, T1J 1W5 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Vancouver, British Columbia, Canada, V5Z 1H6 | |
| Pfizer Investigational Site | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, Manitoba | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R2H 2A5 | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| London, Ontario, Canada, N6A 4L6 | |
| Pfizer Investigational Site | |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| Pfizer Investigational Site | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Pfizer Investigational Site | |
| Weston, Ontario, Canada, M9N 1N8 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Canada | |
| Pfizer Investigational Site | |
| Quebec, Canada, G1S 4L8 | |
| Pfizer Investigational Site | |
| Quebec, Canada, G6V 3Z1 | |
| China, Guangdong | |
| Pfizer Investigational Site | |
| Guangzhou, Guangdong, China, 510060 | |
| China, Zhejiang | |
| Pfizer Investigational Site | |
| Hangzhou, Zhejiang, China, 310022 | |
| China | |
| Pfizer Investigational Site | |
| Beijing, China, 100032 | |
| Pfizer Investigational Site | |
| Beijing, China, 100853 | |
| Pfizer Investigational Site | |
| Beijing, China, 100071 | |
| Pfizer Investigational Site | |
| Beijing, China, 100021 | |
| Pfizer Investigational Site | |
| Guangzhou, China, 510515 | |
| Pfizer Investigational Site | |
| Guangzhou, China, 510060 | |
| Pfizer Investigational Site | |
| Shanghai, China, 200032 | |
| Pfizer Investigational Site | |
| Tianjin, China, 300060 | |
| Colombia | |
| Pfizer Investigational Site | |
| Monteria, Cordoba, Colombia | |
| Pfizer Investigational Site | |
| Pereira, Risaralda, Colombia | |
| Pfizer Investigational Site | |
| Bogota, Colombia | |
| Croatia | |
| Pfizer Investigational Site | |
| Osijek, Croatia, 31000 | |
| Pfizer Investigational Site | |
| Varazdin, Croatia, 42000 | |
| Pfizer Investigational Site | |
| Zagreb, Croatia, 1000 | |
| Pfizer Investigational Site | |
| Zagreb, Croatia, 10000 | |
| Czech Republic | |
| Pfizer Investigational Site | |
| Brno, Czech Republic, 625 00 | |
| Pfizer Investigational Site | |
| Brno, Czech Republic, 65653 | |
| Pfizer Investigational Site | |
| Jihlava, Czech Republic, 58633 | |
| Pfizer Investigational Site | |
| Nova Ves pod Plesi, Czech Republic, 26204 | |
| Pfizer Investigational Site | |
| Pardubice, Czech Republic, 53203 | |
| Pfizer Investigational Site | |
| Praha, Czech Republic, 15006 | |
| Denmark | |
| Pfizer Investigational Site | |
| Aalborg, Denmark, 9000 | |
| Pfizer Investigational Site | |
| Aarhus C, Denmark, DK-8000 | |
| Pfizer Investigational Site | |
| Copenhagen, Denmark, 2100 | |
| Pfizer Investigational Site | |
| Esbjerg, Denmark, 6700 | |
| Pfizer Investigational Site | |
| Herlev, Denmark, 2730 | |
| Pfizer Investigational Site | |
| Hillerod, Denmark, 3400 | |
| Pfizer Investigational Site | |
| Naestved, Denmark, 4700 | |
| Pfizer Investigational Site | |
| Odense C, Denmark | |
| Pfizer Investigational Site | |
| Roskilde, Denmark, 4000 | |
| Pfizer Investigational Site | |
| Sonderborg, Denmark, 6400 | |
| Pfizer Investigational Site | |
| Vejle, Denmark, 7100 | |
| Pfizer Investigational Site | |
| Viborg, Denmark, 8800 | |
| France | |
| Pfizer Investigational Site | |
| Saint Herblain, Cedex, France, 44805 | |
| Pfizer Investigational Site | |
| Bordeaux, Cedex, France, 33000 | |
| Pfizer Investigational Site | |
| Caen, France, 14076 | |
| Pfizer Investigational Site | |
| Dijon, France, 21000 | |
| Pfizer Investigational Site | |
| Grenoble, France, 38043 | |
| Pfizer Investigational Site | |
| Le Chesnay, France, 78157 | |
| Pfizer Investigational Site | |
| Lille, France, 59020 | |
| Pfizer Investigational Site | |
| Montlucon Cedex, France, 3113 | |
| Pfizer Investigational Site | |
| Paris, France, 75248 | |
| Pfizer Investigational Site | |
| PARIS Cedex 10, France, 75475 | |
| Pfizer Investigational Site | |
| Paris cedex 13, France, 75651 | |
| Pfizer Investigational Site | |
| Perigueux, France, 24000 | |
| Pfizer Investigational Site | |
| Rouen, Cedex 1, France, 76038 | |
| Pfizer Investigational Site | |
| Saint Priest en Jarez, France, 42470 | |
| Pfizer Investigational Site | |
| Saint-Nazaire, France, 44600 | |
| Pfizer Investigational Site | |
| Strasbourg, France, 67091 | |
| Pfizer Investigational Site | |
| Strasbourg, France, 67000 | |
| Pfizer Investigational Site | |
| Strasbourg, Cedex, France, 67098 | |
| Pfizer Investigational Site | |
| Tours, France, 37044 | |
| Pfizer Investigational Site | |
| Villejuif, France, 94800 | |
| Pfizer Investigational Site | |
| Villejuif, France, 94804 | |
| Germany | |
| Pfizer Investigational Site | |
| Aachen, Germany, 52066 | |
| Pfizer Investigational Site | |
| Augsburg, Germany, 86150 | |
| Pfizer Investigational Site | |
| Bamberg, Germany, 96049 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 10317 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 12163 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 10367 | |
| Pfizer Investigational Site | |
| Berlin, Germany, 10707 | |
| Pfizer Investigational Site | |
| Duesseldorf, Germany, 40225 | |
| Pfizer Investigational Site | |
| Duesseldorf, Germany, 40235 | |
| Pfizer Investigational Site | |
| Erfurt, Germany, 99084 | |
| Pfizer Investigational Site | |
| Frankfurt am Main, Germany, 60590 | |
| Pfizer Investigational Site | |
| Frankfurt am Main, Germany, 65929 | |
| Pfizer Investigational Site | |
| Frankfurt am Main, Germany, 60389 | |
| Pfizer Investigational Site | |
| Freiburg, Germany, 79106 | |
| Pfizer Investigational Site | |
| Georgsmarienhuette, Germany, 49124 | |
| Pfizer Investigational Site | |
| Hameln, Germany, 31785 | |
| Pfizer Investigational Site | |
| Hannover, Germany, 30177 | |
| Pfizer Investigational Site | |
| Heidelberg, Germany, 69120 | |
| Pfizer Investigational Site | |
| Heidelberg, Germany, 69115 | |
| Pfizer Investigational Site | |
| Kempten, Germany, 87439 | |
| Pfizer Investigational Site | |
| Kiel, Germany, 24103 | |
| Pfizer Investigational Site | |
| Luebeck, Germany, 23538 | |
| Pfizer Investigational Site | |
| Magdeburg, Germany, 39108 | |
| Pfizer Investigational Site | |
| Mainz, Germany, 55131 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 81925 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 80337 | |
| Pfizer Investigational Site | |
| Muenchen, Germany, 80335 | |
| Pfizer Investigational Site | |
| Offenbach, Germany, 63069 | |
| Pfizer Investigational Site | |
| Oldenburg, Germany, 26121 | |
| Pfizer Investigational Site | |
| Oldenburg, Germany, 26133 | |
| Pfizer Investigational Site | |
| Recklinghausen, Germany, 45657 | |
| Pfizer Investigational Site | |
| Tuebingen, Germany, 72076 | |
| Pfizer Investigational Site | |
| Vechta, Germany, 49377 | |
| Pfizer Investigational Site | |
| Westerstede, Germany, 26655 | |
| Pfizer Investigational Site | |
| Wiesbaden, Germany, 65199 | |
| Pfizer Investigational Site | |
| Witten, Germany, 58452 | |
| Greece | |
| Pfizer Investigational Site | |
| Heraklion, Creete, Greece, 71110 | |
| Pfizer Investigational Site | |
| Chania, Crete, Greece, 73300 | |
| Pfizer Investigational Site | |
| Alexandroupolis, Greece, 68100 | |
| Pfizer Investigational Site | |
| Athens, Greece, 115-27 | |
| Pfizer Investigational Site | |
| Athens, Greece, 115 27 | |
| Pfizer Investigational Site | |
| Larissa, Greece, 41110 | |
| Pfizer Investigational Site | |
| Rio Patra, Greece, 26500 | |
| Pfizer Investigational Site | |
| Thessaloniki, Greece, 56403 | |
| Pfizer Investigational Site | |
| Thessaloniki, Greece, 56249 | |
| Hong Kong | |
| Pfizer Investigational Site | |
| Hong Kong, Hong Kong | |
| Hungary | |
| Pfizer Investigational Site | |
| Budapest, Hungary, 1122 | |
| Pfizer Investigational Site | |
| Budapest, Hungary, 1115 | |
| Pfizer Investigational Site | |
| Budapest, Hungary, 1082 | |
| Pfizer Investigational Site | |
| Gyula, Hungary, 5700 | |
| Pfizer Investigational Site | |
| Kaposvar, Hungary, 7400 | |
| Pfizer Investigational Site | |
| Kecskemet, Hungary, 6000 | |
| Pfizer Investigational Site | |
| Miskolc, Hungary, 3526 | |
| Pfizer Investigational Site | |
| Nyiregyhaza, Hungary, 4400 | |
| Pfizer Investigational Site | |
| Veszprem, Hungary, 8200 | |
| Israel | |
| Pfizer Investigational Site | |
| Beer Sheva, Israel, 84101 | |
| Pfizer Investigational Site | |
| Haifa, Israel, 31096 | |
| Pfizer Investigational Site | |
| Ramat Gan, Israel, 52621 | |
| Pfizer Investigational Site | |
| Rehovot, Israel, 76101 | |
| Italy | |
| Pfizer Investigational Site | |
| Albano Laziale (RM), Italy, 00041 | |
| Pfizer Investigational Site | |
| Avellino, Italy, 83100 | |
| Pfizer Investigational Site | |
| Brindisi, Italy, 72100 | |
| Pfizer Investigational Site | |
| Catania, Italy, 95128 | |
| Pfizer Investigational Site | |
| Catanzaro, Italy, 88100 | |
| Pfizer Investigational Site | |
| Monza, Italy, 20052 | |
| Pfizer Investigational Site | |
| Napoli, Italy, 80131 | |
| Pfizer Investigational Site | |
| Orbassano (TO), Italy, 10043 | |
| Pfizer Investigational Site | |
| Padova, Italy, 35128 | |
| Pfizer Investigational Site | |
| Pisa, Italy, 56126 | |
| Pfizer Investigational Site | |
| Reggio Calabria, Italy, 89124 | |
| Pfizer Investigational Site | |
| Roma, Italy, 00128 | |
| Pfizer Investigational Site | |
| Roma, Italy, 00189 | |
| Pfizer Investigational Site | |
| Roma, Italy, 00144 | |
| Pfizer Investigational Site | |
| Sora (FR), Italy, 03039 | |
| Pfizer Investigational Site | |
| Terni, Italy, 05100 | |
| Pfizer Investigational Site | |
| Treviglio, BG, Italy, 24047 | |
| Pfizer Investigational Site | |
| Viagrande (CT), Italy, 95029 | |
| Pfizer Investigational Site | |
| Viterbo, Italy, 01100 | |
| Japan | |
| Pfizer Investigational Site | |
| Aichi, Japan | |
| Pfizer Investigational Site | |
| Chiba, Japan | |
| Pfizer Investigational Site | |
| Ehime, Japan | |
| Pfizer Investigational Site | |
| Fukuoka, Japan | |
| Pfizer Investigational Site | |
| Hiroshima, Japan | |
| Pfizer Investigational Site | |
| Hokkaido, Japan | |
| Pfizer Investigational Site | |
| Hyogo, Japan | |
| Pfizer Investigational Site | |
| Kagoshima, Japan | |
| Pfizer Investigational Site | |
| Kanagawa, Japan | |
| Pfizer Investigational Site | |
| Kumamoto, Japan | |
| Pfizer Investigational Site | |
| Kyoto, Japan | |
| Pfizer Investigational Site | |
| Niigata, Japan | |
| Pfizer Investigational Site | |
| Osaka, Japan | |
| Pfizer Investigational Site | |
| Saitama, Japan | |
| Pfizer Investigational Site | |
| Shizuoka, Japan | |
| Pfizer Investigational Site | |
| Tochigi, Japan | |
| Pfizer Investigational Site | |
| Tokyo, Japan | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Seoul, Korea, Korea, Republic of, 135-710 | |
| Pfizer Investigational Site | |
| Gyeonggi-do, Korea, Republic of, 410-769 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 136-705 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 138-736 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 110-744 | |
| Lithuania | |
| Pfizer Investigational Site | |
| Kaunas, Lithuania, LT-50009 | |
| Pfizer Investigational Site | |
| Kaunas, Lithuania, LT 44307 | |
| Pfizer Investigational Site | |
| Vilnius, Lithuania, LT-08660 | |
| Macedonia, The Former Yugoslav Republic of | |
| Pfizer Investigational Site | |
| Skopje, Macedonia, The Former Yugoslav Republic of, 1000 | |
| Malaysia | |
| Pfizer Investigational Site | |
| Kuala Lumpur, Malaysia, 59100 | |
| Malta | |
| Pfizer Investigational Site | |
| Floriana, Malta, VLT 14 | |
| Mexico | |
| Pfizer Investigational Site | |
| Guadalajara, Jalisco, Mexico, 44670 | |
| Netherlands | |
| Pfizer Investigational Site | |
| Amstelveen, Netherlands, 1186 AM | |
| Pfizer Investigational Site | |
| Apeldoorn, Netherlands, 7334 DZ | |
| Pfizer Investigational Site | |
| Breda, Netherlands, 4819 EV | |
| Pfizer Investigational Site | |
| Den Haag, Netherlands, 2545 CH | |
| Pfizer Investigational Site | |
| Eindhoven, Netherlands, 5631 BM | |
| Pfizer Investigational Site | |
| Schiedam, Netherlands, 3118 JH | |
| Pfizer Investigational Site | |
| Sittard-Geleen, Netherlands, 6162 BG | |
| New Zealand | |
| Pfizer Investigational Site | |
| Auckland, New Zealand | |
| Peru | |
| Pfizer Investigational Site | |
| Surco, Lima, Peru, 33 | |
| Poland | |
| Pfizer Investigational Site | |
| Bialystok, Poland, 15027 | |
| Pfizer Investigational Site | |
| Bydgoszcz, Poland, 85796 | |
| Pfizer Investigational Site | |
| Gdansk, Poland, 80952 | |
| Pfizer Investigational Site | |
| Gdansk, Poland, 80-952 | |
| Pfizer Investigational Site | |
| Gdansk, Poland, 80-305 | |
| Pfizer Investigational Site | |
| Gdynia, Poland, 81519 | |
| Pfizer Investigational Site | |
| Jelenia Gora, Poland, 58-506 | |
| Pfizer Investigational Site | |
| Krakow, Poland, 31-501 | |
| Pfizer Investigational Site | |
| Krakow, Poland, 31501 | |
| Pfizer Investigational Site | |
| Olsztyn, Poland, 10228 | |
| Pfizer Investigational Site | |
| Olsztyn, Poland, 10513 | |
| Pfizer Investigational Site | |
| Tarnow, Poland, 33-100 | |
| Pfizer Investigational Site | |
| Warszawa, Poland, 04125 | |
| Romania | |
| Pfizer Investigational Site | |
| Cluj-Napoca, Cluj, Romania, 400015 | |
| Pfizer Investigational Site | |
| Craiova, Dolj, Romania, 200385 | |
| Pfizer Investigational Site | |
| Bucuresti, Romania, 050098 | |
| Serbia | |
| Pfizer Investigational Site | |
| Belgrade, Serbia, 11000 | |
| Pfizer Investigational Site | |
| Nis, Serbia, 18000 | |
| Singapore | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 169610 | |
| Slovakia | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 81250 | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 812 50 | |
| Pfizer Investigational Site | |
| Kosice, Slovakia, 04001 | |
| Pfizer Investigational Site | |
| Kosice, Slovakia, 04191 | |
| Pfizer Investigational Site | |
| Kosice, Slovakia, 04011 | |
| Pfizer Investigational Site | |
| Kosice-Saca, Slovakia, 04015 | |
| Pfizer Investigational Site | |
| Poprad, Slovakia, 05801 | |
| Pfizer Investigational Site | |
| Poprad, Slovakia, 05845 | |
| Pfizer Investigational Site | |
| Presov, Slovakia, 08001 | |
| Spain | |
| Pfizer Investigational Site | |
| Elche, Alicante, Spain, 03203 | |
| Pfizer Investigational Site | |
| Torrevieja, Alicante, Spain, 03186 | |
| Pfizer Investigational Site | |
| Badalona, Barcelona, Spain, 08916 | |
| Pfizer Investigational Site | |
| Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Pfizer Investigational Site | |
| Terrassa, Barcelona, Spain, 08221 | |
| Pfizer Investigational Site | |
| Terrassa, Barcelona, Spain, 08227 | |
| Pfizer Investigational Site | |
| Barbastro, Huesca, Spain, 22300 | |
| Pfizer Investigational Site | |
| Palma de Mallorca, Islas Baleares, Spain, 07010 | |
| Pfizer Investigational Site | |
| Alcorcon, Madrid, Spain, 28922 | |
| Pfizer Investigational Site | |
| Majadahonda, Madrid, Spain, 28222 | |
| Pfizer Investigational Site | |
| La Laguna, Santa Cruz de Tenerife, Spain, 38320 | |
| Pfizer Investigational Site | |
| Bilbao, Vizcaya, Spain, 48013 | |
| Pfizer Investigational Site | |
| A Coruna, Spain, 15009 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08035 | |
| Pfizer Investigational Site | |
| Barcelona, Spain, 08036 | |
| Pfizer Investigational Site | |
| Caceres, Spain, 10003 | |
| Pfizer Investigational Site | |
| Cadiz, Spain, 11009 | |
| Pfizer Investigational Site | |
| Castellon, Spain, 12002 | |
| Pfizer Investigational Site | |
| Cordoba, Spain, 14004 | |
| Pfizer Investigational Site | |
| Girona, Spain, 17007 | |
| Pfizer Investigational Site | |
| Guadalajara, Spain, 19002 | |
| Pfizer Investigational Site | |
| Jaen, Spain, 23007 | |
| Pfizer Investigational Site | |
| Las Palmas de Gran Canaria, Spain, 35016 | |
| Pfizer Investigational Site | |
| Lleida, Spain, 25198 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28050 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28040 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28007 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28034 | |
| Pfizer Investigational Site | |
| Malaga, Spain, 14004 | |
| Pfizer Investigational Site | |
| Santa Cruz de Tenerife, Spain, 38010 | |
| Pfizer Investigational Site | |
| Sevilla, Spain, 41013 | |
| Pfizer Investigational Site | |
| Toledo, Spain, 45004 | |
| Pfizer Investigational Site | |
| Valencia, Spain, 46009 | |
| Pfizer Investigational Site | |
| Valencia, Spain, 46010 | |
| Pfizer Investigational Site | |
| Zamora, Spain, 49021 | |
| Pfizer Investigational Site | |
| Zaragoza, Spain, 50009 | |
| Sweden | |
| Pfizer Investigational Site | |
| Lund, Sweden, 22185 | |
| Pfizer Investigational Site | |
| Malmo, Sweden, 20502 | |
| Switzerland | |
| Pfizer Investigational Site | |
| Bern, Ch-3007, Switzerland | |
| Pfizer Investigational Site | |
| Bern, Ch-3010, Switzerland | |
| Pfizer Investigational Site | |
| Aarau, Switzerland, CH-5001 | |
| Pfizer Investigational Site | |
| Aarau, Switzerland, 5000 | |
| Pfizer Investigational Site | |
| Baden, Switzerland, 5404 | |
| Pfizer Investigational Site | |
| CH-5405 Baden, Switzerland | |
| Pfizer Investigational Site | |
| Olten, Switzerland, 4600 | |
| Pfizer Investigational Site | |
| Thun, Switzerland, 3600 | |
| Taiwan | |
| Pfizer Investigational Site | |
| Kaohsiung, Taiwan, 807 | |
| Pfizer Investigational Site | |
| Kwei-Shan, Taoyuan, Taiwan, 333 | |
| Pfizer Investigational Site | |
| Taipei TOC, Taiwan, 100 | |
| Turkey | |
| Pfizer Investigational Site | |
| Altunizade/Istanbul, Turkey, 34662 | |
| Pfizer Investigational Site | |
| Besevler/Ankara, Turkey, 06100 | |
| Pfizer Investigational Site | |
| Bornova/Izmir, Turkey, 35100 | |
| Pfizer Investigational Site | |
| Capa/Istanbul, Turkey, 34390 | |
| Pfizer Investigational Site | |
| Cerrahpasa/Istanbul, Turkey, 34098 | |
| Pfizer Investigational Site | |
| Demetevler/Ankara, Turkey, 06200 | |
| Pfizer Investigational Site | |
| Gorukle/Bursa, Turkey, 16059 | |
| Pfizer Investigational Site | |
| Inciralti/Izmir, Turkey, 35340 | |
| Pfizer Investigational Site | |
| Sehitkamil/Gaziantep, Turkey, 27310 | |
| Pfizer Investigational Site | |
| Sihhiye/Ankara, Turkey, 06100 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Reading, Berkshire, United Kingdom, RG1 5AN | |
| Pfizer Investigational Site | |
| Bodelwydan, Denbighshire, United Kingdom, LL18 5UJ | |
| Pfizer Investigational Site | |
| Burton-on-Trent, Staffs, United Kingdom, DE13 0RB | |
| Pfizer Investigational Site | |
| Leeds, United Kingdom, LS9 7TF | |
| Pfizer Investigational Site | |
| Leicester, United Kingdom, LE1 5WW | |
| Pfizer Investigational Site | |
| London, United Kingdom, EC1A 7BE | |
| Pfizer Investigational Site | |
| London, United Kingdom, SE1 9RT | |
| Pfizer Investigational Site | |
| London, United Kingdom, W6 8RF | |
| Pfizer Investigational Site | |
| Manchester, United Kingdom, M20 4BX | |
| Pfizer Investigational Site | |
| Norwich, United Kingdom, NR4 7UY | |
| Pfizer Investigational Site | |
| Nottingham, United Kingdom, NG5 1PB | |
| Pfizer Investigational Site | |
| Sheffield, United Kingdom, S10 2SJ | |
| Pfizer Investigational Site | |
| Swansea, United Kingdom, SA2-8QA | |
| Pfizer Investigational Site | |
| Swansea, United Kingdom, SA2 8QA | |
| Pfizer Investigational Site | |
| Westcliffe-on-Sea, United Kingdom, SS0 0RY | |
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
| Study Director: | Puma | Biotechnology |
More Information
No publications provided
| Responsible Party: | Puma Biotechnology, Inc. |
| ClinicalTrials.gov Identifier: | NCT00878709 History of Changes |
| Other Study ID Numbers: | 3144A2-3004, B1891004 |
| Study First Received: | April 8, 2009 |
| Last Updated: | May 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Puma Biotechnology, Inc.:
|
HER-2/erbB-2 positive breast cancer breast cancer adjuvant therapy neratinib HKI-272 |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Trastuzumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013