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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00878709




Registration number
NCT00878709
Ethics application status
Date submitted
8/04/2009
Date registered
8/04/2009
Date last updated
9/05/2019

Titles & IDs
Public title
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Scientific 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
Secondary ID [1] 0 0
3144A2-3004 / B1891004
Universal Trial Number (UTN)
Trial acronym
ExteNET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Breast Cancer 0 0
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - neratinib
Other interventions - placebo
Treatment: Drugs - neratinib
Other interventions - placebo
Treatment: Drugs - neratinib
Other interventions - placebo

Experimental: Neratinib - 240 mg orally daily for one year

Placebo Comparator: Placebo - orally daily for one year

Experimental: Neratinib - 240 mg orally daily for one year

Placebo Comparator: Placebo - orally daily for one year

Experimental: Neratinib - 240 mg orally daily for one year

Placebo Comparator: Placebo - orally daily for one year


Treatment: Drugs: neratinib


Other interventions: placebo


Treatment: Drugs: neratinib


Other interventions: placebo


Treatment: Drugs: neratinib


Other interventions: placebo


Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm - 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.
Timepoint [1] 0 0
From randomization until time of event up to 2 years
Primary outcome [2] 0 0
Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms
Timepoint [2] 0 0
From randomization until time of event up to 2 years
Primary outcome [3] 0 0
Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm - 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.
Timepoint [3] 0 0
From randomization until time of event up to 2 years
Primary outcome [4] 0 0
Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms
Timepoint [4] 0 0
From randomization until time of event up to 2 years
Primary outcome [5] 0 0
Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm - 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.
Timepoint [5] 0 0
From randomization until time of event up to 2 years
Primary outcome [6] 0 0
Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms
Timepoint [6] 0 0
From randomization until time of event up to 2 years
Secondary outcome [1] 0 0
Overall Survival (OS) - Overall survival is defined as the time from randomization to death from any cause
Timepoint [1] 0 0
From time of randomization to death
Secondary outcome [2] 0 0
Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm - 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.
Timepoint [2] 0 0
From randomization until time of event up to 2 years
Secondary outcome [3] 0 0
Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms
Timepoint [3] 0 0
From randomization until time of event up to 2 years
Secondary outcome [4] 0 0
Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm - 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.
Timepoint [4] 0 0
From randomization until time of event up to 2 years
Secondary outcome [5] 0 0
Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms
Timepoint [5] 0 0
From randomization until time of event up to 2 years
Secondary outcome [6] 0 0
Time to Distant Recurrence (TTDR) in Neratinib Arm Compared to Placebo Arm - 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.
Timepoint [6] 0 0
From randomization until time of event up to 2 years
Secondary outcome [7] 0 0
Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms
Timepoint [7] 0 0
From randomization until time of event up to 2 years
Secondary outcome [8] 0 0
Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm - 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.
Timepoint [8] 0 0
From randomization until time of event up to 2 years
Secondary outcome [9] 0 0
Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2 - Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).
Timepoint [9] 0 0
From randomization until time of event up to 2 years
Secondary outcome [10] 0 0
Overall Survival (OS) - Overall survival is defined as the time from randomization to death from any cause
Timepoint [10] 0 0
From time of randomization to death
Secondary outcome [11] 0 0
Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm - 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.
Timepoint [11] 0 0
From randomization until time of event up to 2 years
Secondary outcome [12] 0 0
Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms
Timepoint [12] 0 0
From randomization until time of event up to 2 years
Secondary outcome [13] 0 0
Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm - 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.
Timepoint [13] 0 0
From randomization until time of event up to 2 years
Secondary outcome [14] 0 0
Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms
Timepoint [14] 0 0
From randomization until time of event up to 2 years
Secondary outcome [15] 0 0
Time to Distant Recurrence (TTDR) in Neratinib Arm Compared to Placebo Arm - 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.
Timepoint [15] 0 0
From randomization until time of event up to 2 years
Secondary outcome [16] 0 0
Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms
Timepoint [16] 0 0
From randomization until time of event up to 2 years
Secondary outcome [17] 0 0
Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm - 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.
Timepoint [17] 0 0
From randomization until time of event up to 2 years
Secondary outcome [18] 0 0
Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2 - Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).
Timepoint [18] 0 0
From randomization until time of event up to 2 years
Secondary outcome [19] 0 0
Overall Survival (OS) - Overall survival is defined as the time from randomization to death from any cause
Timepoint [19] 0 0
From time of randomization to death
Secondary outcome [20] 0 0
Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm - 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.
Timepoint [20] 0 0
From randomization until time of event up to 2 years
Secondary outcome [21] 0 0
Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms
Timepoint [21] 0 0
From randomization until time of event up to 2 years
Secondary outcome [22] 0 0
Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm - 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.
Timepoint [22] 0 0
From randomization until time of event up to 2 years
Secondary outcome [23] 0 0
Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms
Timepoint [23] 0 0
From randomization until time of event up to 2 years
Secondary outcome [24] 0 0
Time to Distant Recurrence (TTDR) in Neratinib Arm Compared to Placebo Arm - 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.
Timepoint [24] 0 0
From randomization until time of event up to 2 years
Secondary outcome [25] 0 0
Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms
Timepoint [25] 0 0
From randomization until time of event up to 2 years
Secondary outcome [26] 0 0
Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm - 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.
Timepoint [26] 0 0
From randomization until time of event up to 2 years
Secondary outcome [27] 0 0
Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2 - Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).
Timepoint [27] 0 0
From randomization until time of event up to 2 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Positive clinical and radiologic assessments for local or regional recurrence of
disease at the time of study entry.

- History of heart disease.

- Corrected QT (QTc) interval >0.45 seconds

- History of gastrointestinal disease with diarrhea as the major symptom.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney West Cancer Trials Centre - Sydney
Recruitment hospital [2] 0 0
Iron Cancer Care South Brisbane - South Brisbane
Recruitment hospital [3] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [4] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [5] 0 0
North Adelaide Oncology Calvary Hospital North Adelaide - North Adelaide
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [7] 0 0
The Western Hospital - Melbourne
Recruitment hospital [8] 0 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5011 - Adelaide
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
5006 - North Adelaide
Recruitment postcode(s) [6] 0 0
3050 - Melbourne
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Hawaii
Country [10] 0 0
United States of America
State/province [10] 0 0
Idaho
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maine
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Minnesota
Country [20] 0 0
United States of America
State/province [20] 0 0
Mississippi
Country [21] 0 0
United States of America
State/province [21] 0 0
Missouri
Country [22] 0 0
United States of America
State/province [22] 0 0
Montana
Country [23] 0 0
United States of America
State/province [23] 0 0
Nebraska
Country [24] 0 0
United States of America
State/province [24] 0 0
New Jersey
Country [25] 0 0
United States of America
State/province [25] 0 0
New York
Country [26] 0 0
United States of America
State/province [26] 0 0
North Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
North Dakota
Country [28] 0 0
United States of America
State/province [28] 0 0
Ohio
Country [29] 0 0
United States of America
State/province [29] 0 0
Oklahoma
Country [30] 0 0
United States of America
State/province [30] 0 0
Oregon
Country [31] 0 0
United States of America
State/province [31] 0 0
Pennsylvania
Country [32] 0 0
United States of America
State/province [32] 0 0
Rhode Island
Country [33] 0 0
United States of America
State/province [33] 0 0
South Carolina
Country [34] 0 0
United States of America
State/province [34] 0 0
South Dakota
Country [35] 0 0
United States of America
State/province [35] 0 0
Tennessee
Country [36] 0 0
United States of America
State/province [36] 0 0
Texas
Country [37] 0 0
United States of America
State/province [37] 0 0
Utah
Country [38] 0 0
United States of America
State/province [38] 0 0
Vermont
Country [39] 0 0
United States of America
State/province [39] 0 0
Virginia
Country [40] 0 0
United States of America
State/province [40] 0 0
Washington
Country [41] 0 0
United States of America
State/province [41] 0 0
West Virginia
Country [42] 0 0
United States of America
State/province [42] 0 0
Wisconsin
Country [43] 0 0
Bahamas
State/province [43] 0 0
Nassau
Country [44] 0 0
Belgium
State/province [44] 0 0
Aalst
Country [45] 0 0
Belgium
State/province [45] 0 0
Brugge
Country [46] 0 0
Belgium
State/province [46] 0 0
Bruxelles
Country [47] 0 0
Belgium
State/province [47] 0 0
Hasselt
Country [48] 0 0
Belgium
State/province [48] 0 0
Ieper
Country [49] 0 0
Belgium
State/province [49] 0 0
Kortrijk
Country [50] 0 0
Belgium
State/province [50] 0 0
Liege
Country [51] 0 0
Belgium
State/province [51] 0 0
Mons
Country [52] 0 0
Belgium
State/province [52] 0 0
Oostende
Country [53] 0 0
Belgium
State/province [53] 0 0
Ronse
Country [54] 0 0
Belgium
State/province [54] 0 0
Sint Niklaas
Country [55] 0 0
Belgium
State/province [55] 0 0
Turnhout
Country [56] 0 0
Brazil
State/province [56] 0 0
RS
Country [57] 0 0
Bulgaria
State/province [57] 0 0
Plovdiv
Country [58] 0 0
Bulgaria
State/province [58] 0 0
Sofia
Country [59] 0 0
Bulgaria
State/province [59] 0 0
Varna
Country [60] 0 0
Canada
State/province [60] 0 0
Alberta
Country [61] 0 0
Canada
State/province [61] 0 0
British Columbia
Country [62] 0 0
Canada
State/province [62] 0 0
Manitoba
Country [63] 0 0
Canada
State/province [63] 0 0
Ontario
Country [64] 0 0
Canada
State/province [64] 0 0
Quebec
Country [65] 0 0
China
State/province [65] 0 0
Zhejiang
Country [66] 0 0
China
State/province [66] 0 0
Beijing
Country [67] 0 0
China
State/province [67] 0 0
Guangzhou
Country [68] 0 0
China
State/province [68] 0 0
Shanghai
Country [69] 0 0
China
State/province [69] 0 0
Tianjin
Country [70] 0 0
Colombia
State/province [70] 0 0
Cordoba
Country [71] 0 0
Colombia
State/province [71] 0 0
Risaralda
Country [72] 0 0
Colombia
State/province [72] 0 0
Bogota
Country [73] 0 0
Croatia
State/province [73] 0 0
Osijek
Country [74] 0 0
Croatia
State/province [74] 0 0
Varazdin
Country [75] 0 0
Croatia
State/province [75] 0 0
Zagreb
Country [76] 0 0
Czechia
State/province [76] 0 0
Brno
Country [77] 0 0
Czechia
State/province [77] 0 0
Jihlava
Country [78] 0 0
Czechia
State/province [78] 0 0
Nova Ves pod Plesi
Country [79] 0 0
Czechia
State/province [79] 0 0
Pardubice
Country [80] 0 0
Czechia
State/province [80] 0 0
Praha
Country [81] 0 0
Denmark
State/province [81] 0 0
Aalborg
Country [82] 0 0
Denmark
State/province [82] 0 0
Aarhus C
Country [83] 0 0
Denmark
State/province [83] 0 0
Copenhagen
Country [84] 0 0
Denmark
State/province [84] 0 0
Esbjerg
Country [85] 0 0
Denmark
State/province [85] 0 0
Herlev
Country [86] 0 0
Denmark
State/province [86] 0 0
Hillerod
Country [87] 0 0
Denmark
State/province [87] 0 0
Naestved
Country [88] 0 0
Denmark
State/province [88] 0 0
Odense C
Country [89] 0 0
Denmark
State/province [89] 0 0
Roskilde
Country [90] 0 0
Denmark
State/province [90] 0 0
Sonderborg
Country [91] 0 0
Denmark
State/province [91] 0 0
Vejle
Country [92] 0 0
Denmark
State/province [92] 0 0
Viborg
Country [93] 0 0
France
State/province [93] 0 0
Cedex
Country [94] 0 0
France
State/province [94] 0 0
Bordeaux, Cedex
Country [95] 0 0
France
State/province [95] 0 0
Caen
Country [96] 0 0
France
State/province [96] 0 0
Clermont-Ferrand
Country [97] 0 0
France
State/province [97] 0 0
Dijon
Country [98] 0 0
France
State/province [98] 0 0
Grenoble
Country [99] 0 0
France
State/province [99] 0 0
Le Chesnay
Country [100] 0 0
France
State/province [100] 0 0
Lille
Country [101] 0 0
France
State/province [101] 0 0
Paris Cedex 10
Country [102] 0 0
France
State/province [102] 0 0
Paris cedex 13
Country [103] 0 0
France
State/province [103] 0 0
Paris
Country [104] 0 0
France
State/province [104] 0 0
Perigueux
Country [105] 0 0
France
State/province [105] 0 0
Rouen, Cedex 1
Country [106] 0 0
France
State/province [106] 0 0
Saint Priest en Jarez
Country [107] 0 0
France
State/province [107] 0 0
Saint-Nazaire
Country [108] 0 0
France
State/province [108] 0 0
Strasbourg
Country [109] 0 0
France
State/province [109] 0 0
Tours
Country [110] 0 0
France
State/province [110] 0 0
Villejuif
Country [111] 0 0
Germany
State/province [111] 0 0
Aachen
Country [112] 0 0
Germany
State/province [112] 0 0
Augsburg
Country [113] 0 0
Germany
State/province [113] 0 0
Bamberg
Country [114] 0 0
Germany
State/province [114] 0 0
Berlin
Country [115] 0 0
Germany
State/province [115] 0 0
Duesseldorf
Country [116] 0 0
Germany
State/province [116] 0 0
Erfurt
Country [117] 0 0
Germany
State/province [117] 0 0
Frankfurt am Main
Country [118] 0 0
Germany
State/province [118] 0 0
Freiburg
Country [119] 0 0
Germany
State/province [119] 0 0
Georgsmarienhuette
Country [120] 0 0
Germany
State/province [120] 0 0
Hameln
Country [121] 0 0
Germany
State/province [121] 0 0
Hannover
Country [122] 0 0
Germany
State/province [122] 0 0
Heidelberg
Country [123] 0 0
Germany
State/province [123] 0 0
Kempten
Country [124] 0 0
Germany
State/province [124] 0 0
Kiel
Country [125] 0 0
Germany
State/province [125] 0 0
Luebeck
Country [126] 0 0
Germany
State/province [126] 0 0
Magdeburg
Country [127] 0 0
Germany
State/province [127] 0 0
Mainz
Country [128] 0 0
Germany
State/province [128] 0 0
Muenchen
Country [129] 0 0
Germany
State/province [129] 0 0
Offenbach
Country [130] 0 0
Germany
State/province [130] 0 0
Oldenburg
Country [131] 0 0
Germany
State/province [131] 0 0
Recklinghausen
Country [132] 0 0
Germany
State/province [132] 0 0
Tuebingen
Country [133] 0 0
Germany
State/province [133] 0 0
Vechta
Country [134] 0 0
Germany
State/province [134] 0 0
Westerstede
Country [135] 0 0
Germany
State/province [135] 0 0
Wiesbaden
Country [136] 0 0
Germany
State/province [136] 0 0
Witten
Country [137] 0 0
Greece
State/province [137] 0 0
Creete
Country [138] 0 0
Greece
State/province [138] 0 0
Crete
Country [139] 0 0
Greece
State/province [139] 0 0
Alexandroúpoli
Country [140] 0 0
Greece
State/province [140] 0 0
Athens
Country [141] 0 0
Greece
State/province [141] 0 0
Larissa
Country [142] 0 0
Greece
State/province [142] 0 0
Rio Patras
Country [143] 0 0
Greece
State/province [143] 0 0
Thessaloniki
Country [144] 0 0
Hong Kong
State/province [144] 0 0
Wanchai
Country [145] 0 0
Hong Kong
State/province [145] 0 0
Hong Kong
Country [146] 0 0
Hungary
State/province [146] 0 0
Budapest
Country [147] 0 0
Hungary
State/province [147] 0 0
Gyula
Country [148] 0 0
Hungary
State/province [148] 0 0
Kaposvar
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Westcliff-on-Sea

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Puma Biotechnology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00878709
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Development Chief Medical and Scientific Officer
Address 0 0
Puma Biotechnology, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications