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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00878709
Registration number
NCT00878709
Ethics application status
Date submitted
8/04/2009
Date registered
9/04/2009
Titles & IDs
Public title
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
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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
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Secondary ID [1]
0
0
3144A2-3004 / B1891004
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Universal Trial Number (UTN)
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Trial acronym
ExteNET
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Neratinib - 240 mg orally daily for one year
Placebo comparator: Placebo - orally daily for one year
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
0
0
Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2
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Assessment method [1]
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0
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.
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Timepoint [1]
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0
From randomization until time of event up to 2 years
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Primary outcome [2]
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0
Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms
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Assessment method [2]
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0
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Timepoint [2]
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From randomization until time of event up to 2 years
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS was defined as the time from randomization to death due to any cause, censored at the last date known alive.
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Timepoint [1]
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Randomization until death due to any cause (up to 119 Months)
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Secondary outcome [2]
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Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 2
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Assessment method [2]
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0
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.
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Timepoint [2]
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0
From randomization until time of event up to 2 years
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Secondary outcome [3]
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0
Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms
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Assessment method [3]
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0
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Timepoint [3]
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From randomization until time of event up to 2 years
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Secondary outcome [4]
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Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 2
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Assessment method [4]
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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.
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Timepoint [4]
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From randomization until time of event up to 2 years
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Secondary outcome [5]
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Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms
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Assessment method [5]
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0
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Timepoint [5]
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From randomization until time of event up to 2 years
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Secondary outcome [6]
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Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 2
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Assessment method [6]
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Percentage of Participants with TTDR events is reported. TTDR is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer.
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Timepoint [6]
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0
From randomization until time of event up to 2 years
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Secondary outcome [7]
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0
Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms
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Assessment method [7]
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0
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Timepoint [7]
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From randomization until time of event up to 2 years
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Secondary outcome [8]
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0
Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm at Year 2
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Assessment method [8]
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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.
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Timepoint [8]
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From randomization until time of event up to 2 years
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Secondary outcome [9]
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Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2
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Assessment method [9]
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Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).
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Timepoint [9]
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From randomization until time of event up to 2 years
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/07/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/10/2019
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Sample size
Target
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Accrual to date
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Final
2840
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Sydney West Cancer Trials Centre - Sydney
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Recruitment hospital [2]
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Iron Cancer Care South Brisbane - South Brisbane
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Recruitment hospital [3]
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The Queen Elizabeth Hospital - Adelaide
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Recruitment hospital [4]
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Ashford Cancer Centre Research - Kurralta Park
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Recruitment hospital [5]
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North Adelaide Oncology Calvary Hospital North Adelaide - North Adelaide
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Recruitment hospital [6]
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [7]
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The Western Hospital - Melbourne
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Recruitment hospital [8]
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Hollywood Private Hospital - Nedlands
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Recruitment postcode(s) [1]
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2145 - Sydney
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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5011 - Adelaide
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Recruitment postcode(s) [4]
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5037 - Kurralta Park
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Recruitment postcode(s) [5]
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5006 - North Adelaide
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Recruitment postcode(s) [6]
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3050 - Melbourne
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Alabama
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Erfurt
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Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Frankfurt am Main
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Freiburg
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Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Georgsmarienhuette
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Hameln
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Hannover
Query!
Country [124]
0
0
Germany
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State/province [124]
0
0
Heidelberg
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Kempten
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Kiel
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Luebeck
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Country [128]
0
0
Germany
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State/province [128]
0
0
Magdeburg
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Country [129]
0
0
Germany
Query!
State/province [129]
0
0
Mainz
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Muenchen
Query!
Country [131]
0
0
Germany
Query!
State/province [131]
0
0
Offenbach
Query!
Country [132]
0
0
Germany
Query!
State/province [132]
0
0
Oldenburg
Query!
Country [133]
0
0
Germany
Query!
State/province [133]
0
0
Recklinghausen
Query!
Country [134]
0
0
Germany
Query!
State/province [134]
0
0
Tuebingen
Query!
Country [135]
0
0
Germany
Query!
State/province [135]
0
0
Vechta
Query!
Country [136]
0
0
Germany
Query!
State/province [136]
0
0
Westerstede
Query!
Country [137]
0
0
Germany
Query!
State/province [137]
0
0
Wiesbaden
Query!
Country [138]
0
0
Germany
Query!
State/province [138]
0
0
Witten
Query!
Country [139]
0
0
Greece
Query!
State/province [139]
0
0
Creete
Query!
Country [140]
0
0
Greece
Query!
State/province [140]
0
0
Crete
Query!
Country [141]
0
0
Greece
Query!
State/province [141]
0
0
Alexandroúpoli
Query!
Country [142]
0
0
Greece
Query!
State/province [142]
0
0
Athens
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Country [143]
0
0
Greece
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State/province [143]
0
0
Larissa
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Country [144]
0
0
Greece
Query!
State/province [144]
0
0
Rio Patras
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Country [145]
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0
Greece
Query!
State/province [145]
0
0
Thessaloniki
Query!
Country [146]
0
0
Hong Kong
Query!
State/province [146]
0
0
Wanchai
Query!
Country [147]
0
0
Hong Kong
Query!
State/province [147]
0
0
Hong Kong
Query!
Country [148]
0
0
Hungary
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State/province [148]
0
0
Budapest
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Country [149]
0
0
Hungary
Query!
State/province [149]
0
0
Gyula
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Country [150]
0
0
Hungary
Query!
State/province [150]
0
0
Kaposvar
Query!
Country [151]
0
0
Hungary
Query!
State/province [151]
0
0
Kecskemet
Query!
Country [152]
0
0
Hungary
Query!
State/province [152]
0
0
Miskolc
Query!
Country [153]
0
0
Hungary
Query!
State/province [153]
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0
Nyiregyhaza
Query!
Country [154]
0
0
Hungary
Query!
State/province [154]
0
0
Veszprem
Query!
Country [155]
0
0
Israel
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State/province [155]
0
0
Beer Sheva
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Country [156]
0
0
Israel
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State/province [156]
0
0
Haifa
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Country [157]
0
0
Israel
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State/province [157]
0
0
Rehovot
Query!
Country [158]
0
0
Israel
Query!
State/province [158]
0
0
Tel Hashomer
Query!
Country [159]
0
0
Italy
Query!
State/province [159]
0
0
Avellino
Query!
Country [160]
0
0
Italy
Query!
State/province [160]
0
0
Brindisi
Query!
Country [161]
0
0
Italy
Query!
State/province [161]
0
0
Catania
Query!
Country [162]
0
0
Italy
Query!
State/province [162]
0
0
Catanzaro
Query!
Country [163]
0
0
Italy
Query!
State/province [163]
0
0
Monza
Query!
Country [164]
0
0
Italy
Query!
State/province [164]
0
0
Napoli
Query!
Country [165]
0
0
Italy
Query!
State/province [165]
0
0
Orbassano (TO)
Query!
Country [166]
0
0
Italy
Query!
State/province [166]
0
0
Padova
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Country [167]
0
0
Italy
Query!
State/province [167]
0
0
Pisa
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Country [168]
0
0
Italy
Query!
State/province [168]
0
0
Reggio Calabria
Query!
Country [169]
0
0
Italy
Query!
State/province [169]
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0
Roma
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Country [170]
0
0
Italy
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State/province [170]
0
0
Sora (FR)
Query!
Country [171]
0
0
Italy
Query!
State/province [171]
0
0
Terni
Query!
Country [172]
0
0
Italy
Query!
State/province [172]
0
0
Treviglio, BG
Query!
Country [173]
0
0
Italy
Query!
State/province [173]
0
0
Viagrande (CT)
Query!
Country [174]
0
0
Italy
Query!
State/province [174]
0
0
Viterbo
Query!
Country [175]
0
0
Japan
Query!
State/province [175]
0
0
Aichi
Query!
Country [176]
0
0
Japan
Query!
State/province [176]
0
0
Chiba
Query!
Country [177]
0
0
Japan
Query!
State/province [177]
0
0
Ehime
Query!
Country [178]
0
0
Japan
Query!
State/province [178]
0
0
Fukuoka
Query!
Country [179]
0
0
Japan
Query!
State/province [179]
0
0
Hiroshima
Query!
Country [180]
0
0
Japan
Query!
State/province [180]
0
0
Hokkaido
Query!
Country [181]
0
0
Japan
Query!
State/province [181]
0
0
Hyogo
Query!
Country [182]
0
0
Japan
Query!
State/province [182]
0
0
Kagoshima
Query!
Country [183]
0
0
Japan
Query!
State/province [183]
0
0
Kanagawa
Query!
Country [184]
0
0
Japan
Query!
State/province [184]
0
0
Kumamoto
Query!
Country [185]
0
0
Japan
Query!
State/province [185]
0
0
Kyoto
Query!
Country [186]
0
0
Japan
Query!
State/province [186]
0
0
Niigata
Query!
Country [187]
0
0
Japan
Query!
State/province [187]
0
0
Osaka
Query!
Country [188]
0
0
Japan
Query!
State/province [188]
0
0
Saitama
Query!
Country [189]
0
0
Japan
Query!
State/province [189]
0
0
Shizuoka
Query!
Country [190]
0
0
Japan
Query!
State/province [190]
0
0
Tochigi
Query!
Country [191]
0
0
Japan
Query!
State/province [191]
0
0
Tokyo
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Country [192]
0
0
Korea, Republic of
Query!
State/province [192]
0
0
Korea
Query!
Country [193]
0
0
Korea, Republic of
Query!
State/province [193]
0
0
Gyeonggi-do
Query!
Country [194]
0
0
Korea, Republic of
Query!
State/province [194]
0
0
Seoul
Query!
Country [195]
0
0
Lithuania
Query!
State/province [195]
0
0
Kaunas
Query!
Country [196]
0
0
Lithuania
Query!
State/province [196]
0
0
Vilnius
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Country [197]
0
0
Malaysia
Query!
State/province [197]
0
0
Kuala Lumpur
Query!
Country [198]
0
0
Malta
Query!
State/province [198]
0
0
Floriana
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Country [199]
0
0
Mexico
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State/province [199]
0
0
Jalisco
Query!
Country [200]
0
0
Netherlands
Query!
State/province [200]
0
0
Amstelveen
Query!
Country [201]
0
0
Netherlands
Query!
State/province [201]
0
0
Apeldoorn
Query!
Country [202]
0
0
Netherlands
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State/province [202]
0
0
Breda
Query!
Country [203]
0
0
Netherlands
Query!
State/province [203]
0
0
Den Haag
Query!
Country [204]
0
0
Netherlands
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State/province [204]
0
0
Eindhoven
Query!
Country [205]
0
0
Netherlands
Query!
State/province [205]
0
0
Schiedam
Query!
Country [206]
0
0
Netherlands
Query!
State/province [206]
0
0
Sittard-Geleen
Query!
Country [207]
0
0
New Zealand
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State/province [207]
0
0
Auckland
Query!
Country [208]
0
0
North Macedonia
Query!
State/province [208]
0
0
Skopje
Query!
Country [209]
0
0
Peru
Query!
State/province [209]
0
0
Lima
Query!
Country [210]
0
0
Poland
Query!
State/province [210]
0
0
Bialystok
Query!
Country [211]
0
0
Poland
Query!
State/province [211]
0
0
Bydgoszcz
Query!
Country [212]
0
0
Poland
Query!
State/province [212]
0
0
Gdansk
Query!
Country [213]
0
0
Poland
Query!
State/province [213]
0
0
Gdynia
Query!
Country [214]
0
0
Poland
Query!
State/province [214]
0
0
Jelenia Gora
Query!
Country [215]
0
0
Poland
Query!
State/province [215]
0
0
Krakow
Query!
Country [216]
0
0
Poland
Query!
State/province [216]
0
0
Olsztyn
Query!
Country [217]
0
0
Poland
Query!
State/province [217]
0
0
Tarnow
Query!
Country [218]
0
0
Poland
Query!
State/province [218]
0
0
Warszawa
Query!
Country [219]
0
0
Romania
Query!
State/province [219]
0
0
Cluj
Query!
Country [220]
0
0
Romania
Query!
State/province [220]
0
0
Dolj
Query!
Country [221]
0
0
Romania
Query!
State/province [221]
0
0
Bucuresti
Query!
Country [222]
0
0
Serbia
Query!
State/province [222]
0
0
Belgrade
Query!
Country [223]
0
0
Serbia
Query!
State/province [223]
0
0
Nis
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Country [224]
0
0
Singapore
Query!
State/province [224]
0
0
Singapore
Query!
Country [225]
0
0
Slovakia
Query!
State/province [225]
0
0
Bratislava
Query!
Country [226]
0
0
Slovakia
Query!
State/province [226]
0
0
Kosice
Query!
Country [227]
0
0
Slovakia
Query!
State/province [227]
0
0
Poprad
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Country [228]
0
0
Spain
Query!
State/province [228]
0
0
Alicante
Query!
Country [229]
0
0
Spain
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State/province [229]
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0
Barcelona
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Country [230]
0
0
Spain
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State/province [230]
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0
Huesca
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Country [231]
0
0
Spain
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State/province [231]
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0
Islas Baleares
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Country [232]
0
0
Spain
Query!
State/province [232]
0
0
Madrid
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Country [233]
0
0
Spain
Query!
State/province [233]
0
0
Santa Cruz De Tenerife
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Country [234]
0
0
Spain
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State/province [234]
0
0
Vizcaya
Query!
Country [235]
0
0
Spain
Query!
State/province [235]
0
0
A Coruna
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Country [236]
0
0
Spain
Query!
State/province [236]
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0
Caceres
Query!
Country [237]
0
0
Spain
Query!
State/province [237]
0
0
Cadiz
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Country [238]
0
0
Spain
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State/province [238]
0
0
Castellon
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Country [239]
0
0
Spain
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State/province [239]
0
0
Cordoba
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Country [240]
0
0
Spain
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State/province [240]
0
0
Girona
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Country [241]
0
0
Spain
Query!
State/province [241]
0
0
Guadalajara
Query!
Country [242]
0
0
Spain
Query!
State/province [242]
0
0
Jaen
Query!
Country [243]
0
0
Spain
Query!
State/province [243]
0
0
Las Palmas de Gran Canaria
Query!
Country [244]
0
0
Spain
Query!
State/province [244]
0
0
Lleida
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Country [245]
0
0
Spain
Query!
State/province [245]
0
0
Malaga
Query!
Country [246]
0
0
Spain
Query!
State/province [246]
0
0
Santa Cruz de Tenerife
Query!
Country [247]
0
0
Spain
Query!
State/province [247]
0
0
Sevilla
Query!
Country [248]
0
0
Spain
Query!
State/province [248]
0
0
Toledo
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Country [249]
0
0
Spain
Query!
State/province [249]
0
0
Valencia
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Country [250]
0
0
Spain
Query!
State/province [250]
0
0
Zamora
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Country [251]
0
0
Spain
Query!
State/province [251]
0
0
Zaragoza
Query!
Country [252]
0
0
Sweden
Query!
State/province [252]
0
0
Lund
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Country [253]
0
0
Switzerland
Query!
State/province [253]
0
0
Aarau
Query!
Country [254]
0
0
Switzerland
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State/province [254]
0
0
Baden
Query!
Country [255]
0
0
Switzerland
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State/province [255]
0
0
Olten
Query!
Country [256]
0
0
Switzerland
Query!
State/province [256]
0
0
Thun
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Country [257]
0
0
Taiwan
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State/province [257]
0
0
Kaohsiung
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Country [258]
0
0
Taiwan
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State/province [258]
0
0
Kwei-Shan, Taoyuan
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Country [259]
0
0
Taiwan
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State/province [259]
0
0
Taipei TOC
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Country [260]
0
0
Turkey
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State/province [260]
0
0
Besevler/Ankara
Query!
Country [261]
0
0
Turkey
Query!
State/province [261]
0
0
Bornova/Izmir
Query!
Country [262]
0
0
Turkey
Query!
State/province [262]
0
0
Capa/Istanbul
Query!
Country [263]
0
0
Turkey
Query!
State/province [263]
0
0
Cerrahpasa/Istanbul
Query!
Country [264]
0
0
Turkey
Query!
State/province [264]
0
0
Demetevler/Ankara
Query!
Country [265]
0
0
Turkey
Query!
State/province [265]
0
0
Gorukle/Bursa
Query!
Country [266]
0
0
Turkey
Query!
State/province [266]
0
0
Inciralti/Izmir
Query!
Country [267]
0
0
Turkey
Query!
State/province [267]
0
0
Istanbul
Query!
Country [268]
0
0
Turkey
Query!
State/province [268]
0
0
Sehitkamil/Gaziantep
Query!
Country [269]
0
0
Turkey
Query!
State/province [269]
0
0
Sihhiye/Ankara
Query!
Country [270]
0
0
United Kingdom
Query!
State/province [270]
0
0
Denbighshire
Query!
Country [271]
0
0
United Kingdom
Query!
State/province [271]
0
0
Staffs
Query!
Country [272]
0
0
United Kingdom
Query!
State/province [272]
0
0
Leeds
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Country [273]
0
0
United Kingdom
Query!
State/province [273]
0
0
Leicester
Query!
Country [274]
0
0
United Kingdom
Query!
State/province [274]
0
0
London
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Country [275]
0
0
United Kingdom
Query!
State/province [275]
0
0
Manchester
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Country [276]
0
0
United Kingdom
Query!
State/province [276]
0
0
Norwich
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Country [277]
0
0
United Kingdom
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State/province [277]
0
0
Nottingham
Query!
Country [278]
0
0
United Kingdom
Query!
State/province [278]
0
0
Sheffield
Query!
Country [279]
0
0
United Kingdom
Query!
State/province [279]
0
0
Swansea
Query!
Country [280]
0
0
United Kingdom
Query!
State/province [280]
0
0
Westcliff-on-Sea
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Puma Biotechnology, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00878709
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Trial related presentations / publications
Iwata H, Masuda N, Kim SB, Inoue K, Rai Y, Fujita T, Chiu J, Ohtani S, Takahashi M, Miyaki T, Lu YS, Xu B, Yap YS, Bustam A, Yao B, Zhang B, Bryce R, Chan A. Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer. Future Oncol. 2019 Jul;15(21):2489-2501. doi: 10.2217/fon-2019-0143. Epub 2019 May 29. Chia SKL, Martin M, Holmes FA, Ejlertsen B, Delaloge S, Moy B, Iwata H, von Minckwitz G, Mansi J, Barrios CH, Gnant M, Tomasevic Z, Denduluri N, Separovic R, Kim SB, Jakobsen EH, Harvey V, Robert N, Smith J 2nd, Harker G, Zhang B, Eli LD, Ye Y, Lalani AS, Buyse M, Chan A. PIK3CA alterations and benefit with neratinib: analysis from the randomized, double-blind, placebo-controlled, phase III ExteNET trial. Breast Cancer Res. 2019 Mar 11;21(1):39. doi: 10.1186/s13058-019-1115-2. Mortimer J, Di Palma J, Schmid K, Ye Y, Jahanzeb M. Patterns of occurrence and implications of neratinib-associated diarrhea in patients with HER2-positive breast cancer: analyses from the randomized phase III ExteNET trial. Breast Cancer Res. 2019 Feb 27;21(1):32. doi: 10.1186/s13058-019-1112-5. Delaloge S, Cella D, Ye Y, Buyse M, Chan A, Barrios CH, Holmes FA, Mansi J, Iwata H, Ejlertsen B, Moy B, Chia SKL, Gnant M, Smichkoska S, Ciceniene A, Martinez N, Filipovic S, Ben-Baruch NE, Joy AA, Langkjer ST, Senecal F, de Boer RH, Moran S, Yao B, Bryce R, Auerbach A, Fallowfield L, Martin M. Effects of neratinib on health-related quality of life in women with HER2-positive early-stage breast cancer: longitudinal analyses from the randomized phase III ExteNET trial. Ann Oncol. 2019 Apr 1;30(4):567-574. doi: 10.1093/annonc/mdz016. Martin M, Holmes FA, Ejlertsen B, Delaloge S, Moy B, Iwata H, von Minckwitz G, Chia SKL, Mansi J, Barrios CH, Gnant M, Tomasevic Z, Denduluri N, Separovic R, Gokmen E, Bashford A, Ruiz Borrego M, Kim SB, Jakobsen EH, Ciceniene A, Inoue K, Overkamp F, Heijns JB, Armstrong AC, Link JS, Joy AA, Bryce R, Wong A, Moran S, Yao B, Xu F, Auerbach A, Buyse M, Chan A; ExteNET Study Group. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1688-1700. doi: 10.1016/S1470-2045(17)30717-9. Epub 2017 Nov 13. Chan A, Delaloge S, Holmes FA, Moy B, Iwata H, Harvey VJ, Robert NJ, Silovski T, Gokmen E, von Minckwitz G, Ejlertsen B, Chia SKL, Mansi J, Barrios CH, Gnant M, Buyse M, Gore I, Smith J 2nd, Harker G, Masuda N, Petrakova K, Zotano AG, Iannotti N, Rodriguez G, Tassone P, Wong A, Bryce R, Ye Y, Yao B, Martin M; ExteNET Study Group. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):367-377. doi: 10.1016/S1470-2045(15)00551-3. Epub 2016 Feb 10.
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Contacts
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Senior Vice President Clinical Science and Pharmacology
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Puma Biotechnology, Inc.
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.
In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.
Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.
Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to
[email protected]
for consideration.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
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Available to whom?
Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.
Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://pumabiotechnology.com/data_sharing_policy.html
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00878709