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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00878709
Registration number
NCT00878709
Ethics application status
Date submitted
8/04/2009
Date registered
9/04/2009
Date last updated
11/06/2021
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]
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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
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0
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Condition category
Condition code
Cancer
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0
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - neratinib
Other interventions - placebo
Experimental: Neratinib - 240 mg orally daily for one year
Placebo Comparator: Placebo - orally daily for one year
Treatment: Drugs: neratinib
Other interventions: placebo
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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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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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From randomization until time of event up to 2 years
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Primary outcome [2]
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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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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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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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From randomization until time of event up to 2 years
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Secondary outcome [3]
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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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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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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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From randomization until time of event up to 2 years
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Secondary outcome [7]
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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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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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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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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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Country [118]
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Germany
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Erfurt
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Germany
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Frankfurt am Main
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Germany
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Freiburg
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Germany
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Georgsmarienhuette
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Germany
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Hameln
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Kempten
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Germany
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Kiel
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Germany
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Luebeck
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Germany
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Magdeburg
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Germany
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Mainz
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Germany
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Muenchen
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Germany
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Offenbach
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Germany
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Oldenburg
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Germany
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Recklinghausen
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Germany
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Tuebingen
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Germany
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Vechta
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Germany
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Westerstede
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Germany
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Wiesbaden
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Germany
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Witten
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Greece
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Creete
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Greece
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Crete
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Greece
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Alexandroúpoli
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Greece
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Athens
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Greece
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Larissa
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Greece
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Rio Patras
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Greece
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Thessaloniki
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Hong Kong
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Wanchai
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Hungary
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Gyula
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Hungary
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Kaposvar
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Hungary
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Kecskemet
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Hungary
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Miskolc
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Hungary
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Nyiregyhaza
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Hungary
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Beer Sheva
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Israel
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Haifa
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Israel
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Rehovot
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Israel
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Tel Hashomer
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Italy
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Avellino
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Italy
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Brindisi
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Italy
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Catania
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Italy
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Catanzaro
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Italy
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Monza
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Italy
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Napoli
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Italy
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Orbassano (TO)
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Italy
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Padova
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Italy
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Pisa
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Italy
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Reggio Calabria
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Italy
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Roma
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Italy
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Sora (FR)
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Italy
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Terni
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Italy
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Treviglio, BG
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Italy
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Viagrande (CT)
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Italy
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Viterbo
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Hiroshima
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kagoshima
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Japan
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Kanagawa
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Japan
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Kumamoto
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Japan
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Kyoto
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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Tochigi
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Japan
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Tokyo
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Korea, Republic of
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Korea
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Malaysia
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Kuala Lumpur
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Floriana
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Amstelveen
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Apeldoorn
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Breda
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Netherlands
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Den Haag
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Netherlands
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Eindhoven
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Netherlands
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Schiedam
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Netherlands
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Auckland
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North Macedonia
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Skopje
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Peru
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Lima
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Gdynia
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Poland
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Jelenia Gora
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Poland
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Krakow
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Poland
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Olsztyn
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Poland
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Tarnow
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Poland
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Warszawa
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Romania
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Cluj
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Romania
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Dolj
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Romania
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Bucuresti
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Serbia
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Belgrade
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Serbia
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Nis
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Singapore
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Singapore
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Poprad
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Alicante
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Barcelona
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Spain
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Huesca
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Spain
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Islas Baleares
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Spain
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Madrid
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Spain
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Santa Cruz De Tenerife
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Spain
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Vizcaya
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Spain
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A Coruna
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Spain
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Caceres
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Spain
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Cadiz
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Spain
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Castellon
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Spain
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Cordoba
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Spain
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Girona
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Spain
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Guadalajara
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Spain
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Jaen
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Spain
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Las Palmas de Gran Canaria
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Spain
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Lleida
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Spain
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Malaga
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Spain
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Santa Cruz de Tenerife
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Spain
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Sevilla
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Spain
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Toledo
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Spain
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Valencia
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Spain
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Zamora
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Spain
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Zaragoza
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Sweden
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Lund
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Switzerland
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Aarau
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Switzerland
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Baden
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Switzerland
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Olten
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Switzerland
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Thun
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Taiwan
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Kaohsiung
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Taiwan
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Kwei-Shan, Taoyuan
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Taiwan
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Taipei TOC
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Turkey
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Turkey
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Bornova/Izmir
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Turkey
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Capa/Istanbul
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Turkey
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Cerrahpasa/Istanbul
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Turkey
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Demetevler/Ankara
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Turkey
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Gorukle/Bursa
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Turkey
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Inciralti/Izmir
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Country [267]
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Turkey
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Istanbul
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Turkey
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Sehitkamil/Gaziantep
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Turkey
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Sihhiye/Ankara
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Country [270]
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United Kingdom
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Denbighshire
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United Kingdom
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Staffs
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United Kingdom
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Leeds
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Norwich
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United Kingdom
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Nottingham
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United Kingdom
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Sheffield
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Country [279]
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United Kingdom
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Swansea
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Country [280]
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0
United Kingdom
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State/province [280]
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0
Westcliff-on-Sea
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Puma Biotechnology, Inc.
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Address
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Country
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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/ct2/show/NCT00878709
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Senior Vice President Clinical Science and Pharmacology
Query!
Address
0
0
Puma Biotechnology, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
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Email
0
0
Query!
Contact person for public queries
Name
0
0
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Address
0
0
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Country
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0
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Phone
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0
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Fax
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0
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Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00878709
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