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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
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
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Neratinib - 240 mg orally daily for one year

Placebo comparator: Placebo - orally daily for one year
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2
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
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization until death due to any cause (up to 119 Months)
Secondary outcome [2] 0 0
Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 2
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 at Year 2
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
Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 2
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 at Year 2
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
Timepoint [9] 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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/10/2019
Sample size
Target
Accrual to date
Final
2840
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
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Jelenia Gora
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Tarnow
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Cluj
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Dolj
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Puma Biotechnology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Senior Vice President Clinical Science and Pharmacology
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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 clinicaltrials@pumabiotechnology.com for consideration.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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.
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://pumabiotechnology.com/data_sharing_policy.html


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