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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/NCT00915018
Registration number
NCT00915018
Ethics application status
Date submitted
4/06/2009
Date registered
5/06/2009
Date last updated
22/08/2018
Titles & IDs
Public title
Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
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Scientific title
A Randomized, Open-Label, Two-Arm Study Of Neratinib Plus Paclitaxel Versus Trastuzumab Plus Paclitaxel As First-Line Treatment For ErbB-2-Positive Locally Recurrent Or Metastatic Breast Cancer
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Secondary ID [1]
0
0
3144A2-3005 / B1891005
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Universal Trial Number (UTN)
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Trial acronym
NEFERTT
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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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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
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Paclitaxel
Experimental: neratinib plus paclitaxel -
Active Comparator: trastuzumab plus paclitaxel -
Treatment: Drugs: Neratinib
Neratinib - 240 mg orally daily, administered once daily. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Treatment: Drugs: Trastuzumab
Trastuzumab - 4 mg/kg IV initial loading dose followed by subsequent once weekly doses of 2mg/kg IV. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
Treatment: Drugs: Paclitaxel
Paclitaxel - 80 mg/m² IV administered on days 1, 8, and 15 of a 28-day cycle. Treatment will be administered until documented disease progression, symptomatic deterioration, unacceptable toxicity, death or withdrawal of consent.
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Intervention code [1]
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Treatment: Drugs
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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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Progression-Free Survival
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Assessment method [1]
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Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy.
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Timepoint [1]
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From randomization to disease progression or death, assessed up to 5.3 years
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Secondary outcome [1]
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Objective Response Rate
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Assessment method [1]
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Defined as the percentage of subjects who achieved confirmed tumor response (complete or partial response) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-Progressive Disease for non-target lesions, and no new lesions.
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Timepoint [1]
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From randomization to disease progression or last tumor assessment, assessed up to 5.3 years
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Secondary outcome [2]
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Duration of Response
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Assessment method [2]
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Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, disease progression (PD), or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
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Timepoint [2]
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From first response to first PD or death, assessed up to 5.3 years after first subject randomized
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Secondary outcome [3]
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Clinical Benefit Rate
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Assessment method [3]
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Defined as the proportion of patients who achieved overall tumor response (CR or PR) or SD for at least 24 weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
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Timepoint [3]
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From randomization to disease progression or death, assessed up to 5.3 years
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Secondary outcome [4]
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Symptomatic or Progressive Central Nervous System (CNS) Lesions
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Assessment method [4]
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Defined as the time interval from the date of randomization until the first date of CNS symptoms, the imaging examination shows CNS progression or is censored at the last assessable evaluation on study or prior to new anti-cancer therapy, if applicable.
If median time to Symptomatic or Progressive CNS Lesions is not estimable, cumulative incidence will be reported instead.
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Timepoint [4]
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From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 years
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Eligibility
Key inclusion criteria
- ErbB-2 positive locally recurrent or metastatic breast cancer
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Measurable disease
- Availability of tumor tissue for HER2 status confirmation
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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
- Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent
or metastatic disease
- Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or
adjuvant setting
- Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant
therapy
- History of heart disease
- History of gastrointestinal disease
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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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
21/08/2009
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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
28/06/2018
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Sample size
Target
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Accrual to date
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Final
479
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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The Queen Elizabeth Hospital - North Adelaide
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Recruitment hospital [2]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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5011 - North Adelaide
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Recruitment postcode(s) [2]
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3050 - Parkville
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Recruitment outside Australia
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Chernivtsi
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Country [133]
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Ukraine
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State/province [133]
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Dnipropetrovsk
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Country [134]
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Ukraine
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State/province [134]
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Donetsk
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Country [135]
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Ukraine
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State/province [135]
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Kharkiv
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Country [136]
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Ukraine
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State/province [136]
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Kyiv
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Country [137]
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Ukraine
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State/province [137]
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Lutsk
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Country [138]
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Ukraine
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State/province [138]
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Lviv
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Country [139]
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Ukraine
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State/province [139]
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Mariupil
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Country [140]
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Ukraine
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State/province [140]
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Sumy
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Country [141]
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United Kingdom
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State/province [141]
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London
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Country [142]
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United Kingdom
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State/province [142]
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Nottingham
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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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Ethics approval
Ethics application status
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Summary
Brief summary
This study is investigating the effects of an experimental drug (neratinib) in combination
with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women
who have not received previous treatment for erbB-2-positive locally recurrent or metastatic
breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors
and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will
also compare the safety of the two regimens and as well as the quality of life of subjects
receiving either regimen.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00915018
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Puma
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Address
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Biotechnology
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00915018
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