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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
3144A2-3005 / B1891005
Universal Trial Number (UTN)
Trial acronym
NEFERTT
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
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival
Timepoint [1] 0 0
From randomization to disease progression or death, assessed up to 5.3 years
Secondary outcome [1] 0 0
Objective Response Rate
Timepoint [1] 0 0
From randomization to disease progression or last tumor assessment, assessed up to 5.3 years
Secondary outcome [2] 0 0
Duration of Response
Timepoint [2] 0 0
From first response to first PD or death, assessed up to 5.3 years after first subject randomized
Secondary outcome [3] 0 0
Clinical Benefit Rate
Timepoint [3] 0 0
From randomization to disease progression or death, assessed up to 5.3 years
Secondary outcome [4] 0 0
Symptomatic or Progressive Central Nervous System (CNS) Lesions
Timepoint [4] 0 0
From randomization to disease progression PD or last tumor assessment, assessed up to 5.3 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
21/08/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/06/2018
Sample size
Target
Accrual to date
Final
479
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - North Adelaide
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
5011 - North Adelaide
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
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United States of America
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California
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Connecticut
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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
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.
Trial website
https://clinicaltrials.gov/study/NCT00915018
Trial related presentations / publications
Awada A, Colomer R, Inoue K, Bondarenko I, Badwe RA, Demetriou G, Lee SC, Mehta AO, Kim SB, Bachelot T, Goswami C, Deo S, Bose R, Wong A, Xu F, Yao B, Bryce R, Carey LA. Neratinib Plus Paclitaxel vs Trastuzumab Plus Paclitaxel in Previously Untreated Metastatic ERBB2-Positive Breast Cancer: The NEfERT-T Randomized Clinical Trial. JAMA Oncol. 2016 Dec 1;2(12):1557-1564. doi: 10.1001/jamaoncol.2016.0237.
Public notes

Contacts
Principal investigator
Name 0 0
Puma
Address 0 0
Biotechnology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00915018