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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
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
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United States of America
State/province [3] 0 0
Florida
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United States of America
State/province [4] 0 0
Georgia
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United States of America
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Illinois
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United States of America
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Louisiana
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Oregon
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United States of America
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Utah
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United States of America
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West Virginia
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Bahamas
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CB
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Belarus
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Minsk Region
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Belarus
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Gomel
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Belarus
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Grodno
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Belarus
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Vitebsk
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Belgium
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Brussels
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Canada
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Quebec
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China
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Guangdong
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China
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Zhejiang
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China
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Beijing
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China
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Shanghai
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China
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Tian Jin
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Croatia
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Osijek
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Croatia
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Zagreb
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Denmark
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Copenhagen
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France
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Creteil
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France
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Lyon
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France
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Montpellier
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France
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Paris
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France
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Perigueux
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France
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St. Brieuc
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France
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Strasbourg
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France
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Tours
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Germany
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Bamberg
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Hong Kong
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Chai Wan
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Hong Kong
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Hong Kong
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Hong Kong
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Wanchai
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Hungary
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Budapest
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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
State/province [52] 0 0
Miskolc
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Hungary
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Szeged
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India
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Delhi
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India
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Madhya Pradesh
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India
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Maharashtra
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India
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Rajasthan
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India
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Tamil Nadu
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India
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West Bengal
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Israel
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Rehovot
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Israel
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Tel Aviv
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Israel
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Zerifin
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Italy
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Modena
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Italy
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Pavia
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Italy
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Roma
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Italy
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Torino
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Japan
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Akashi-shi
Country [68] 0 0
Japan
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Beppu-shi
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Japan
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Bunkyo-ku
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Japan
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Chiba-shi
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Japan
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Fukuoka-shi
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Japan
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Higashiibaraki-gun
Country [73] 0 0
Japan
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Hiroshima-shi
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Japan
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Kagoshima-city
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Japan
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Kashiwa-shi
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Japan
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Kitaadachi-gun
Country [77] 0 0
Japan
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Kumamoto-city
Country [78] 0 0
Japan
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Kurume-Shi
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Japan
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Matsuyama-city
Country [80] 0 0
Japan
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Morioka-shi
Country [81] 0 0
Japan
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Nagoya-shi
Country [82] 0 0
Japan
State/province [82] 0 0
Nagoya
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Japan
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Niigata-shi
Country [84] 0 0
Japan
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Osaka-shi
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Japan
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Sapporo-shi
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Japan
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Sendai-city
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Japan
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Tenri-shi
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Japan
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Yokohama-City
Country [89] 0 0
Japan
State/province [89] 0 0
Hiroshima
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Japan
State/province [90] 0 0
Hyogo
Country [91] 0 0
Japan
State/province [91] 0 0
Kumamoto
Country [92] 0 0
Japan
State/province [92] 0 0
Osaka
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Japan
State/province [93] 0 0
Tochigi
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Japan
State/province [94] 0 0
Tokyo
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Korea, Republic of
State/province [95] 0 0
Gyeonggi-do
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Korea, Republic of
State/province [96] 0 0
Korea
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Korea, Republic of
State/province [97] 0 0
Seoul/Korea
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Latvia
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Liepaja
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Latvia
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Riga
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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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Malta
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Floriana
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Poland
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Dolnoslaskie
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Poland
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Mazowieckie
Country [106] 0 0
Poland
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Opolskie
Country [107] 0 0
Poland
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Warminsko-Mazurskie
Country [108] 0 0
Poland
State/province [108] 0 0
Bialystok
Country [109] 0 0
Portugal
State/province [109] 0 0
Lisboa
Country [110] 0 0
Romania
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Cluj
Country [111] 0 0
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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South Africa
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Eastern Cape
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South Africa
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Gauteng
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South Africa
State/province [118] 0 0
KwaZulu Natal
Country [119] 0 0
South Africa
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Western Cape
Country [120] 0 0
Spain
State/province [120] 0 0
Cataluna
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Spain
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Galicia
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Spain
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Illes Balears
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Vizcaya
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Switzerland
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Aarau
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Switzerland
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Thun
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Switzerland
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Winterthur
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Taiwan
State/province [129] 0 0
Taoyuan
Country [130] 0 0
Turkey
State/province [130] 0 0
Izmir
Country [131] 0 0
Ukraine
State/province [131] 0 0
Cherkassy
Country [132] 0 0
Ukraine
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Chernivtsi
Country [133] 0 0
Ukraine
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Dnipropetrovsk
Country [134] 0 0
Ukraine
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Donetsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
Country [137] 0 0
Ukraine
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Lutsk
Country [138] 0 0
Ukraine
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Lviv
Country [139] 0 0
Ukraine
State/province [139] 0 0
Mariupil
Country [140] 0 0
Ukraine
State/province [140] 0 0
Sumy
Country [141] 0 0
United Kingdom
State/province [141] 0 0
London
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Nottingham

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
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

No information has been provided regarding IPD availability


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/NCT00915018