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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00777101




Registration number
NCT00777101
Ethics application status
Date submitted
21/10/2008
Date registered
22/10/2008
Date last updated
9/08/2018

Titles & IDs
Public title
Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer
Scientific title
A Phase 2 Randomized Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine For The Treatment Of ErbB-2 Positive Locally Advanced Or Metastatic Breast Cancer
Secondary ID [1] 0 0
3144A2-3003 / B1891003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Breast Cancer 0 0
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 - Lapatinib
Treatment: Drugs - Capecitabine

Experimental: Neratinib -

Active comparator: Lapatinib plus Capecitabine -


Treatment: Drugs: Neratinib
Tablets 240 mg orally once per day until disease progression or unacceptable toxicity

Treatment: Drugs: Lapatinib
Tablets 1250 mg orally once per day until disease progression or unacceptable toxicity.

Treatment: Drugs: Capecitabine
Tablets 2000 mg/m² given orally in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.
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 date to progression or death, assessed up to 69 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
From randomization date to death, assessed up to 69 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR).
Timepoint [2] 0 0
From randomization date to progression or last tumor assessment, assessed up to 69 months
Secondary outcome [3] 0 0
Clinical Benefit Rate
Timepoint [3] 0 0
From randomization date to progression or last tumor assessment, assessed up to 69 months
Secondary outcome [4] 0 0
Duration of Response
Timepoint [4] 0 0
From start date of response to first PD, assessed up to 69 months after the first subject was randomized.
Secondary outcome [5] 0 0
Frequency of CNS Metastases (Frequency)
Timepoint [5] 0 0
From randomization date to first CNS symptom or lesions
Secondary outcome [6] 0 0
Time to CNS Metastases
Timepoint [6] 0 0
From randomization date to first CNS symptom or lesions

Eligibility
Key inclusion criteria
* Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
* Prior use of Herceptin (trastuzumab), and a taxane
* Adequate cardiac and renal function
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) [Tyverb]
* Bone as the only site of disease
* Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
* Significant gastrointestinal disorder with diarrhea as 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
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
4/02/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/06/2018
Sample size
Target
Accrual to date
Final
233
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Mater Private Centre for HOCA - South Brisbane
Recruitment hospital [2] 0 0
Medical Oncology Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Western Hospital - Footscray
Recruitment hospital [4] 0 0
Mount Hospital - West Perth
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 0 0
6000 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
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New York
Country [11] 0 0
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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Pennsylvania
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United States of America
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Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
Austria
State/province [17] 0 0
Wien
Country [18] 0 0
Belgium
State/province [18] 0 0
Brussels
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Sofia
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Varna
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Croatia
State/province [23] 0 0
Varazdin
Country [24] 0 0
Croatia
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Zagreb
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Czechia
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Olomouc
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France
State/province [26] 0 0
Lille
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France
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Pierre Benite
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France
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Poitiers
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France
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Villejuif
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Germany
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Hamburg
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Germany
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Heidelberg
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Greece
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Thessaloníki
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Hong Kong
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Hong Kong
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Hungary
State/province [34] 0 0
Budapest
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Hungary
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Kecskemet
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Hungary
State/province [36] 0 0
Nyiregyhaza
Country [37] 0 0
Hungary
State/province [37] 0 0
Szeged
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Hungary
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Veszprem
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Italy
State/province [39] 0 0
Prato
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Italy
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Roma
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Japan
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Hokkaido
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Japan
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Tokyo
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Japan
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Aichi
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Japan
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Chiba
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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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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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Jordan
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Amman
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Korea, Republic of
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Gyeonggi-do
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Korea
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Korea, Republic of
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Seoul
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Mexico
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Nuevo Leon
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Poland
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Bialystok
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Poland
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Gdansk
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Poland
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Krakow
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Poland
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Lublin
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Puerto Rico
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San Juan
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Romania
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Bucuresti
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Romania
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Iasi
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Romania
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Sibiu
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Russian Federation
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Saint Petersburg
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Russian Federation
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Moscow
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Russian Federation
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Perm
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Russian Federation
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Ryazan
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Russian Federation
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Sochi
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Russian Federation
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Ufa
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Serbia
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Belgrade
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Singapore
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Singapore
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Slovenia
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Ljubljana
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South Africa
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Gauteng
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South Africa
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KwaZulu Natal
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South Africa
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Western Cape Province
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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A Coruña
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Spain
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Alicante
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Spain
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Caceres
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Spain
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Cordoba
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Spain
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Gerona
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Spain
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Jaen
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Spain
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Madrid
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Spain
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Valencia
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Spain
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Zaragoza
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Switzerland
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Lausanne
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Switzerland
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Winterthur
Country [95] 0 0
Switzerland
State/province [95] 0 0
Zuerich
Country [96] 0 0
Taiwan
State/province [96] 0 0
Taipei
Country [97] 0 0
Thailand
State/province [97] 0 0
Bangkok
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Essex
Country [99] 0 0
United Kingdom
State/province [99] 0 0
London

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/NCT00777101