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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.
Timepoint [1] 0 0
From randomization date to progression or death, assessed up to 69 months
Secondary outcome [1] 0 0
Overall Survival (OS) - Overall Survival (OS) was defined as the time from randomization to death due to any cause. Subjects last known to be alive were censored at the last date of last contact or the data cutoff employed for the analysis, whichever was earlier.
Timepoint [1] 0 0
From randomization date to death, assessed up to 69 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR). - Objective Response Rate, investigator assessment. The ORR was defined as the percentage of participants demonstrating a confirmed objective response, either Complete Response (CR) or Partial Response (PR) during the study per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: 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.
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 - Clinical benefit rate (CR, PR, or SD = 24 weeks) for women For ErbB2 Positive Advanced Breast Cancer. Clinical benefit rate was the percentage of subjects who achieved overall tumor 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; 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.
Clinical Benefit (CB) = CR + PR + SD >= 24 weeks.
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 - Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death. For subjects without death or progression, censorship was at the last valid tumor assessment 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.
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) - The percent of patients with symptomatic or progressive CNS lesions was the proportion of subjects who had PD considering CNS lesions only, according to RECIST criteria.
Timepoint [5] 0 0
From randomization date to first CNS symptom or lesions
Secondary outcome [6] 0 0
Time to CNS Metastases - Time to symptomatic or progressive Central nervous system (CNS) lesions. Time to symptomatic or progressive CNS lesions was the time from the date of randomization until the date of progressive disease (PD) considering CNS lesions only (ie, appearance of newly diagnosed CNS lesions or progressive CNS lesions).
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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Arizona
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California
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Wien
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Sofia
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Varna
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Quebec
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Varazdin
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Zagreb
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Olomouc
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France
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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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Villejuif
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Hamburg
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Heidelberg
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Greece
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Hong Kong
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Hungary
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Budapest
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Kecskemet
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Sochi
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Winterthur
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Essex
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Puma Biotechnology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib
and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced
breast cancer. The goal of this study is to compare the two regimens in shrinking tumors and
extending the lives of women with erbB2 (HER2) positive breast cancer. The study will also
compare the safety of the two regimens and to compare quality of life of patients taking the
two regimens.
Trial website
https://clinicaltrials.gov/show/NCT00777101
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

Summary results
Other publications