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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/NCT01808573
Registration number
NCT01808573
Ethics application status
Date submitted
4/03/2013
Date registered
11/03/2013
Date last updated
11/06/2021
Titles & IDs
Public title
A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting
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Scientific title
A STUDY OF NERATINIB PLUS CAPECITABINE VERSUS LAPATINIB PLUS CAPECITABINE IN PATIENTS WITH HER2+ METASTATIC BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR HER2-DIRECTED REGIMENS IN THE METASTATIC SETTING (NALA)
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Secondary ID [1]
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2012-004492-38
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Secondary ID [2]
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PUMA-NER-1301
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Universal Trial Number (UTN)
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Trial acronym
NALA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HER2+ Metastatic Breast Cancer (MBC)
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Condition category
Condition code
Cancer
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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 - capecitabine
Treatment: Drugs - lapatinib
Experimental: neratinib plus capecitabine - neratinib 240 mg orally, once daily with food, continuously in 21 day cycles, and capecitabine 1500 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
Active Comparator: lapatinib plus capecitabine - lapatinib 1250 mg orally, once daily, continuously in 21 day cycles, and capecitabine 2000 mg/m^2 daily in 2 evenly divided doses, orally with water within 30 minutes after a meal, taken on days 1 to 14 of each 21 day cycle.
Treatment: Drugs: neratinib
Treatment: Drugs: capecitabine
Treatment: Drugs: lapatinib
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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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Centrally Assessed Progression Free Survival
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Assessment method [1]
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Progression Free Survival (PFS), Measured in Months, for Randomized Subjects of the Central Assessment. The time interval from the date of randomization until the first date on which recurrence, progression (per Response Evaluation Criteria in Solid Tumors Criteria (RECIST) v1.1), or death due to any cause, is documented. For subjects without recurrence, progression or death, it is censored at the last valid tumor assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 24 months.
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Timepoint [1]
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From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut.
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Primary outcome [2]
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Overall Survival
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Assessment method [2]
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Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier. Here, the time to event was reported as the restricted mean survival time. The restricted mean survival time was defined as the area under the curve of the survival function up to 48 months.
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Timepoint [2]
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From randomization date to death, assessed up to 59 months.The result is based on primary analysis data cut.
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Secondary outcome [1]
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Intervention for Symptomatic Metastatic Central Nervous System Disease
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Assessment method [1]
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Intervention for symptomatic metastatic central nervous system disease is defined as the time from randomization to the first start date of an intervention for symptomatic metastatic CNS disease. Subjects that do not have an intervention for symptomatic metastatic CNS and do not die will be censored at the last date known alive on or prior to the data cutoff. Deaths are treated as competing events. Percentage of participants with intervention for CNS, estimated by cumulative incidence methods. Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring.
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Timepoint [1]
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From randomization date to first intervention for symptomatic metastatic CNS disease, assessed up to 59 months.The result is based on primary analysis data cut.
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Secondary outcome [2]
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Objective Response Rate (ORR) - Central Assessment (ITT Population With Measurable Disease at Screening)
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Assessment method [2]
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Objective response rate is defined as the percentage of participants demonstrating an objective response during the study. Objective response includes confirmed complete responses (CR) and partial responses (PR) as defined in the RECIST criteria included in the study protocol. The ORR is for Central Assessment for subjects that had measurable disease at screening. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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Timepoint [2]
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From randomization date to first confirmed Complete or Partial Response, whichever came earlier, up to 42 months.The result is based on primary analysis data cut.
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Secondary outcome [3]
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Clinical Benefit Rate (CBR) - Central Assessment (ITT Population With Measurable Disease at Screening)
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Assessment method [3]
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Clinical benefit rate is the percentage of participants who achieve overall tumor response (confirmed CR or PR) or stable disease (SD) lasting for at least 24 weeks from randomization. The CBR was for Central Assessment for subjects who had Measurable Disease at Screening.
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Timepoint [3]
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From randomization date to either first confirmed CR or PR or Stable Disease, whichever came earlier, up to 42 months.The result is based on primary analysis data cut.
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Secondary outcome [4]
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Duration of Response (DOR) - Central Assessment (Population That Had a Response With Measurable Disease at Screening)
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Assessment method [4]
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The Duration of Response (DOR) is for Central Assessment for the Population that Had a Response with Measurable Disease at Screening.
Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per RECIST v1.1. This value is censored at the last valid tumor assessment if PD or death has not been documented.
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Timepoint [4]
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From start date of response after randomization to first PD, up to 33 months.The result is based on primary analysis data cut.
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Secondary outcome [5]
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Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events)
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Assessment method [5]
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Adverse Events to be measured are Treatment-Emergent and Serious AEs that occurred on or after first dose of investigational product and up to 28 days after the last dose
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Timepoint [5]
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From first dose through last dose + 28 days, up to 41 months. The result is based on final data cut.
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Eligibility
Key inclusion criteria
- Aged =18 years at signing of informed consent.
- Histologically confirmed MBC, current stage IV.
- Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+,
with confirmatory fluorescence in situ hybridization (FISH) +.
- Prior treatment with at least two (2) HER2-directed regimens for metastatic breast
cancer.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2
directed tyrosine kinase inhibitor.
Note: There are additional inclusion and exclusion criteria. The study center will
determine if you meet all of the criteria.
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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 3
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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
29/03/2013
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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
9/12/2019
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Sample size
Target
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Accrual to date
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Final
621
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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The Tweed Hospital - Tweed Heads
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Sunshine Coast University Hospital - Birtinya
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Bankstown-Lidcombe Hospital - Bankstown
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St. George Hospital - Kogarah
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Box Hill Hospital, Oncology Department - Melbourne
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Maroondah Hospital, Maroondah Breast Clinic - Melbourne
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Sydney Adventist Hospital - Wahroonga
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2485 - Tweed Heads
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4575 - Birtinya
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NSW 2200 - Bankstown
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NSW 2217 - Kogarah
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3128 - Melbourne
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Recruitment postcode(s) [6]
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3135 - Melbourne
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Recruitment postcode(s) [7]
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8833 - Wahroonga
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Recruitment outside Australia
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Spain
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Girona
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Spain
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Las Palmas de Gran Canaria
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Country [114]
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Spain
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Madrid
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Country [115]
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Spain
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Murcia
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Spain
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Palma de Mallorca
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Country [117]
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Spain
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Sevilla
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Country [118]
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Spain
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Valencia
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Spain
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Zaragoza
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Country [120]
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Sweden
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Orebro
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Sweden
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Uppsala
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Switzerland
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Bern
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Switzerland
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Geneva
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Switzerland
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Winterthur
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Switzerland
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Zurich
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Taiwan
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Province Of China
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Country [127]
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Taiwan
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State/province [127]
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Taiwan, Province Of China
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Country [128]
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Taiwan
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State/province [128]
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New Taipei City
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Country [129]
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Taiwan
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State/province [129]
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Taichung
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Country [130]
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Taiwan
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State/province [130]
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Taipei
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Country [131]
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Turkey
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Izmir
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Turkey
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Istanbul
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Country [133]
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United Kingdom
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Essex
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United Kingdom
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West Midlands
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United Kingdom
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Cardiff
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United Kingdom
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Halifax
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United Kingdom
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Huddersfield
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United Kingdom
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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
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Summary
Brief summary
This is a randomized, multi-center, multinational, open-label, active-controlled, parallel
design study of the combination of neratinib plus capecitabine versus the combination of
lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2
directed regimens in the metastatic setting.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01808573
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Public notes
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Contacts
Principal investigator
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Senior Vice President Clinical Science and Pharmacology
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Address
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Puma Biotechnology, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01808573
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