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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/NCT00263588
Registration number
NCT00263588
Ethics application status
Date submitted
2/12/2005
Date registered
9/12/2005
Date last updated
12/12/2019
Titles & IDs
Public title
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
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Scientific title
A Phase II Study of Lapatinib for Brain Metastases in Subjects With ErbB2-Positive Breast Cancer Following Trastuzumab-based Systemic Therapy and Cranial Radiotherapy
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Secondary ID [1]
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CLAP016A2202
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Secondary ID [2]
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EGF105084
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Breast
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Condition category
Condition code
Cancer
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Breast
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Cancer
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Brain
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - lapatinib
Experimental: single arm - 750 mg lapatinib administered orally twice daily
Treatment: Drugs: lapatinib
tyrosine kinase inhibitor
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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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The Number of Participants With Central Nervous System (CNS) Best Overall Response
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Assessment method [1]
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Summary of CNS Objective Response (Lapatinib Monotherapy - MITT Population)
Response to lapatinib in patients with progressive brain metastases from ErbB2-overexpressing breast cancer.
The primary indicator of drug efficacy was CNS objective response rate. A CNS objective response was defined as either a Complete response (CR) or Partial response (PR), as assessed by volumetric analysis of brain Magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of Neurological signs and symptoms (NSS)
A CNS objective response rate was defined as a 50% volumetric reduction in sum of CNS target lesions, with no new or progressive CNS or non-CNS lesions, no increases in tumor-related steroid requirements and no worsening of neurological signs or symptoms
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Timepoint [1]
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time from baseline to data cutoff (25 Sept 2007); approximately 2 years
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Primary outcome [2]
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The Percentage of Participants With Central Nervous System (CNS) Objective Response Rate - Response Rate (CR + PR)
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Assessment method [2]
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Summary of CNS Objective Response (the Complete Response + Partial Response)
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Timepoint [2]
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time from baseline to data cutoff (25 Sept 2007); approximately 2 years
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Secondary outcome [1]
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Percentage of Participants With Improvement in Neurological Signs and Symptoms (NSS) Measured Using the Neurological Examination Worksheet
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Assessment method [1]
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Physician-reported NSS worksheet is derived from 13 AEs and measured by NCI CTCAE v3.0 grouped into 7 categories: level of consciousness, neurological symptoms, cranial nerves, language, strength, sensation, & ataxia. Improvement of NSS required: Decrease by 1 or more grades from baseline of any tumor-related NSS, with confirmation at least 4 wks later, No development or worsening in any tumor-related NSS during interval, No radiographic evidence of CNS progression (assessed by volumetric MRI) or systemic (non-CNS) progression (assessed by RECIST) during interval, Stable or decreasing steroids during interval as defined by GSK equivalent doses of an alternative corticosteroid or a dose increase for non-tumor related reasons didn't constitute a steroid increase. Improvement in any non-tumor associated NSS didn't constitute improvement in NSS. Neurological exam, using Neurological Examination Worksheet was assessed at baseline & each 4 wks. Categories below are not mutually exclusive.
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Timepoint [1]
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time from baseline to data cutoff (25 Sept 2007); approximately 2 years
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Secondary outcome [2]
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Percentage of Subjects With a CNS Objective Response or Improvement in Baseline Neurological Signs and Symptoms (NSS)
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Assessment method [2]
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Summary of Proportion of Subjects with a CNS Objective Response or Improvement in Baseline NSS
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Timepoint [2]
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baseline and weeks 8, 16, 24, 32, 40, 48
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Secondary outcome [3]
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Duration of Central Nervous System (CNS) Objective Response
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Assessment method [3]
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The duration of CNS objective response, defined as the time from first CNS
Objective response until tumor progression at any site or death due to any cause.
A CNS objective response was defined as either a Complete Response (CR) or Partial Response (PR), as assessed by volumetric analysis of magnetic resonance imaging (MRI), provided there was no progression of systemic disease outside of the CNS, increasing steroid requirements, or worsening of tumor-related neurological signs or symptoms.
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Timepoint [3]
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time from baseline to data cutoff (25 Sept 2007); approximately 2 years
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Secondary outcome [4]
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Percentage of Patients With CNS Disease Control (Complete Response, Partial Response or Stable Disease) at 6 Months of Lapatinib Therapy
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Assessment method [4]
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The CNS disease control rate, defined as the percentage of subjects with CR, PR or stable disease at Week 24
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Timepoint [4]
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from Start of lapatinib to 6 months
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Secondary outcome [5]
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Time to Progression (TTP) at Any Site
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Assessment method [5]
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Summary of Kaplan-Meier Estimates for Progression Free Survival at Any Site
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Timepoint [5]
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time from baseline to data cutoff (25 Sept 2007); approximately 2 years
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Secondary outcome [6]
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Overall Survival (OS)
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Assessment method [6]
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Overall survival (OS) defined as the time from initiation of investigational product to death due to any cause.
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Timepoint [6]
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time from baseline to data cutoff (25 Sept 2007); approximately 2 years
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Secondary outcome [7]
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Summary of Site of First Progression
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Assessment method [7]
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baseline to time of disease progression or death
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Timepoint [7]
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time from baseline to data cutoff (25 Sept 2007); approximately 2 years
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Secondary outcome [8]
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Primary Cause of Death
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Assessment method [8]
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Summary of Overall All-cause mortality (Main Study and Extension)
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Timepoint [8]
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time from baseline to data cutoff (25 Sept 2007); approximately 2 years
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Eligibility
Key inclusion criteria
Inclusion criteria:
- Signed Informed Consent
- ErbB2(HER2)overexpressing breast cancer.
- Brain lesion(s) which are progressing.
- Prior treatment of brain metastases with Whole Brain Radiotherapy (WBR)and/or
Stereotactic Radiosurgery (SRS).
- Prior treatment with trastuzumab (Herceptin), either alone or in combination with
chemotherapy.
- Cardiac ejection fraction(LVEF)within the institutional range of normal as measured by
Echocardiogram.
- Able to swallow an oral medication.
- Adequate kidney and liver function.
- Adequate bone marrow function.
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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
Exclusion criteria:
- Pregnant or lactating females.
- Conditions that would effect the absorption of an oral drug.
- History of immediate or delayed hypersensitivity reaction to gadolinium contrast
agents.
- Pre-existing severe cerebral vascular disease, such as stroke involving a major
vessel.
- Serious medical or psychiatric disorder that would interfere with the patient's safety
or informed consent.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
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Other design features
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Phase
Phase 2
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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
2/12/2005
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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
15/03/2018
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Sample size
Target
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Accrual to date
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Final
242
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - North Sydney
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Recruitment hospital [2]
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Novartis Investigative Site - Herston
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Recruitment hospital [3]
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Novartis Investigative Site - South Brisbane
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Recruitment hospital [4]
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Novartis Investigative Site - Box Hill
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Recruitment hospital [5]
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Novartis Investigative Site - Ringwood East
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Recruitment hospital [6]
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Novartis Investigative Site - Perth
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Recruitment hospital [7]
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Novartis Investigative Site - Adelaide
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Recruitment postcode(s) [1]
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2060 - North Sydney
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3135 - Ringwood East
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Recruitment postcode(s) [6]
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6000 - Perth
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Recruitment postcode(s) [7]
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5000 - Adelaide
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Recruitment outside Australia
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California
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Colorado
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Brighton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
Determine how safe and effective lapatinib is when used to treat patients with ErbB2
overexpressing breast cancer that has spread to the brain and is still progressing there even
after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic
radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for
safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during
the course of the study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00263588
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Trial related presentations / publications
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00263588
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