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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00263588




Registration number
NCT00263588
Ethics application status
Date submitted
2/12/2005
Date registered
9/12/2005

Titles & IDs
Public title
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
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
Secondary ID [1] 0 0
CLAP016A2202
Secondary ID [2] 0 0
EGF105084
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Breast 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lapatinib

Experimental: single arm - 750 mg lapatinib administered orally twice daily


Treatment: Drugs: lapatinib
tyrosine kinase inhibitor
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Number of Participants With Central Nervous System (CNS) Best Overall Response
Timepoint [1] 0 0
time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Primary outcome [2] 0 0
The Percentage of Participants With Central Nervous System (CNS) Objective Response Rate - Response Rate (CR + PR)
Timepoint [2] 0 0
time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Secondary outcome [1] 0 0
Percentage of Participants With Improvement in Neurological Signs and Symptoms (NSS) Measured Using the Neurological Examination Worksheet
Timepoint [1] 0 0
time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Secondary outcome [2] 0 0
Percentage of Subjects With a CNS Objective Response or Improvement in Baseline Neurological Signs and Symptoms (NSS)
Timepoint [2] 0 0
baseline and weeks 8, 16, 24, 32, 40, 48
Secondary outcome [3] 0 0
Duration of Central Nervous System (CNS) Objective Response
Timepoint [3] 0 0
time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Secondary outcome [4] 0 0
Percentage of Patients With CNS Disease Control (Complete Response, Partial Response or Stable Disease) at 6 Months of Lapatinib Therapy
Timepoint [4] 0 0
from Start of lapatinib to 6 months
Secondary outcome [5] 0 0
Time to Progression (TTP) at Any Site
Timepoint [5] 0 0
time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Secondary outcome [7] 0 0
Summary of Site of First Progression
Timepoint [7] 0 0
time from baseline to data cutoff (25 Sept 2007); approximately 2 years
Secondary outcome [8] 0 0
Primary Cause of Death
Timepoint [8] 0 0
time from baseline to data cutoff (25 Sept 2007); approximately 2 years

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
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
2/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/03/2018
Sample size
Target
Accrual to date
Final
242
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - North Sydney
Recruitment hospital [2] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [3] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [4] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [5] 0 0
Novartis Investigative Site - Ringwood East
Recruitment hospital [6] 0 0
Novartis Investigative Site - Perth
Recruitment hospital [7] 0 0
Novartis Investigative Site - Adelaide
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3135 - Ringwood East
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
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 Mexico
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United States of America
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New York
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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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Pennsylvania
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United States of America
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Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Austria
State/province [19] 0 0
Salzburg
Country [20] 0 0
Austria
State/province [20] 0 0
Vienna
Country [21] 0 0
Belgium
State/province [21] 0 0
Bruxelles
Country [22] 0 0
Canada
State/province [22] 0 0
British Columbia
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
France
State/province [24] 0 0
Dijon Cedex
Country [25] 0 0
France
State/province [25] 0 0
Paris Cedex 05
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
France
State/province [27] 0 0
Toulouse cedex
Country [28] 0 0
Germany
State/province [28] 0 0
Bayern
Country [29] 0 0
Germany
State/province [29] 0 0
Hessen
Country [30] 0 0
Greece
State/province [30] 0 0
Neo Faliro
Country [31] 0 0
India
State/province [31] 0 0
Bangalore
Country [32] 0 0
India
State/province [32] 0 0
Mumbai
Country [33] 0 0
Italy
State/province [33] 0 0
Emilia-Romagna
Country [34] 0 0
Italy
State/province [34] 0 0
Lombardia
Country [35] 0 0
Italy
State/province [35] 0 0
Umbria
Country [36] 0 0
Japan
State/province [36] 0 0
Aichi
Country [37] 0 0
Japan
State/province [37] 0 0
Saitama
Country [38] 0 0
Japan
State/province [38] 0 0
Tokyo
Country [39] 0 0
Poland
State/province [39] 0 0
Olsztyn
Country [40] 0 0
Poland
State/province [40] 0 0
Warszawa
Country [41] 0 0
Spain
State/province [41] 0 0
Barcelona
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid
Country [43] 0 0
Sweden
State/province [43] 0 0
Uppsala
Country [44] 0 0
Switzerland
State/province [44] 0 0
Geneve
Country [45] 0 0
Switzerland
State/province [45] 0 0
Locarno
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Taiwan
State/province [46] 0 0
Tainan County
Country [47] 0 0
Taiwan
State/province [47] 0 0
Taipei
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Lancashire
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Brighton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Sutherland S, Ashley S, Miles D, Chan S, Wardley A... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT00263588