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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00111787




Registration number
NCT00111787
Ethics application status
Date submitted
25/05/2005
Date registered
26/05/2005
Date last updated
31/05/2017

Titles & IDs
Public title
Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer
Scientific title
A Phase II Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Lapatinib in Combination With Paclitaxel as Neoadjuvant Therapy in Patients With Newly Diagnosed Inflammatory Breast Cancer
Secondary ID [1] 0 0
EGF102580
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

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

Experimental: Overall study - A Single arm study with 2 cohorts of participants. Cohort A consists of participants with tumors overexpressing HER2 and/or EGFR. Cohort B consists of participants with tumors expressing EGFR without overexpressing HER2.


Treatment: Drugs: Lapatinib
Daily-monotherapy \[1500 milligrams (mg)\] for 14 days, then daily combination therapy (with weekly paclitaxel) for 12 weeks

Treatment: Drugs: Paclitaxel
Weekly (80mg/m\^2) combination therapy (with daily Lapatinib) for 12 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants with pathologic complete response rate (pCR)
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of participants with pCR that underwent surgical resection
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of participants with objective response rate (ORR) at the end of study (Response evaluation criteria in solid tumor [RECIST])
Timepoint [2] 0 0
Week 14
Secondary outcome [3] 0 0
Percentage of participants with ORR at the end of study (Clinically Evaluable Skin Disease Criteria)
Timepoint [3] 0 0
Week 14
Secondary outcome [4] 0 0
Percentage of participants with ORR at the end of study ('Best' of RECIST and Clinically Evaluable Skin Disease Criteria)
Timepoint [4] 0 0
Week 14
Secondary outcome [5] 0 0
Percentage of participants with investigator-Assessed Best Response at the end of monotherapy phase (Day 14) (Clinically Evaluable Skin Disease Criteria)
Timepoint [5] 0 0
Day 14
Secondary outcome [6] 0 0
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timepoint [6] 0 0
Up to Week 14, surgical resection and post treatment
Secondary outcome [7] 0 0
Number of participants with shift from Baseline in hematological toxicity grade
Timepoint [7] 0 0
Day 14 and up to Week 23, surg resection and post treatment
Secondary outcome [8] 0 0
Number of participants with shift from Baseline in clinical chemistry toxicity grade
Timepoint [8] 0 0
Day 14, Week 4, 8, 12, 16, 20, Surg resection and post treatment
Secondary outcome [9] 0 0
Change from Baseline in vital signs- Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)
Timepoint [9] 0 0
Day 14, Week 1 and up to Week 24, surg resection and post treatment
Secondary outcome [10] 0 0
Change from Baseline in vital signs- Heart Rate (HR)
Timepoint [10] 0 0
Day 14, Week 1 and up to Week 24, surg resection and post treatment
Secondary outcome [11] 0 0
Change from Baseline in vital signs- Body temperature
Timepoint [11] 0 0
Day 14, Week 1 and up to Week 24, surg resection and post treatment
Secondary outcome [12] 0 0
Number of participants with abnormal electrocardiogram (ECG) findings
Timepoint [12] 0 0
Screening and unscheduled
Secondary outcome [13] 0 0
Number of participants with change from Baseline in echocardiogram (ECHO) or Multi-gated angiogram (MUGA) results at any post Baseline visit
Timepoint [13] 0 0
Screening, Week 8, 16, 24, post treatment

Eligibility
Key inclusion criteria
Inclusion criteria:

* Tumor accessible for multiple biopsies
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2
* Adequate bone marrow
* Renal and hepatic function
* LVEF (left ventricular ejection fraction) greater than 0% based on ECHO (echocardiogram) or MUGA (multigated acquisition).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Females who are pregnant or nursing.
* Any unstable, pre-existing major medical condition.
* Received an investigational drug within the past 4 weeks.
* Had major surgery in the past 2 weeks.
* Currently receiving amiodarone or has received amiodarone in the past 6 months.

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
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
11/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2006
Sample size
Target
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Campbelltown
Recruitment hospital [2] 0 0
GSK Investigational Site - Liverpool
Recruitment hospital [3] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [4] 0 0
GSK Investigational Site - South Brisbane
Recruitment hospital [5] 0 0
GSK Investigational Site - Bedford Park
Recruitment hospital [6] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [7] 0 0
GSK Investigational Site - Ringwood East
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3128 - Ringwood East
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
France
State/province [5] 0 0
Bayonne
Country [6] 0 0
France
State/province [6] 0 0
Lille Cedex
Country [7] 0 0
France
State/province [7] 0 0
Paris cedex 13
Country [8] 0 0
Israel
State/province [8] 0 0
Ramat Gan
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
Spain
State/province [10] 0 0
Barcelona
Country [11] 0 0
Spain
State/province [11] 0 0
Girona
Country [12] 0 0
Spain
State/province [12] 0 0
Valencia
Country [13] 0 0
Tunisia
State/province [13] 0 0
Sfax
Country [14] 0 0
Tunisia
State/province [14] 0 0
Tunis
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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 not provided in https://clinicaltrials.gov/study/NCT00111787