Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer
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
1 other identifier
interventional
49
9 countries
25
Brief Summary
This Study was designed to determine how effective and safe a new investigational drug, lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed inflammatory breast cancer. Tumor tissue collected pre-treatment, following 14 days of treatment and at the time of surgical resection will be examined for pathologic response and biologic activity by IHC (immunohistochemistry) within the tumor. Treatment will consist of 14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib and paclitaxel. Blood samples for hematology and chemistry panels, MUGA/ECHO exams and physical exams will be performed throughout the study to monitor safety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2005
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 11, 2005
CompletedFirst Submitted
Initial submission to the registry
May 25, 2005
CompletedFirst Posted
Study publicly available on registry
May 26, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedMay 31, 2017
May 1, 2017
1.6 years
May 25, 2005
May 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of participants with pathologic complete response rate (pCR)
pCR was defined as the percentage of participants who achieved an assessment of complete response (CR) following pathologic review of resected tissue. CR was the disappearance of all target lesions. Participants in each cohort with unknown or missing response (i.e., those that did not undergo surgery) were included in the denominator when calculating the percentage. From an efficacy standpoint, the HER2+ population response was considered to be of special interest.
Week 12
Secondary Outcomes (13)
Percentage of participants with pCR that underwent surgical resection
Week 12
Percentage of participants with objective response rate (ORR) at the end of study (Response evaluation criteria in solid tumor [RECIST])
Week 14
Percentage of participants with ORR at the end of study (Clinically Evaluable Skin Disease Criteria)
Week 14
Percentage of participants with ORR at the end of study ('Best' of RECIST and Clinically Evaluable Skin Disease Criteria)
Week 14
Percentage of participants with investigator-Assessed Best Response at the end of monotherapy phase (Day 14) (Clinically Evaluable Skin Disease Criteria)
Day 14
- +8 more secondary outcomes
Study Arms (1)
Overall study
EXPERIMENTALA 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.
Interventions
Daily-monotherapy \[1500 milligrams (mg)\] for 14 days, then daily combination therapy (with weekly paclitaxel) for 12 weeks
Weekly (80mg/m\^2) combination therapy (with daily Lapatinib) for 12 weeks
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (25)
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
Chicago, Illinois, 60637, United States
GSK Investigational Site
Zion, Illinois, 60099, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Campbelltown, New South Wales, 2560, Australia
GSK Investigational Site
Liverpool, New South Wales, 2170, Australia
GSK Investigational Site
Randwick, New South Wales, 2031, Australia
GSK Investigational Site
South Brisbane, Queensland, 4101, Australia
GSK Investigational Site
Bedford Park, South Australia, 5042, Australia
GSK Investigational Site
Box Hill, Victoria, 3128, Australia
GSK Investigational Site
Ringwood East, Victoria, 3128, Australia
GSK Investigational Site
Toronto, Ontario, M4N 3M5, Canada
GSK Investigational Site
Bayonne, 64100, France
GSK Investigational Site
Lille, 59020, France
GSK Investigational Site
Paris, 75651, France
GSK Investigational Site
Ramat Gan, 52621, Israel
GSK Investigational Site
Auckland, New Zealand
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Girona, 17007, Spain
GSK Investigational Site
Valencia, 46010, Spain
GSK Investigational Site
Sfax, 3000, Tunisia
GSK Investigational Site
Sfax, 3029, Tunisia
GSK Investigational Site
Tunis, 1004, Tunisia
GSK Investigational Site
Tunis, 1007, Tunisia
GSK Investigational Site
London, SW3 6JJ, United Kingdom
Related Publications (1)
Boussen H, Cristofanilli M, Zaks T, DeSilvio M, Salazar V, Spector N. Phase II study to evaluate the efficacy and safety of neoadjuvant lapatinib plus paclitaxel in patients with inflammatory breast cancer. J Clin Oncol. 2010 Jul 10;28(20):3248-55. doi: 10.1200/JCO.2009.21.8594. Epub 2010 Jun 7.
PMID: 20530274BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2005
First Posted
May 26, 2005
Study Start
April 11, 2005
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
May 31, 2017
Record last verified: 2017-05