Last updated: 11/04/2018 06:23:37
Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Percentage of participants with pathologic complete response rate (pCR)
Timeframe: Week 12
Secondary outcomes:
Percentage of participants with pCR that underwent surgical resection
Timeframe: Week 12
Percentage of participants with objective response rate (ORR) at the end of study (Response evaluation criteria in solid tumor [RECIST])
Timeframe: Week 14
Percentage of participants with ORR at the end of study (Clinically Evaluable Skin Disease Criteria)
Timeframe: Week 14
Percentage of participants with ORR at the end of study (’Best’ of RECIST and Clinically Evaluable Skin Disease Criteria)
Timeframe: Week 14
Percentage of participants with investigator-Assessed Best Response at the end of monotherapy phase (Day 14) (Clinically Evaluable Skin Disease Criteria)
Timeframe: Day 14
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to Week 14, surgical resection and post treatment
Number of participants with shift from Baseline in hematological toxicity grade
Timeframe: Day 14 and up to Week 23, surg resection and post treatment
Number of participants with shift from Baseline in clinical chemistry toxicity grade
Timeframe: Day 14, Week 4, 8, 12, 16, 20, Surg resection and post treatment
Change from Baseline in vital signs- Systolic blood pressure (SBP) and Diastolic blood pressure (DBP)
Timeframe: Day 14, Week 1 and up to Week 24, surg resection and post treatment
Change from Baseline in vital signs- Heart Rate (HR)
Timeframe: Day 14, Week 1 and up to Week 24, surg resection and post treatment
Change from Baseline in vital signs- Body temperature
Timeframe: Day 14, Week 1 and up to Week 24, surg resection and post treatment
Number of participants with abnormal electrocardiogram (ECG) findings
Timeframe: Screening and unscheduled
Number of participants with change from Baseline in echocardiogram (ECHO) or Multi-gated angiogram (MUGA) results at any post Baseline visit
Timeframe: Screening, Week 8, 16, 24, post treatment
Interventions:
Drug: Lapatinib
Drug: Paclitaxel
Enrollment:
49
Observational study model:
Not applicable
Primary completion date:
2006-01-11
Time perspective:
Not applicable
Clinical publications:
Boussen H, Cristofanilli M, Zaks T, DeSilvio M, Salazar V, Spector N. Phase II Study to Evaluate the Efficacy and Safety of Neoadjuvant Lapatinib in Combination With Paclitaxel in Patients With Newly Diagnosed Inflammatory Breast Cancer. [J Clin Oncol]. 2010;28(20):3248-3255.
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
April 2005 to November 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Tumor accessible for multiple biopsies
- ECOG (Eastern Cooperative Oncology Group) performance status 0-2
- Females who are pregnant or nursing.
- Any unstable, pre-existing major medical condition.
Inclusion and exclusion 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).
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.
Trial location(s)
Location
GSK Investigational Site
South Brisbane, Queensland, Australia, 4101
Status
Study Complete
Location
GSK Investigational Site
Bedford Park, South Australia, Australia, 5042
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Campbelltown, New South Wales, Australia, 2560
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Zion, Illinois, United States, 60099
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ringwood East, Victoria, Australia, 3128
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Liverpool, New South Wales, Australia, 2170
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60637
Status
Study Complete
Location
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Box Hill, Victoria, Australia, 3128
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-01-11
Actual study completion date
2006-01-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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