Clinical trial NCT00111787: Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms, Breast
Keywords: breast cancer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-05-26
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of participants with pathologic complete response rate (pCR)
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of participants with pCR that underwent surgical resection
timeFrame: Week 12
measure: Percentage of participants with objective response rate (ORR) at the end of study (Response evaluation criteria in solid tumor [RECIST])
timeFrame: Week 14
measure: Percentage of participants with ORR at the end of study (Clinically Evaluable Skin Disease Criteria)
timeFrame: Week 14
measure: Percentage of participants with ORR at the end of study ('Best' of RECIST and Clinically Evaluable Skin Disease Criteria)
timeFrame: Week 14
measure: Percentage of participants with investigator-Assessed Best Response at the end of monotherapy phase (Day 14) (Clinically Evaluable Skin Disease Criteria)
timeFrame: Day 14
measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to Week 14, surgical resection and post treatment
measure: Number of participants with shift from Baseline in hematological toxicity grade
timeFrame: Day 14 and up to Week 23, surg resection and post treatment
measure: 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
measure: 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
measure: Change from Baseline in vital signs- Heart Rate (HR)
timeFrame: Day 14, Week 1 and up to Week 24, surg resection and post treatment
measure: Change from Baseline in vital signs- Body temperature
timeFrame: Day 14, Week 1 and up to Week 24, surg resection and post treatment
measure: Number of participants with abnormal electrocardiogram (ECG) findings
timeFrame: Screening and unscheduled
measure: 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
Other outcomes:
Locations:
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Zion
country: United States
facility: GSK Investigational Site
state: Illinois
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Campbelltown
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Liverpool
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Randwick
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: South Brisbane
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Bedford Park
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Ringwood East
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Bayonne
country: France
facility: GSK Investigational Site
city: Lille Cedex
country: France
facility: GSK Investigational Site
city: Paris cedex 13
country: France
facility: GSK Investigational Site
city: Ramat Gan
country: Israel
facility: GSK Investigational Site
city: Auckland
country: New Zealand
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Girona
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Sfax
country: Tunisia
facility: GSK Investigational Site
city: Sfax
country: Tunisia
facility: GSK Investigational Site
city: Tunis
country: Tunisia
facility: GSK Investigational Site
city: Tunis
country: Tunisia
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.