Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Neoplasms, Breast

Treatments: Drug: Lapatinib; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00111787

EGF102580

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Overall study

Experimental group

Description:

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:

Drug: Paclitaxel

Drug: Lapatinib