Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Neoplasms, Breast

Treatments: Drug: Paclitaxel; Drug: GW572016 (Lapatinib)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00075270

EGF30001

Details and patient eligibility

About

The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.

Enrollment: 580 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed Informed Consent
• Able to swallow an oral medication
• Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
• Adequate kidney and liver function
• Adequate bone marrow function
• Tumor tissue available for testing
• Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
• No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested

Exclusion criteria

• Prior treatment regimens for advanced or metastatic breast cancer.
• Pregnant or lactating
• Conditions that would effect the absorption of an oral drug
• Active infection
• Brain metastases
• Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.
• Known hypersensitivity to Taxol or excipients of Taxol
• Peripheral neuropathy of Grade 2 or greater is not permitted
• Severe Cardiovascular disease or cardiac disease requiring a device.
• Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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580 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Description:

Lapatinib 1500 mg, once daily and Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks

Treatment:

Drug: GW572016 (Lapatinib)

Drug: Paclitaxel

Arm 2

Placebo Comparator group

Description:

Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks and Placebo

Treatment:

Drug: Paclitaxel