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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 November 2012
• Main ID: NCT00075270
• Date of registration: 07/01/2004
• Primary sponsor: GlaxoSmithKline
• Public title: Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
• Scientific title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Phase III Study of Oral GW572016 in Combination With Paclitaxel in Subjects Previously Untreated or Advanced or Metastatic Breast Cancer
• Date of first enrolment: January 2004
• Target sample size: 577
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00075270
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czech Republic, Germany, Hungary, Italy, Korea, Republic of, Latvia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Poland, Russian Federation, Slovakia, South Africa, Spain, Turkey, United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Neoplasms, Breast

Intervention(s)

Drug: GW572016 (Lapatinib)

Drug: Paclitaxel

Primary Outcome(s)

To evaluate and compare the 2 treatment groups with respect to time to progression (TTP) in subjects with metastatic breast cancer. [Time Frame: 34 Weeks]

Secondary Outcome(s)

Compare the following data between the 2 treatment groups: Tumor Response Clinical Benefit Time to Response Duration of Response Survival Rate Toxicity Biomarker Signals [Time Frame: 72 Weeks]

Secondary ID(s)

EGF30001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors