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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00075270
First received: January 7, 2004
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Neoplasms, Breast
 Drug: Paclitaxel
Drug: GW572016 (Lapatinib)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]

Enrollment: 577
Study Start Date: January 2004
Study Completion Date: March 2012
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Lapatinib 1500 mg, once daily and Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks
 Drug: Paclitaxel
Active Comparator
Drug: GW572016 (Lapatinib)
Oral GW572016 Lapatinib
Other Names:
  • Paclitaxel
  • GW572016 (Lapatinib)
Placebo Comparator: Arm 2
Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks and Placebo
 Drug: Paclitaxel
Active Comparator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075270

  Show 137 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00075270     History of Changes
Obsolete Identifiers: NCT00085046
Other Study ID Numbers: EGF30001
Study First Received: January 7, 2004
Last Updated: November 21, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
lapatinib
ErbB1
kinase inhibitor
metastatic breast cancer
 ErbB2
Her2-neu
EGFR

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Paclitaxel
Lapatinib
Tubulin Modulators
Antimitotic Agents
 Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013