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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


Phase 3
18 Years
N/A
Not Enrolling
Female
Neoplasms, Breast

Thank you

Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate and compare the 2 treatment groups with respect to time to progression (TTP) in subjects with metastatic breast cancer.

Outcome Time Frame:

34 Weeks

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

EGF30001

NCT ID:

NCT00075270

Start Date:

January 2004

Completion Date:

March 2012

Related Keywords:

  • Neoplasms, Breast
  • lapatinib
  • ErbB1
  • kinase inhibitor
  • metastatic breast cancer
  • ErbB2
  • Her2-neu
  • EGFR
  • Breast Neoplasms
  • Neoplasms

Name

Location

GSK Investigational Site Phoenix, Arizona  85013 - 4496
GSK Investigational Site Little Rock, Arkansas  72205
GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Gainesville, Florida  32610
GSK Investigational Site Indianapolis, Indiana  46260
GSK Investigational Site New Orleans, Louisiana  70112
GSK Investigational Site Springfield, Massachusetts  01107
GSK Investigational Site Duluth, Minnesota  55805
GSK Investigational Site St. Louis, Missouri  63141
GSK Investigational Site Akron, Ohio  44304
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Green Bay, Wisconsin  54301
GSK Investigational Site Savannah, Georgia  31405
GSK Investigational Site Baltimore, Maryland  21201
GSK Investigational Site Fargo, North Dakota  58103
GSK Investigational Site Columbia, South Carolina  29210
GSK Investigational Site Germantown, Tennessee  38138
GSK Investigational Site Salem, Virginia  24153
GSK Investigational Site New York, New York  10021
GSK Investigational Site Aurora, Colorado  80012
GSK Investigational Site Kansas City, Kansas  66160
GSK Investigational Site Edison, New Jersey  08837
GSK Investigational Site Oregon City, Oregon  97045
GSK Investigational Site Seattle, Washington  98133