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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 SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteLittle Rock, Arkansas  72205
GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteNew Orleans, Louisiana  70112
GSK Investigational SiteSpringfield, Massachusetts  01107
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteGreen Bay, Wisconsin  54301
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SiteBaltimore, Maryland  21201
GSK Investigational SiteFargo, North Dakota  58103
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteSalem, Virginia  24153
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteKansas City, Kansas  66160
GSK Investigational SiteEdison, New Jersey  08837
GSK Investigational SiteOregon City, Oregon  97045
GSK Investigational SiteSeattle, Washington  98133