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Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00051103
Recruitment Status : Completed
First Posted : January 6, 2003
Last Update Posted : April 15, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Neoplasms, Breast Drug: Investigational Cancer Drug Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving Herceptin Containing Regimens
Study Start Date : October 2002
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: (The patient must meet the following criteria in order to be eligible for this study.)

  • Signed informed consent
  • No more than two prior regimens for metastatic breast cancer. Each regimen must have contained Herceptin.
  • Refractory Stage IIIb or IV breast cancer
  • HER2/neu tumor overexpression
  • Disease progression while receiving a prior chemotherapy regimen with Herceptin alone or in combination with other chemotherapy.
  • Tumor tissue available for testing.
  • 2 weeks since treatment with Herceptin (alone or in combination).
  • Able to swallow and retain oral medication
  • Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan).
  • Adequate kidney and liver function
  • Adequate bone marrow function

Exclusion Criteria: (The patient cannot meet any of the following criteria in order to be eligible for this study.)

  • Prior regimens did not include Herceptin.
  • Pregnant or lactating.
  • Conditions that would affect absorption of an oral drug
  • Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
  • Severe cardiovascular disease or cardiac disease requiring a device.
  • Active infection.
  • Brain metastases.
  • Concurrent cancer therapy or investigational therapy.
  • Use of oral or IV steroids.
  • Unresolved or unstable serious toxicity from prior therapy.
  • Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor other than Herceptin.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00051103


  Show 30 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Additional Information:
Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00051103     History of Changes
Obsolete Identifiers: NCT00044330, NCT00053066
Other Study ID Numbers: EGF 20002
First Posted: January 6, 2003    Key Record Dates
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by GlaxoSmithKline:
Refractory

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents