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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00051103
• Other study ID #: EGF 20002
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2003
• Last updated: April 14, 2015
• Start date: October 2002
• Est. completion date: June 2005

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00044330
• NCT00053066

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer
• Neoplasms, Breast

Intervention

Drug:
• Investigational Cancer Drug

Locations

Country	Name	City	State
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bettendorf	Iowa
United States	GSK Investigational Site	Billings	Montana
United States	GSK Investigational Site	Chula Vista	California
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Des Moines	Iowa
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Fargo	North Dakota
United States	GSK Investigational Site	Fort Myers	Florida
United States	GSK Investigational Site	Germantown	Tennessee
United States	GSK Investigational Site	Greenville	North Carolina
United States	GSK Investigational Site	Hickory	North Carolina
United States	GSK Investigational Site	Hooksett	New Hampshire
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Park Ridge	Illinois
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Plantation	Florida
United States	GSK Investigational Site	Poway	California
United States	GSK Investigational Site	Royal Oak	Michigan
United States	GSK Investigational Site	Salem	Virginia
United States	GSK Investigational Site	Savannah	Georgia
United States	GSK Investigational Site	Skokie	Illinois
United States	GSK Investigational Site	Skokie	Illinois
United States	GSK Investigational Site	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

Blackwell KL, Pegram MD, Tan-Chiu E, Schwartzberg LS, Arbushites MC, Maltzman JD, Forster JK, Rubin SD, Stein SH, Burstein HJ. Single-agent lapatinib for HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab-containing regimens. Ann Oncol. 2009 Jun;20(6):1026-31. doi: 10.1093/annonc/mdn759. Epub 2009 Jan 29. — View Citation

External Links

•   A website where viewers can complete a clinical study-matching questionnaire and also sign up for future study notification and healthcare newsletters.