Clinical trial NCT00051103: Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Neoplasms, Breast
Keywords: Refractory
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2003-01-06
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Poway
country: United States
facility: GSK Investigational Site
state: California
city: Fort Myers
country: United States
facility: GSK Investigational Site
state: Florida
city: Plantation
country: United States
facility: GSK Investigational Site
state: Florida
city: Savannah
country: United States
facility: GSK Investigational Site
state: Georgia
city: Park Ridge
country: United States
facility: GSK Investigational Site
state: Illinois
city: Skokie
country: United States
facility: GSK Investigational Site
state: Illinois
city: Skokie
country: United States
facility: GSK Investigational Site
state: Illinois
city: Bettendorf
country: United States
facility: GSK Investigational Site
state: Iowa
city: Des Moines
country: United States
facility: GSK Investigational Site
state: Iowa
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Royal Oak
country: United States
facility: GSK Investigational Site
state: Michigan
city: Billings
country: United States
facility: GSK Investigational Site
state: Montana
city: Hooksett
country: United States
facility: GSK Investigational Site
state: New Hampshire
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: GSK Investigational Site
state: North Dakota
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Germantown
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Salem
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.