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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Neoplasms, Breast; Metastatic Breast Cancer

Treatments: Drug: Investigational Cancer Drug

Study type: Interventional

Funder types: Industry

Identifiers

NCT00051103

EGF 20002

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)