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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00051103

Enrollment

Unknown

Registered

2003-01-06

Start date

2002-10-31

Completion date

2005-06-30

Last updated

2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer, Neoplasms, Breast

Keywords

Refractory

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.

Interventions

DRUGInvestigational Cancer Drug

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026