Neoplasms, Breast
Conditions
Keywords
lapatinib, metastatic breast cancer, trastuzumab (Herceptin), Stage IV breast cancer, ErbB2, ErbB1
Brief summary
This study is designed to evaluate the efficacy and safety of GW572016 in patients with refractory breast cancer and consists of two cohorts of patients. Patients in Cohort A must have ErbB2 overexpressing tumors while patients in Cohort B must have non-ErbB2 overexpressing tumors. Patients eligible for this study must have advanced metastatic breast cancer who have previously received treatment with anthracycline and taxane.
Interventions
DRUGTykerb
lapatinib 1500mg daily
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed advanced (IIIb or Stage IV) breast cancer who have progressed on prior anthracycline and taxanes containing regimens + trastuzumab for cohort A patients. * Patients must have adequate blood, liver, and kidney function and either be fully active or restricted only in performing strenuous activity. * Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.
Exclusion criteria
* Patients with certain heart problems.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate tumor response rate in both cohort A (ErbB2 overexpressors) and in cohort B (ErbB2 non-overexpressor) population when treated with GW572016 | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefitTime to tumor responseLength of responseTime to progression of cancer4 and 6 month progression free survivalOverall survival as well as specific biomarkers in tumor tissue | — |
Countries
Japan
Outcome results
None listed