EUCTR2005-003926-24-ITActive, not recruitingNot Applicable
A Randomized, Multicenter Open-Label Phase III Study of Lapatinib in Combination with Trastuzumab versus Lapatinib Monotherapy in Subjects with Metastatic Breast Cancer whose disease has progressed on Trastuzumab-Containing Regimens - A Study of GW572016 (lapatinib) in Advanced Breast Cancer
GlaxoSmithKline Research and Development Ltd0 sites270 target enrollmentStarted: February 17, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 270
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •1. Signed informed consent. 2. Female >18 years. 3. Metastatic breast cancer, histologically/cytologically confirmed. 4. Subjects must have stage IV breast cancer whereby their disease has progressed in either the adjuvant or metastatic setting. Prior therapies must include, but are not limited toTaxane and Anthracycline. 5. Subjects must have received and progressed following treatment with at least TWO trastuzumab plus cytotoxic chemotherapy regimens in the metastatic settingSubjects must have archived tumor tissue available for testing. 6. Documented amplification of the ErbB2 gene by fluorescence in situ hybridization (FISH) in primary or metastatic tumor tissue.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Pregnant or lactating females. 2. Prior therapy with an ErbB1 and/or ErbB2 inhibitor other than trastuzumab. 5. Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject`s safety. 10. Known history or clinical evidence of leptomeningeal carcinomatosis. 11. Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy).15. Current active hepatic or biliary disease.
Investigators
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