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

• Conditions: Metastatic breast cancer; MedDRA version: 14.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2005-003926-24-IT
• Lead Sponsor: GlaxoSmithKline Research and Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-17
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 270

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified