Conditions: Neoplasms, Breast
Keywords: Breast Cancer ErbB2-overexpressing early-stage breast cancer adjuvant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3166
Healthy volunteers: no

Brief summary:
This study was designed to evaluate and compare the safety and efficacy of an oral dual tyrosine kinase inhibitor, lapatinib, versus placebo in women with early-stage ErbB2-overexpressing breast cancer who have completed their primary neoadjuvant or adjuvant chemotherapy and have no clinical or radiographic evidence of disease.

Detailed description:

Arms:
arm 1: 6 tablets daily for 12 months arm 2: Lapatinib 1500 mg (6 tablets) daily for 12 months

Interventions: intervention 1: lapatinib intervention 2: placebo
Intervention descriptions: intervention 1: Lapatinib 1500 mg (6 tablets) daily for 12 months intervention 2: 6 tablets daily for 12 months

Protocol document: