LUX: An open label, randomised phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior trastuzumab treatment

Summary:
This is a research study to test a new investigational drug, BIBW 2992. The study drug, BIBW 2992 attaches securely to HER2 and EGFR (the receptors that have the ability to send signals that promote tumor growth) and has been shown to slow or stop these two types of receptors in previous clinical studies. BIBW 2992 has shown some effectiveness even when given alone to subjects who failed previous treatment that targeted the HER2 receptor.

The purpose of this research study is to test the safety and effectiveness of the investigational drug, BIBW 2992, combined with vinorelbine compared to trastuzumab combined with vinorelbine in subjects with metastatic breast cancer who failed one prior trastuzumab treatment.

There are two study drug treatment groups in this research study:
1. Vinorelbine (Navelbine®) combined with trastuzumab
2. BIBW 2992 combined with vinorelbine

Vinorelbine has previously been tested in combination with trastuzumab and has shown lower toxicity than with other trastuzumab combination therapies.

Eligibility Participants:
• Female of at least 18 years old with histologically confirmed diagnosis of HER2-overexpressing breast cancer
• No prior HER2-targeted treatment other than trastuzumab
• No prior vinorelbine treatment
• No radiotherapy, chemotherapy, hormone therapy, immunotherapy or surgery (other than biopsy) within 4 weeks
• Not pregnant or breast-feeding

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