Lapatinib versus Trastuzumab in ErbB2Positive Metastatic Breast Cancer
A Randomized, Multicentre, Open-Label, Phase III Study of Lapatinib plus Capecitabine versus Trastuzumab plus Capecitabine in Patients with Anthracycline- or Taxane-Exposed ErbB2-Positive Metastatic Breast Cancer
This is a multi-centre, open-label Phase III study in subjects with ErbB2-positive metastatic breast cancer who have received prior treatment with anthracyclines or taxanes in the adjuvant or metastatic setting. Prior treatment with trastuzumab is allowed but not required. Eligible subjects must not have any history of central nervous system (CNS) metastases and must have negative brain MRI at start of study. Eligible subjects will be randomised to receive either lapatinib plus capecitibine or trastuzumab plus capecitabine. All subjects will receive study treatment until disease progression, unacceptable toxicity or the subject withdraws from study. Subjects will then be followed for survival and any subsequent anti-cancer therapy. In addition, subjects who discontinue from investigational product without documented progression will continue to be followed up for progression. Cross-over to the alternative treatment arm is not allowed in this study. Subjects will be stratified using the following factors: prior trastuzumab treatment (yes versus no) and number of prior treatments for metastatic disease (0 versus =1 line). The primary endpoint is the incidence of first relapse in CNS and CNS disease progression. Secondary endpoints include: Progression free survival, Overall survival, Time to first CNS progression, Overall response rate, Clinical benefit response rate and Duration of response. It is estimated that a total of 650 subjects (325 per group) will be required, 80 of which are to be recruited in the UK. A blinded sample size re-estimation is planned after 50% of subjects have been followed until progression due to any cause, death, or for at least one year.
East Midlands - Nottingham 2 Research Ethics Committee
Date of REC Opinion
7 May 2009
Further Information Favourable Opinion