Metastases, Brain Clinical Trial
Official title:
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 open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.
The study was terminated based on the IDMC recommendation in 2012, collection of efficacy
outcome measures was discontinued and all primary and secondary outcome measures were
reported in 2012.
An amendment protocol allowed subjects who were on study treatment to enroll in a Long Term
Follow Up (LTFU) phase if they had evidence of clinical benefit but no local access to
standard of care treatments. Subjects received study treatment until disease progression,
unacceptable toxicity, or subject withdrawal. In LTFU only Adverse Events data were
collected. For the LTFU the Outcome Measure "Number of participants with the indicated Grade
3 or Grade 4 Adverse Events (AEs) occurring in >=2% of participants in either treatment arm"
and "Adverse Events" were updated.
;