Conditions: Metastases, Brain
Keywords: ErbB2 HERCEPTIN XELODA ErbB1 TYKERB metastatic breast cancer trastuzumab breast cancer capecitabine lapatinib brain metastases HER2 positive TYVERB
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 540
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Lapatinib 1250 mg once daily and capecitabine 2000mg/m2/day, days 1-14, every 21 days arm 2: trastuzumab loading dose of 8mg/kg followed by 6mg/kg q3weekly infusions, and capecitabine 2500mg/m2/day, days 1-14, every 21 days

Interventions: intervention 1: capecitabine intervention 2: lapatinib intervention 3: trastuzumab
Intervention descriptions: intervention 1: oral medication; daily dose divided into morning and evening dose and taken for 14 days of 21 day cycle intervention 2: oral medication; daily dose taken once a day intervention 3: infusion therapy; loading dose of 8mg/kg, followed by 6mg/kg given every 3 weeks

Protocol document: