This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early relapse on adjuvant Herceptin therapy. Patients will receive Herceptin at a loading dose of 8mg/kg iv followed by 6mg/kg iv every three weeks, and Avastin 15mg/kg every 3 weeks. At first sign of disease progression Xeloda 1000mg/m2 bid po will be added on days 1-14 of each cycle, or docetaxel (100mg/m2 iv every 3 weeks) if Xeloda is not indicated for a patient. Anticipated time on study treatment is until disease-progression on second line treatment and target sample size is \<100.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
15mg/kg iv every 3 weeks
added at time of disease-progression, 1000mg/m2 bid po days 1-14 of every 3-week cycle
background therapy at time of disease progression, 100mg/m2 iv every 3 weeks
Progression-Free Survival on second-line treatment
Time frame: event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter
Safety and tolerability: AEs, laboratory parameters, LVEF
Time frame: throughout study, laboratory parameters every 3 weeks, LVEF every 12 weeks
Overall Response Rate, Best Overall Response, Duration of Response, Progression-free Survival (first-line), Overall Survival
Time frame: event-driven, tumour assessment every 6 weeks for 24 weeks, every 12 weeks thereafter
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8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg every 3 weeks