At a glance
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A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients With HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab With Chemotherapy Plus Trastuzumab Plus Bevacizumab
In Brief
A Phase 3 clinical trial evaluating Docetaxel, Trastuzumab, and 5 other interventions for Breast Cancer. Terminated early, enrolled 3,509 participants across 649 sites in 40 countries.
Signals
Detailed Summary
The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer.
Study Details
Timeline
Interventions
75 mg/m2 IV on day 1 every 3 weeks for cycles 1-6, Arms 1A and 1B 100 mg/m2 on day 1 every 3 weeks for cycles 1-3, Arms 2A and 2B
First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-6. Following completion of chemotherapy cycles: 6 mg/kg IV every 3 weeks until 1 year following first trastuzumab dose. Arms 1A and 1B First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-3. 21 days after last dose of FEC: 8 mg/kg IV first post-FEC dose only; subsequent doses 6 mg/kg IV every 3 weeks for a total of 1 year. Arms 2A and 2B
6 mg/ml/min IV on day 1 every 3 weeks for cycles 1-6
15 mg/kg IV on day 1 every 3 weeks for cycles 1-6. Following completion of chemotherapy cycles: 15 mg/kg IV on day 1 every 3 weeks until 1 year following first bevacizumab dose. Arm 1B 15 mg/kg IV on day 1 every 3 weeks for cycles 1-3. 21 days after the last dose of FEC: 15 mg/kg IV on day 1 every 3 weeks until 1 year following first bevacizumab dose. Arm 2B
600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6
90 mg/m2 IV on day 1 every 3 weeks for cycles 4-6
600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6