The Role of Trastuzumab in Adjuvant and Neoadjuvant Therapy in Women with HER2/neu-overexpressing Breast Cancer

Research Question(s)

In women with HER2/neu-overexpressing breast cancer:

1. Compared with adjuvant or neoadjuvant chemotherapy alone, does trastuzumab in combination with chemotherapy improve clinically meaningful outcomes (overall response rate, time-to-disease-progression, overall survival, toxicity, or quality of life)?
2. Compared with placebo or observation, does single-agent trastuzumab adjuvant or neoadjuvant therapy improve clinically meaningful outcomes?
3. What is the best way to identify women who will benefit from adjuvant or neoadjuvant trastuzumab therapy?
4. What are the adverse events associated with adjuvant or neoadjuvant trastuzumab therapy?
5. What are the optimal dose, schedule, and duration for adjuvant trastuzumab therapy?