Dataset from A Randomized Three-Arm, Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy

The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic chemotherapy, definitive surgery, and radiotherapy, if applicable. Efficacy and safety will be assessed for 10 years from randomization for each participant. All participants will continue to be followed for survival until 10 years after enrollment of the last participant.

本临床试验旨在针对已完成（新）辅助全身化疗、根治性手术，并在适用情况下接受放射治疗的人表皮生长因子受体2（HER2）过表达原发性乳腺癌女性患者，对比评估1年疗程、2年疗程赫赛汀（Herceptin）治疗方案与观察组（不予赫赛汀治疗）的疗效与安全性。所有受试者将自随机分组起，接受为期10年的疗效与安全性评估。全体受试者将持续接受生存随访，直至最后1例受试者入组满10年为止。