A Randomized, Multi-Center Cross-Over Study to Evaluate Patient Preference and Health Care Professional (HCP) Satisfaction With Subcutaneous (SC) Administration of Trastuzumab in HER2-Positive Early Breast Cancer (EBC)
收藏资源简介:
This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer. Participants will be randomized to receive either SC Herceptin or IV Herceptin every 3 weeks for Cycles 1 to 4, followed by crossover to the other treatment administration for Cycles 5 to 8. For up to 10 additional cycles (for a total of 18 cycles), participants will receive IV or SC Herceptin every 3 weeks.
本项随机、开放标签、交叉临床试验,旨在评估HER2阳性早期乳腺癌受试者对皮下注射(Subcutaneous, SC)与静脉注射(Intravenous, IV)赫赛汀(Herceptin)给药方式的偏好,以及医疗保健专业人员(Healthcare Professional, HCP)的满意度。受试者将被随机分配,在第1至第4周期每3周接受一次皮下注射赫赛汀或静脉注射赫赛汀治疗,随后在第5至第8周期交叉接受另一种给药方式的治疗。在最多额外10个周期(总周期数共计18个周期)中,受试者将每3周接受一次静脉注射或皮下注射赫赛汀治疗。



