2
项与 非格司亭生物类似药(Insmed, Inc.) 相关的临床试验 / Active, not recruiting临床3期 A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).
After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence.
The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.
A Phase III Randomized, Double-Blind, Active-Controlled Clinical Trial to Study the Efficacy and Safety of MK-4214 (filgrastim) and Neupogen™ as an Adjunct to Combination Chemotherapy with Doxorubicin and Docetaxel in Breast Cancer Patients
100 项与 非格司亭生物类似药(Insmed, Inc.) 相关的临床结果
100 项与 非格司亭生物类似药(Insmed, Inc.) 相关的转化医学
100 项与 非格司亭生物类似药(Insmed, Inc.) 相关的专利(医药)
100 项与 非格司亭生物类似药(Insmed, Inc.) 相关的药物交易