drugset / Trial / NCT03747120
Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]
Phase 2
Active not recruiting
138 enrolled
University of Texas Southwestern Medical Center
Breast Cancer Research Foundation · collabMerck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and weekly paclitaxel (THP-pembrolizumab), or neoadjuvant trastuzumab, pembrolizumab and weekly paclitaxel (TH-pembrolizumab ) in chemo naive patients with invasive human epidermal growth factor receptor 2 (HER2) positive breast cancer whose primary tumors are \> 2 cm and/or clinically lymph node positive. Treatment will be followed by standard of care breast surgery and physician's choice adjuvant therapy per standard of care.
Timeline
- Start
- 2019-01-25
- Primary completion
- 2024-11-08
- Completion
- 2029-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | — | — |
| Subject | Pertuzumab | Monoclonal antibody | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | Trastuzumab | Monoclonal antibody | — | — |