drugset / Trial / NCT02073487
Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab Plus Pertuzumab With Paclitaxel
Phase 2
Completed
32 enrolled
The Methodist Hospital Research Institute
Celgene Corporation · collabNovartis · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a randomized, open label Phase II neoadjuvant study comparing the efficacy and safety of trastuzumab emtansine (T-DM1) plus lapatinib (L)followed by abraxane (A) versus trastuzumab plus pertuzumab followed by paclitaxel in patients with HER2-overexpressing breast cancer.
Timeline
- Start
- 2014-02
- Primary completion
- 2019-01
- Completion
- 2019-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lapatinib | Small molecule | — | Oral |
| Comparator | Paclitaxel | Small molecule | — | Intravenous |
| Comparator | Pertuzumab | Monoclonal antibody | — | Intravenous |
| Comparator | Trastuzumab | Monoclonal antibody | — | Intravenous |
| Subject | Trastuzumab emtansine | Other / unclassified | — | Intravenous |