Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab Plus Pertuzumab With Paclitaxel

NCT02073487 ↗

Phase 2 Completed 32 enrolled The Methodist Hospital Research Institute Celgene Corporation · collab Novartis · 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

Outcome

Met primary endpoint

paper The proportion of patients with RCB 0 or I was higher in the experimental arm (100% vs. 62.5% in the standard arm, p = 0.0035). PMID 31477168 ↗

Publications

Patel TA, Ensor JE, Creamer SL, Boone T, Rodriguez AA, Niravath PA, Darcourt JG, Meisel JL, Li X, Zhao J, Kuhn JG, Rosato RR, Qian W, Belcheva A, Schwartz MR, Kaklamani VG, Chang JC. A randomized, controlled phase II trial of neoadjuvant ado-trastuzumab emtansine, lapatinib, and nab-paclitaxel versus trastuzumab, pertuzumab, and paclitaxel in HER2-positive breast cancer (TEAL study). Breast Cancer Res. 2019 Sep 2;21(1):100. doi: 10.1186/s13058-019-1186-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abraxane	Small molecule	—	Intravenous
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