Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer

Summary

The purpose of this study is to study a new treatment for HER2-positive breast cancer.

Timeline

Start

2013-04

Primary completion

2019-01

Completion

2019-01

Outcome

Missed primary endpoint

paper Only 13 of 19 evaluable patients (68%) completed PTL without a dose delay or reduction or unacceptable toxicities. PMID 26454612 ↗

paper The trial was halted, because the initial discontinuation rate from overall toxicity made it unlikely that full accrual would demonstrate feasibility. PMID 26454612 ↗

Publications

• Iyengar NM, Fornier MN, Sugarman SM, Theodoulou M, Troso-Sandoval TA, D'Andrea GM, Drullinsky PR, Gajria D, Goldfarb SB, Comen EA, Lake DE, Modi S, Traina TA, Lacouture ME, Chen MF, Patil S, Baselga J, Norton L, Hudis CA, Dang CT. A Pilot Study of Dose-Dense Paclitaxel With Trastuzumab and Lapatinib for Node-negative HER2-Overexpressed Breast Cancer. Clin Breast Cancer. 2016 Apr;16(2):87-94. doi: 10.1016/j.clbc.2015.09.009. Epub 2015 Sep 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lapatinib	Small molecule	1000 mg	Oral
Subject	Paclitaxel	Small molecule	175 mg/m2	—
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	—
Background	Pegfilgrastim	Protein / enzyme biologic	6 mg	Subcutaneous

Indications