Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer

Summary

This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer. The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.

Timeline

Start

2009-08-21

Primary completion

2013-08

Completion

2018-06-28

Outcome

Missed primary endpoint

registry analysis (superiority test); Neratinib + Paclitaxel vs Trastuzumab + Paclitaxel; p = 0.8934; Hazard Ratio (HR) 1.015 (95% CI 0.813 to 1.269); Log Rank NCT00915018 ↗

paper In first-line ERBB2-positive metastatic breast cancer, neratinib-paclitaxel was not superior to trastuzumab-paclitaxel in terms of progression-free survival. PMID 27078022 ↗

Publications

• Awada A, Colomer R, Inoue K, Bondarenko I, Badwe RA, Demetriou G, Lee SC, Mehta AO, Kim SB, Bachelot T, Goswami C, Deo S, Bose R, Wong A, Xu F, Yao B, Bryce R, Carey LA. Neratinib Plus Paclitaxel vs Trastuzumab Plus Paclitaxel in Previously Untreated Metastatic ERBB2-Positive Breast Cancer: The NEfERT-T Randomized Clinical Trial. JAMA Oncol. 2016 Dec 1;2(12):1557-1564. doi: 10.1001/jamaoncol.2016.0237.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Neratinib	Small molecule	240 mg	Oral
Comparator	Trastuzumab	Monoclonal antibody	2 mg/kg	Intravenous
Background	Paclitaxel	Small molecule	80 mg/m2	Intravenous

Indications