Quantum Leap Healthcare Collaborative

Agent Information Sheet

Widely hailed as the future of phase II drug development, the adaptive I-SPY 2 platform trial has set a new benchmark for
Close
Close
I-SPY Trial Manuscript
<- Back to All Agents

neratinib

Trade Name:
Nerlynx
Status:
Graduated
Agent Chaperone(s):
Treatment Protocol:
Neratinib is a multikinase inhibitor; EGFR, HER2, HER3 Inhibitor. Neratinib was adminstered orally at 240 mg (qd) for 12 weeks with Paclitaxel (q1w) at 80 mg/m2. This regimen is followed by AC (q2w or q3w).
Date Entered I-SPY:
March 10, 2010
Date Left I-SPY:
January 13, 2013
No. Participants in Arm:
127
Graduating Subtypes:
HER2+, HR-HER2+
Agent Description:

Neratinib is an orally available, 6,7-disubstituted-4-anilinoquinoline-3-carbonitrile irreversible inhibitor of the HER-2 receptor tyrosine kinase. Treatment of cells with this agent results in inhibition of downstream signal transduction events and cell cycle regulatory pathways; arrest at the G1-S (Gap 1/DNA synthesis)-phase transition of the cell division cycle; and ultimately decreased cellular proliferation. Neratinib also inhibits the epidermal growth factor receptor (EGFR) kinase and the proliferation of EGFR-dependent cells.

Notes:
Final pCR Probabilities:
Primary Manuscript:
Park JW, Liu MC, Yee D, et al.
Adaptive Randomization of Neratinib in Early Breast Cancer
N Engl J Med
 
375
11-22
2016
abstractpdfview original