Agent Information Sheet

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I-SPY Trial Manuscript
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pertuzumab

Trade Name:
Perjeta
Company:
Status:
Graduated
Agent Chaperone(s):
Treatment Protocol:
Pertuzumab is an ErbB2/EGFR/ErbB3 dimerization inhibitor. Pertuzumab was administered at 840 mg (loading dose) and a 420 mg (thereafter) intravenously once every 3 weeks (q3wk), Paclitaxel was administered at 80 mg/m2 weekly (q1w), and Trastuzumab was administered at 4 mg/kg (loading dose) and 2 mg/kg (thereafter) weekly (q1w) for a total of 12 weeks. This regimen was followed by AC (q2w or q3w) for 4 weeks.
Date Entered I-SPY:
June 3, 2013
Date Left I-SPY:
August 17, 2015
No. Participants in Arm:
99
Graduating Subtypes:
HER2+, HR-HER2+, HR+HER2+
Agent Description:

Pertuzumab is a recombinant humanized monoclonal antibody targeting the extracellular dimerization domain of Her2. This inhibits Her2 dimerization with Her1, Her3, and Her4, and downstream activation of the PI3K and MAPK pathways. Specifically, pertuzumab counters increased Her2 and Her3 dimerization signaling associated with trastuzumab resistance and is used in combination with trastuzumab and chemotherapy. Pertuzumab is approved for the first line treatment of Her2 overexpressing metastatic breast cancer and for neoadjuvant and adjuvant treatment of Her2 positive breast cancer.

Final pCR Probabilities:
Primary Manuscript:
 
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