Re: Phase II Trial of Combination Immunotherapy With NeuVax and Trastuzumab in High-r
To clarify who is consider High Risk
1) Neoadjuvant treatment with residual disease found at surgery
Completed neoadjuvant therapy with an approved regimen that includes trastuzumab and at least four cycles (12 weeks) of taxane-containing chemotherapy and underwent surgery with final pathology showing evidence of residual disease in the breast or axilla (residual ductal carcinoma in situ or microinvasive disease not eligible)
2) Surgery as a first intervention and was found to be pathologically node-positive: ≥ 4 positive lymph nodes (pN2 or pN3) regardless of hormone receptor status
3) 1-3 positive lymph nodes (pN1) if hormone receptor negative.
So if you are agonizing because you did not get a complete response to chemo before surgery, if you had 4 or more positive nodes, OR if you are ER-/PR-/HER2+ and had 1-3 positive nodes - this is a great option for you.
Thanks and keep us posted on if you could or could not enroll.
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