USO 21462
A Randomized, Multicenter, Placebo-controlled, Phase 3 study to Evaluate the Efficacy and Safety of HER2/neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/neu Positive Subjects with Residual Disease or High-Risk PCR after both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy
Disease Types: Breast Cancer Research
Eligibility Requirements:
• Histologically confirmed HER2+ primary BC
• Stage I, II, or III at presentation with residual disease at surgery or Stage III at
presentation with pCR at surgery
• Stage IV disease is excluded
• All HLA types are eligible. HLA screening can occur as early as surgery (blood
test).
• Completion of primary SOC BC therapy
• At least 6 cycles of neoadjuvant chemotherapy
• MUST include at least 3 cycles of taxane-based chemo over 9 weeks
• May include anthracycline-based chemo
• At least 3 cycles of trastuzumab (or approved biosimilar) over 9 weeks
• Surgery
• Adjuvant tx with at least 90% of planned post-surgical trastuzumab-based (or
approved biosimilar) tx
• For residual disease at surgery, T-DM1 must be attempted as 1st tx
• For pCR at surgery, adjuvant trastuzumab-based tx must be completed (at
least 16 cycles total over one year)
• Pts may continue hormone-based therapy but must not be receiving
chemotherapy. Concurrent neratinib is prohibited.
For more information on this trial CLICK HERE .
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