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AE37 vaccine plus GM-CSF (n=154) vs. GM-CSF (n=147)
randomized controlled trial
AE37 plus GM-CSF
AE37: 500 mcg of the peptide / GM-CSF: 125 mcg
GM-CSF
GM-CSF: 125 mcg
After the initial 6 inoculations, patients were given a total of 4 booster inoculations at six-month intervals beginning one year after each subject’s date of enrollment (at 12, 18, 24, and 30 months).
breast cancer (BC)
single blinded
16 sites throughout the United States
P2 / Groups were compared using a two-sided test (no more information). Exploratory results
No protocol available. No information on the SAP, however, it seems that AE37 vaccin in combination with GM-CSF did not improve DFS in patients compare to GM-CSF alone, exploratory results
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