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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
GP2 vaccine plus GM-CSF (n=89) vs. GM-CSF (n=91)
randomized controlled trial
GP2 plus GM-CSF
GP2: 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 GP2 vaccin in combination with GM-CSF did not improve DFS in patients compare to GM-CSF alone, exploratory results
OBI-822/OBI-821 plus cyclophosphamide (n=225) vs. chemotherapy (n=124)
randomized controlled trial
OBI-822/OBI-821 plus cyclophsophamide
OPT-822/OPT-821: 30 μg/100 μg at weeks 1, 2, 3, 5, 9, 13, 17, 25, and 37 for a total of nine doses or until disease progression / cyclophosphamide: IV 300 mg/m2 weeks 1, 5, 9, 13, 17, 25, and 37, 3 days prior to each dose of study drug
cyclophsophamide
cyclophosphamide: IV 300 mg/m2 weeks 1, 5, 9, 13, 17, 25, and 37, 3 days prior to each dose of study drug
la/mBC - HR-positive - 2nd line (L2)
Exclusion criteria included more than two lines of prior anticancer therapy; chemotherapy within 4 weeks of randomization; autoimmune disease or disorder requiring treatment with systemic corticosteroids or immunosuppressive therapies; any other investigational drug; any evidence or history of central nervous system metastases; and bone-only metastases.
double blind
at 40 sites in Taiwan (15), USA (12), Korea (10), India (2), and Hong Kong (1)
P2 / PFS at 2-sided at 5%
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