Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GLSI-100 · 1 trial · 1 indication
IBCFS is defined as the time from the first dose of study medication until the date of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or any cause mortality.
| Arm | Type | Description |
|---|---|---|
| 0.9% Normal Saline | PLACEBO_COMPARATOR | 0.9% normal saline in HLA-A\*02 positive and HER2/neu positive subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years) |
| GLSI-100 | EXPERIMENTAL | GLSI-100 immunotherapy in HLA-A\*02 positive and HER2/neu positive subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years) |
| GLSI-100, Open-label | EXPERIMENTAL | Open-label arm: GLSI-100 immunotherapy in non-HLA-A\*02 positive and HER2/neu positive subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years) |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | 0.9% Normal Saline |
| GLSI-100 | BIOLOGICAL | 500 mcg/mL GP2 and 125 mcg/mL GM-CSF |
Inclusion Criteria: * HLA-A\*02-positive, unless being enrolled in the third non-HLA-A\*02 arm * Histologically confirmed diagnosis of HER2/neu positive primary breast cancer for all tumors biopsied (multifocal, multicentric, or synchronous contralateral disease) * Completion of both neoadjuvant an...
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