Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01632332 | Vaccine Therapy in Treating Patients With Previously Treated Stage II-III HER2-Positive Breast Cancer | PHASE1 | COMPLETED | 22 | — | — | Jul 9, 2012 | Jul 9, 2018 | Oct 9, 2018 | 1 | United States |
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Immune responses to to the vaccine components will be periodically assessed using various assays measuring cytokine release, frequency of T cells, and antibody generation.
| Arm | Type | Description |
|---|---|---|
| Treatment (HER-2/neu peptide vaccine) | EXPERIMENTAL | Patients receive HER-2/neu peptide vaccine ID every 28 days for up to 6 courses in the absence of disease recurrence or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| HER-2/neu peptide vaccine | BIOLOGICAL | Given ID |
| laboratory biomarker analysis | OTHER | Correlative studies |
Inclusion Criteria: * Histological confirmation of primary breast cancer, stage II or III, completely resected; Note: history of a local recurrence allowable if also completely resected * Prior diagnosis of HER-2 positive primary breast cancer using American Society of Clinical Oncologists (ASCO)/C...