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Phase I Trial of Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Patients With Non-Metastatic Triple-Negative Breast Cancer at High Risk of Recurrence
The purpose of this study is to determine the safety as well as the most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat patients with non-metastatic triple negative breast cancer, participants who are of cancer-free but may be at risk for triple-negative breast cancer, and for participants who are receiving adjuvant pembrolizumab following initial triple negative breast cancer treatment.
Details
| Lead sponsor | George T. Budd |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 35 |
| Start date | 2021-10-01 |
| Completion | 2026-05 |
Conditions
- Pathologic Stage IIA-IIIC Triple-Negative Breast Cancer
- TNBC - Triple-Negative Breast Cancer
- Residual Disease
Interventions
- α-lactalbumin vaccine
- Zymosan
Primary outcomes
- Treatment Cohort MTD of α-lactalbumin vaccine — Day 84
MTD of an α-lactalbumin vaccine in participants with operable triple-negative breast cancer - Preventative Cohort MTD of α-lactalbumin vaccine — Day 84
MTD of an α-lactalbumin vaccine in participants at risk for TNBC who are scheduled for prophylactic double mastectomy. - Pembrolizumab Cohort of α-lactalbumin vaccine — Day 84
MTD of an α-lactalbumin vaccine in participants who are receiving adjuvant pembrolizumab following initial TNBC treatment.
Countries
United States