CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccinebiological
Likely dose
Not stated in record
Key inclusion· 10
  • ✓Histologically or cytologically confirmed adenocarcinoma of the breast, stage III or IV (primary or recurrent)
  • ✓HLA-A1, -A2, -A3, or -A31 positive
  • ✓Recovered from prior primary therapy (surgery, chemotherapy, radiotherapy within 36 months for patients with no evidence of disease)
  • ✓At least one undissected axillary and/or inguinal lymph node basin
Key exclusion· 7
  • ✕History of brain metastases
  • ✕Known or suspected allergies to any vaccine component
  • ✕Active infection requiring antibiotics
  • ✕NYHA class III or IV heart disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00304096
NCT00304096Phase 1Completed
CompareCT.gov

Evaluation of the Safety and Immunogenicity of Vaccination With Multiple Synthetic Peptides in Participants With Advanced Breast Cancer

University of Virginia·interventional·Posted Mar 17, 2006·Updated Apr 9, 2013

In Brief

A Phase 1 clinical trial evaluating synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine for Breast Cancer. Completed, enrolled 12 participants across 1 site.

Detailed Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III or stage IV breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 17, 2006
Enrollment StartDec 1, 2005
Primary CompletionJun 1, 2007
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 20.3 years ago

Interventions

synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccinebiological