CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine +1 morebiological
Likely dose
Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine plus QS21 (specific dose not stated)AI-extracted
Key inclusion· 3
  • ✓Diagnosis of breast cancer at high risk for recurrence: Stage IV free of all known disease after treatment; Stage I-III with prior adjuvant chemotherapy and rising CA 15-3 or CEA levels; Stage III completed adjuvant therapy ≤24 months ago; recurrence in ipsilateral axilla or breast after lumpectomy/mastectomy; Stage II with ≥4 positive axillary nodes completed adjuvant therapy ≤24 months ago; or Stage IV stable on hormonal therapy
  • ✓Age ≥18 years
  • ✓Karnofsky performance status 80-100%
Key exclusion· 6
  • ✕Prior seafood allergy
  • ✕Known prior immunodeficiency or autoimmune disease
  • ✕Other active cancer except basal cell or squamous cell skin cancer
  • ✕Pregnant or positive pregnancy test

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

Search/NCT00030823
NCT00030823N/ACompleted
CompareCT.gov

Vaccination Of High Risk Breast Cancer Patients With Heptavalent Antigen - Keyhole Limpet Hemocyanin Conjugate Plus The Immunological Adjuvant QS21

Memorial Sloan Kettering Cancer Center·interventional·Posted Jan 27, 2003·Updated Dec 30, 2015

In Brief

A clinical study evaluating Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine and QS21 for Breast Cancer. Completed, enrolled 14 participants across 1 site.

Detailed Summary

RATIONALE: Vaccines may make the body build an immune response and decrease the recurrence of breast cancer. PURPOSE: Pilot trial to study the effectiveness of vaccine therapy in treating patients who are at high risk for breast cancer recurrence.

Study Details

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

Timeline

N/ACompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMar 1, 2001
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 23.4 years ago

Interventions

Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccinebiological

QS21biological