Clinical trial · Interventional
Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence
Vaccination Of High Risk Breast Cancer Patients With Heptavalent Antigen - Keyhole Limpet Hemocyanin Conjugate Plus The Immunological Adjuvant QS21
NCT00030823CI-TRIAL-00020386completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine | Biological | — | UNRESOLVED |
| QS21 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vaccine
- description
- Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
- interventionNames
- Biological: Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine
- Biological: QS21
Primary outcomes (1)
- measure
- Safety
- timeFrame
- 2 years
- description
- By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of breast cancer at high risk for recurrence, defined by one of the following:
* Stage IV that is free of all known disease after eradication by surgery, radiotherapy, or chemotherapy
* May or may not have elevated CA 15-3 or CEA levels
* Stage I, II, or III previously treated with adjuvant chemotherapy and clinically free of identifiable disease, but have rising CA 15-3 or CEA levels
* Rising CA 15-3 and CEA defined as a prior normal level increased on 2 consecutive occasions at least 2 weeks apart
* For patients with a significant history of smoking who have a chronically elevated CEA (less than 15), CEA must be increased at least 1.5 times the uppermost chronic value on 2 consecutive occasions at least 2 weeks apart
* Stage III and completed adjuvant therapy no more than 24 months ago
* Recurrence in the ipsilateral axilla after lumpectomy and/or axillary dissection or modified radical mastectomy
* Recurrence in the ipsilateral breast after lumpectomy and/or axillary dissection
* Stage II with at least 4 positive axillary nodes and completed adjuvant therapy no more than 24 months ago
* Stage IV that is stable on hormonal therapy
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Male or female
Menopausal status:
* Not specified
Performance status:
* Karnofsky 80-100%
Life expectancy:
* Not specified
Hematopoietic:
* Lymphocyte count at least 500/mm\^3
* WBC at least 3,000/mm\^3
Hepatic:
* AST no greater than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 1.5 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No clinically significant New York Heart Association class III or IV cardiac disease
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior seafood allergy
* No known prior immunodeficiency or autoimmune disease
* No other active cancer except basal cell or squamous cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 6 weeks since prior immunotherapy
* No prior vaccine with any of the antigens in this study
Chemotherapy:
* See Disease Characteristics
* At least 4 weeks since prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery:
* See Disease Characteristics
* At least 4 weeks since prior surgery
* Concurrent surgery for local recurrence allowed if patient remains disease freeReferences
Publications (1)
- RESULTArmstrong JL, Ragupathi G, Powell S, et al.: Preliminary data of vaccination of high risk breast cancer (BC) patients (pts) with a heptavalent antigen: keyhole limpet hemocyanin (KLH) conjugate plus the immunologic adjuvant QS-21. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-675, 2003.