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NCT00470574
Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer
NA trial testing QS21 in Breast Cancer in 7 participants. Completed in 24 January 2020.
24 January 2020
Quick facts
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 7 |
| Start date | 20 March 2007 |
| Primary completion | 24 January 2020 |
| Estimated completion | 24 January 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- QS21 — full drug profile →
- sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine — full drug profile →
- immunoenzyme technique
- immunologic technique
- laboratory biomarker analysis — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Memorial Sloan Kettering Cancer Center — full company profile →
Who can join
Adults 18 to 120, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: 2 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (3 terms)
| Reaction | System | Vaccine Therapy and QS21 |
|---|---|---|
| Ocular/Visual - Other (specify) | Eye disorders | — |
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | — |
| Rash/desquamation | Skin and subcutaneous tissue disorders | — |
Other adverse events (25 terms — click to expand)
| Reaction | System | Vaccine Therapy and QS21 |
|---|---|---|
| Injection site reaction/extravasation | General disorders | — |
| Fatigue (asthenia, lethargy, malaise) | General disorders | — |
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | — |
| Dermatology/Skin, other | Skin and subcutaneous tissue disorders | — |
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | — |
| Metabolic/Lab - Other (specify) | Metabolism and nutrition disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Pain - Head/headache | Nervous system disorders | — |
| Pain - Muscle | Musculoskeletal and connective tissue disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Pain - Joint | Musculoskeletal and connective tissue disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Edema: limb | General disorders | — |
| Fever (in the absence of neutropenia) | General disorders | — |
| Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | — |
| Hemoglobin | Blood and lymphatic system disorders | — |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | — |
| Mucositis (func/sympt)- Oral cavity | Gastrointestinal disorders | — |
| Ocular/Visual - Other (specify) | Eye disorders | — |
| Pruritus/itching | Skin and subcutaneous tissue disorders | — |
| Rash/desquamation | Skin and subcutaneous tissue disorders | — |
| Rigors/chills | General disorders | — |
| Sodium, high (hypernatremia) | Metabolism and nutrition disorders | — |
| Vomiting | Gastrointestinal disorders | — |
Most-reported serious reactions: Ocular/Visual - Other (specify), Potassium, low (hypokalemia), Rash/desquamation.
Data from ClinicalTrials.gov NCT00470574 adverse events section.
Sponsor's own description
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more tumor cells. PURPOSE: This clinical trial is studying the side effects and how well giving vaccine therapy together with QS21 works in treating patients with metastatic breast cancer.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
The clinical impact of glycobiology: targeting selectins, Siglecs and mammalian glycans.
Smith BAH, Bertozzi CR. · · 2021 · cited 380× · PMID 33462432 · DOI 10.1038/s41573-020-00093-1 -
Glycosylation: mechanisms, biological functions and clinical implications.
He M, Zhou X, Wang X. · · 2024 · cited 248× · PMID 39098853 · DOI 10.1038/s41392-024-01886-1 -
Emerging role of natural products in cancer immunotherapy.
Dong S, Guo X, Han F, He Z, et al · · 2022 · cited 182× · PMID 35530162 · DOI 10.1016/j.apsb.2021.08.020 -
Targeting Tumor Glycans for Cancer Therapy: Successes, Limitations, and Perspectives.
Berois N, Pittini A, Osinaga E. · · 2022 · cited 96× · PMID 35158915 · DOI 10.3390/cancers14030645 -
Aberrant Sialylation in Cancer: Therapeutic Opportunities.
Munkley J. · · 2022 · cited 77× · PMID 36077781 · DOI 10.3390/cancers14174248 -
Aberrant Glycosylation as Immune Therapeutic Targets for Solid Tumors.
Matsumoto Y, Ju T. · · 2023 · cited 31× · PMID 37509200 · DOI 10.3390/cancers15143536
Verify or expand the search:
- PubMed search for NCT00470574
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of QS21
Trials testing the same drug.
- NCT06741072 — BZLF1 Peptide Vaccine (OSU-2131) With QS-21 for the Prevention of Epstein-Barr Virus Related Cancer in Patients Awaiting · Phase 1 · suspended
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Currently open trials in the same condition.
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Other Memorial Sloan Kettering Cancer Center trials
Trials by the same sponsor.
- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
- NCT07507643 — A Study of Methylprednisolone in People Having Liver Surgery · Phase 3 · recruiting
- NCT07483307 — A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer · Phase 2 · recruiting
- NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
- NCT07449195 — A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00470574 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
- Last refreshed: 18 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00470574.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing