Clinical trial · Interventional
Safety and Efficacy Study of Mix Vaccine in Breast Carcinoma Patient
Safety Issue and Efficacy Study of Combining Mix Vaccine and Standard Therapy in the Treatment of Breast Carcinoma Patient
NCT02338804CI-TRIAL-00019091completedPhase 1 / Phase 2ClinicalTrials.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)
The purpose of this study is to evaluate the safeness and effectiveness of mix vaccine (MV). Enrolled patients will receive standard treatment according to National Comprehensive Cancer Network (NCCN) guide line with or without combining MV injection. The efficacy and side effect will be compared between the two groups.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MV | Biological | — | UNRESOLVED |
| standard treatment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- control
- description
- Patients in this group will be receiving standard therapy according to National Comprehensive Cancer Network (NCCN) guide line
- interventionNames
- Other: standard treatment
- type
- EXPERIMENTAL
- label
- MV+control
- description
- Patients in this group will be receiving both standard therapy according to NCCN guide line and simultaneous injection of mix vaccine (MV).
- interventionNames
- Biological: MV
- Other: standard treatment
Primary outcomes (1)
- measure
- efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 1.Patients diagnosed with breast carcinoma based on histology * 2.Evaluable lesions on imaging study * 3.Without known immunodeficiency * 4.Age \>18 and \<80 years ago Exclusion Criteria: * 1.Patients is unable or unwilling to sign informed consent * 2.Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication * 3.Positive HIV and/or RPR (rapid plasma reagin) * 4.Female patient who is pregnant or breast feeding * 5.Patients, based on the opinion pf the investigator, should not be enrolled into this study * 6.Prior anti-cancer vaccine or biological immunotherapy * 7.Allergic to any known ingredient of the MV compound
References
Publications (0)
Data not yet available
No reference posted for this study.