Clinical trial · Interventional
S0348 Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer in Remission
S0348: A Phase II Study of 5T4-Modified Vaccinia Ankara (MVA) Vaccine (TROVAX) in Patients With Advanced Breast Cancer
NCT00227474CI-TRIAL-00009088withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): SWOG has decided to not pursue this trial
Summary
Brief summary (as posted)
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB or stage IV breast cancer in remission.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| recombinant modified vaccinia Ankara-5T4 vaccine | Drug | — | UNRESOLVED |
| recombinant viral vaccine therapy | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Stage IIIB-IV disease
* Patients with stage IV disease must have metastasis to the bone only AND documentation of negative or improved bone scan showing evidence of recalcification by plain film x-ray OR MRI showing normalization of marrow signal
* In remission (no evidence of disease)
* Must have completed appropriate treatment (e.g., radiotherapy and chemotherapy) for primary disease
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Not specified
Menopausal status
* Not specified
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* No known history of hepatitis B or C
Renal
* Not specified
Immunologic
* No known HIV positivity
* No known history of immune-deficiency disorder
* No history of allergic reaction to prior vaccinia vaccinations
* No autoimmune disease requiring concurrent treatment
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Concurrent trastuzumab (Herceptin®) allowed provided it is not part of treatment on another clinical trial
Chemotherapy
* See Disease Characteristics
* At least 28 days since prior cytotoxic chemotherapy
Endocrine therapy
* At least 28 days since prior steroid therapy
* Concurrent hormonal therapy allowed provided it is not part of treatment on another clinical trial
Radiotherapy
* See Disease Characteristics
* At least 28 days since prior radiotherapy
Surgery
* Not specified
Other
* At least 28 days since prior and no concurrent treatment on another clinical trial
* Patients enrolled in a SWOG phase III metastatic trial (e.g.,SWOG-S0226 or SWOG-S0347) who have achieved complete remission but not yet progressed are not eligible
* Patients enrolled in a SWOG phase II metastatic trial or phase II/III adjuvant or neoadjuvant trial (e.g., SWOG-S0012, SWOG-S0215, SWOG-S0221, SWOG-S0338, or SWOG-S0430) who have achieved complete remission/no evidence of disease status and are no longer receiving study treatment are eligible
* Concurrent bisphosphonates allowed provided it is not part of treatment on another clinical trialReferences
Publications (0)
Data not yet available
No reference posted for this study.