Clinical trial · Interventional
Vaccine Therapy in Treating Patients Receiving Trastuzumab For HER2-Positive Stage IIIB-IV Breast Cancer
Phase II Study of a HER-2/Neu (HER2) Intracellular Domain (ICD) Peptide-Based Vaccine Administered to Patients With Locally Advanced or Stage IV HER2 Positive Breast Cancer
NCT00343109CI-TRIAL-00043368completedPhase 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)
This phase II trial is studying how well vaccine therapy works in treating patients receiving trastuzumab for HER2-positive stage IIIB- IV breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Male Breast Cancer | Male Breast Carcinoma | ALIAS | 0.90 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HER-2/neu intracellular domain protein | Biological | — | UNRESOLVED |
| immunologic technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| leukapheresis | Procedure | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| synthetic tumor-associated peptide vaccine therapy | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive HER-2/neu intracellular domain peptide-based vaccine mixed with GM-CSF intradermally once monthly for 6 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Biological: HER-2/neu intracellular domain protein
- Procedure: leukapheresis
- Other: laboratory biomarker analysis
- Biological: sargramostim
- Other: immunologic technique
- Biological: synthetic tumor-associated peptide vaccine therapy
Primary outcomes (1)
- measure
- Relapse-free survival
- timeFrame
- At 4 years
Secondary outcomes (3)
- measure
- Safety as assessed by NCI CTCAE version 3.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Stage IIIB or Stage IIIC breast cancer who are within 1 year of diagnosis and initiating treatment with chemotherapy and trastuzumab; and are in complete remission * Stage IV breast cancer in first complete remission and defined as NED (no evidence of disease) or with stable bone only disease who are within 6 months of initiating maintenance trastuzumab * NED status should be documented by chest/abdominal CT, PET or PET/CT within the last 90 days * Bone only disease documented as stable or healed by PET, PET/CT, or MRI within the last 90 days; stable bone-only disease must be documented with bone scan performed within the last 6 months * HER2 overexpression by IHC of 2+ or 3+, in the primary tumor or metastasis or documented gene amplification by FISH analysis; if overexpression is 2+ by IHC, then patients must have HER2 gene amplification documented by FISH * Eligible subjects must have been treated to NED or stable bone only disease status with trastuzumab and/or chemotherapy and be off cytotoxic chemotherapy or immunosuppressive agents (e.g. systemic steroids) for at least 30 days prior to enrollment (concurrent hormonal therapy allowed; concurrent bisphosphonate therapy allowed) * Patients on trastuzumab should continue trastuzumab monotherapy per standard of care (the dosing and schedule of trastuzumab should follow standard guidelines as described below: trastuzumab 2mg/kg IV weekly or trastuzumab 6mg/kg IV every 3 weeks) * Subjects must have an ECOG Performance Status Score =\< 1 * Non-menopausal female subjects must agree to contraception for the remainder of their childbearing years * Male subjects must use an acceptable form of contraception throughout the course of the study * Hematocrit \>= 30,000 * Platelet count \>= 100,000 * WBC \>= 3000/mcl * Stable creatinine =\< 2.0 mg/dl or a creatinine clearance greater than 60 ml/min * Serum bilirubin \< 1.5 mg/dl * SGOT \< 2x ULN * Laboratory tests should be performed within 60 days of enrollment * Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment * Patients on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fraction (EF) on MUGA scan or echocardiogram performed within last 6 months Exclusion Criteria: * Subjects cannot be simultaneously enrolled in other treatment studies * Patients cannot be receiving any other concurrent immunomodulators besides trastuzumab * Any contraindication to receiving GM-CSF based vaccine products * Cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart failure on active treatment with normalized LVEF on therapy, and symptomatic pericardial effusion * Active autoimmune disease * Subjects can not have active immunodeficiency disorder, e.g. HIV * Cannot be pregnant or breast feeding
References
Publications (0)
Data not yet available
No reference posted for this study.