NCT00068614

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of HER-2 protein vaccine in treating women who have breast cancer.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Last Updated

February 5, 2014

Status Verified

February 1, 2014

Enrollment Period

2.3 years

First QC Date

September 10, 2003

Last Update Submit

February 4, 2014

Conditions

Breast Cancer

Keywords

stage IV breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Interventions

HER-2/neu peptide vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast, meeting criteria for 1 of the following: * Metastatic disease currently in complete or partial response or stable disease * Have been receiving a stable endocrine therapy regimen (e.g., aromatase inhibitor, tamoxifen, fulvestrant, or gonadotropin-releasing hormone agonist) for at least 30 days OR status post oophorectomy * Completed a course of local and adjuvant systemic therapy for high-risk stage II or III disease (i.e., anticipated 5-year relative survival is no greater than 50%) meeting any of the following staging criteria: * Stage IIB with involvement of at least 4 nodes * Stage IIIA (T3 disease with involvement of at least 4 nodes) * Any stage IIIB or IIIC disease * Stage IV with no evidence of disease (e.g., prior resection of local chest wall recurrence with no evidence of disease elsewhere) * 1+, 2+, or 3+ HER2/neu expression by immunohistochemistry * Treatment with trastuzumab (Herceptin®) not clinically indicated * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * At least 6 months Hematopoietic * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL * Absolute neutrophil count at least 1,500/mm\^3 Hepatic * ALT or AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN for patients with liver metastases) * Bilirubin no greater than 2 mg/dL (unless due to Gilbert's disease) Renal * Creatinine no greater than 2 mg/dL Cardiovascular * No history of significant cardiovascular disease * No myocardial infarction within the past 6 months * No poorly controlled cardiac arrhythmia * No New York Heart Association class III or IV heart disease * LVEF at least 50% by MUGA Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy except basal cell skin cancer or adequately treated carcinoma in situ of the cervix * No concurrent severe autoimmune disease * No other clinically significant or serious medical disease that would preclude study participation or compromise patient safety or the results of this study PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 months since prior trastuzumab * No prior anticancer vaccine therapy * No concurrent trastuzumab * No concurrent immunomodulators (e.g., thalidomide or interferons/interleukins) Chemotherapy * More than 4 weeks since prior chemotherapy * No concurrent low-dose methotrexate or cyclophosphamide * No concurrent cytotoxic chemotherapy Endocrine therapy * See Disease Characteristics * No concurrent corticosteroids * Topical or inhaled steroids are allowed * No changes to current endocrine therapy regimen (e.g., discontinuation or addition of an agent) Radiotherapy * More than 3 months since prior radiotherapy involving more than 25% of the bone marrow * No concurrent radiotherapy Surgery * See Disease Characteristics * No prior bilateral breast procedures Other * More than 4 weeks since prior immunosuppressive therapy * More than 30 days since prior investigational agents or clinical trial participation * No other concurrent experimental or investigational agents * No concurrent cyclosporine * No concurrent immunosuppressive agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Ireland Cancer Center

Cleveland, Ohio, 44106-5055, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Beth A. Overmoyer, MD, FACP

    Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2003

First Posted

September 11, 2003

Study Start

July 1, 2003

Primary Completion

October 1, 2005

Last Updated

February 5, 2014

Record last verified: 2014-02

Locations

US(1)