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Home > "A" Clinical Trials Conditions > A Dose-Escalation Vaccine Trial In HER2-Overexpressing Patients With High-Risk Breast Cancer  A Dose-Escalation Vaccine Trial In HER2-Overexpressing Patients With High-Risk Breast Cancer
A Dose-Escalation Vaccine Trial In HER2-Overexpressing Patients With High-Risk Breast Cancer
For Condition: Breast Cancer
Status: Recruiting
Sponsor(s): Sponsor Name Pending ,
Synopsis: This trial will test how safe this vaccine is. It also tests whether its introduction induces an immune response by stimulating the patient's own immune system to recognize a specific target molecule called HER2, which is overexpressed in many breast cancers. The vaccine in this trial has not previously been administered to humans, and therefore the induction of the desired immune responses in humans remains to be established. Patients will receive 6 intramuscular vaccinations over a 14 week period, with 9 clinic visits and 3 follow up visits. In addition, patients are asked to revisit the study physician once a year for 5 years after the study ends to evaluate any long-term effects.
Details:
Eligibility:
Study Type: Interventional, Prevention, Non-Randomized, Single Blind, Dose Comparison, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 40 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: (patients must meet the following criteria in order to be eligible for this study) - Provide written informed consent. - Previous diagnosis of HER2/neu-positive breast cancer. - Stage II with 4 or more positive nodes, or Stage III in remission. - Have had standard treatment for their cancer, including lymph node dissection and at least one course of standard adjuvant treatment with or without local-regional breast irradiation. - Free of recurrent breast cancer disease. - Current chest X-ray showing no evidence of disease. - Completed at least one course of standard adjuvant treatment within 2 years of study entry. - Life expectancy of at least 12 months. Exclusion Criteria (patients cannot meet the following criteria in order to be eligible for this study): - Surgery or chemotherapy treatment within 8 weeks of study enrollment. - Radiotherapy within 12 weeks of study enrollment. - Use of other experimental agents during study. - Use of investigational or commercial agents or therapies intended to treat the malignancy during the study or within 1 month prior to first study vaccination. - Patients younger than 40 years of age must be sterile or incapable of childbearing. - Heart problems or uncontrolled hypertension, bleeding or coagulation disorders, auto-immune disorders, or psychiatric illness or addictive disorders. - Known to be HIV positive. - Past or current treatment with drug Herceptin. - Pregnant or breastfeeding. - Any uncontrolled illness that would preclude the study.
Total Enrollment:
Location and Contact Information:
Study Site *Not yet recruiting*
Paris Cedex 05, , F-75 248
France
Not yet recruiting Study Coordinator
Study Site *Not yet recruiting*
Hollywood, Florida, 33324
United States
Not yet recruiting Study Coordinator 954-476-0342
Study Site *Not yet recruiting*
Leuven, , B-3000
Belgium
Not yet recruiting Study Coordinator 011 32 16 34 46 35
Study Site *Not yet recruiting*
Nashville, Tennessee, 37203
United States
Not yet recruiting Study Coordinator 615-342-1725
Study Site *Not yet recruiting*
Milano, , 20141
Italy
Not yet recruiting Study Coordinator 011 39 02 57489498
Study Site *Not yet recruiting*
Philadelphia, Pennsylvania, 19111
United States
Not yet recruiting Study Coordinator 215-728-2480
Study Site *Not yet recruiting*
Rochester, Minnesota, 55905
United States
Not yet recruiting Study Coordinator 507-284-8432
Study Site *Recruiting*
Charlotte, North Carolina, 28203
United States
Recruiting Study Coordinator 704-446-9046
Study Site *Not yet recruiting*
Buffalo, New York, 14263
United States
Not yet recruiting Study Coordinator 716-845-8547
Study Site *Not yet recruiting*
Brussels, , B-1000
Belgium
Not yet recruiting Study Coordinator 011 32 2 541 32 19
Study Site *Not yet recruiting*
Lyon Cedex 08, , F-69 373
France
Not yet recruiting Study Coordinator 011 33 4 78 78 27 51
Study Site *Not yet recruiting*
Louisville, Kentucky, 40202
United States
Not yet recruiting Study Coordinator 502-629-2500
Study Site *Not yet recruiting*
Leuven, , B-3000
Belgium
Not yet recruiting Study Coordinator 011 32 16 34 69 00
Study Site *Recruiting*
Charleroi, Hainaut, B-6000
Belgium
Recruiting Study Coordinator 32 071 28 16 65
Study Site *Not yet recruiting*
Perugia, , 06122
France
Not yet recruiting Study Coordinator
Study Site *Not yet recruiting*
Greenbrae, California, 94904
United States
Not yet recruiting Study Coordinator 415-925-5001
Study Site *Not yet recruiting*
BRUXELLES, , B-1200
Belgium
Not yet recruiting Study Coordinator 011 32 2 764 83 00
Study Site *Not yet recruiting*
Roma, , 00161
Italy
Not yet recruiting Study Coordinator 011 39 06 4462982
Study Site *Not yet recruiting*
Seattle, Washington, 98195
United States
Not yet recruiting Study Coordinator 206-616-1823
Study Site *Not yet recruiting*
Nantes-St-Herblain, , F-44805
France
Not yet recruiting Study Coordinator 011 33 240 67 99 75
Additional Information:
Study ID Numbers: 719125/002;
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058526
Other Breast Cancer Studies:
1. Primary Chemotherapy with Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer
2. Flavopiridol in Treating Patients With Metastatic or Unresectable Mantle Cell Lymphoma, Squamous Cell Carcinoma of the Head and Neck, Small Cell Lung Cancer, or Invasive Breast Cancer
3. Phase II Study of MDX-010 in Stage IV Breast Cancer
4. A Phase II Trial of Raloxifene in Pre-Menopausal Women at High Risk for Developing Invasive Breast Cancer
5. Treatment with Zometa in patients with breast cancer, multiple myeloma, and prostate cancer with cancer related bone lesions
Related Studies:
Other Breast Cancer Clinical Trials
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A Dose-Escalation Vaccine Trial In HER2-Overexpressing Patients With High-Risk Breast Cancer
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