Status:
WITHDRAWN
Dendritic Cell Based Therapy for Breast Cancer Patients
Lead Sponsor:
Inge Marie Svane
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The primary aim of this study is to investigate time to progression in breast cancer patients vaccinated with autologous dendritic cells pulsed with peptides in combination with adjuvant aromatase inh...
Detailed Description
Only patients who have tumors \> 5 % positive for p53 by IHC can be referred to this treatment. All patients will receive standard dosage of AI +/- p53-DC vaccination. Patients who express HLA-A2 will...
Eligibility Criteria
Inclusion
- Patients with histological proven metastatic or locally advanced ER+/PGR+ breast cancer in progression after receiving 1. line endocrine therapy.
- Further inclusion criteria: p53+ tumour, PS≤1, postmenopausal. Age \>18, PS ≤ 1 and acceptable CBC and blood chemistry results
Exclusion
- Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinoma in situ of the cervix and basal/squamous carcinoma of the skin)
- Patients with metastatic disease in the central nervous system
- Patients with other significant illness including severe allergy, asthma, DM, angina pectoris or congestive heart failure
- Patients with acute or chronic infection including HIV, hepatitis og TB
- Patients who received antineoplastic therapy including chemotherapy, radiation, immunotherapy or other agents, less than 4 weeks before the beginning of the trial
- Patients who received corticosteroids or other immunosuppressive agents
- Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis
- Severe hypercalcemia
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00935558
Start Date
July 1 2009
Last Update
May 31 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Oncology, Copenhagen University Hospital, Herlev
Herlev, Denmark, 2730