Status:
COMPLETED
Trial With Autologous Dendritic Cell Vaccination in Patients With Stage II-III HER2 Negative Breast Cancer
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Collaborating Sponsors:
Spanish Clinical Research Network - SCReN
National Institutes of Health (NIH)
Conditions:
Stage II Breast Cancer
Stage III Breast Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Molecular expression in breast cancer (BC) defines special fenotypes with different prognostic and predictive features.Since the addition of trastuzumab and lapatinib to chemotherapy, HER2 overexpress...
Detailed Description
Chemotherapy schedule: * dose dense epirubucin 100 mgr/m2 plus ciclofosfamide 600 mgr/m2 every two weeks for four cycles with with GM-CSF support on day +1 (pegylated filgastrim) or on days +5 to +9 ...
Eligibility Criteria
Inclusion
- HER2 negative and stage II and III Breast cancer patients who benefit with neoadjuvant chemotherapy
- age 18-75
- to get enough tumoral sample to elaborate the vaccine
Exclusion
- pregnancy
- severe diseases
- hepatitis or HIV
- need to be on immunosuppressant drugs
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01431196
Start Date
February 1 2011
End Date
December 1 2013
Last Update
May 19 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clínica Universidad de Navarra
Pamplona, Navarre, Spain, 31008