Trial | NCT01431196  Report issue

Title

Trial With Autologous Dendritic Cell Vaccination in Patients With Stage II-III HER2 Negative Breast Cancer
Phase II Trial With Autologous Dendritic Cell Vaccination in Patients With Stage II-III HER2 Negative Breast Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    29
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 overexpressing tumors have become the best responders to systemic therapies, reaching pathologic complete response rates (pCR) around 50%. But HER2 negative tumors (luminal A and triple negative) are characterized by low chemosensitivity (luminal A) or early distant relapse after diagnosis (triple negative BC) . In this open, prospective, non-randomized and multicentric phase II study the investigators include stage II and III HER2 negative BC patients that are going to receive neoadjuvant sequential chemotherapy Epirubicin+Ciclofosfamide x 4 and then Docetaxel x 4)with an individualized vaccination with autologous dendritic cells pulsed with their own tumor. The hypothesis is that the reinforcement of the immune system with the autologous dendritic cell vaccination against HER2 negative BC could increase pathologic complete responses (pCR) and disease free survival(DFS), when added to chemo, surgery and radiation therapy and in a maintenance schedule.
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 (filgastrim) subcutaneously
docetaxel 80-100 mgr/m2 every three weeks for four cycles. Addition of GM-CSF if docetaxel doses are > 85 mgr/m2
Study Started
Feb 28
2011
Primary Completion
Jun 30
2012
Study Completion
Dec 31
2013
Last Update
May 19
2016
Estimate

Biological Autologous dendritic cell vaccination

Autologous dendritic cell vaccination. Dendritic cells are pulsed with their own tumor antigens

DENDRITIC CELL VACCINATION Experimental

Px will receive standard neoadjuvant chemotherapy plus active vaccination. we will compare results with an historic cohort of patients treated with the same chemotherapy without the vaccines

Criteria 

Inclusion Criteria:

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 Criteria:

pregnancy
severe diseases
hepatitis or HIV
need to be on immunosuppressant drugs
No Results Posted