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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
CAIBER (Spanish Clinical Research Network)
Ministerio de Sanidad de España (Spanish Institute of Health)
Information provided by (Responsible Party):
Marta Santisteban, Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01431196
First received: April 1, 2011
Last updated: November 28, 2013
Last verified: December 2013

April 1, 2011
November 28, 2013
February 2011
June 2012   (final data collection date for primary outcome measure)
pathologic complete response (pCR) in the breast and the axilla [ Time Frame: 6 months after starting chemotherapy ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01431196 on ClinicalTrials.gov Archive Site
  • Number of participants with adverse events [ Time Frame: During the 6-24 months of administration of the vaccine ] [ Designated as safety issue: Yes ]
  • Impact of the vaccine on patients DFS and OS [ Time Frame: three to five years after the diagnosis of breast cancer ] [ Designated as safety issue: Yes ]
    We will compare our cohort of patients vaccinated and treated with chemotherapy, surgery and radiation therapy with an historic cohort in our center treated with the same schedule of chemotherapy , surgery and radiation therapy without the vaccine
  • EORTC quality of life [ Time Frame: From 9 months and up to two years ] [ Designated as safety issue: Yes ]
  • Correlation among the specific immune response induced in patients and the pathologic response of the tumor [ Time Frame: 6-24 months ] [ Designated as safety issue: No ]
    Specific immune response will be evaluated as delayed hipesrsensitivity (DTH), humoral response by cuantification antibodies against tumoral cells (ELISA)and cellullar response (proliferation assay and citokines production)
Same as current
Not Provided
Not Provided
 
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

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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stage II Breast Cancer
  • Stage III Breast Cancer
Biological: Autologous dendritic cell vaccination. Dendritic cells are pulsed with their own tumor antigens
Autologous dendritic cell vaccination. Dendritic cells are pulsed with their own tumor antigens
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
29
December 2013
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01431196
DEND/CM
No
Marta Santisteban, Clinica Universidad de Navarra, Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
  • CAIBER (Spanish Clinical Research Network)
  • Ministerio de Sanidad de España (Spanish Institute of Health)
Principal Investigator: Marta Santisteban, MD, PhD. Clinica Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP