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

This study has been completed.
Sponsor:
Collaborators:
Spanish Clinical Research Network - CAIBER
National Institutes of Health (NIH)
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: May 18, 2016
Last verified: May 2016

April 1, 2011
May 18, 2016
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
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
Autologous dendritic cell vaccination. Dendritic cells are pulsed with their own tumor antigens
Experimental: DENDRITIC CELL VACCINATION
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
Intervention: Biological: Autologous dendritic cell vaccination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01431196
DEND/CM
No
Yes
By 2017 scientific data should be communicated
Marta Santisteban, Clinica Universidad de Navarra, Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
  • Spanish Clinical Research Network - CAIBER
  • National Institutes of Health (NIH)
Principal Investigator: Marta Santisteban, MD, PhD. Clinica Universidad de Navarra
Clinica Universidad de Navarra, Universidad de Navarra
May 2016

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