Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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
History of Changes
  Purpose
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.

Condition Intervention Phase
Stage II Breast Cancer
Stage III Breast Cancer
 Biological: Autologous dendritic cell vaccination
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial With Autologous Dendritic Cell Vaccination in Patients With Stage II-III HER2 Negative Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • pathologic complete response (pCR) in the breast and the axilla [ Time Frame: 6 months after starting chemotherapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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)
Enrollment: 29
Study Start Date: February 2011
Study Completion Date: December 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Biological: Autologous dendritic cell vaccination
Autologous dendritic cell vaccination. Dendritic cells are pulsed with their own tumor antigens

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 (filgastrim) subcutaneously
  • docetaxel 80-100 mgr/m2 every three weeks for four cycles. Addition of GM-CSF if docetaxel doses are > 85 mgr/m2
  Eligibility
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431196

Locations
Spain
Clínica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Spanish Clinical Research Network - CAIBER
National Institutes of Health (NIH)
Investigators
Principal Investigator: Marta Santisteban, MD, PhD. Clinica Universidad de Navarra
  More Information

Responsible Party: Marta Santisteban, MD, PhD, Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01431196     History of Changes
Other Study ID Numbers: DEND/CM 
Study First Received: April 1, 2011
Last Updated: May 18, 2016
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: By 2017 scientific data should be communicated

Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
breast cancer
neoadjuvant chemotherapy
autologous dendritic cell vaccination

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016