ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01431196
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : May 19, 2016
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 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 or disease Intervention/treatment Phase
Stage II Breast Cancer Stage III Breast Cancer Biological: Autologous dendritic cell vaccination Phase 2

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : February 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. pathologic complete response (pCR) in the breast and the axilla [ Time Frame: 6 months after starting chemotherapy ]

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: During the 6-24 months of administration of the vaccine ]
  2. Impact of the vaccine on patients DFS and OS [ Time Frame: three to five years after the diagnosis of breast cancer ]
    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

  3. EORTC quality of life [ Time Frame: From 9 months and up to two years ]
  4. Correlation among the specific immune response induced in patients and the pathologic response of the tumor [ Time Frame: 6-24 months ]
    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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: By 2017 scientific data should be communicated

Keywords provided by Marta Santisteban, 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