Trial With Autologous Dendritic Cell Vaccination in Patients With Stage II-III HER2 Negative Breast Cancer
This study is currently recruiting participants.
Verified September 2011 by Clinica Universidad de Navarra, Universidad de Navarra
Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators:
CAIBER (Spanish Clinical Research Network)
Ministerio de Sanidad de España (Spanish Institute of Health)
Information provided by (Responsible Party):
Marta Santisteban, Instituto Cientifico y Tecnologico de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01431196
First received: April 1, 2011
Last updated: September 8, 2011
Last verified: September 2011
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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. Dendritic cells are pulsed with their own tumor antigens |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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:
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)
| Estimated Enrollment: | 29 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431196
Contacts
| Contact: Marta Santisteban, MD, PhD. | +34 948 255 400 ext 5853 | msantisteb@unav.es |
Locations
| Spain | |
| Clínica Universidad de Navarra | Recruiting |
| Pamplona, Navarra, Spain, 31008 | |
| Principal Investigator: Marta Santisteban, MD, PhD | |
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
CAIBER (Spanish Clinical Research Network)
Ministerio de Sanidad de España (Spanish Institute of Health)
Investigators
| Principal Investigator: | Marta Santisteban, MD, PhD. | Clinica Universidad de Navarra |
More Information
No publications provided
| Responsible Party: | Marta Santisteban, MD, PhD, Instituto Cientifico y Tecnologico 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: | September 8, 2011 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
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 |
ClinicalTrials.gov processed this record on May 16, 2013