Trial With Autologous Dendritic Cell Vaccination in Patients With Stage II-III HER2 Negative Breast Cancer
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ClinicalTrials.gov Identifier: NCT01431196 |
Recruitment Status :
Completed
First Posted : September 9, 2011
Last Update Posted : May 19, 2016
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Condition or disease | Intervention/treatment | Phase |
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Stage II Breast Cancer Stage III Breast Cancer | Biological: Autologous dendritic cell vaccination | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | N/A |
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 |

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
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Biological: Autologous dendritic cell vaccination
Autologous dendritic cell vaccination. Dendritic cells are pulsed with their own tumor antigens |
- pathologic complete response (pCR) in the breast and the axilla [ Time Frame: 6 months after starting chemotherapy ]
- Number of participants with adverse events [ Time Frame: During the 6-24 months of administration of the vaccine ]
- 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
- EORTC quality of life [ Time Frame: From 9 months and up to two years ]
- 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)

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Spain | |
Clínica Universidad de Navarra | |
Pamplona, Navarra, Spain, 31008 |
Principal Investigator: | Marta Santisteban, MD, PhD. | Clinica Universidad de Navarra |
Responsible Party: | Marta Santisteban, MD, PhD, Clinica Universidad de Navarra, Universidad de Navarra |
ClinicalTrials.gov Identifier: | NCT01431196 |
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 |
breast cancer neoadjuvant chemotherapy autologous dendritic cell vaccination |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Vaccines Immunologic Factors Physiological Effects of Drugs |