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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01431196

First Posted: September 9, 2011

Last Update Posted: May 19, 2016

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.

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

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:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer

U.S. FDA Resources

Further study details as provided by Marta Santisteban, 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 ]

Secondary Outcome Measures:

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)


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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
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

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


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 Submitted:	April 1, 2011
First Posted:	September 9, 2011
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

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