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

Stage II Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431196
• Other study ID #: DEND/CM
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2011
• Last updated: May 18, 2016
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: May 2016
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Stage II Breast Cancer
• Stage III Breast Cancer

Intervention

Biological:
• Autologous dendritic cell vaccination
Autologous dendritic cell vaccination. Dendritic cells are pulsed with their own tumor antigens

Locations

Country	Name	City	State
Spain	Clínica Universidad de Navarra	Pamplona	Navarra

Sponsors (3)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	National Institutes of Health (NIH), Spanish Clinical Research Network - CAIBER

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathologic complete response (pCR) in the breast and the axilla		6 months after starting chemotherapy	Yes
Secondary	Number of participants with adverse events		During the 6-24 months of administration of the vaccine	Yes
Secondary	Impact of the vaccine on patients DFS and OS	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	three to five years after the diagnosis of breast cancer	Yes
Secondary	EORTC quality of life		From 9 months and up to two years	Yes
Secondary	Correlation among the specific immune response induced in patients and the pathologic response of the tumor	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)	6-24 months	No