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

NCT01431196 | Completed Phase 2

• 1 other identifier: DEND/CM
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage II Breast Cancer; Stage III Breast Cancer

Keywords

breast cancer; neoadjuvant chemotherapy; autologous dendritic cell vaccination

Outcome Measures

Primary Outcomes (1)

• pathologic complete response (pCR) in the breast and the axilla

  6 months after starting chemotherapy

Secondary Outcomes (4)

• Number of participants with adverse events

  During the 6-24 months of administration of the vaccine

• Impact of the vaccine on patients DFS and OS

  three to five years after the diagnosis of breast cancer

• EORTC quality of life

  From 9 months and up to two years

• Correlation among the specific immune response induced in patients and the pathologic response of the tumor

  6-24 months

Study Arms (1)

DENDRITIC CELL VACCINATION

EXPERIMENTAL

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

Interventions

Autologous dendritic cell vaccination BIOLOGICAL

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

DENDRITIC CELL VACCINATION

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnancy
• severe diseases
• hepatitis or HIV
• need to be on immunosuppressant drugs

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead
• Spanish Clinical Research Network - SCReN: collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (1)

• Santisteban M, Solans BP, Hato L, Urrizola A, Mejias LD, Salgado E, Sanchez-Bayona R, Toledo E, Rodriguez-Spiteri N, Olartecoechea B, Idoate MA, Lopez-Diaz de Cerio A, Inoges S. Final results regarding the addition of dendritic cell vaccines to neoadjuvant chemotherapy in early HER2-negative breast cancer patients: clinical and translational analysis. Ther Adv Med Oncol. 2021 Dec 23;13:17588359211064653. doi: 10.1177/17588359211064653. eCollection 2021.

  PMID: 34987618 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marta Santisteban, MD, PhD.

  Clinica Universidad de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 1, 2011
• First Posted: September 9, 2011
• Study Start: February 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2013
• Last Updated: May 19, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)