Skip to main content
OpenTrials
Completed

NCT Number: NCT01431196

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous dendritic cell vaccination

Biological

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

Primary outcomes

  1. pathologic complete response (pCR) in the breast and the axilla

    Time frame: 6 months after starting chemotherapy

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: During the 6-24 months of administration of the vaccine

  2. 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

  3. EORTC quality of life

    Time frame: From 9 months and up to two years

  4. 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)

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Collaborators

  • National Institutes of Health (NIH)
  • Spanish Clinical Research Network - SCReN

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Sep 9, 2011
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.