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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Stage II Breast Cancer, Stage III Breast Cancer

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

6 months after starting chemotherapy

Safety Issue:

Yes

Principal Investigator

Marta Santisteban, MD, PhD.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Clinica Universidad de Navarra

Authority:

Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:

DEND/CM

NCT ID:

NCT01431196

Start Date:

February 2011

Completion Date:

December 2013

Related Keywords:

  • Stage II Breast Cancer
  • Stage III Breast Cancer
  • breast cancer
  • neoadjuvant chemotherapy
  • autologous dendritic cell vaccination
  • Breast Neoplasms

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