Clinical trial NCT01431196: Trial With Autologous Dendritic Cell Vaccination in Patients With Stage II-III HER2 Negative Breast Cancer
Official title: Phase II Trial With Autologous Dendritic Cell Vaccination in Patients With Stage II-III HER2 Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stage II Breast Cancer
Stage III Breast Cancer
Keywords: breast cancer
neoadjuvant chemotherapy
autologous dendritic cell vaccination
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Spanish Clinical Research Network - SCReN
name: National Institutes of Health (NIH)
First posted: 2011-09-09
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: pathologic complete response (pCR) in the breast and the axilla
timeFrame: 6 months after starting chemotherapy
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: During the 6-24 months of administration of the vaccine
measure: Impact of the vaccine on patients DFS and OS
timeFrame: three to five years after the diagnosis of breast cancer
measure: EORTC quality of life
timeFrame: From 9 months and up to two years
measure: Correlation among the specific immune response induced in patients and the pathologic response of the tumor
timeFrame: 6-24 months
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
state: Navarra
Study officials:
affiliation: Clinica Universidad de Navarra
name: Marta Santisteban, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.