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| Name | Class |
|---|---|
| Spanish Clinical Research Network - SCReN | NETWORK |
| National Institutes of Health (NIH) | NIH |
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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.
Chemotherapy schedule:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous dendritic cell vaccination | Biological | Autologous dendritic cell vaccination. Dendritic cells are pulsed with their own tumor antigens |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathologic complete response (pCR) in the breast and the axilla | 6 months after starting chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta Santisteban, MD, PhD. | Clinica Universidad de Navarra | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Universidad de Navarra | Pamplona | Navarre | 31008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34987618 | Derived | 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. |
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By 2017 scientific data should be communicated
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| 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 | 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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