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Research

AWARE-1

Research

Research

Clinicaltrial.gov identifier:
Status:
Open
Scenario:
Neoadjuvant
Tumour subtype:
HER2+ HR+ TNBC
Phase:
Phase 0
Drug/Intervention:
pelareorep

A window-of-opportunity Study of pelareorep in Early Breast Cancer (AWARE-1)

The augmentation of specific anti-tumor immune responses, such as those mediated by T-cells, might represent such an additional strategy for the control or elimination of tumor cells. We hypothesize that combination of pelareorep with different therapies offers clinical benefit in terms of CeLTIL in the preoperative setting for early breast cancer patients. This is an exploratory window opportunity study to gather efficacy and safety data in support to these hypotheses. Positive signals from this study would provide strong evidence for further clinical investigations aimed to increase the pCR rate at early setting.
We will include extended translational research to provide comprehensive biological information leading to the identification of patient populations who benefit the most from this combination, and the characterization of resistance/response biomarkers.
The goal would be to manipulate the cytokine milieu within the tumor microenvironment to trigger a beneficial immune response.

Principal investigators

Luis Manso, MD, PhD

Hospital Universitario 12 de Octubre, Madrid

Joaquín Gavilá, MD, PhD

Instituto Valenciano de Oncología

Aleix Prat, MD,PhD (Translational PI)

Hospital Clínic, Barcelona

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