Safety and Efficacy Evaluation of the P2Et Extract in Patients With Breast Cancer
Status:
Not yet recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
Currently, the study of many extracts in different types of cancer has allowed the validation
of scientific knowledge either as a therapy that reduces the size of the tumor or that helps
to improve the quality of life of the patient by reducing the associated effects of the
treatment.
In the Immunobiology and Cell Biology group of the Pontificia Universidad Javeriana, a
standardized extract of Caesalpinia spinosa (Dividivi) called P2Et has been obtained. This
extract has been shown to have cytotoxic activity in different human and murine tumor cell
lines, favoring the induction of immunogenic cell death with the release of danger signals
such as calreticulin, HMGB1 and ATP. Additionally, treating mice with murine melanoma and
sinus tumors significantly reduces tumor size and metastases. On the other hand, induction of
complete autophagic flux and synergistic effects with anthracycline-type chemotherapeutics
have been shown in human cell lines and in animal models of breast cancer.
With this background, and the results of the Phase I clinical study carried out in healthy
volunteers that showed that the extract is safe, the investigators propose that treatment
with the P2Et extract in patients with breast cancer could improve their general condition,
impacting their quality of life. , and induce antitumor immune response, improving the immune
infiltrate and acting as a transforming agent from a cold tumor to a warm tumor. This would
lead to an improvement in the long-term survival of patients treated with the phytomedicine
in conjunction with the chemotherapeutic treatment selected by the treating oncologist.
In order to advance on this path, and responding to the adjustments suggested in the phase I
study in healthy individuals, it is proposed to carry out a clinical study that allows
determining the optimal biological dose of the P2Et extract in a design based on randomized
simulations of adaptive form and considering the safety of the extract as an objective in
patients with breast cancer. Additionally, those parameters that allow defining the best
indicators of effectiveness of P2Et in this group of patients will be evaluated, such as
modulation of the immune response, quality of life, reduction of adverse effects and
progression-free survival.