# Oleocanthal functional food products for breast cancer recurrence control

> **NIH NIH R41** · OLEOLIVE, INC. · 2021 · $54,756

## Abstract

SUMMARY
From Parent Grant (R41CA247025)
Triple negative breast cancer (TNBC) represents 20% of the breast cancer (BC) cases in the US. TNBC patients
have a poor recurrence-free, overall survival rate, and limited available treatment options. The Mediterranean
olive oil-rich diet is documented to reduce BC incidence. (-)-Oleocanthal (OC) is a natural phenolic secoiridoid
exclusively occurring in extra-virgin olive oil (EVOO) and it has shown selective anti-BC activities, including
preliminary results showing prevention of recurrence of TNBC in animal models. The HGF/Met signaling
pathway, a validated major OC molecular target, is likely involved in initiating aggressive and recurrent TNBC in
a subset of patients. To improve taste, dissolution and stability, a solid dispersion formulation of OC (OC-X) was
recently developed and characterized. We hypothesize that the EVOO powdered formulation of OC, OC-X,
could be developed as a nutraceutical product to help control locoregional TNBC recurrence. This will be
tested in the following Specific Aims. In the first aim, we will perform dose dependent studies to determine the
optimal effective dose of orally administered OC-X on tumor recurrence in a nude mouse model after primary
tumor surgical resection. This aim will assess the efficacy of formulations in preventive, treatment, and after
completion of paclitaxel neoadjuvant regimen modes. In the second aim, we will perform dose dependent studies
to determine the optimal effective dose of orally administered OC-X on tumor recurrence in the MMTV-PyMT
transgenic mouse model. This immune competent mouse model develops BC mimicking progression seen in
human patients and will be used to assess BC recurrence (after surgical excision of early mammary gland
tumors) and metastasis following treatment with OC-X. Expected outcomes: EVOO enriched in OC has been
safely consumed throughout human history with increasing evidence of effectiveness against many human
pathologies, including BC. Given the lack of other safe therapeutic alternatives, OC is a candidate bioactive
natural product that could be safe for long-term use to prevent BC recurrence. The data generated by this project
will be combined with future studies of OC-X to facilitate commercialization of OC-X as a nutraceutical product
to prevent BC recurrence.

## Key facts

- **NIH application ID:** 10276305
- **Project number:** 3R41CA247025-01A1S1
- **Recipient organization:** OLEOLIVE, INC.
- **Principal Investigator:** KHALID A EL SAYED
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $54,756
- **Award type:** 3
- **Project period:** 2020-06-01 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10276305

## Citation

> US National Institutes of Health, RePORTER application 10276305, Oleocanthal functional food products for breast cancer recurrence control (3R41CA247025-01A1S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10276305. Licensed CC0.

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