Phase I trial investigates IH636 grape seed extract's safety and optimal dose for breast cancer prevention

Breast cancer remains a significant health concern, particularly in postmenopausal women, with current chemoprevention strategies often involving drugs like tamoxifen. While effective, these agents can carry substantial side effects, limiting their broader adoption for prevention. There's a critical need for safer, well-tolerated alternatives to reduce breast cancer incidence in high-risk populations. Natural compounds, such as those found in grape seed extract, are being explored for their potential anti-cancer properties, aiming to offer a less toxic approach to chemoprevention by targeting various oncogenic pathways.

This Phase I clinical trial is designed to assess the safety, tolerability, and optimal dosing of IH636 grape seed extract in postmenopausal women identified as being at high risk for developing breast cancer. The study's primary objective is to determine the side effects and establish the maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of the extract. Participants will receive escalating doses of IH636 grape seed extract over a specified duration, with safety endpoints including adverse event reporting, laboratory parameter monitoring, and clinical assessments. This dose-escalation design is standard for Phase I trials, systematically increasing the dose to identify a safe and biologically active range.

As a Phase I trial, the primary objective is to establish safety and optimal dosing parameters for IH636 grape seed extract. The provided abstract outlines the rationale and purpose of the study but does not contain specific results regarding side effects, dose-limiting toxicities, or the maximum tolerated dose (MTD). Therefore, no numerical findings, p-values, or fold-changes can be reported at this stage. The trial is designed to systematically identify a safe and tolerable dose range in postmenopausal women at risk for breast cancer, which will inform the design of future efficacy studies. Specific data on the safety profile and dose recommendations are anticipated upon completion and publication of the trial results.