# Phase I clinical trial to assess safety and efficacy of Oraxol, a novel oral paclitaxel chemotherapy agent, in patients with previously treated metastatic breast cancer

## TL;DR

This study evaluates the safety and effectiveness of Oraxol, an oral chemotherapy drug, in patients with advanced breast cancer, showing promising results.

## Contribution

The study presents new evidence on the safety and antitumor activity of Oraxol in metastatic breast cancer patients.

## Key findings

- Oraxol showed consistent absorption and manageable safety with 96% of patients experiencing treatment-related adverse events.
- The overall response rate was 34.8%, with a 100% disease control rate in triple-negative breast cancer patients.
- Median progression-free survival was 8.90 months for triple-negative breast cancer, higher than other subtypes.

## Abstract

Oraxol, a novel oral paclitaxel chemotherapy agent, has emerged as a potential alternative for treating metastatic breast cancer (MBC). However, its safety and efficacy remain uncertain due to insufficient evidence supporting it. This open‐label, single‐arm, phase I trial was designed to assess the pharmacokinetics, safety, and preliminary antitumor activity of Oraxol in previously treated MBC. The primary objective was to investigate the pharmacokinetics of Oraxol, while secondary endpoints included assessing safety, tolerability, and antitumor activity. Twenty‐four patients (median age, 53 years) were enrolled, and pharmacokinetic analysis showed consistent and reproducible absorption of Oraxol. Note that 96% patients experienced treatment‐related adverse events (TRAEs) and no deaths attributed to TRAEs. The overall response rate was 34.8%, including 34.8% achieving partial response and 56.5% having stable disease. The median follow‐up was 45.7 months, with median progression‐free survival (PFS) of 3.41 months and median overall survival of 17.80 months. Notably, among patients with triple‐negative breast cancer, the disease control rate was 100%, and the median PFS was 8.90 months, which notably exceeded the outcomes observed in other subtypes. Oraxol significantly alters metabolism and correlates with response and survival. In conclusion, Oraxol exhibited promising antitumor efficacy and manageable safety profiles in MBC patients.

This phase I clinical trial demonstrates the safety, efficacy, and survival of Oraxol. They analyze the correlation between metabolites and Oraxol. The study provides valuable evidence supporting the promising antitumor activity and manageable safety profile of Oraxol in patients with metastatic breast cancer, including those with TNBC.