A Team Led by Professor Sung-Bae Kim of Asan Medical Center Reports Phase 3 Clinical Trial Results of Oral Paclitaxel

Comparable Efficacy to Injectable Therapy, including Progression Free Survival, with Proven Safety and Convenience

Published in the Globally Renowned Journal ‘Annals of Oncology’ (impact factor 65.4)

▲ Professors Sung-Bae Kim and Hyehyun Jeong of the Division of Oncology at Asan Medical Center

HER2-negative metastatic breast cancer is an advanced disease that is often difficult to treat. In this setting, patients typically need to visit the hospital nearly every week, about three times a month, to receive intravenous chemotherapy, which often leads to a reduced quality of life.

Amid these challenges, a Korean research team has recently reported Phase 3 clinical trial results showing that an oral chemotherapy agent, which can be conveniently taken at home without hospital visits, demonstrates efficacy comparable to that of injectable therapy.

A research team led by Professors Sung-Bae Kim and Hyehyun Jeong of the Division of Oncology at Asan Medical Center conducted a multinational Phase 3 clinical trial in patients with HER2-negative recurrent or metastatic breast cancer. The study demonstrated that oral paclitaxel (DHP107) showed efficacy comparable to that of the conventional weekly intravenous formulation in extending progression free survival and overall survival.

Notably, adverse events such as peripheral neuropathy and hypersensitivity reactions, which are frequently associated with injectable formulations, were significantly less frequent in patients receiving the oral therapy, confirming its favorable safety profile.

Based on the results of this multinational Phase 3 trial, the findings are meaningful in that they establish the potential of oral paclitaxel as a practical alternative to conventional injectable paclitaxel. It is expected not only to improve convenience and safety for patients with HER2-negative metastatic breast cancer, but also to contribute to reducing overall healthcare costs from a broader societal perspective.

The study findings were recently published online in Annals of Oncology (impact factor 65.4), a leading international journal in the field of cancer treatment. Prior to publication, the results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, where they were selected as one of the “Best 10 Abstracts” in the breast cancer category.

The research team conducted a large scale multinational clinical trial involving a total of 549 patients across 51 institutions in five countries, including Korea, China, and several European countries, from January 2018 to December 2023. To enhance the precision of the study, participants were limited to patients with HER2-negative recurrent or metastatic breast cancer who had not previously received chemotherapy.

Patients were randomly assigned in a 1:1 ratio to either the oral treatment group or the intravenous treatment group. The oral group (n=277) received 200 mg/m² of the drug twice daily on Days 1, 8, and 15 of a 28 day cycle. The control group (n=272) received intravenous administration at a dose of 80 mg/m² on the same schedule.

The results showed that the median progression free survival, the primary endpoint, was 10 months in the oral group compared with 8.5 months in the intravenous group, indicating noninferiority. Overall survival was also comparable between the two groups, at 32.6 months in the oral group and 31.8 months in the intravenous group, with no statistically significant difference.

The objective response rate, an indicator of tumor reduction, was also comparable between the two groups, with 43.3% in the oral treatment group versus 38.8% in the intravenous group. This finding suggests that oral chemotherapy alone can achieve outcomes that are not inferior to the current standard injectable regimen.

In terms of safety, peripheral neuropathy and hypersensitivity reactions, which were commonly observed in the intravenous group, occurred at markedly lower rates in the oral formulation group. This is likely attributable to the absence of Cremophor EL, a solvent used in injectable formulations. Although gastrointestinal toxicities were more frequently reported in the oral group due to the nature of oral administration, most cases were mild, and no treatment related deaths were reported.

Professor Sung-Bae Kim of the Division of Oncology at Asan Medical Center stated, “This study demonstrates that oral chemotherapy can provide treatment efficacy comparable to injectable therapy while maintaining patients’ quality of life and maximizing convenience.”

He added, “Oral paclitaxel has the potential to become an effective and convenient treatment option for patients with metastatic breast cancer, as it can reduce the frequency of hospital visits and lower overall medical costs.”

Meanwhile, the oral paclitaxel used in this study is a drug whose development has been led by Asan Medical Center since the early Phase 1 clinical trial stage. Having already been approved as a treatment for gastric cancer both in Korea and internationally, this study further confirms its value in the field of breast cancer.