Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer

Phase 2 Completed 72 enrolled Daehwa Pharmaceutical Co., Ltd.

RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of DHP107 (Oral Paclitaxel, Korea brand name: Liporaxel®) compared to IV Paclitaxel in patients with Recurrent or Metastatic Breast Cancer.

Timeline

Start: 2018-07-06
Primary completion: 2022-12-13
Completion: 2022-12-13

Outcome

Missed primary endpoint

paper IV paclitaxel (objective response rate [ORR] 28.6%; 90% CI 13.2-48.7; p = 0.7559). PMID 41910867 ↗

Publications

Rugo HS, Pluard TJ, Sharma P, Melisko M, Al-Jazayrly G, Ji Y, Vidula N, Ellerton J, Smakal M, Zimovjanova M, Weng D. OPERA: a phase II study of DHP107 (oral paclitaxel) versus intravenous paclitaxel in patients with HER2-negative recurrent or metastatic breast cancer. Breast Cancer Res Treat. 2026 Mar 30;217(1):5. doi: 10.1007/s10549-026-07944-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	200 mg/m2	Oral