NCT03315364

Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy

A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Liporaxel® (Oral Paclitaxel) Compared to Taxol® (IV Paclitaxel) as First-line Therapy in Patients With Recurrent or Metastatic HER2 Negative Breast Cancer

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 549 (actual)
• Sponsor: Daehwa Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.

Conditions

• Recurrent or Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Oral paclitaxel	Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
DRUG	Paclitaxel injection	Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent

Timeline

• Start date: 2017-12-18
• Primary completion: 2024-02-19
• Completion: 2028-11-30
• First posted: 2017-10-20
• Last updated: 2026-04-01

Locations

51 sites across 5 countries: Bulgaria, China, Hungary, Serbia, South Korea