Phase 2/3Active, not recruiting
Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy (OPTIMAL)
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
- Sponsor
- Daehwa Pharmaceutical Co., Ltd. (Industry)
- Enrolment
- 549 enrolled
- Conditions
- Recurrent or Metastatic Breast Cancer
- Interventions
- Oral paclitaxel; Paclitaxel injection
- Ages
- adults, older adults
- Registry
- NCT03315364
Full record on ClinicalTrials.gov
From the registry
To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.
Primary outcomes
- [Phase II] Objective Response Rate (ORR)
- [Phase III] Progression Free Survival (PFS)
History
Study completion expected
Last registry update
Primary completion
Started
Registered