Clinical trial · Interventional
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
NCT03315364CI-TRIAL-00107080OPTIMALactive not recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent or Metastatic Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral paclitaxel | Drug | Paclitaxel | ALIAS |
| Paclitaxel injection | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Liporaxel® (oral paclitaxel)
- description
- * 28 days (4 weeks) will be set as one cycle of administration and Liporaxel® will be administered for 3 weeks, twice a day, every morning and evening (D1, D8, D15) and will take a week off on 4th week. * Liproaxel® 200mg/m2 will be orally administered twice a day (morning, evening) 1 hour after meal for D1, D8, D15 of every cycle. 10 hour-interval is recommended for between each administration.
- interventionNames
- Drug: Oral paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- Taxol® (IV paclitaxel)
- description
- * 28 days (4 weeks) will be set as one cycle and for every 3 week administration, 1 week off dose period will be given. * Taxol® 80mg/m2 will be administered via IV and it must be diluted before drip administration. Dilute with 0.9% sodium chloride injection solution to make final concentration of 0.3-1.2 mg/mL.
- interventionNames
- Drug: Paclitaxel injection
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Key inclusion/exclusion criteria * Histologically or cytologically confirmed to have recurrent, or metastatic breast cancer. * Measurable disease (revised RECIST, version 1.1). * Hormone receptor (ER/PR) positive or negative, HER2 negative. * Subjects were eligible for the study regardless of their previous lines of endocrine therapy. * No prior chemotherapy is allowed in metastatic disease. * Subjects who administrated the last dose of taxane class drug ≥12months ago as from the first administration day. * ECOG performance status ≤1. * Neuropathy grade \<2. * Subjects with central nervous system metastasis should be excluded.
References
Publications (1)
- DERIVEDKim SB, Seo JH, Ahn JH, Kim TY, Kang SY, Sohn J, Yang Y, Park KH, Moon YW, Lim S, Kang MJ, Yoon KE, Cho HJ, Lee KS. Phase II study of DHP107 (oral paclitaxel) in the first-line treatment of HER2-negative recurrent or metastatic breast cancer (OPTIMAL study). Ther Adv Med Oncol. 2021 Dec 15;13:17588359211061989. doi: 10.1177/17588359211061989. eCollection 2021. PMID 34925553