Clinical trial · Interventional
Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer
A Multi-national,Multi-center, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of DHP107 (Liporaxel®,Oral Paclitaxel) Compared to IV Paclitaxel in Patients With Recurrent or Metastatic Breast Cancer(OPERA)
NCT03326102CI-TRIAL-00074084OPERAcompletedPhase 2ClinicalTrials.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)
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.
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 |
|---|---|---|---|
| DHP107 | Drug | — | UNRESOLVED |
| IV Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DHP107
- description
- The 12 eligible subjects will receive DHP107 and be taken blood samples for PK analysis on Day 1, 8 of cycle 1. Total 48 subjects (including PK subjects) will receive DHP107 200 mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days.
- interventionNames
- Drug: DHP107
- type
- EXPERIMENTAL
- label
- IV paclitaxel
- description
- Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off)
- interventionNames
- Drug: IV Paclitaxel
Primary outcomes (1)
- measure
- Objective Response Rate(ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination 2. Subjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples 3. Subjects who have received up to 3 lines of therapy for advanced disease, without prior exposure to taxane in the advanced stage setting 4. Subjects who have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale. 5. Subjects who have measurable disease according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1). Key Exclusion Criteria: 1. Subjects who have received prior taxane therapy in the metastatic setting 2. Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study. 3. Subjects with neuropathy grade ≥2 based on CTCAE v4.03 at the time of study entry 4. Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at the time of screening. 5. Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1).
References
Publications (1)
- DERIVEDRugo 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. PMID 41910867