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Clinical trial

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

ID
Name
107CS-5
Description
To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.
Trial arms
Trial start
2017-12-18
Estimated PCD
2024-01-30
Trial end
2024-03-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Oral paclitaxel
Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Arms:
Liporaxel® (oral paclitaxel)
Other names:
Liporaxel®
Paclitaxel injection
Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Arms:
Taxol® (IV paclitaxel)
Other names:
Taxol®
Size
549
Primary endpoint
[Phase II] Objective Response Rate (ORR)
Participants will be followed every 6 weeks until progression, an expected average of 9 months.
[Phase III] Progression Free Survival (PFS)
From date of randomization, assessed up to 18 months.
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "1. Phase II clinical trial\n\n * Multicenter, Open-label, Single arm, Simon's optimal two-stage design\n2. Phase III clinical trial\n\n * Multicenter, Prospective Randomized Open-label Blinded Endpoint (PROBE) design", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 549, 'type': 'ACTUAL'}}
Updated at
2023-12-28

1 organization

1 product

1 indication

Product
Paclitaxel
Indication
Breast Cancer
Organization
Daehwa Pharmaceutical