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

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

Official Title
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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

Conditions
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Recurrent or Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Oral paclitaxel
* Drug: Paclitaxel injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase II clinical trial Multicenter, Open-label, Single arm, Simon's optimal two-stage design Phase III clinical trial Multicenter, Prospective Randomized Open-label Blinded Endpoint (PROBE) design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liporaxel® (oral paclitaxel)<br>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. | Drug: Oral paclitaxel<br>* Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent<br>* Other names: Liporaxel®;|
| Active Comparator: Taxol® (IV paclitaxel)<br>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. | Drug: Paclitaxel injection<br>* Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent<br>* Other names: Taxol®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [Phase II] Objective Response Rate (ORR) | Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria. | Participants will be followed every 6 weeks until progression, an expected average of 9 months. | 
| [Phase III] Progression Free Survival (PFS) | Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death | From date of randomization, assessed up to 18 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [Phase II] Progression Free Survival (PFS) | Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death | From date of randomization, assessed up to 18 months. | 
| [Phase III] Objective Response Rate (ORR) | Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria. | Participants will be followed every 6 weeks until progression, an expected average of 9 months. | 
| [Phase II&III] Overall Survival(OS) | Overall survival(OS) is defined as the time from the date of inclusion to the date of death, regardless of the cause of death. | Until 6 months after the last participant is enrolled, assessed minimum to 18 months. | 
| [Phase II&III] Time to Treatment Failure(TTF) | TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause. | through study completion, an expected average of 4.5 year. | 
| [Phase II&III] Disease Control Rate(DCR) | DCR is defined as the percentage of subjects who were evaluated for complete response(CR), partial response(PR), and stable disease(SD) as the best response among from randomization to End of treatment(EOT). | through study completion, an expected average of 4.5 year. | 
| [Phase II&III] Quality of life(QoL) | To evaluate changes versus baseline using the EQ-5D. | C1D1, C2D1, C4D1, C7D1, C10D1 (each cycle is 28 days) and study completion, up to 18 months. | 
| Incidence of Treatment-Emergent Adverse Events [Safety] | Number and Description of Adverse Events | Up to 28 days after last investigational product administraion. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent breast cancer, Metastatic breast cancer, MBC, Firstline chemotherapy, Paclitaxel, Liporaxel, Taxol