Description:
To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and
Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.
Title
- Brief Title: Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
107CS-5
- NCT ID:
NCT03315364
Conditions
- Recurrent or Metastatic Breast Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| Oral paclitaxel | Liporaxel® | Liporaxel® (oral paclitaxel) |
| Paclitaxel injection | Taxol® | Taxol® (IV paclitaxel) |
Purpose
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
| Name | Type | Description | Interventions |
|---|
| Liporaxel® (oral paclitaxel) | Experimental | 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. | |
| Taxol® (IV paclitaxel) | Active Comparator | 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. | |
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 19 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | [Phase II] Objective Response Rate (ORR) |
| Time Frame: | Participants will be followed every 6 weeks until progression, an expected average of 9 months. |
| Safety Issue: | |
| Description: | Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria. |
Secondary Outcome Measures
| Measure: | [Phase II] Progression Free Survival (PFS) |
| Time Frame: | From date of randomization, assessed up to 18 months. |
| Safety Issue: | |
| Description: | Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death |
| Measure: | [Phase III] Objective Response Rate (ORR) |
| Time Frame: | Participants will be followed every 6 weeks until progression, an expected average of 9 months. |
| Safety Issue: | |
| Description: | Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria. |
| Measure: | [Phase II&III] Overall Survival(OS) |
| Time Frame: | Until 6 months after the last participant is enrolled, assessed minimum to 18 months. |
| Safety Issue: | |
| Description: | Overall survival(OS) is defined as the time from the date of inclusion to the date of death, regardless of the cause of death. |
| Measure: | [Phase II&III] Time to Treatment Failure(TTF) |
| Time Frame: | through study completion, an expected average of 4.5 year. |
| Safety Issue: | |
| Description: | TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause. |
| Measure: | [Phase II&III] Disease Control Rate(DCR) |
| Time Frame: | through study completion, an expected average of 4.5 year. |
| Safety Issue: | |
| Description: | 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). |
| Measure: | [Phase II&III] Quality of life(QoL) |
| Time Frame: | C1D1, C2D1, C4D1, C7D1, C10D1 (each cycle is 28 days) and study completion, up to 18 months. |
| Safety Issue: | |
| Description: | To evaluate changes versus baseline using the EQ-5D. |
| Measure: | Incidence of Treatment-Emergent Adverse Events [Safety] |
| Time Frame: | Up to 28 days after last investigational product administraion. |
| Safety Issue: | |
| Description: | Number and Description of Adverse Events |
Details
| Phase: | Phase 2/Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Daehwa Pharmaceutical Co., Ltd. |
Trial Keywords
- Recurrent breast cancer
- Metastatic breast cancer
- MBC
- Firstline chemotherapy
- Paclitaxel
- Liporaxel
- Taxol
Last Updated
March 12, 2020
