Anti-mitotic Agent

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

Cheongju-si, Korea, Republic of

Phase 2 & 3

Waitlist Available

Led By Sung-bae Kim, M.D., Ph.D

Research Sponsored by Daehwa Pharmaceutical Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Key inclusion/

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an expected average of 4.5 year.

Awards & highlights

No Placebo-Only Group

Approved for 10 Other Conditions

All Individual Drugs Already Approved

Summary

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

Eligible Conditions

Breast cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an expected average of 4.5 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an expected average of 4.5 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an expected average of 4.5 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

[Phase III] Progression Free Survival (PFS)

[Phase II] Objective Response Rate (ORR)

Secondary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety]

[Phase II&III] Disease Control Rate(DCR)

[Phase II&III] Overall Survival(OS)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Liporaxel® (oral paclitaxel)Experimental Treatment1 Intervention

* 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.

Group II: Taxol® (IV paclitaxel)Active Control1 Intervention

* 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.

0 / 1Eligibility criteria met