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

Daehwa Pharmaceutical

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Recurrent or Metastatic Breast Cancer

Treatments: Drug: Oral paclitaxel; Drug: Paclitaxel injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03315364

107CS-5

Details and patient eligibility

About

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

Enrollment: 549 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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549 participants in 2 patient groups

Liporaxel® (oral paclitaxel)

Experimental group

Description:

* 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.

Treatment:

Drug: Oral paclitaxel

Taxol® (IV paclitaxel)

Active Comparator group

Description:

* 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.

Treatment:

Drug: Paclitaxel injection