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)

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