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

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daehwa Pharmaceutical Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

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.