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

NCT03315364 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 549

Last updated 2026-04-01

No results posted yet for this study

Summary

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

Conditions

  • Recurrent or Metastatic Breast Cancer

Interventions

DRUG

Oral paclitaxel

Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent

DRUG

Paclitaxel injection

Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent

Sponsors & Collaborators

  • Daehwa Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Sung-bae Kim, M.D., Ph.D · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-18
Primary Completion
2024-02-19
Completion
2028-11-30

Countries

  • Bulgaria
  • China
  • Hungary
  • Serbia
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03315364 on ClinicalTrials.gov