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

March 30, 2026 updated by: Daehwa Pharmaceutical Co., Ltd.

A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Liporaxel® (Oral Paclitaxel) Compared to Taxol® (IV Paclitaxel) as First-line Therapy in Patients With Recurrent or Metastatic HER2 Negative Breast Cancer

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
549

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Bulgaria
      • Burgas, Bulgaria, 8000
        • Oncology Complex Center - Burgas'' Ltd., Medical Oncology Department
      • Panagyurishte, Bulgaria, 4500
        • Multi-profile Hospital for Active Treatment Uni Hospital Ltd. Medical Oncology Department
      • Sofia, Bulgaria, 1330
        • Medical Center Nadezhda Clinical" Ltd.,
  • China
      • Zhengzhou, China
        • Henan Cancer Hospital
    • Anhui
      • Hefei, Anhui, China
        • Anhui Cancer Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Cancer Hospital Chinese Academy of Medical Sciences
    • Guangdong
      • Guangzhou, Guangdong, China
        • Sun Yat-sen University Cancer Center
    • Hainan
      • Haikou, Hainan, China
        • The First Affiliated Hospital Of Hainan Medical College
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Harbin Medical University Cancer Hospital
    • Henan
      • Zhengzhou, Henan, China
        • Tianjin Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, China
        • Jiangsu Cancer Hospital
    • Jilin
      • Changchun, Jilin, China
        • First Affiliated Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China
        • Liaoning Cancer Hospital
    • Shandong
      • Jinan, Shandong, China
        • Shangdong Cancer Hospital
      • Linyi, Shandong, China
        • LinYi Cancer Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Fudan University Shanghai Cancer Center
    • Shanxi
      • Xi’an, Shanxi, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China
        • West China School Of Medicine Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China
        • Zhejiang University School Of Medicine Sir Run Run Shaw Hospital
  • Hungary
      • Szekszárd, Hungary, 7100
        • Tolna County Balassa Janos Hospital
      • Tatabánya, Hungary, 2800
        • Szent Borbála Hospital
  • Serbia
      • Belgrade, Serbia, 11000
        • Institute for Oncology and Radiology of Serbia
      • Belgrade, Serbia, 11080
        • Clinical Hospital Center Bežanijska Kosa, Department of Oncology
      • Kamenitz, Serbia, 21204
        • Oncology Institute of Vojvodina
      • Kladovo, Serbia, 19320
        • Health Center Kladovo, Oncology Department
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac Center of Oncology and Radiotherapy
      • Kruševac, Serbia, 37000
        • General Hospital Krusevac, Outpatient Clinic for chemotherapy
      • Niš, Serbia, 18000
        • Clinical Center Niš, Clinic for Oncology
  • South Korea
      • Busan, South Korea
        • Kosin University Gospel Hospital
      • Busan, South Korea, 612-896
        • Inje University Haeundae Paik Hospital
      • Busan, South Korea
        • Pusan National University Yangsan Hospital
      • Daegu, South Korea
        • Keimyung University Dongsan Medical Center
      • Daejeon, South Korea, 35365
        • Konyang University Hospital
      • Gangneung, South Korea
        • Gang Neung Asan Hospital
      • Incheon, South Korea
        • Gachon University Gil Medical Center
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, South Korea
        • Gangnam Severance Hospital
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital
      • Seoul, South Korea, 03722
        • Yonsei University Severance Hospital
      • Seoul, South Korea
        • Catholic university of korea seoul st. mary's hospital
      • Uijeongbu-si, South Korea
        • Uijeongbu St. Mary's Hospital
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 220-701
        • Wonju Severance Christian Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea, 10408
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, South Korea, 13496
        • Cha University Cha Bundang Medical Center
      • Suwon, Gyeonggi-do, South Korea, 16499
        • Ajou University Hospital
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea, 28644
        • Chungbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Liporaxel® (oral paclitaxel)
  • 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.
Drug: Oral paclitaxel
Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Other Names:
  • Liporaxel®
Active Comparator: Taxol® (IV paclitaxel)
  • 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.
Drug: Paclitaxel injection
Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Other Names:
  • Taxol®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
[Phase II] Objective Response Rate (ORR)
Time Frame: Participants will be followed every 6 weeks until progression, an expected average of 9 months.
Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.
Participants will be followed every 6 weeks until progression, an expected average of 9 months.
[Phase III] Progression Free Survival (PFS)
Time Frame: From date of randomization, assessed up to 18 months.
Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death
From date of randomization, assessed up to 18 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
[Phase II] Progression Free Survival (PFS)
Time Frame: From date of randomization, assessed up to 18 months.
Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death
From date of randomization, assessed up to 18 months.
[Phase III] Objective Response Rate (ORR)
Time Frame: Participants will be followed every 6 weeks until progression, an expected average of 9 months.
Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.
Participants will be followed every 6 weeks until progression, an expected average of 9 months.
[Phase II&III] Overall Survival(OS)
Time Frame: Until 6 months after the last participant is enrolled, assessed minimum to 18 months.
Overall survival(OS) is defined as the time from the date of inclusion to the date of death, regardless of the cause of death.
Until 6 months after the last participant is enrolled, assessed minimum to 18 months.
[Phase II&III] Time to Treatment Failure(TTF)
Time Frame: through study completion, an expected average of 4.5 year.
TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause.
through study completion, an expected average of 4.5 year.
[Phase II&III] Disease Control Rate(DCR)
Time Frame: through study completion, an expected average of 4.5 year.
DCR is defined as the percentage of subjects who were evaluated for complete response(CR), partial response(PR), and stable disease(SD) as the best response among from randomization to End of treatment(EOT).
through study completion, an expected average of 4.5 year.
[Phase II&III] Quality of life(QoL)
Time Frame: C1D1, C2D1, C4D1, C7D1, C10D1 (each cycle is 28 days) and study completion, up to 18 months.
To evaluate changes versus baseline using the EQ-5D.
C1D1, C2D1, C4D1, C7D1, C10D1 (each cycle is 28 days) and study completion, up to 18 months.
Incidence of Treatment-Emergent Adverse Events [Safety]
Time Frame: Up to 28 days after last investigational product administraion.
Number and Description of Adverse Events
Up to 28 days after last investigational product administraion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daehwa Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sung-bae Kim, M.D., Ph.D, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 19, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 107CS-5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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