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Recurrent or Metastatic Breast CancerPhase 2/3OPTIMALNCT03315364

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

A Phase 2/3 study testing Oral paclitaxel and Paclitaxel injection in people with Recurrent or Metastatic Breast Cancer, run by Daehwa Pharmaceutical Co., Ltd. at 51 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 19 years and older
Conditions the study is for
Recurrent or Metastatic Breast Cancer
What is being tested?
Oral paclitaxel and Paclitaxel injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
549 participants
Where
51 sitesin 5 countries
Study dates
18 Dec 2017to 30 Nov 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • ECOG performance status ≤1.
  • Neuropathy grade <2.
  • Subjects with central nervous system metastasis should be excluded.

Who cannot join

None listed.

Trial locations and contacts

51 sites in 5 countries.

51 sites in 5 countries

South Korea21 sites

  • Inje University Haeundae Paik Hospital

    Busan, 612-896

  • Kosin University Gospel Hospital

    Busan

  • Pusan National University Yangsan Hospital

    Busan

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644

  • Keimyung University Dongsan Medical Center

    Daegu

  • Konyang University Hospital

    Daejeon, 35365

  • Gang Neung Asan Hospital

    Gangneung

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

  • Gachon University Gil Medical Center

    Incheon

  • Cha University Cha Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 13496

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 03080

  • Yonsei University Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Korea University Guro Hospital

    Seoul, 08308

  • Catholic University of Korea Seoul ST. Mary's Hospital

    Seoul

  • Gangnam Severance Hospital

    Seoul

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

  • Uijeongbu ST. Mary's Hospital

    Uijeongbu-si

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 220-701

Other trials in South Korea

China18 sites

  • Cancer Hospital Chinese Academy Of Medical Sciences

    Beijing, Beijing Municipality

  • First Affiliated Hospital of Jilin University

    Changchun, Jilin

  • West China School Of Medicine Sichuan University

    Chengdu, Sichuan

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • The First Affiliated Hospital Of Hainan Medical College

    Haikou, Hainan

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Zhejiang University School Of Medicine Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

  • Anhui Cancer Hospital

    Hefei, Anhui

  • Shangdong Cancer Hospital

    Jinan, Shandong

  • Linyi Cancer Hospital

    Linyi, Shandong

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

  • Liaoning Cancer Hospital

    Shenyang, Liaoning

  • The First Affiliated Hospital of Xi'an Jiaotong university

    Xi’an, Shanxi

  • Tianjin Cancer Hospital

    Zhengzhou, Henan

  • Henan Cancer Hospital

    Zhengzhou

Other trials in China

Serbia7 sites

  • Institute for Oncology and Radiology of Serbia

    Belgrade, 11000

  • Clinical Hospital Center Bežanijska Kosa, Department of Oncology

    Belgrade, 11080

  • Oncology Institute of Vojvodina

    Kamenitz, 21204

  • Health Center Kladovo, Oncology Department

    Kladovo, 19320

  • Clinical Center Kragujevac Center of Oncology and Radiotherapy

    Kragujevac, 34000

  • General Hospital Krusevac, Outpatient Clinic for chemotherapy

    Kruševac, 37000

  • Clinical Center Niš, Clinic for Oncology

    Niš, 18000

Other trials in Serbia

Bulgaria3 sites

  • Oncology Complex Center - Burgas'' Ltd., Medical Oncology Department

    Burgas, 8000

  • Multi-profile Hospital for Active Treatment Uni Hospital Ltd. Medical Oncology Department

    Panagyurishte, 4500

  • Medical Center Nadezhda Clinical" Ltd.,

    Sofia, 1330

Other trials in Bulgaria

Hungary2 sites

  • Tolna County Balassa János Hospital

    Szekszárd, 7100

  • Szent Borbála Hospital

    Tatabánya, 2800

Other trials in Hungary

About this study

Official title: 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.

Being tested
Oral paclitaxel, Paclitaxel injection
Keywords
Recurrent breast cancer, Metastatic breast cancer, MBC, Firstline chemotherapy, Paclitaxel, Liporaxel, Taxol
Medical subject headings
Recurrence, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral paclitaxelDrug

    Also called Liporaxel®

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

  • Paclitaxel injectionDrug

    Also called Taxol®

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

Study groups in NCT03315364
Study groupRoleWhat they receive
Liporaxel® (oral paclitaxel)Experimental* 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.
Receives: Drug: Oral paclitaxel
Taxol® (IV paclitaxel)Active comparator* 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.
Receives: Drug: Paclitaxel injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. [Phase II] Objective Response Rate (ORR)

    Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.

    Measured: Participants will be followed every 6 weeks until progression, an expected average of 9 months.

  2. [Phase III] Progression Free Survival (PFS)

    Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death

    Measured: From date of randomization, assessed up to 18 months.

Secondary outcomes (7)

  1. [Phase II] Progression Free Survival (PFS)

    Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death

    Measured: From date of randomization, assessed up to 18 months.

  2. [Phase III] Objective Response Rate (ORR)

    Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.

    Measured: Participants will be followed every 6 weeks until progression, an expected average of 9 months.

  3. [Phase II&III] Overall Survival(OS)

    Overall survival(OS) is defined as the time from the date of inclusion to the date of death, regardless of the cause of death.

    Measured: Until 6 months after the last participant is enrolled, assessed minimum to 18 months.

  4. [Phase II&III] Time to Treatment Failure(TTF)

    TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause.

    Measured: through study completion, an expected average of 4.5 year.

  5. [Phase II&III] Disease Control Rate(DCR)

    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).

    Measured: through study completion, an expected average of 4.5 year.

  6. [Phase II&III] Quality of life(QoL)

    To evaluate changes versus baseline using the EQ-5D.

    Measured: C1D1, C2D1, C4D1, C7D1, C10D1 (each cycle is 28 days) and study completion, up to 18 months.

  7. Incidence of Treatment-Emergent Adverse Events [Safety]

    Number and Description of Adverse Events

    Measured: Up to 28 days after last investigational product administraion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2017
  2. Study start18 Dec 2017
  3. Primary completion19 Feb 2024
  4. Study completion30 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1. Phase II clinical trial * Multicenter, Open-label, Single arm, Simon's optimal two-stage design 2. Phase III clinical trial * Multicenter, Prospective Randomized Open-label Blinded Endpoint (PROBE) design
Masking
None (open label)
Enrolment
549 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03315364
Sponsor's protocol ID
107CS-5
Acronym
OPTIMAL
Status last verified
Mar 2026
First submitted
28 Sep 2017
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kim SB, Seo JH, Ahn JH, Kim TY, Kang SY, Sohn J, Yang Y, Park KH, Moon YW, Lim S, Kang MJ, Yoon KE, Cho HJ, Lee KS. Phase II study of DHP107 (oral paclitaxel) in the first-line treatment of HER2-negative recurrent or metastatic breast cancer (OPTIMAL study). Ther Adv Med Oncol. 2021 Dec 15;13:17588359211061989. doi: 10.1177/17588359211061989. eCollection 2021.

    PubMed 34925553

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Oral paclitaxel and Paclitaxel injection in people with Recurrent or Metastatic Breast Cancer, run by Daehwa Pharmaceutical Co., Ltd. at 51 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in South Korea, China, Serbia, Bulgaria, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

[Phase II] Objective Response Rate (ORR) (time frame: Participants will be followed every 6 weeks until progression, an expected average of 9 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03315364, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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