Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy
OPTIMAL
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
1 other identifier
interventional
549
5 countries
51
Brief Summary
To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2017
Longer than P75 for phase_2
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2017
CompletedFirst Posted
Study publicly available on registry
October 20, 2017
CompletedStudy Start
First participant enrolled
December 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
ExpectedApril 1, 2026
March 1, 2026
6.2 years
September 28, 2017
March 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
[Phase II] Objective Response Rate (ORR)
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)
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 Outcomes (7)
[Phase II] Progression Free Survival (PFS)
From date of randomization, assessed up to 18 months.
[Phase III] Objective Response Rate (ORR)
Participants will be followed every 6 weeks until progression, an expected average of 9 months.
[Phase II&III] Overall Survival(OS)
Until 6 months after the last participant is enrolled, assessed minimum to 18 months.
[Phase II&III] Time to Treatment Failure(TTF)
through study completion, an expected average of 4.5 year.
[Phase II&III] Disease Control Rate(DCR)
through study completion, an expected average of 4.5 year.
- +2 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Oncology Complex Center - Burgas'' Ltd., Medical Oncology Department
Burgas, 8000, Bulgaria
Multi-profile Hospital for Active Treatment Uni Hospital Ltd. Medical Oncology Department
Panagyurishte, 4500, Bulgaria
Medical Center Nadezhda Clinical" Ltd.,
Sofia, 1330, Bulgaria
Anhui Cancer Hospital
Hefei, Anhui, China
Cancer Hospital Chinese Academy Of Medical Sciences
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The First Affiliated Hospital Of Hainan Medical College
Haikou, Hainan, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Tianjin Cancer Hospital
Zhengzhou, Henan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
First Affiliated Hospital of Jilin University
Changchun, Jilin, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Shangdong Cancer Hospital
Jinan, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong university
Xi’an, Shanxi, China
West China School Of Medicine Sichuan University
Chengdu, Sichuan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Zhejiang University School Of Medicine Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Henan Cancer Hospital
Zhengzhou, China
Tolna County Balassa János Hospital
Szekszárd, 7100, Hungary
Szent Borbála Hospital
Tatabánya, 2800, Hungary
Institute for Oncology and Radiology of Serbia
Belgrade, 11000, Serbia
Clinical Hospital Center Bežanijska Kosa, Department of Oncology
Belgrade, 11080, Serbia
Oncology Institute of Vojvodina
Kamenitz, 21204, Serbia
Health Center Kladovo, Oncology Department
Kladovo, 19320, Serbia
Clinical Center Kragujevac Center of Oncology and Radiotherapy
Kragujevac, 34000, Serbia
General Hospital Krusevac, Outpatient Clinic for chemotherapy
Kruševac, 37000, Serbia
Clinical Center Niš, Clinic for Oncology
Niš, 18000, Serbia
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 220-701, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Cha University Cha Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, 28644, South Korea
Inje University Haeundae Paik Hospital
Busan, 612-896, South Korea
Kosin University Gospel Hospital
Busan, South Korea
Pusan National University Yangsan Hospital
Busan, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Konyang University Hospital
Daejeon, 35365, South Korea
Gang Neung Asan Hospital
Gangneung, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Yonsei University Severance Hospital
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Catholic University of Korea Seoul ST. Mary's Hospital
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Uijeongbu ST. Mary's Hospital
Uijeongbu-si, South Korea
Related Publications (1)
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.
PMID: 34925553DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sung-bae Kim, M.D., Ph.D
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2017
First Posted
October 20, 2017
Study Start
December 18, 2017
Primary Completion
February 19, 2024
Study Completion (Estimated)
November 30, 2028
Last Updated
April 1, 2026
Record last verified: 2026-03