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

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: Active, not recruiting
• Conditions: Recurrent or Metastatic Breast Cancer
• Intervention / Treatment: Drug: Oral paclitaxel; Drug: Paclitaxel injection

• Study Type: Interventional
• Enrollment (Actual): 549
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Sung-bae Kim, M.D., Ph.D; Phone Number: 82-2-3010-3217; Email: sbkim3@amc.seoul.kr

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
    • Beijing, Beijing, 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
    • Shanghai, Shanghai, 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 János Hospital
  • Tatabánya, Hungary, 2800
    • Szent Borbála Hospital
• Korea, Republic of
  • Busan, Korea, Republic of
    • Kosin University Gospel Hospital
  • Busan, Korea, Republic of, 612-896
    • Inje University Haeundae Paik Hospital
  • Busan, Korea, Republic of
    • Pusan National University Yangsan Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daejeon, Korea, Republic of, 35365
    • Konyang University Hospital
  • Gangneung, Korea, Republic of
    • Gang Neung Asan Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03722
    • Yonsei University Severance Hospital
  • Seoul, Korea, Republic of
    • Catholic University of Korea Seoul St. Mary's Hospital
  • Uijeongbu, Korea, Republic of
    • Uijeongbu St. Mary's Hospital
  • Chungcheongbuk-do
    • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
      • Chungbuk National University Hospital
  • Gangwon-do
    • Wŏnju, Gangwon-do, Korea, Republic of, 220-701
      • Wonju Severance Christian Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
      • National Cancer Center
    • Seongnam, Gyeonggi-do, Korea, Republic of, 13496
      • Cha University Cha Bundang Medical Center
    • Suwon, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital
• Serbia
  • Belgrade, Serbia, 11000
    • Institute for Oncology and Radiology of Serbia
  • Belgrade, Serbia, 11080
    • Clinical Hospital Center Bežanijska Kosa, Department of Oncology
  • 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
  • Sremska Kamenica, Serbia, 21204
    • Oncology Institute of Vojvodina

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
[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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
[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	From date of randomization, assessed up to 18 months.
[Phase III] 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 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.	Until 6 months after the last participant is enrolled, assessed minimum to 18 months.
[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.	through study completion, an expected average of 4.5 year.
[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).	through study completion, an expected average of 4.5 year.
[Phase II&III] Quality of life(QoL)	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]	Number and Description of Adverse Events	Up to 28 days after last investigational product administraion.

Collaborators and Investigators

• Sponsor: Daehwa Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Sung-bae Kim, M.D., Ph.D, Asan Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2017
• Primary Completion (Estimated): January 30, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: October 16, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Metastatic breast cancer; Paclitaxel; Taxol; MBC; Recurrent breast cancer; Firstline chemotherapy; Liporaxel
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Breast Neoplasms; Recurrence; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID 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