Back to resultsOral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy (OPTIMAL)
Primary Purpose
Recurrent or Metastatic Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Oral paclitaxel
Paclitaxel injection
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent or Metastatic Breast Cancer focused on measuring Recurrent breast cancer, Metastatic breast cancer, MBC, Firstline chemotherapy, Paclitaxel, Liporaxel, Taxol
Eligibility Criteria
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.
Sites / Locations
- Anhui Cancer HospitalRecruiting
- Cancer Hospital Chinese Academy Of Medical Sciences
- Sun Yat-sen University Cancer CenterRecruiting
- The First Affiliated Hospital Of Hainan Medical CollegeRecruiting
- Harbin Medical University Cancer HospitalRecruiting
- Tianjin Cancer HospitalRecruiting
- Jiangsu Cancer Hospital
- Jiangsu Province Hospital
- First Affiliated Hospital of Jilin UniversityRecruiting
- Liaoning Cancer HospitalRecruiting
- Shangdong Cancer Hospital
- Linyi Cancer HospitalRecruiting
- Fudan University Shanghai Cancer Center
- The First Affiliated Hospital of Xi'an Jiaotong university
- West China School Of Medicine Sichuan UniversityRecruiting
- Zhejiang Cancer HospitalRecruiting
- Zhejiang University School Of Medicine Sir Run Run Shaw HospitalRecruiting
- Henan Cancer HospitalRecruiting
- Chungbuk National University HospitalRecruiting
- Wonju Severance Christian Hospital
- National Cancer CenterRecruiting
- Cha University Cha Bundang Medical CenterRecruiting
- Ajou University HospitalRecruiting
- Inje University Haeundae Paik HospitalRecruiting
- Kosin University Gospel HospitalRecruiting
- Pusan National University Yangsan HospitalRecruiting
- Keimyung University Dongsan Medical CenterRecruiting
- Konyang University HospitalRecruiting
- Gang Neung Asan HospitalRecruiting
- Gachon University Gil Medical CenterRecruiting
- Korea University Anam HospitalRecruiting
- Seoul National University HospitalRecruiting
- Yonsei University Severance HospitalRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- Korea University Guro HospitalRecruiting
- Catholic University of Korea Seoul ST. Mary's HospitalRecruiting
- Gangnam Severance HospitalRecruiting
- Uijeongbu ST. Mary's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Liporaxel® (oral paclitaxel)
Taxol® (IV paclitaxel)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
[Phase II] Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.
[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
Secondary Outcome Measures
[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
[Phase III] Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.
[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.
[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.
[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).
[Phase II&III] Quality of life(QoL)
To evaluate changes versus baseline using the EQ-5D.
Incidence of Treatment-Emergent Adverse Events [Safety]
Number and Description of Adverse Events
Full Information
NCT ID
NCT03315364
First Posted
September 28, 2017
Last Updated
March 11, 2020
Sponsor
Daehwa Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03315364
Brief Title
Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy
Acronym
OPTIMAL
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 18, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daehwa Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent or Metastatic Breast Cancer
Keywords
Recurrent breast cancer, Metastatic breast cancer, MBC, Firstline chemotherapy, Paclitaxel, Liporaxel, Taxol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase II clinical trial
Multicenter, Open-label, Single arm, Simon's optimal two-stage design
Phase III clinical trial
Multicenter, Prospective Randomized Open-label Blinded Endpoint (PROBE) design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
476 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Liporaxel® (oral paclitaxel)
Arm Type
Experimental
Arm Description
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.
Arm Title
Taxol® (IV paclitaxel)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral paclitaxel
Other Intervention Name(s)
Liporaxel®
Intervention Description
Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Intervention Type
Drug
Intervention Name(s)
Paclitaxel injection
Other Intervention Name(s)
Taxol®
Intervention Description
Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Primary Outcome Measure Information:
Title
[Phase II] Objective Response Rate (ORR)
Description
Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.
Time Frame
Participants will be followed every 6 weeks until progression, an expected average of 9 months.
Title
[Phase III] Progression Free Survival (PFS)
Description
Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death
Time Frame
From date of randomization, assessed up to 18 months.
Secondary Outcome Measure Information:
Title
[Phase II] Progression Free Survival (PFS)
Description
Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death
Time Frame
From date of randomization, assessed up to 18 months.
Title
[Phase III] Objective Response Rate (ORR)
Description
Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.
Time Frame
Participants will be followed every 6 weeks until progression, an expected average of 9 months.
Title
[Phase II&III] Overall Survival(OS)
Description
Overall survival(OS) is defined as the time from the date of inclusion to the date of death, regardless of the cause of death.
Time Frame
Until 6 months after the last participant is enrolled, assessed minimum to 18 months.
Title
[Phase II&III] Time to Treatment Failure(TTF)
Description
TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause.
Time Frame
through study completion, an expected average of 4.5 year.
Title
[Phase II&III] Disease Control Rate(DCR)
Description
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).
Time Frame
through study completion, an expected average of 4.5 year.
Title
[Phase II&III] Quality of life(QoL)
Description
To evaluate changes versus baseline using the EQ-5D.
Time Frame
C1D1, C2D1, C4D1, C7D1, C10D1 (each cycle is 28 days) and study completion, up to 18 months.
Title
Incidence of Treatment-Emergent Adverse Events [Safety]
Description
Number and Description of Adverse Events
Time Frame
Up to 28 days after last investigational product administraion.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung-bae Kim, M.D., Ph.D
Phone
82-2-3010-3217
Email
sbkim3@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-bae Kim, M.D., Ph.D
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Cancer Hospital
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hu Liu
Facility Name
Cancer Hospital Chinese Academy Of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binghe Xu
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shusen Wang
Facility Name
The First Affiliated Hospital Of Hainan Medical College
City
Haikou
State/Province
Hainan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinsheng Wu
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingyuan Zhang
Facility Name
Tianjin Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jifeng Feng
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongmei Yin
Facility Name
First Affiliated Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Li
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Sun
Facility Name
Shangdong Cancer Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huihui Li
Facility Name
Linyi Cancer Hospital
City
Linyi
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingfen Wang
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xichuan Hu
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong university
City
Xi'an
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Yang
Facility Name
West China School Of Medicine Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Luo
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojia Wang Wang
Facility Name
Zhejiang University School Of Medicine Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xian Wang
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Yan
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
State/Province
Chungcheongbuk-do
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Hyeong Lee, M.D.
Phone
82-43-269-6015
Email
kihlee@chungbuk.ac.kr
Facility Name
Wonju Severance Christian Hospital
City
Wŏnju
State/Province
Gangwon-do
ZIP/Postal Code
220-701
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Taek Lim, M.D.
Phone
82-10-3470-6566
Email
darksgtlim@naver.com
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keun Seok Lee, M.D., Ph.D
Phone
82-31-920-1623
Email
kslee@ncc.re.kr
Facility Name
Cha University Cha Bundang Medical Center
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13496
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Wha Moon, Ph.D.
Phone
82-10-2825-6357
Email
ymoon@cha.ac.kr
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seok Yun Kang, M.D.,Ph.D
Phone
82-31-219-4911
Email
kagnsy01@ajou.ac.kr
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
612-896
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myoung-joo Kang, M.D.
Phone
82-51-797-0001
Email
daniel0602@hanmail.net
Facility Name
Kosin University Gospel Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Mi Lee
Phone
82-51-990-6532
Email
byule00@hanmail.net
Facility Name
Pusan National University Yangsan Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
So Yeon Oh
Phone
82-55-360-2369
Email
manic2db@gmail.com
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keon Uk Park
Phone
82-53-258-7716
Email
kupark@dsmc.or.kr
Facility Name
Konyang University Hospital
City
Daejeon
ZIP/Postal Code
35365
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Gwon Choi
Phone
82-42-600-9434
Email
jabuss@naver.com
Facility Name
Gang Neung Asan Hospital
City
Gangneung
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ho Suk Oh
Phone
82-33-610-3136
Email
hosukoh@hanmail.net
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Kyung Ahn
Phone
82-10-9933-5099
Email
hkahn.onco@gmail.com
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyung-hwa Park, M.D., Ph.D
Phone
82-2-920-6841
Email
khpark@korea.ac.kr
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae-yong Kim, M.D., Ph.D
Phone
82-2-765-6433
Email
ktyongmd@gmail.com
Facility Name
Yonsei University Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo Hyuk Sohn, M.D.,Ph.D
Phone
82-2-2228-8135
Email
oncosohn@yuhs.ac
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-bae Kim, M.D., Ph.D
Phone
82-2-3010-3217
Email
sbkim3@amc.seoul.kr
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Hyuck Im, M.D., Ph.D
Phone
82-2-3410-3445
Email
yh00.im@samsung.com
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Hong Seo, M.D., Ph.D
Phone
82-2-2626-3059
Email
cancer@korea.ac.kr
Facility Name
Catholic University of Korea Seoul ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Eun Lee
Phone
82-10-8934-9310
Email
befamiliar@catholic.ac.kr
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jee Hung Kim
Phone
82-2-2019-3310
Email
OK8504@yuhs.ac
Facility Name
Uijeongbu ST. Mary's Hospital
City
Uijeongbu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Der Sheng Sun
Phone
82-10-2717-9652
Email
ds-sun@daum.net
12. IPD Sharing Statement
Citations:
PubMed Identifier
34925553
Citation
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.
Results Reference
derived
Learn more about this trial
Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy
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