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To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liporaxel® (oral paclitaxel) | Experimental |
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| Taxol® (IV paclitaxel) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral paclitaxel | Drug | Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent |
|
| 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. |
| 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) |
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Key inclusion/exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sung-bae Kim, M.D., Ph.D | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Complex Center - Burgas'' Ltd., Medical Oncology Department | Burgas | 8000 | Bulgaria | |||
| Multi-profile Hospital for Active Treatment Uni Hospital Ltd. Medical Oncology Department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34925553 | Derived | 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. |
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Phase II clinical trial
Phase III clinical trial
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|
| Paclitaxel injection | Drug | Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent |
|
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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. |
| 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 |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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