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

Recurrent or Metastatic Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03315364
• Other study ID #: 107CS-5
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: December 18, 2017
• Est. completion date: March 31, 2024

Study information

• Verified date: December 2023
• Source: Daehwa Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 549
• Est. completion date: March 31, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Recurrence
• Recurrent or Metastatic Breast Cancer

Intervention

Drug:
• Oral paclitaxel
Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
• Paclitaxel injection
Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent

Locations

Country	Name	City	State
Bulgaria	Oncology Complex Center - Burgas'' Ltd., Medical Oncology Department	Burgas
Bulgaria	Multi-profile Hospital for Active Treatment Uni Hospital Ltd. Medical Oncology Department	Panagyurishte
Bulgaria	Medical Center Nadezhda Clinical" Ltd.,	Sofia
China	Cancer Hospital Chinese Academy Of Medical Sciences	Beijing	Beijing
China	First Affiliated Hospital of Jilin University	Changchun	Jilin
China	West China School Of Medicine Sichuan University	Chengdu	Sichuan
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital Of Hainan Medical College	Haikou	Hainan
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang University School Of Medicine Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Cancer Hospital	Hefei	Anhui
China	Shangdong Cancer Hospital	Jinan	Shandong
China	Linyi Cancer Hospital	Linyi	Shandong
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Liaoning Cancer Hospital	Shenyang	Liaoning
China	The First Affiliated Hospital of Xi'an Jiaotong university	Xi'an	Shanxi
China	Henan Cancer Hospital	Zhengzhou
China	Tianjin Cancer Hospital	Zhengzhou	Henan
Hungary	Tolna County Balassa János Hospital	Szekszárd
Hungary	Szent Borbála Hospital	Tatabánya
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Pusan National University Yangsan Hospital	Busan
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-do
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	Gang Neung Asan Hospital	Gangneung
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Cha University Cha Bundang Medical Center	Seongnam	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Catholic University of Korea Seoul ST. Mary's Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon	Gyeonggi-do
Korea, Republic of	Uijeongbu ST. Mary's Hospital	Uijeongbu
Korea, Republic of	Wonju Severance Christian Hospital	Wonju	Gangwon-do
Serbia	Clinical Hospital Center Bežanijska Kosa, Department of Oncology	Belgrade
Serbia	Institute for Oncology and Radiology of Serbia	Belgrade
Serbia	Health Center Kladovo, Oncology Department	Kladovo
Serbia	Clinical Center Kragujevac Center of Oncology and Radiotherapy	Kragujevac
Serbia	General Hospital Krusevac, Outpatient Clinic for chemotherapy	Kruševac
Serbia	Clinical Center Niš, Clinic for Oncology	Niš
Serbia	Oncology Institute of Vojvodina	Sremska Kamenica

Sponsors (1)

Lead Sponsor	Collaborator
Daehwa Pharmaceutical Co., Ltd.

Countries where clinical trial is conducted

Bulgaria,  China,  Hungary,  Korea, Republic of,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[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.
Primary	[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	[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.
Secondary	[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.
Secondary	[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.
Secondary	[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.
Secondary	[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.
Secondary	[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.
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety]	Number and Description of Adverse Events	Up to 28 days after last investigational product administraion.