Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy
- Conditions
- Recurrent or Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT03315364
- Lead Sponsor
- Daehwa Pharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 549
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liporaxel® (oral paclitaxel) 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. Taxol® (IV paclitaxel) Paclitaxel injection * 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.
- Primary Outcome Measures
Name Time Method [Phase II] Objective Response Rate (ORR) Participants will be followed every 6 weeks until progression, an expected average of 9 months. Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.
[Phase III] Progression Free Survival (PFS) From date of randomization, assessed up to 18 months. 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
Name Time Method [Phase II] Progression Free Survival (PFS) From date of randomization, assessed up to 18 months. 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) Participants will be followed every 6 weeks until progression, an expected average of 9 months. Objective Response Rate (ORR) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria.
[Phase II&III] Overall Survival(OS) Until 6 months after the last participant is enrolled, assessed minimum to 18 months. 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) through study completion, an expected average of 4.5 year. 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) through study completion, an expected average of 4.5 year. 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) C1D1, C2D1, C4D1, C7D1, C10D1 (each cycle is 28 days) and study completion, up to 18 months. To evaluate changes versus baseline using the EQ-5D.
Incidence of Treatment-Emergent Adverse Events [Safety] Up to 28 days after last investigational product administraion. Number and Description of Adverse Events
Trial Locations
- Locations (51)
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, Bulgaria
Anhui Cancer Hospital
🇨🇳Hefei, Anhui, China
Cancer Hospital Chinese Academy Of Medical Sciences
🇨🇳Beijing, Beijing, 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
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