Recurrent or Metastatic Breast Cancer
Conditions
Keywords
Recurrent breast cancer, Metastatic breast cancer, MBC, Firstline chemotherapy, Paclitaxel, Liporaxel, Taxol
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.
Interventions
DRUGOral paclitaxel
Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
DRUGPaclitaxel injection
Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
Sponsors
Daehwa Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
1. Phase II clinical trial * Multicenter, Open-label, Single arm, Simon's optimal two-stage design 2. Phase III clinical trial * Multicenter, Prospective Randomized Open-label Blinded Endpoint (PROBE) design
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| [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
| Measure | Time frame | Description |
|---|---|---|
| [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 |
Countries
Bulgaria, China, Hungary, Serbia, South Korea
Contacts
PRINCIPAL_INVESTIGATORSung-bae Kim, M.D., Ph.D
Asan Medical Center
Outcome results
None listed