Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer
Phase 3
Completed
- Conditions
- Breast Cancer
- Interventions
- Drug: Genexol-PM®Drug: Genexol®
- Registration Number
- NCT00876486
- Lead Sponsor
- Samyang Biopharmaceuticals Corporation
- Brief Summary
Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 213
Inclusion Criteria
Subjects should meet all of the following criteria to participate in the trial.
- Subjects who aged 18 years or older.
- Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
- Subjects who have histologically or cytologically confirmed breast cancer with evidence of recurrence or metastasis.
- If subjects have received Taxanes as neo-adjuvant or adjuvant therapy, the subjects should have relapsed with breast cancer after 12 months of completing neo-adjuvant or adjuvant therapy with Taxanes.
- Subjects who have measurable disease in accordance with the RECIST criteria
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Genexol®-PM Genexol-PM® This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel). Genexol® Genexol® This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel).
- Primary Outcome Measures
Name Time Method Objective Response Rate 6 months Evaluate the efficacy of Genexol®-PM versus Genexol® in subjects with recurrent or metastatic breast cancer based on Objective Response Rate.
- Secondary Outcome Measures
Name Time Method Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response Event driven To evaluate the efficacy of Genexol®-PM relative to Genexol® as measured by Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response.
Safety and toxicity Throughout study To compare the safety and toxicity of Genexol®-PM with those of Genexol®
Trial Locations
- Locations (1)
National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of