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Trial Title:
Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin in Metastatic Breast Cancer
NCT ID:
NCT02207361
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Epirubicin
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Paclitaxel, Carboplatin
Description:
Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of
treatment.
Arm group label:
Paclitaxel, Carboplatin，injection
Intervention type:
Drug
Intervention name:
Paclitaxel, Epirubicin
Description:
Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of
treatment.
Arm group label:
Paclitaxel, Epirubicin，injection
Summary:
Paclitaxel plus Epirubicin in metastatic breast cancer is a recommended scheme in
National Comprehensive Cancer Network (NCCN) guideline. Paclitaxel in Combination with
Carboplatin is also effective in Metastatic Breast Cancer (MBC) in some clinical study
with small sample.
Detailed description:
A Randomized Prospective Clinical Trial of Paclitaxel in Combination with Carboplatin
Versus Paclitaxel plus Epirubicin as First-Line Treatment in Metastatic Breast Cancer.
The primary endpoints of the study is progression free survival (PFS). The secondary
endpoints are overall response rate (ORR), overall survival (OS) and safety.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- female ≥ 18 years old, ECOG 0-2 or KPS≥60, Expected lifetime more than 12 weeks.
Exclusion Criteria:
- Pregnancy, Paclitaxel, platinum and anthracycline-based drugs' allergy, Severe
Infection.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300061
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhongsheng Tong, Master
Start date:
December 2013
Completion date:
December 2016
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02207361
