Back to resultsPaclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin in Metastatic Breast Cancer
Primary Purpose
Metastatic Breast Cancer
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Paclitaxel, Carboplatin
Paclitaxel, Epirubicin
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer
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.
Sites / Locations
- Tianjin Medical University Cancer Institute and HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Paclitaxel, Carboplatin，injection
Paclitaxel, Epirubicin，injection
Arm Description
Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.
Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.
Outcomes
Primary Outcome Measures
RECIST 1.1
Secondary Outcome Measures
Full Information
NCT ID
NCT02207361
First Posted
April 22, 2014
Last Updated
December 21, 2015
Sponsor
Tianjin Medical University Cancer Institute and Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02207361
Brief Title
Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin in Metastatic Breast Cancer
Official Title
A Randomized Prospective Clinical Trial of Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin as First-Line Treatment in Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paclitaxel, Carboplatin，injection
Arm Type
Experimental
Arm Description
Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.
Arm Title
Paclitaxel, Epirubicin，injection
Arm Type
Active Comparator
Arm Description
Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel, Carboplatin
Intervention Description
Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel, Epirubicin
Intervention Description
Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.
Primary Outcome Measure Information:
Title
RECIST 1.1
Time Frame
-7 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongsheng Tong, Master
Phone
+86 18622221181
Email
18622221181@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong, Master
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong, Master
12. IPD Sharing Statement
Citations:
PubMed Identifier
33084020
Citation
Egger SJ, Chan MMK, Luo Q, Wilcken N. Platinum-containing regimens for triple-negative metastatic breast cancer. Cochrane Database Syst Rev. 2020 Oct 21;10(10):CD013750. doi: 10.1002/14651858.CD013750.
Results Reference
derived
Learn more about this trial
Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin in Metastatic Breast Cancer
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