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Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer

Primary Purpose

Metastatic Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Gemcitabine，Capecitabine
Gemcitabine, Carboplatin
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female
  • 18-70 years old
  • ECOG 0-1
  • Expected lifetime more than 12 weeks

Exclusion Criteria:

  • Pregnancy
  • Brain Metastasis,
  • 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

Gemcitabine，Capecitabine

Gemcitabine, Carboplatin

Arm Description

Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14

Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8

Outcomes

Primary Outcome Measures

RECIST 1.1

Secondary Outcome Measures

Full Information

First Posted
April 22, 2014
Last Updated
December 21, 2015
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02207335
Brief Title
Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer
Official Title
A Multicenter Randomized Phase Ⅲ Clinical Trial of Gemcitabine in Combination With Capecitabine Versus Gemcitabine Plus Carboplatin as First-line Treatment in Triple-negative Recurrent or 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
Gemcitabine plus carboplatin in recurrent or metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. gemcitabine in combination with capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.
Detailed Description
A multicenter randomized phase Ⅲ clinical trial of gemcitabine in combination with capecitabine versus gemcitabine plus carboplatin as first-line treatment in triple-negative recurrent or 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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine，Capecitabine
Arm Type
Experimental
Arm Description
Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14
Arm Title
Gemcitabine, Carboplatin
Arm Type
Active Comparator
Arm Description
Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8
Intervention Type
Drug
Intervention Name(s)
Gemcitabine，Capecitabine
Intervention Description
Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14
Intervention Type
Drug
Intervention Name(s)
Gemcitabine, Carboplatin
Intervention Description
Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8
Primary Outcome Measure Information:
Title
RECIST 1.1
Time Frame
-7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female 18-70 years old ECOG 0-1 Expected lifetime more than 12 weeks Exclusion Criteria: Pregnancy Brain Metastasis, 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
Phone
+86 18622221181
Email
18622221181@163.com

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
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Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer

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