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Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2013 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT02207335
First received: April 22, 2014
Last updated: December 21, 2015
Last verified: June 2013
  Purpose
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.

Condition Intervention Phase
Metastatic Breast Cancer
Drug: Gemcitabine,Capecitabine
Drug: Gemcitabine, Carboplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • RECIST 1.1 [ Time Frame: -7 days ]

Estimated Enrollment: 120
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine,Capecitabine
Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14
Drug: Gemcitabine,Capecitabine
Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14
Active Comparator: Gemcitabine, Carboplatin
Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8
Drug: Gemcitabine, Carboplatin
Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Brain Metastasis,
  • Severe Infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02207335

Contacts
Contact: Zhongsheng Tong, Master +86 18622221181 18622221181@163.com

Locations
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Recruiting
Tianjin, Tianjin, China, 300061
Contact: Zhongsheng Tong, Master    +86 18622221181    18622221181@163.com   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Study Director: Zhongsheng Tong, Master Tianjin Medical University Cancer Institute and Hospital
  More Information

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT02207335     History of Changes
Other Study ID Numbers: CIH-TZS-20140421-01
Study First Received: April 22, 2014
Last Updated: December 21, 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Capecitabine
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 26, 2017