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Trial of Gemcitabine_Capecitabine Versus Gemcitabine_Carboplatin in Breast Cancer

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ClinicalTrials.gov Identifier: NCT02207335
Recruitment Status : Unknown
Verified June 2013 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Recruiting
First Posted : August 4, 2014
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Gemcitabine,Capecitabine Drug: Gemcitabine, Carboplatin Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2013
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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




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


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT02207335     History of Changes
Other Study ID Numbers: CIH-TZS-20140421-01
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: June 2013

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