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Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT01635465
Recruitment Status : Unknown
Verified July 2012 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 9, 2012
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Docetaxel plus Capecitabine in anthracycline-pretreated metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Vinorelbine plus Capecitabine is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Condition or disease
Anthracycline-pretreated Metastatic Breast Cancer

Detailed Description:
A randomised controlled trial of vinorelbine plus capecitabine versus docetaxel plus capecitabine in anthracycline-pretreated women with 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 Design

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Randomised Controlled Phase II Trial of Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic Breast Cancer.
Study Start Date : November 2016
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
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Observation group:vinorelbine plus capecitabine
Control group:docetaxel plus capecitabine


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
120
Criteria

Inclusion Criteria:

  • female ≥ 18 years old ECOG 0-2

Exclusion Criteria:

  • brain metastasis
Contacts and Locations

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): NCT01635465


Contacts
Contact: Li shufen, bachelor 022-23340123-1052 lishufen@medmail.com.cn

Locations
China, Tianjin
Tianjin Cancer Hospital Recruiting
Tianjin, Tianjin, China, 022
Contact: Li Shufen, bachelor    022-23340123 ext 1052    lishufen@medmail.com.cn   
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
More Information

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01635465     History of Changes
Other Study ID Numbers: CIH-LSF-201205001
First Posted: July 9, 2012    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: July 2012

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Vinorelbine
Capecitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents, Phytogenic