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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by Tianjin Medical University Cancer Institute and Hospital
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01635465
First received: June 17, 2012
Last updated: December 21, 2015
Last verified: July 2012
  Purpose
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
Anthracycline-pretreated Metastatic Breast Cancer

Study Type: Observational
Study Design: 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.

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: November 2016
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation group:vinorelbine plus capecitabine
Control group:docetaxel plus capecitabine

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
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: 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 
Study First Received: June 17, 2012
Last Updated: December 21, 2015
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 27, 2016