We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic 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 July 2012 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01635465
First Posted: July 9, 2012
Last Update Posted: December 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
  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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted: June 17, 2012
First Posted: July 9, 2012
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


To Top