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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: May 5, 2014
Last verified: July 2012

June 17, 2012
May 5, 2014
May 2014
May 2015   (final data collection date for primary outcome measure)
RECIST 1.1 [ Time Frame: -7 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01635465 on ClinicalTrials.gov Archive Site
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Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic Breast Cancer
A Randomised Controlled Phase II Trial of Vinorelbine Plus Capecitabine Versus Docetaxel Plus Capecitabine in Anthracycline-pretreated Women With Metastatic Breast Cancer.

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

120

Anthracycline-pretreated Metastatic Breast Cancer
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  • Observation group:vinorelbine plus capecitabine
  • Control group:docetaxel plus capecitabine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
120
December 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • female ≥ 18 years old ECOG 0-2

Exclusion Criteria:

  • brain metastasis
Female
18 Years and older
No
Contact: Li shufen, bachelor 022-23340123-1052 lishufen@medmail.com.cn
China
 
NCT01635465
CIH-LSF-201205001
Yes
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
Not Provided
Not Provided
Tianjin Medical University Cancer Institute and Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP