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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:
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

June 17, 2012
December 21, 2015
November 2016
November 2016   (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.
 
Unknown status
120
December 2016
November 2016   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01635465
CIH-LSF-201205001
Yes
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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