Randomized Multicenter Phase II Study of Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine as First Line Chemotherapy for Patients With Metastatic Breast Cancer
Sponsor study identifier
interventional
60
1 country
1
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2009
Actual (reported)Study Completion
December 2010
Actual (reported)The primary objective of this study is to evaluate the efficacy and tolerability of sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
February 26, 2008
Actual (reported)March 5, 2008
Actual (reported)August 2009
Actual (reported)December 2010
Actual (reported)PFS(progression-free survival,defined as the time period between randomization and disease progress or death) and TTF (time to treatment failure, defined as all discontinuations for any cause)
PFS was assessed every two cycles (3 weeks per cycle)and during the follow up time, by serum tumor markers, physical examination and image examination, until disease progression event occurs. If a patient has the sign or hint of disease progression, then the lab examination, physical examination or image examination could be taken at any time.
Every two cycles (3 weeks per cycle) and during the follow up time, until disease progression event occurs.
Safety, QOL(quality of life)
Safety and QOL were assessed every cycle and during the follow up time, until 28 days after the last cycle.
TTP(time to progression) and OS (overall survival)
TTP and OS were assessed every cycle and during the follow up time, until the event occurs.
Simultaneous use of Vinorelbine and Capecitabine
Sequential use of Vinorelbine and Capecitabine
Vinorelbine 25mg/m2 D1, D8 q3w Capecitabine 1000mg/m2 D1-D14 q3w
Vinorelbine 25mg/m2 D1, D8 q3w. When disease progression or untolerated toxicity occurs, Capecitabine 1000mg/m2 D1-D14 q3w
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Vinorelbine and Capecitabine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Vinorelbine and Capecitabine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordFudan University Cancer Hospital
Shanghai, 200032, China
XiChun Hu, MD, PhD
Fudan University
60 participants (actual enrollment reported by the registry).
First Submitted
February 26, 2008
First Posted
March 5, 2008
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Liposomal Doxorubicin, Trastuzumab, and Docetaxel in HER2 Positive Metastatic Breast Cancer
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2009
Actual (reported)Study Completion
December 2010
Actual (reported)Last Updated
July 7, 2011
Record last verified: 2011-06
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Source: ClinicalTrials.gov.
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