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Capecitabine, Vinorelbine, and Trastuzumab in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00093808
First Posted: October 8, 2004
Last Update Posted: March 6, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
Results First Submitted: November 28, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Biological: trastuzumab
Drug: capecitabine
Drug: vinorelbine tartrate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Capecitabine + Vinorelbine + Trastuzumab Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).

Participant Flow:   Overall Study
    Capecitabine + Vinorelbine + Trastuzumab
STARTED   47 
COMPLETED   45 
NOT COMPLETED   2 
Cancel participation before receiving tx                1 
Protocol Violation                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients who completed the study or deemed a protocol violation were included in all analyses unless otherwise specified.

Reporting Groups
  Description
Capecitabine + Vinorelbine + Trastuzumab Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).

Baseline Measures
   Capecitabine + Vinorelbine + Trastuzumab 
Overall Participants Analyzed 
[Units: Participants]
 46 
Age 
[Units: Years]
Median (Full Range)
 60 
 (40 to 77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      46 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   46 


  Outcome Measures
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1.  Primary:   Confirmed Response Rate   [ Time Frame: Up to 5 years ]

2.  Secondary:   Time to Progression (TTP)   [ Time Frame: Up to 5 years ]

3.  Secondary:   Duration of Response as Measured by RECIST Criteria   [ Time Frame: Up to 5 years ]

4.  Secondary:   Overall Survival as Assessed by Time   [ Time Frame: Up to 5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Winston Tan, MD
Organization: Mayo Clinic
phone: 904-953-7290
e-mail: Tan.Winston@mayo.edu


Publications of Results:

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00093808     History of Changes
Other Study ID Numbers: NCCTG-N0337
NCI-2012-02625 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000390344 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: October 6, 2004
First Posted: October 8, 2004
Results First Submitted: November 28, 2016
Results First Posted: January 23, 2017
Last Update Posted: March 6, 2017