Capecitabine in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00274768
First received: January 10, 2006
Last updated: March 18, 2013
Last verified: January 2013
Results First Received: November 21, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Drug: capecitabine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirty patients with metastatic breast cancer were consented between August 2005 and December 2008. Twenty six patients were eligible and initiated treatment on-study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Women (≥ 18 or older) with a histologically confirmed metastatic (stage 4) adenocarcinoma of the breast were eligible. Several inclusion and exclusion applied to confirm that women were appropriate to take part in the study intervention.

Reporting Groups
  Description
Capecitabine The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.

Participant Flow:   Overall Study
    Capecitabine  
STARTED     26  
COMPLETED     26  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
Capecitabine The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.

Baseline Measures
    Capecitabine  
Number of Participants  
[units: participants]
  26  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     24  
>=65 years     2  
Gender  
[units: participants]
 
Female     26  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     26  



  Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: Participants were followed to progression, evaluated every 12 weeks ]

2.  Secondary:   Clinical Benefit, Time to Treatment Failure, Safety and Toxicity   [ Time Frame: Time to progression ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Pharmacokinetic and Pharmacodynamic Effects   [ Time Frame: Time to progression ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Adherence and Compliance to Oral Medication Using Electronic Monitoring   [ Time Frame: Every 3 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
The small sample size limited a number of the secondary objectives.  


Results Point of Contact:  
Name/Title: Dr. Antonio Wolff
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
phone: 410-614-6192
e-mail: awolff@jhmi.edu


No publications provided


Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00274768     History of Changes
Other Study ID Numbers: J0425 CDR0000446286, P30CA006973, JHOC-J0425, JHOC-SKCCC-J0425, JHOC-IRB-04032502
Study First Received: January 10, 2006
Results First Received: November 21, 2012
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board