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XEBRA Study: An Observational Study of Xeloda (Capecitabine) in Combination With Docetaxel in First Line in Participants With HER2-Negative Metastatic Breast Cancer

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.
 
ClinicalTrials.gov Identifier: NCT01777945
Recruitment Status : Completed
First Posted : January 29, 2013
Results First Posted : August 19, 2016
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Breast Cancer
Interventions Drug: capecitabine
Drug: docetaxel
Enrollment 46
Recruitment Details  
Pre-assignment Details 46 participants were enrolled in the study and included in safety assessments. 45 participants were included in other assessments.
Arm/Group Title Participants Receiving Capecitabine/Docetaxel
Hide Arm/Group Description Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Period Title: Overall Study
Started 46
Evaluable Participants 45
Completed 46
Not Completed 0
Arm/Group Title Participants Receiving Capecitabine/Docetaxel
Hide Arm/Group Description Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
All participants were female.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
  66.7%
>=65 years
15
  33.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants
58.58  (11.359)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
45
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Hungary Number Analyzed 45 participants
45
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause.
Time Frame approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants Receiving Capecitabine/Docetaxel
Hide Arm/Group Description:
Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Overall Number of Participants Analyzed 45
Median (Standard Deviation)
Unit of Measure: months
9.89  (2.97)
2.Secondary Outcome
Title Time to Treatment Failure
Hide Description The time from enrollment to discontinuation of any drug of the treatment combination.
Time Frame approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants Receiving Capecitabine/Docetaxel
Hide Arm/Group Description:
Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: months
4.64  (5.14)
3.Secondary Outcome
Title Overall Response Rate
Hide Description The percentage of participants with complete or partial remission, based on evaluation of tumor responses assessed at regular examinations per routine clinical practice.
Time Frame approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants Receiving Capecitabine/Docetaxel
Hide Arm/Group Description:
Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: percentage of participants
28.9
4.Secondary Outcome
Title Clinical Benefit Rate
Hide Description The percentage of participants with an overall response (complete or partial remission) or with stable disease.
Time Frame approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants Receiving Capecitabine/Docetaxel
Hide Arm/Group Description:
Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: percentage of participants
73.3
5.Secondary Outcome
Title Duration of Treatment With Xeloda
Hide Description [Not Specified]
Time Frame approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants Receiving Capecitabine/Docetaxel
Hide Arm/Group Description:
Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: treatment cycle
6.24  (4.80)
6.Secondary Outcome
Title Percentage of Capecitabine Dose Modifications
Hide Description [Not Specified]
Time Frame approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants Receiving Capecitabine/Docetaxel
Hide Arm/Group Description:
Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: percentage of doses
44.4
7.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
46 participants enrolled in the study were evaluable with regards to tolerability; however, 1 participant did not meet the eligibility criteria, was excluded from the efficacy analyses, but was included in the safety analyses.
Arm/Group Title Participants Receiving Capecitabine/Docetaxel
Hide Arm/Group Description:
Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: participants
33
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Participants Receiving Capecitabine/Docetaxel
Hide Arm/Group Description Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
All-Cause Mortality
Participants Receiving Capecitabine/Docetaxel
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Participants Receiving Capecitabine/Docetaxel
Affected / at Risk (%) # Events
Total   8/46 (17.39%)    
Blood and lymphatic system disorders   
Anemia  1  1/46 (2.17%)  1
Neutropenia  1  3/46 (6.52%)  3
Thrombocytopenia  1  1/46 (2.17%)  1
Cardiac disorders   
Heart Failure  1  1/46 (2.17%)  1
Gastrointestinal disorders   
Diarrhea  1  1/46 (2.17%)  1
General disorders   
Disease Progression  1  3/46 (6.52%)  3
Mucositis  1  1/46 (2.17%)  1
Infections and infestations   
Pneumonia  1  1/46 (2.17%)  1
Skin and subcutaneous tissue disorders   
Dermatitis  1  1/46 (2.17%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Participants Receiving Capecitabine/Docetaxel
Affected / at Risk (%) # Events
Total   21/46 (45.65%)    
Blood and lymphatic system disorders   
Neutropenia  1  10/46 (21.74%)  14
Gastrointestinal disorders   
Diarrhea  1  3/46 (6.52%)  4
General disorders   
Mucositis  1  4/46 (8.70%)  4
Skin and subcutaneous tissue disorders   
Palmoplantar erythrodysesthesia syndrome  1  12/46 (26.09%)  13
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 1-800-821-8590
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01777945    
Other Study ID Numbers: ML28505
First Submitted: January 25, 2013
First Posted: January 29, 2013
Results First Submitted: April 12, 2016
Results First Posted: August 19, 2016
Last Update Posted: August 19, 2016