Text Size

XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00127933
First received: August 5, 2005
Last updated: July 13, 2011
Last verified: July 2011
History of Changes
Results First Received: March 30, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: capecitabine [Xeloda]
Drug: Taxotere
Drug: Herceptin (HER2-neu positive patients only)

  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
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
HER2-Neu Negative

Dose and route per treatment cycle (Q3W):

Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1

HER2-neu negative: capecitabine + docetaxel

Duration: Four 3-week treatment cycles
HER2-Neu Positive

Dose and route per treatment cycle (Q3W):

Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly

HER2-neu positive: capecitabine + docetaxel + trastuzumab

Duration: Four 3-week treatment cycles

Participant Flow:   Overall Study
    HER2-Neu Negative     HER2-Neu Positive  
STARTED     123     34  
Pathological Response     101     28  
Clinical Response     122     34  
Safety Population     122     34  
Quality of Life Population     118     33  
Postoperative     98     27  
COMPLETED     122     34  
NOT COMPLETED     1     0  
Randomized but not dosed                 1                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
HER2-Neu Negative

Dose and route per treatment cycle (Q3W):

Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1

HER2-neu negative: capecitabine + docetaxel

Duration: Four 3-week treatment cycles
HER2-Neu Positive

Dose and route per treatment cycle (Q3W):

Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly

HER2-neu positive: capecitabine + docetaxel + trastuzumab

Duration: Four 3-week treatment cycles
Total Total of all reporting groups

Baseline Measures
    HER2-Neu Negative     HER2-Neu Positive     Total  
Number of Participants  
[units: participants]
 		  122     34     156  
Age [1]
[units: years]
Mean ± Standard Deviation 		  51.0  ± 11.20     52.2  ± 9.36     51.3  ± 10.79  
Gender  
[units: participants]
 		     
Female     122     34     156  
Male     0     0     0  
[1] Safety Population



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Assessed for Pathological Complete Response (pCR) Plus Near Complete (npCR) in Primary Breast Tumor at Time of Definitive Surgery   [ Time Frame: at the time of definitive surgery; after four 3-week cycles (3-4 months) ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Participants With Complete Pathological Response in the Primary Breast Tumor at the Time of Definitive Surgery   [ Time Frame: at the time of definitive surgery; after four 3-week cycles (3-4 months) ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants With Overall Clinical Response (Complete Response (CR) Plus Partial Response (PR))   [ Time Frame: post 2 and 4, 3-week cycles of treatment ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants With Local Recurrence   [ Time Frame: 30 - 1102 days ]
  Show Outcome Measure 4

5.  Secondary:   Participants With Disease-Free Survival   [ Time Frame: 30 - 1102 days ]
  Show Outcome Measure 5

6.  Secondary:   Participants With Overall Survival   [ Time Frame: 22 - 1191 days ]
  Show Outcome Measure 6


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


No publications provided


Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00127933     History of Changes
Other Study ID Numbers: ML18530
Study First Received: August 5, 2005
Results First Received: March 30, 2011
Last Updated: July 13, 2011
Health Authority: United States: Food and Drug Administration