Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00080301
First received: March 26, 2004
Last updated: August 4, 2010
Last verified: June 2010
Results First Received: May 1, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Breast Cancer
Metastases
Interventions: Drug: Ixabepilone + Capecitabine
Drug: Capecitabine

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ixabepilone + Capecitabine Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
Capecitabine Capecitabine 1250 mg/m2 BID x 14 days

Participant Flow:   Overall Study
    Ixabepilone + Capecitabine     Capecitabine  
STARTED     375     377  
Never Treated     5     10  
Still on Treatment     0     1  
COMPLETED     370 [1]   366 [1]
NOT COMPLETED     5     11  
Randomized but Never Treated                 5                 10  
Still on Treatment as of CSR date                 0                 1  
[1] Participants who are off treatment



  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.
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Reporting Groups
  Description
Ixabepilone + Capecitabine Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
Capecitabine Capecitabine 1250 mg/m2 BID x 14 days
Total Total of all reporting groups

Baseline Measures
    Ixabepilone + Capecitabine     Capecitabine     Total  
Number of Participants  
[units: participants]
  375     377     752  
Age, Customized  
[units: participants]
     
<65 years     336     322     658  
>= 65 years     39     54     93  
<50 years     135     145     280  
>= 50 years     240     231     471  
Unknown     0     1     1  
Age  
[units: years]
Median ( Full Range )
  53.0  
  ( 25.0 to 76.0 )  
  52.0  
  ( 25.0 to 79.0 )  
  53.0  
  ( 25.0 to 79.0 )  
Gender  
[units: participants]
     
Female     375     376     751  
Male     0     1     1  
Race/Ethnicity, Customized  
[units: participants]
     
American Indian or Alaska Native     1     0     1  
Asian     83     87     170  
Black or African American     11     11     22  
White     257     247     504  
Other     23     32     55  
Disease Sites  
[units: participants]
     
Ascites     14     14     28  
Bone     168     162     330  
Breast     61     63     124  
Chest Wall     53     53     106  
Effusion     57     55     112  
Lymph Node     250     249     499  
Other     20     18     38  
Peritoneum     7     14     21  
Pleura     29     35     64  
Skin/Soft Tissue     60     62     122  
Visceral, Liver     245     228     473  
Visceral, Lung     180     174     354  
Visceral, Other     34     28     62  
Disease Sites at Baseline  
[units: participants]
     
Liver ± Lung ± Skin/Soft Tissue ± Bone     245     228     473  
Lung ± Skin/Soft Tissue ± Bone     71     87     158  
Skin/Soft Tissue ± Bone     49     52     101  
Bone     0     3     3  
Other     6     5     11  
Karnofsky Performance Status [1]
[units: Units on a scale]
     
100     108     105     213  
90     145     132     277  
80     86     102     188  
70     33     34     67  
<70     0     1     1  
Not reported     3     3     6  
Menopausal Status  
[units: participants]
     
Premenopausal     54     51     105  
Perimenopausal     19     23     42  
Postmenopausal     288     289     577  
Not reported     14     14     28  
Number of Disease Sites  
[units: participants]
     
1 disease site     39     34     73  
2 disease sites     85     98     183  
3 disease sites     110     121     231  
4 disease sites     79     69     148  
≥5 disease sites     58     53     111  
Presence of All Lesions  
[units: participants]
     
Subjects with at least 1 lesion     371     375     746  
Subjects with no lesions     4     2     6  
Visceral Disease in Liver and/or Lung  
[units: participants]
     
Yes     316     315     631  
No     55     60     115  
Missing     4     2     6  
[1] Karnofsky Performance Scale Index measures a patient's functional impairment: 100-80=Able to carry on normal activity and work, no special care; 70-50=Unable to work; able to live at home and care for most personal needs with assistance; 40-0=Unable to care for self; institutional or hospital care needed. Score reported in multiples of 10.



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)   [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]

2.  Secondary:   Overall Response Rate (ORR) Per IRRC   [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]

3.  Secondary:   Duration of Response Per IRRC   [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]

4.  Secondary:   Time to Response Per IRRC   [ Time Frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: from date of randomization until death ]

6.  Secondary:   Treatment-related Safety Summary   [ Time Frame: safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible. ]

7.  Secondary:   Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)   [ Time Frame: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment. ]


  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:  
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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00080301     History of Changes
Other Study ID Numbers: CA163-046
Study First Received: March 26, 2004
Results First Received: May 1, 2009
Last Updated: August 4, 2010
Health Authority: United States: Food and Drug Administration