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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00080301
First Posted: March 30, 2004
Last Update Posted: March 10, 2016
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.
Information provided by:
R-Pharm
Results First Submitted: May 1, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
No text entered.

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.
No text entered.

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 
Overall Participants Analyzed 
[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 
[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.
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 


  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 by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00080301     History of Changes
Other Study ID Numbers: CA163-046
First Submitted: March 26, 2004
First Posted: March 30, 2004
Results First Submitted: May 1, 2009
Results First Posted: August 17, 2009
Last Update Posted: March 10, 2016