A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00490646
First received: June 21, 2007
Last updated: June 14, 2012
Last verified: June 2012
Results First Received: June 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: ixabepilone
Drug: docetaxel
Drug: trastuzumab

  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
No text entered.

Reporting Groups
  Description
Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV     Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV  
STARTED     25     25  
Treated     24     24  
COMPLETED     23 [1]   23 [2]
NOT COMPLETED     2     2  
Still on trastuzumab monotherapy                 1                 1  
Never Treated (had an adverse event)                 1                 0  
Never Treated (withdrew consent)                 0                 1  
[1] Completed=Off-treatment (Major reasons: Disease progression=14; study drug toxicity=4)
[2] Completed=Off-treatment (Major reasons: Disease progression=13; study drug toxicity=1)



  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
Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
    Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV     Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV     Total  
Number of Participants  
[units: participants]
  25     25     50  
Age  
[units: years]
Median ( Full Range )
  52.0  
  ( 29.0 to 71.0 )  
  53.0  
  ( 37.0 to 82.0 )  
  52.5  
  ( 29.0 to 82.0 )  
Age, Customized  
[units: participants]
     
< 65 years     19     21     40  
>=65 years     6     4     10  
Gender, Customized  
[units: participants]
     
Female     25     25     50  
Race/Ethnicity, Customized  
[units: participants]
     
White     25     25     50  
Karnofsky Performance Status [1]
[units: participants]
     
100     15     15     30  
90     5     9     14  
80     4     0     4  
70     1     0     1  
Not Reported     0     1     1  
Menopausal Status  
[units: participants]
     
Pre-menopausal     8     6     14  
Peri-menopausal     1     2     3  
Post-menopausal     14     15     29  
Not Reported     2     2     4  
Number of participants who received prior chemotherapy in neoadjuvant/adjuvant setting  
[units: participants]
  8     8     16  
[1]

Karnofsky Performance Status classifies participants according to their functional impairment. Scores range from 0-100 units on a scale; lower the score, the worse the survival for most serious illnesses.

100: Normal, no complaints. 90: Able to carry on normal activities; minor signs or symptoms of disease. 80: Normal activity with effort. 70: Cares for self. Unable to carry on normal activity or to do active work. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Scores were converted to Karnofsky Performance Status Scores.




  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Objective Response (OR; Assessed by Response Evaluation Criteria in Solid Tumors [RECIST] Version 1.1)   [ Time Frame: Assessed every 6 weeks from initiation of study therapy up to 12 months; then every 3 months until disease progression (maximum time that any participant was on therapy was 108 weeks) ]

2.  Primary:   Number of Participants With Best Overall Response (BOR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1   [ Time Frame: Assessed every 6 weeks from initiation of study therapy up to 12 months; then every 3 months until disease progression (maximum time that any participant was on therapy was 108 weeks). ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: From randomization until the first date of documented progressive disease (PD) or death from any cause without prior documentation of progression (maximum participant PFS of 39.7 months). ]

4.  Secondary:   Time to Response   [ Time Frame: From randomization every 6 weeks for first 12 months and thereafter every 3 months until CR or PR whichever was recorded first (maximum participant time to response of 18.4 weeks.) ]

5.  Secondary:   Duration of Response   [ Time Frame: From the date of first PR or CR assessment to the date of documented progressive disease or death without prior documentation of progression (maximum participant duration of response of 38 months.) ]

6.  Secondary:   Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Adverse Events (AEs), and AEs Leading to Discontinuation of Study Therapy Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0   [ Time Frame: Assessed from the date of first dose until at least 30 days after the last dose of study drug (maximum time that any participant was on therapy was 108 weeks.) ]

7.  Secondary:   Number of Participants With Hematology Abnormalities by Worst Grade Per National Cancer Institute Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0   [ Time Frame: Prior to every cycle of therapy (i.e. before starting of every 21 day or 3 week cycle; maximum time that any participant was on therapy was 108 weeks.) ]

8.  Secondary:   Number of Participants With Serum Chemistry Abnormalities by Worst Grade Per National Cancer Institure Common Terminology Criteria Adverse Events (NCI CTCAE), Version 3.0   [ Time Frame: Prior to every cycle of therapy (i.e. before starting of every 21 day or 3 week cycle; maximum time that any participant was on therapy was 108 weeks.) ]


  Serious Adverse Events


  Other Adverse Events


  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.


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: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


No publications provided


Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00490646     History of Changes
Other Study ID Numbers: CA163-140, Eudract No: 2007-000721-21
Study First Received: June 21, 2007
Results First Received: June 14, 2012
Last Updated: June 14, 2012
Health Authority: Italy: Ministry of Health