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Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00785291
First received: November 4, 2008
Last updated: November 14, 2016
Last verified: November 2016
Results First Received: June 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Estrogen Receptor Negative
Estrogen Receptor Positive
HER2/Neu Negative
HER2/Neu Positive
Male Breast Carcinoma
Progesterone Receptor Negative
Progesterone Receptor Positive
Recurrent Breast Carcinoma
Stage IIIC Breast Cancer AJCC v6
Stage IV Breast Cancer
Interventions: Drug: Paclitaxel
Drug: Paclitaxel Albumin-Stabilized Nanoparticle Formulation
Drug: Ixabepilone
Biological: Bevacizumab
Other: Questionnaire Administration
Other: Laboratory Biomarker Analysis

  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
Between October 2008 - November 2011, a total of 799 participants were recruited.

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
Arm A (Paclitaxel) Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Arm B (Nab-paclitaxel) Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Arm C (Ixabepilone) Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)

Participant Flow:   Overall Study
    Arm A (Paclitaxel)   Arm B (Nab-paclitaxel)   Arm C (Ixabepilone)
STARTED   283   271   245 
COMPLETED   147   122   139 
NOT COMPLETED   136   149   106 
Never began treatment                8                4                4 
Adverse Event                39                70                56 
Death                7                4                3 
Withdrawal by Subject                35                36                17 
Alternative Therapy                12                6                7 
Complicating illness                6                4                4 
Other Medical Reasons                29                25                15 



  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.
All randomized participants are included in baseline characteristics.

Reporting Groups
  Description
Arm A (Paclitaxel) Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Arm B (Nab-paclitaxel) Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Arm C (Ixabepilone) Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Total Total of all reporting groups

Baseline Measures
   Arm A (Paclitaxel)   Arm B (Nab-paclitaxel)   Arm C (Ixabepilone)   Total 
Overall Participants Analyzed 
[Units: Participants]
 283   271   245   799 
Age, Customized 
[Units: Participants]
       
20-29   2   2   1   5 
30-39   15   18   17   50 
40-49   52   56   55   163 
50-59   109   89   86   284 
60-69   74   74   68   216 
70-79   24   28   15   67 
80+   7   4   3   14 
Gender 
[Units: Participants]
Count of Participants
       
Female      277  97.9%      268  98.9%      243  99.2%      788  98.6% 
Male      6   2.1%      3   1.1%      2   0.8%      11   1.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      19   6.7%      15   5.5%      13   5.3%      47   5.9% 
Not Hispanic or Latino      252  89.0%      239  88.2%      221  90.2%      712  89.1% 
Unknown or Not Reported      12   4.2%      17   6.3%      11   4.5%      40   5.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      2   0.7%      1   0.4%      2   0.8%      5   0.6% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      3   1.1%      0   0.0%      1   0.4%      4   0.5% 
Black or African American      42  14.8%      45  16.6%      26  10.6%      113  14.1% 
White      220  77.7%      214  79.0%      206  84.1%      640  80.1% 
More than one race      1   0.4%      1   0.4%      2   0.8%      4   0.5% 
Unknown or Not Reported      15   5.3%      10   3.7%      8   3.3%      33   4.1% 
Region of Enrollment 
[Units: Participants]
       
United States   283   271   245   799 
Prior Adjuvant Taxane 
[Units: Participants]
       
Yes   125   120   107   352 
No   158   151   138   447 
Hormone Receptor Status 
[Units: Participants]
       
ER/PgR Positive   201   195   178   574 
ER/PgR Negative   82   76   67   225 
Physician's Decision to use Bevacizumab 
[Units: Participants]
       
Bevacizumab planned   51   44   15   110 
Bevacizumab not planned   8   4   8   20 
Bevacizumab required   224   223   222   669 


  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: Time from randomization to progression or death due to any cause, whichever occurs first (up to 5 years) ]

2.  Secondary:   Objective Tumor Response Rate   [ Time Frame: Up to 5 years ]

3.  Secondary:   Time to Treatment Failure   [ Time Frame: Time from randomization until progression, death, or yearly termination of protocol therapy (up to 5 years) ]

4.  Secondary:   12 Month Progression Free Survival   [ Time Frame: 12 months ]

5.  Secondary:   Overall Survival   [ Time Frame: Time from randomization to death or last follow-up (up to 5 years) ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Hope Rugo, M.D.
Organization: UCSF Comprehensive Cancer Center
e-mail: hrugo@medicine.ucsf.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00785291     History of Changes
Other Study ID Numbers: NCI-2009-00476
NCI-2009-00476 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CTSU 40502
NCCTG N063H
CDR0000617539
CALGB 40502 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-40502 ( Other Identifier: CTEP )
U10CA031946 ( US NIH Grant/Contract Award Number )
U10CA180821 ( US NIH Grant/Contract Award Number )
Study First Received: November 4, 2008
Results First Received: June 5, 2015
Last Updated: November 14, 2016
Health Authority: United States: Food and Drug Administration