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: June 5, 2015
Last verified: March 2015
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  
Number of Participants  
[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]
       
Female     277     268     243     788  
Male     6     3     2     11  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     19     15     13     47  
Not Hispanic or Latino     252     239     221     712  
Unknown or Not Reported     12     17     11     40  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     2     1     2     5  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     3     0     1     4  
Black or African American     42     45     26     113  
White     220     214     206     640  
More than one race     1     1     2     4  
Unknown or Not Reported     15     10     8     33  
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
No text entered.


  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


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00785291     History of Changes
Other Study ID Numbers: NCI-2009-00476, NCI-2009-00476, CTSU 40502, NCCTG N063H, CDR0000617539, CALGB 40502, CALGB-40502, U10CA031946, U10CA180821
Study First Received: November 4, 2008
Results First Received: June 5, 2015
Last Updated: June 5, 2015
Health Authority: United States: Food and Drug Administration