Trial of Paclitaxel/Bevacizumab +/- Everolimus for Patients With HER2-Negative Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00915603
First received: June 4, 2009
Last updated: December 11, 2014
Last verified: December 2014
Results First Received: November 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Everolimus
Drug: Bevacizumab
Drug: Paclitaxel
Drug: Placebo

  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
Paclitaxel/Carboplatin/Placebo No text entered.
Paclitaxel/Carboplatin/Everolimus No text entered.

Participant Flow:   Overall Study
    Paclitaxel/Carboplatin/Placebo     Paclitaxel/Carboplatin/Everolimus  
STARTED     56 [1]   55 [1]
COMPLETED     0     0  
NOT COMPLETED     56     55  
[1] One patient enrolled/randomized but did not start 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.
Includes all enrolled and randomized patients

Reporting Groups
  Description
Paclitaxel/Carboplatin/Placebo No text entered.
Paclitaxel/Carboplatin/Everolimus No text entered.
Total Total of all reporting groups

Baseline Measures
    Paclitaxel/Carboplatin/Placebo     Paclitaxel/Carboplatin/Everolimus     Total  
Number of Participants  
[units: participants]
  57     56     113  
Age  
[units: Years]
Median ( Full Range )
  57  
  ( 25 to 79 )  
  61  
  ( 30 to 77 )  
  58  
  ( 25 to 79 )  
Gender  
[units: participants]
     
Female     57     56     113  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     57     56     113  



  Outcome Measures
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1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: every 8 weeks until progressive disease, expected average of 18 months ]

2.  Secondary:   Number of Patients With Treatment-related Adverse Events (AEs) as a Measure of Safety and Tolerability   [ Time Frame: every 4 weeks until intolerable toxicity occurs ]

3.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: every 8 weeks until treatment discontinuation, expected average of 18 months ]

4.  Secondary:   Duration of Response (DOR)   [ Time Frame: every 8 weeks until treatment discontinuation, expected average 6 months ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: every 8 weeks until treatment discontinuation, expected average 6 months ]


  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: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


No publications provided


Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00915603     History of Changes
Other Study ID Numbers: SCRI BRE 154
Study First Received: June 4, 2009
Results First Received: November 21, 2014
Last Updated: December 11, 2014
Health Authority: United States: Food and Drug Administration