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Pilot Study of Docetaxel & Bevacizumab +/- Trastuzumab in First-Line Treatment of Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00364611
First received: August 14, 2006
Last updated: July 20, 2012
Last verified: April 2012
History of Changes
Results First Received: June 18, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Bevacizumab
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
103 participants signed the informed consent for this study. Of these, 73 were determined to be eligible for inclusion. One participant did not receive any study treatment.

Reporting Groups
  Description
Docetaxel and Bevacizumab Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
Docetaxel, Bevacizumab and Trastuzumab Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met

Participant Flow:   Overall Study
    Docetaxel and Bevacizumab     Docetaxel, Bevacizumab and Trastuzumab  
STARTED     52     21  
TREATED (SAFTEY POPULATION)     52 [1]   20 [1]
COMPLETED     1 [2]   0  
NOT COMPLETED     51     21  
Did not receive study medication                 0                 1  
Adverse Event                 7                 4  
Participant's Request                 3                 4  
Disease Progression                 38                 8  
Investigator decision                 2                 2  
Found Ineligible                 1                 0  
Presumed CR on Study                 0                 1  
Receiving Liver Ablation                 0                 1  
[1] Received at least one dose of study medication
[2] Ongoing treatment (June 2011-initial analysis). Continued treatment till March 2012 (study closed).



  Baseline Characteristics
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Reporting Groups
  Description
Docetaxel and Bevacizumab Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
Docetaxel, Bevacizumab and Trastuzumab Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
Total Total of all reporting groups

Baseline Measures
    Docetaxel and Bevacizumab     Docetaxel, Bevacizumab and Trastuzumab     Total  
Number of Participants  
[units: participants]
 		  52     21     73  
Age  
[units: years]
Mean ± Standard Deviation 		  56.2  ± 10.78     52.8  ± 12.65     55.2  ± 11.37  
Age, Customized  
[units: participants]
 		     
<=65 years     41     17     58  
Between 65 and 75 years     8     3     11  
>=75 years     3     1     4  
Gender  
[units: participants]
 		     
Female     52     21     73  
Male     0     0     0  
Eastern Cooperative Oncology [1]
[units: participants]
 		     
ECOG Performance Score is 0     28     16     44  
ECOG Performance Score is 1     24     5     29  
[1] The ECOG performance status score is used to assess how a patient's disease is progressing and to assess how the disease affects the patient's daily living abilities. The ECOG score ranges from 0-5, with 0 indicating the best outcome and a score of 5 indicating the worst outcome. An ECOG score "0" reflects a fully active patient, able to carry on all pre-disease performance without restriction. An ECOG score "1" reflects a participant restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS) Rate: Percentage of Participants With PFS   [ Time Frame: Up to 6 months and 12 months after treatment initiation ]
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2.  Primary:   Time to Progression-free Survival (PFS)   [ Time Frame: From treatment initiation to PFS event (up to June 2011) ]
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3.  Secondary:   Confirmed Overall Response (OR) Based on RECIST Criteria   [ Time Frame: From treatment initiation to June 2011 ]
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4.  Secondary:   Number of Participants With Confirmed Clinical Benefit Based on RECIST Criteria   [ Time Frame: From treatment initiation to June 2011 ]
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5.  Secondary:   Duration of Response (DR)   [ Time Frame: From treatment initiation to June 2011 ]
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6.  Secondary:   Overall Survival (OS) Time   [ Time Frame: From treatment initiation to June 2011 ]
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7.  Secondary:   Number of Participants With Adverse Events (AE)   [ Time Frame: From treatment initiation to 30 days after the last dose of study treatment ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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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.


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: Trial Transparency Team
Organization: Sanofi-aventis
e-mail: Contact-us@sanofi.com


No publications provided


Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00364611     History of Changes
Other Study ID Numbers: DOCET_L_00712
Study First Received: August 14, 2006
Results First Received: June 18, 2012
Last Updated: July 20, 2012
Health Authority: United States: Food and Drug Administration