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1st or 2nd Line MBC (Metastatic Breast Cancer) With Previous Avastin (Bevacizumab) Therapy

This study has been completed.
Sponsor:
Collaborator:
Onyx Pharmaceuticals
Information provided by (Responsible Party):
Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier:
NCT00493636
First received: June 26, 2007
Last updated: May 15, 2014
Last verified: May 2014
Results First Received: April 17, 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: Breast Cancer
Interventions: Drug: Gemcitabine
Drug: Sorafenib
Drug: Placebo
Drug: Capecitabine

  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
The period of study was 28 Jun 2007 (first subject randomized) to 29 Feb 2012 (overall survival data cutoff date). There were 40 centers in the United States that participated in this trial.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
181 patients were assessed for eligiblity. Of these, 21 patients were excluded from the trial due to not meeting the eligibility criteria, leaving 160 patients who were randomized.

Reporting Groups
  Description
A (Sorafenib + Gemcitabine or Capecitabine)

Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)

Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle

Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)

Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).

B (Placebo + Gemcitabine or Capecitabine)

Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)

Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle

Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)

Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).


Participant Flow:   Overall Study
    A (Sorafenib + Gemcitabine or Capecitabine)     B (Placebo + Gemcitabine or Capecitabine)  
STARTED     81     79  
COMPLETED     79     77  
NOT COMPLETED     2     2  
Withdrawal by Subject                 1                 0  
Disease progression/recurrence/relapse                 0                 1  
Mis-randomization                 1                 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.
All randomized patients are included (i.e., the intent-to-treat population)

Reporting Groups
  Description
A (Sorafenib + Gemcitabine or Capecitabine)

Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)

Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle

Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)

Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).

B (Placebo + Gemcitabine or Capecitabine)

Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)

Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle

Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)

Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).

Total Total of all reporting groups

Baseline Measures
    A (Sorafenib + Gemcitabine or Capecitabine)     B (Placebo + Gemcitabine or Capecitabine)     Total  
Number of Participants  
[units: participants]
  81     79     160  
Age  
[units: years]
Mean ± Standard Deviation
  53.5  ± 10.6     54.2  ± 11.0     53.8  ± 10.8  
Gender  
[units: participants]
     
Female     81     79     160  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     81     79     160  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival   [ Time Frame: From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months. ]

2.  Secondary:   Overall Survival   [ Time Frame: From the date of randomization to date of death due to any cause, assessed up to 56 months. ]

3.  Secondary:   Time to Progression   [ Time Frame: Calculated as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier), assessed up to 39 months. ]

4.  Secondary:   Overall Response Rate   [ Time Frame: The overall tumor burden at baseline will be compared with subsequent measurements up to the date of first documented disease progression or the date of death due to any cause, if before progression, assessed up to 39 months. ]

5.  Secondary:   Duration of Overall Response   [ Time Frame: Period measured from the first documentation of complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease or death is objectively documented. ]


  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: Study Chair
Organization: ACORN Research, LLC
phone: 901-435-5570
e-mail: lschwartzberg@acornresearch.net


No publications provided by Accelerated Community Oncology Research Network

Publications automatically indexed to this study:

Responsible Party: Accelerated Community Oncology Research Network
ClinicalTrials.gov Identifier: NCT00493636     History of Changes
Other Study ID Numbers: ACORN AC01B07
Study First Received: June 26, 2007
Results First Received: April 17, 2014
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration