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Fresolimumab and Radiotherapy in Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01401062
First received: July 20, 2011
Last updated: February 21, 2017
Last verified: February 2017
History of Changes
Results First Received: February 21, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Fresolimumab
Radiation: Radiation Therapy

  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
Arm 1 (Fresolimumab 1 mg/kg)

Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).

Fresolimumab

Radiation Therapy
Arm 2 (Fresolimumab 10 mg/kg)

Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).

Fresolimumab

Radiation Therapy

Participant Flow:   Overall Study
    Arm 1 (Fresolimumab 1 mg/kg)   Arm 2 (Fresolimumab 10 mg/kg)
STARTED   11   12 
COMPLETED   0   4 [1] 
NOT COMPLETED   11   8 
Death                9                7 
Physician Decision                1                0 
Withdrawal by Subject                1                1 
[1] At time of data entry, these 4 patients are still undergoing follow-up



  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.
No text entered.

Reporting Groups
  Description
Arm 1 (Fresolimumab 1 mg/kg)

Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).

Fresolimumab

Radiation Therapy
Arm 2 (Fresolimumab 10 mg/kg)

Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).

Fresolimumab

Radiation Therapy
Total Total of all reporting groups

Baseline Measures
   Arm 1 (Fresolimumab 1 mg/kg)   Arm 2 (Fresolimumab 10 mg/kg)   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 11   12   23 
Age 
[Units: Participants]
Count of Participants 		     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      9  81.8%      7  58.3%      16  69.6% 
>=65 years      2  18.2%      5  41.7%      7  30.4% 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      11 100.0%      12 100.0%      23 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
 		     
Asian or Pacific Islander   1   3   4 
Black, not of Hispanic-American Origin   3   0   3 
White, not of Hispanic-American origin   6   8   14 
Other/Unknown   1   1   2 


  Outcome Measures

1.  Primary:   Abscopal Response Rate   [ Time Frame: up to 20 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  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 NOT 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.


Results Point of Contact:  
Name/Title: Nelly Huppert
Organization: NYU Langone Medical Center
phone: 212-731-5003
e-mail: Nelly.Huppert@nyumc.org


Publications:

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


Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01401062     History of Changes
Other Study ID Numbers: S11-00533
BC100481 ( Other Grant/Funding Number: DOD )
Study First Received: July 20, 2011
Results First Received: February 21, 2017
Last Updated: February 21, 2017