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Fresolimumab and Radiotherapy in Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT01401062
Recruitment Status : Active, not recruiting
First Posted : July 25, 2011
Results First Posted : April 6, 2017
Last Update Posted : March 16, 2018
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Fresolimumab
Radiation: Radiation Therapy

  Participant Flow

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
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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

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 ]
  Show Outcome Measure 1


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

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 )
First Submitted: July 20, 2011
First Posted: July 25, 2011
Results First Submitted: February 21, 2017
Results First Posted: April 6, 2017
Last Update Posted: March 16, 2018