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Fresolimumab and Radiotherapy in Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT01401062
Recruitment Status : Completed
First Posted : July 25, 2011
Results First Posted : April 6, 2017
Last Update Posted : March 5, 2019
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
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 (Fresolimumab 1 mg/kg) Arm 2 (Fresolimumab 10 mg/kg)
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 11 12
Completed 0 4 [1]
Not Completed 11 8
Reason Not Completed
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
Arm/Group Title Arm 1 (Fresolimumab 1 mg/kg) Arm 2 (Fresolimumab 10 mg/kg) Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 11 12 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 participants
Female
11
 100.0%
12
 100.0%
23
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants 12 participants 23 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
1.Primary Outcome
Title Abscopal Response Rate
Hide Description Defined as the percentage of patients who have responses (complete or partial) outside the irradiated lesions. The abscopal response is assessed at 15 weeks, and confirmed minimum 4 weeks later. The abscopal response is evaluated based on immune-related response criteria (irRC) (Wolchok et al, 2009).
Time Frame up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 (Fresolimumab 1 mg/kg) Arm 2 (Fresolimumab 10 mg/kg)
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 11 12
Measure Type: Count of Participants
Unit of Measure: Participants
11
 100.0%
12
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 (Fresolimumab 1 mg/kg) Arm 2 (Fresolimumab 10 mg/kg)
Hide Arm/Group Description

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

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

All-Cause Mortality
Arm 1 (Fresolimumab 1 mg/kg) Arm 2 (Fresolimumab 10 mg/kg)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 (Fresolimumab 1 mg/kg) Arm 2 (Fresolimumab 10 mg/kg)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/11 (27.27%)   3/12 (25.00%) 
Cardiac disorders     
atrial fibrillation  2/11 (18.18%)  0/12 (0.00%) 
Endocrine disorders     
Hypercalcemia  1/11 (9.09%)  1/12 (8.33%) 
Immune system disorders     
Dyspnea  0/11 (0.00%)  1/12 (8.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Disease progression  2/11 (18.18%)  2/12 (16.67%) 
Nervous system disorders     
Cord compression  1/11 (9.09%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion  0/11 (0.00%)  1/12 (8.33%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 (Fresolimumab 1 mg/kg) Arm 2 (Fresolimumab 10 mg/kg)
Affected / at Risk (%) Affected / at Risk (%)
Total   9/11 (81.82%)   8/12 (66.67%) 
Blood and lymphatic system disorders     
Thrombocytopenia  2/11 (18.18%)  0/12 (0.00%) 
Anemia  1/11 (9.09%)  1/12 (8.33%) 
Neutropenia  0/11 (0.00%)  1/12 (8.33%) 
Gastrointestinal disorders     
Abdominal Pain- Severe  1/11 (9.09%)  0/12 (0.00%) 
Nausea  1/11 (9.09%)  0/12 (0.00%) 
General disorders     
Fatigue  3/11 (27.27%)  2/12 (16.67%) 
Investigations     
Aspartate Aminotransferase Increased  3/11 (27.27%)  0/12 (0.00%) 
Alkaline Phosphate Increased  2/11 (18.18%)  0/12 (0.00%) 
alanine aminotransferase  1/11 (9.09%)  0/12 (0.00%) 
INR  1/11 (9.09%)  0/12 (0.00%) 
Elevated Bilirubin  1/11 (9.09%)  0/12 (0.00%) 
Elevated Amylase  1/11 (9.09%)  0/12 (0.00%) 
Elevated Lipase  1/11 (9.09%)  0/12 (0.00%) 
Oliguria  1/11 (9.09%)  0/12 (0.00%) 
PTT  0/11 (0.00%)  1/12 (8.33%) 
Elevated AST  0/11 (0.00%)  1/12 (8.33%) 
Metabolism and nutrition disorders     
hypercalcemia  1/11 (9.09%)  1/12 (8.33%) 
Hypercalcemia  1/11 (9.09%)  0/12 (0.00%) 
Dehydration  1/11 (9.09%)  0/12 (0.00%) 
Hyperglycemia  1/11 (9.09%)  0/12 (0.00%) 
Hypoalbuminemia  1/11 (9.09%)  0/12 (0.00%) 
Hypocalcemia  1/11 (9.09%)  1/12 (8.33%) 
Hypokalemia  1/11 (9.09%)  0/12 (0.00%) 
Anorexia  0/11 (0.00%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders     
Bilaterial Effusion  1/11 (9.09%)  0/12 (0.00%) 
Lower Sacral Pain  1/11 (9.09%)  0/12 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Disease Progression  2/11 (18.18%)  2/12 (16.67%) 
Nervous system disorders     
Cord compression  1/11 (9.09%)  0/12 (0.00%) 
Neuropathy  1/11 (9.09%)  0/12 (0.00%) 
Neuropathy- Lower Extremities  1/11 (9.09%)  0/12 (0.00%) 
Hepatic Encephalopathy  1/11 (9.09%)  0/12 (0.00%) 
Reproductive system and breast disorders     
Pain (under R breast)  1/11 (9.09%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  0/11 (0.00%)  1/12 (8.33%) 
Pleural Effusion  0/11 (0.00%)  1/12 (8.33%) 
Pneumonia  0/11 (0.00%)  1/12 (8.33%) 
Skin and subcutaneous tissue disorders     
Spinal Edema  1/11 (9.09%)  0/12 (0.00%) 
Cellulitis  1/11 (9.09%)  0/12 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Nelly Huppert
Organization: NYU Langone Medical Center
Phone: 212-731-5003
EMail: Nelly.Huppert@nyumc.org
Layout table for additonal information
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 5, 2019