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Trial record 6 of 15 for:    TNFRSF10B

Abraxane With or Without Tigatuzumab in Patients With Metastatic, Triple Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01307891
Recruitment Status : Completed
First Posted : March 3, 2011
Results First Posted : September 13, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
Susan G. Komen Breast Cancer Foundation
Daiichi Sankyo UK Ltd.
Triple Negative Breast Cancer Foundation
Information provided by (Responsible Party):
Andres Forero, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer
Triple Negative Breast Cancer
Stage IV Breast Cancer
Metastatic Breast Cancer
Interventions Drug: Abraxane alone
Drug: Abraxane + Tigatuzumab
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Abraxane + Tigatuzumab Abraxane Alone
Hide Arm/Group Description Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study. Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
Period Title: Overall Study
Started 42 22
Completed 39 21
Not Completed 3 1
Reason Not Completed
Progressive Disease             3             1
Arm/Group Title Abraxane + Tigatuzumab Abraxane Alone Total
Hide Arm/Group Description Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study. Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks). Total of all reporting groups
Overall Number of Baseline Participants 42 22 64
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 22 participants 64 participants
<=18 years 0 0 0
Between 18 and 65 years 35 18 53
>=65 years 7 4 11
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 22 participants 64 participants
Female 42 22 64
Male 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 22 participants 64 participants
American Indian or Alaska Native 1 0 1
Asian 0 0 0
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 14 6 20
White 26 16 42
More than one race 0 0 0
Unknown or Not Reported 1 0 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants 22 participants 64 participants
42 22 64
1.Primary Outcome
Title Objective Response Rate
Hide Description Patient response rates will be measured by the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI. Responses include the following: Complete Response (CR) disappearance of all target lesions; Partial Response (PR) at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) best response from the start of treatment until disease progression.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Abraxane + Tigatuzumab Abraxane Alone
Hide Arm/Group Description:
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
Overall Number of Participants Analyzed 39 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
28
(14.9 to 45.0)
38
(18 to 61.1)
2.Secondary Outcome
Title Number of Participants With Serious Adverse Events
Hide Description Patients will be assessed throughout the study for Grade 4 or 5 toxicities utilizing the Common Toxicity Criteria for Adverse Events (CTCAE) v4.0.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Abraxane + Tigatuzumab Abraxane Alone
Hide Arm/Group Description:
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
Overall Number of Participants Analyzed 39 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Progression-free Survival
Hide Description Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Time Frame Baseline through 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Abraxane + Tigatuzumab Abraxane Alone
Hide Arm/Group Description:
Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients with disease progression will be taken off the study.
Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
Overall Number of Participants Analyzed 39 21
Median (95% Confidence Interval)
Unit of Measure: months
2.8
(1.9 to 3.6)
3.8
(2.8 to 19.7)
Time Frame Baseline to 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Abraxane + Tigatuzumab Abraxane Alone
Hide Arm/Group Description Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8, and 15 at 28-day intervals and tigatuzumab to be administered as a 10 mg/kg loading dose followed by 5 mg/kg for the first cycle and then every other week on Days 1 and 15 for subsequent cycles. Patients will be evaluated for response every 8 weeks. Patients will receive Abraxane at 100 mg/m2 weekly X 3 doses on Days 1, 8, and 15 at 28-day intervals. Patients will have the option to crossover to the combination arm based upon the pre-clinical data. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
All-Cause Mortality
Abraxane + Tigatuzumab Abraxane Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/39 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Abraxane + Tigatuzumab Abraxane Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/39 (7.69%)      3/21 (14.29%)    
Blood and lymphatic system disorders     
Neutropenia   1/39 (2.56%)  1 1/21 (4.76%)  1
Bilateral Pulmonary Thromboembolism   0/39 (0.00%)  0 1/21 (4.76%)  1
Infections and infestations     
Fever   1/39 (2.56%)  39 1/21 (4.76%)  21
Empyema associated with a permanent thoracic catheter   1/39 (2.56%)  1 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Abraxane + Tigatuzumab Abraxane Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/39 (100.00%)      21/21 (100.00%)    
Blood and lymphatic system disorders     
Anemia   16/39 (41.03%)  16 9/21 (42.86%)  9
Thrombocytopenia   3/39 (7.69%)  3 3/21 (14.29%)  3
Gastrointestinal disorders     
Nausea   9/39 (23.08%)  9 5/21 (23.81%)  5
Anorexia   2/39 (5.13%)  2 4/21 (19.05%)  4
Diarrhea   4/39 (10.26%)  4 2/21 (9.52%)  2
Vomiting   4/39 (10.26%)  4 2/21 (9.52%)  2
General disorders     
Fatigue   22/39 (56.41%)  22 11/21 (52.38%)  11
Alopecia   19/39 (48.72%)  19 11/21 (52.38%)  11
Nervous system disorders     
Pheripheral Sensory Neuropathy   17/39 (43.59%)  17 10/21 (47.62%)  10
Indicates events were collected by systematic assessment
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: Andres Forero, M.D.
Organization: University of Alabama at Birmingham
Phone: 205-934-7167
EMail: aforero@uab.edu
Layout table for additonal information
Responsible Party: Andres Forero, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01307891     History of Changes
Other Study ID Numbers: F101004001 (UAB1028)
TBCRC 019 ( Other Identifier: The Translational Breast Cancer Research Consortium )
First Submitted: March 1, 2011
First Posted: March 3, 2011
Results First Submitted: May 24, 2017
Results First Posted: September 13, 2017
Last Update Posted: October 26, 2017