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Denosumab in Treating Patients With ER and/or PR Positive, HER2 Negative Metastatic Breast Cancer With Bone Metastases and Detectable Circulating Tumor Cells

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: NCT03070002
Recruitment Status : Terminated (Low accrual)
First Posted : March 3, 2017
Results First Posted : November 20, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborators:
Amgen
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Carcinoma Metastatic in the Bone
Circulating Tumor Cell Count
Estrogen Receptor Positive
HER2/Neu Negative
Progesterone Receptor Positive
Stage IV Breast Cancer
Interventions Biological: Denosumab
Other: Laboratory Biomarker Analysis
Enrollment 1
Recruitment Details The study opened for enrollment on March 23, 2017 with an accrual goal of 42 patients. The first patient started treatment on study October 19, 2017. The study closed permanently to enrollment on March 6 2018 with one patient enrolled, due to low accrual and before total accrual to the study could be met.
Pre-assignment Details  
Arm/Group Title Treatment (Denosumab)
Hide Arm/Group Description

Patients receive denosumab SC on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression, unexpected toxicity, or patient withdrawal or death.

Denosumab: Given SC

Laboratory Biomarker Analysis: Correlative studies

Period Title: 3 Cycles of Treatment
Started 1
Completed 1
Not Completed 0
Period Title: Follow up for 2 Years
Started [1] 1
Completed 0
Not Completed 1
Reason Not Completed
Death             1
[1]
Everyone that receives treatment on study goes into the follow up phase
Arm/Group Title Treatment (Denosumab)
Hide Arm/Group Description

Patients receive denosumab SC on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression, unexpected toxicity, or patient withdrawal or death.

Denosumab: Given SC

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
 100.0%
1.Primary Outcome
Title Fraction of Patients With Reduction in CTCs
Hide Description Assess the effect of denosumab in Her2/neu negative ER+ and/ or PR+ metastatic breast cancer patients who are in Partial Response (PR) or Stable Disease (SD) after starting systemic therapy with bone metastases and ≥ 5 CTCs by measuring the fraction of patients with reduction in CTCs.
Time Frame Up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected or analyzed for this outcome measure. The study was terminated early with only 1 patient enrolled.
Arm/Group Title Treatment (Denosumab)
Hide Arm/Group Description:

Patients receive denosumab SC on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression, unexpected toxicity, or patient withdrawal or death.

Denosumab: Given SC

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Percent Change in CTCs
Hide Description Evaluate the effect of denosumab on CTCs enumeration by assessing the percent change from baseline.
Time Frame Baseline up to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected or analyzed for this outcome measure. The study was terminated early with only 1 patient enrolled.
Arm/Group Title Treatment (Denosumab)
Hide Arm/Group Description:

Patients receive denosumab SC on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression, unexpected toxicity, or patient withdrawal or death.

Denosumab: Given SC

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Median Progression Free Survival
Hide Description Assess median progression free survival (m-PFS) using statistical analysis evaluating the relationship between longitudinal CTC counts and PFS. PRS will be measured from the time of treatment up until progressive disease.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected or analyzed for this outcome measure. The study was terminated early with only 1 patient enrolled.
Arm/Group Title Treatment (Denosumab)
Hide Arm/Group Description:

Patients receive denosumab SC on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression, unexpected toxicity, or patient withdrawal or death.

Denosumab: Given SC

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events were collected for 3 cycles of treatment and up to 30 days past the last treatment, where 1 cycle of treatment equals 28 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Denosumab)
Hide Arm/Group Description

Patients receive denosumab SC on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression, unexpected toxicity, or patient withdrawal or death.

Denosumab: Given SC

Laboratory Biomarker Analysis: Correlative studies

All-Cause Mortality
Treatment (Denosumab)
Affected / at Risk (%)
Total   1/1 (100.00%) 
Hide Serious Adverse Events
Treatment (Denosumab)
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Denosumab)
Affected / at Risk (%)
Total   1/1 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  1/1 (100.00%) 
Gastrointestinal disorders   
Nausea  1  1/1 (100.00%) 
Gastrointestinal pain  1  1/1 (100.00%) 
Abdominal pain  1  1/1 (100.00%) 
Investigations   
Alanine aminotransferase increased  1  1/1 (100.00%) 
Aspartate aminotransferase increased  1  1/1 (100.00%) 
Alkaline phosphatase increased  1  1/1 (100.00%) 
Metabolism and nutrition disorders   
Hypercalcemia  1  1/1 (100.00%) 
Hypokalemia  1  1/1 (100.00%) 
Hypoabuminemia  1  1/1 (100.00%) 
Musculoskeletal and connective tissue disorders   
Bone pain  1  1/1 (100.00%) 
Back pain  1  1/1 (100.00%) 
Nervous system disorders   
Dizziness  1  1/1 (100.00%) 
Respiratory, thoracic and mediastinal disorders   
Hoarsness  1  1/1 (100.00%) 
1
Term from vocabulary, CTCAE (4.03)
Indicates events were collected by systematic assessment
The study was terminated early with only 1 patient enrolled due to slow accrual.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: MASSIMO CRISTOFANILLI, MD
Organization: Northwestern University
Phone: 312-503-1114
EMail: massimo.cristofanilli@nm.org
Layout table for additonal information
Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT03070002    
Other Study ID Numbers: NU 16B09
STU00203216 ( CTRP (Clinical Trial Reporting Program) )
NU 16B09 ( Other Identifier: Northwestern University )
P30CA060553 ( U.S. NIH Grant/Contract )
NCI-2017-00015 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: February 27, 2017
First Posted: March 3, 2017
Results First Submitted: October 22, 2018
Results First Posted: November 20, 2018
Last Update Posted: November 20, 2018