Trial Outcomes & Findings for Denosumab for Breast Cancer With Bone Mets (NCT NCT01952054)
NCT ID: NCT01952054
Last Updated: 2019-11-22
Results Overview
The difference in number of CTCs in 7.5 ml whole blood from baseline to week4. CTC reduction from baseline to week4 is statistically analyzed using the two-sided paired t-test with the significance level of 0.05.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Baseline, week 4
Results posted on
2019-11-22
Participant Flow
Recruitment Period: May 8, 2015 to Apr 4, 2017. All recruitment performed at The University of Texas MD Anderson Cancer Center.
One participant was ineligible due to screen failure
Participant milestones
| Measure |
Denosumab
Subcutaneous administration of Denosumab 120 mg every 4 weeks (+/- 5days). Starting week 5, also receive a hormonal agent chosen by physician.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Denosumab
Subcutaneous administration of Denosumab 120 mg every 4 weeks (+/- 5days). Starting week 5, also receive a hormonal agent chosen by physician.
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Denosumab for Breast Cancer With Bone Mets
Baseline characteristics by cohort
| Measure |
Denosumab
n=6 Participants
Subcutaneous administration of Denosumab 120 mg every 4 weeks (+/- 5days). Starting week 5, also receive a hormonal agent chosen by physician.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, week 4Population: The primary objective could not be met due to technical issues.
The difference in number of CTCs in 7.5 ml whole blood from baseline to week4. CTC reduction from baseline to week4 is statistically analyzed using the two-sided paired t-test with the significance level of 0.05.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, week 4The change in Her2, Muc-1, GA733-2 (EpCAM), Twist, Akt, PI3K and ALDH-1 in CTCs after 1 st cycle of treatment with denosumab.
Outcome measures
| Measure |
Denosumab
n=6 Participants
Subcutaneous administration of Denosumab 120 mg every 4 weeks (+/- 5days). Starting week 5, also receive a hormonal agent chosen by physician.
|
|---|---|
|
The Changes of Epithelial-mesenchymal Transition (EMT) in CTCs
HER 2
|
.003 ng/uL
Standard Deviation .032
|
|
The Changes of Epithelial-mesenchymal Transition (EMT) in CTCs
Muc-1
|
.065 ng/uL
Standard Deviation .062
|
|
The Changes of Epithelial-mesenchymal Transition (EMT) in CTCs
GA733-2 (EpCAM)
|
-.372 ng/uL
Standard Deviation .750
|
|
The Changes of Epithelial-mesenchymal Transition (EMT) in CTCs
Twist
|
.018 ng/uL
Standard Deviation .045
|
|
The Changes of Epithelial-mesenchymal Transition (EMT) in CTCs
Akt
|
.028 ng/uL
Standard Deviation .077
|
|
The Changes of Epithelial-mesenchymal Transition (EMT) in CTCs
ALDH-1
|
.328 ng/uL
Standard Deviation .808
|
SECONDARY outcome
Timeframe: Baseline up to week 13The collection urine is performed at baseline, at week4 and the end of 3rd cycle (week13) to evaluate the level of N-telopeptide.
Outcome measures
| Measure |
Denosumab
n=6 Participants
Subcutaneous administration of Denosumab 120 mg every 4 weeks (+/- 5days). Starting week 5, also receive a hormonal agent chosen by physician.
|
|---|---|
|
The Changes in Urine N-telopeptide Level
Baseline
|
59.0 nmol/mmol
Standard Deviation 59.0
|
|
The Changes in Urine N-telopeptide Level
Week 4
|
19.3 nmol/mmol
Standard Deviation 7.7
|
|
The Changes in Urine N-telopeptide Level
Week 13
|
21 nmol/mmol
Standard Deviation 9.5
|
Adverse Events
Denosumab
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Denosumab
n=6 participants at risk
Subcutaneous administration of Denosumab 120 mg every 4 weeks (+/- 5days). Starting week 5, also receive a hormonal agent chosen by physician.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
66.7%
4/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
2/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
2/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
General disorders
Fatigue
|
33.3%
2/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Reproductive system and breast disorders
Breast pain
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Psychiatric disorders
Agitation
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Infections and infestations
Bladder infection
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Eye disorders
Eye disorders-other specify-red/burning, tearing eyes
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Eye disorders
Eyelid function disorder
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
General disorders
Fever
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
General disorders
Chills
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Vascular disorders
Hot Flashes
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Gastrointestinal disorders
Oral pain
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Musculoskeletal and connective tissue disorders
Hip pain
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Nervous system disorders
Paresthesia
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Gastrointestinal disorders
Toothache
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Renal and urinary disorders
Urinary urgency
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Through study completion 13 weeks
A serious adverse event is any adverse drug experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity and a congenital anomaly/birth detect. One participant was ineligible due to screen failure.
|
Additional Information
Ueno,Naoto,M.D., PH.D. / Breast Medical Oncology
UT MD Anderson Cancer Center
Phone: 713-792-2817
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place