Trial Outcomes & Findings for Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer (NCT NCT01545648)

Last Updated: 2020-01-02

Results Overview

Reduction of disseminated tumor cells (DTC)/ mililitre (ml) from \>10DTC/ml to ≤ 10DTC/ml. DTC measured by IE/FC in patients with early stage

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2020-01-02

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Patients will be treated with denosumab at a dose of 120 mg by subcutaneous injection monthly(-3/+3 days) for total of 6 months, then every 12 weeks (-7/+7 days) for 2 doses, for a total treatment course of one year.
Overall Study STARTED	4
Overall Study 6 Months of Treatment	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study to Evaluate the Impact of Denosumab on Disseminated Tumor Cells (DTC) in Patients With Early Stage Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=4 Participants Patients will be treated with denosumab at a dose of 120 mg by subcutaneous injection monthly(-3/+3 days) for total of 6 months, then every 12 weeks (-7/+7 days) for 2 doses, for a total treatment course of one year.
Age, Continuous	49 years STANDARD_DEVIATION 2.7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: Low accrual resulted in insufficient data to power statistical analyses for this outcome

Reduction of disseminated tumor cells (DTC)/ mililitre (ml) from \>10DTC/ml to ≤ 10DTC/ml. DTC measured by IE/FC in patients with early stage

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Up to 12 months

Population: Low accrual resulted in insufficient data to power statistical analyses for this outcome

Changes from baseline in disseminated tumor cell counts

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Population: Low accrual resulted in insufficient data to power statistical analyses for this outcome

Correlate breast cancer recurrence risk with individual values for DTC at each time point

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=4 participants at risk Patients will be treated with denosumab at a dose of 120 mg by subcutaneous injection monthly(-3/+3 days) for total of 6 months, then every 12 weeks (-7/+7 days) for 2 doses, for a total treatment course of one year.
Skin and subcutaneous tissue disorders cellulitis	25.0% 1/4

Other adverse events

Other adverse events
Measure	Treatment n=4 participants at risk Patients will be treated with denosumab at a dose of 120 mg by subcutaneous injection monthly(-3/+3 days) for total of 6 months, then every 12 weeks (-7/+7 days) for 2 doses, for a total treatment course of one year.
Psychiatric disorders anxiety	25.0% 1/4
Musculoskeletal and connective tissue disorders arthralgia	25.0% 1/4
Musculoskeletal and connective tissue disorders back pain	25.0% 1/4
Reproductive system and breast disorders breast pain	25.0% 1/4
Respiratory, thoracic and mediastinal disorders bronchitis	25.0% 1/4
Skin and subcutaneous tissue disorders cellulitis	25.0% 1/4
Investigations elevated LFTs	25.0% 1/4
General disorders fatigue	25.0% 1/4
Metabolism and nutrition disorders hypertriglyceridemia	25.0% 1/4
Vascular disorders lymphedema	25.0% 1/4
Reproductive system and breast disorders neuroma of breast	25.0% 1/4
Musculoskeletal and connective tissue disorders osteopenia	25.0% 1/4
Musculoskeletal and connective tissue disorders pain in extremity	25.0% 1/4
Nervous system disorders syncopy episode	25.0% 1/4
Reproductive system and breast disorders vaginal discharge	25.0% 1/4
Investigations weight gain	25.0% 1/4

Additional Information

Hope Rugo, MD

University of California, San Francisco

Phone: 877-827-3222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place