Trial Outcomes & Findings for Denosumab in Treating Patients With ER and/or PR Positive, HER2 Negative Metastatic Breast Cancer With Bone Metastases and Detectable Circulating Tumor Cells (NCT NCT03070002)

Last Updated: 2018-11-20

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Up to 3 months

Results posted on

2018-11-20

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Treatment (Denosumab) 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
3 Cycles of Treatment STARTED	1
3 Cycles of Treatment COMPLETED	1
3 Cycles of Treatment NOT COMPLETED	0
Follow up for 2 Years STARTED	1
Follow up for 2 Years COMPLETED	0
Follow up for 2 Years NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Denosumab) 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
Follow up for 2 Years Death	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Denosumab) n=1 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 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	0 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	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 months

Population: Data was not collected or analyzed for this outcome measure. The study was terminated early with only 1 patient enrolled.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to 3 months

Population: Data was not collected or analyzed for this outcome measure. The study was terminated early with only 1 patient enrolled.

Evaluate the effect of denosumab on CTCs enumeration by assessing the percent change from baseline.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Data was not collected or analyzed for this outcome measure. The study was terminated early with only 1 patient enrolled.

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.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Denosumab)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Denosumab) n=1 participants at risk 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
Metabolism and nutrition disorders Hypercalcemia	100.0% 1/1 • 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.
Metabolism and nutrition disorders Hypokalemia	100.0% 1/1 • 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.
Gastrointestinal disorders Nausea	100.0% 1/1 • 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.
Gastrointestinal disorders Gastrointestinal pain	100.0% 1/1 • 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.
Investigations Alanine aminotransferase increased	100.0% 1/1 • 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.
Investigations Aspartate aminotransferase increased	100.0% 1/1 • 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.
Blood and lymphatic system disorders Anemia	100.0% 1/1 • 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.
Musculoskeletal and connective tissue disorders Bone pain	100.0% 1/1 • 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.
Gastrointestinal disorders Abdominal pain	100.0% 1/1 • 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.
Respiratory, thoracic and mediastinal disorders Hoarsness	100.0% 1/1 • 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.
Metabolism and nutrition disorders Hypoabuminemia	100.0% 1/1 • 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.
Investigations Alkaline phosphatase increased	100.0% 1/1 • 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.
Nervous system disorders Dizziness	100.0% 1/1 • 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.
Musculoskeletal and connective tissue disorders Back pain	100.0% 1/1 • 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.

Additional Information

MASSIMO CRISTOFANILLI, MD

Northwestern University

Phone: 312-503-1114

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place