Effect of Denosumab on Cellular Biomarkers in the Human B... | NCT02099461

Effect of Denosumab on Cellular Biomarkers in the Human B... | NCT02099461 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No treatment	Other	Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.	Procedure: Percutaneous core needle breast biopsy
Denosumab 60 mg	Experimental	Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 (prior to study treatment) and Day 28.	Drug: Denosumab Procedure: Percutaneous core needle breast biopsy
Denosumab 120 mg	Experimental	Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 (prior to study treatment) and Day 28.	Drug: Denosumab Procedure: Percutaneous core needle breast biopsy

Name	Type	Description	Arm Group Labels	Other Names
Denosumab	Drug	Single sucutaneous dose	Denosumab 120 mg Denosumab 60 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Log Ratio of Post-baseline to Baseline Ki-67 Index in Mammary Epithelial Cells	Ki-67 is a marker for cell proliferation. Participants underwent percutaneous core needle breast biopsies on Day 1 (Baseline, prior to treatment) and Day 28. Levels of Ki67 were measured using immunohistochemical staining and digital imaging. The proliferation index was calculated as the percentage of Ki-67 positive terminal ductal lobular unit (TDLU) and duct epithelial cells. The higher the percentage, the higher the rate of epithelial cell proliferation.	Baseline and Day 28

Contacts/Locations Module

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Cypress	California	90630	United States
Research Site

Label	URL
AmgenTrials clinical trials website	View source

Arm/Group Information

ID	Title	Description
FG000	No Treatment	Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
FG001	Denosumab 60 mg	Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
FG002	Denosumab 120 mg	Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00027 subjects FG00127 subjects FG00228 subjects
COMPLETED		FG00027 subjects FG00127 subjects FG00228 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	No Treatment	Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
BG001	Denosumab 60 mg	Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Log Ratio of Post-baseline to Baseline Ki-67 Index in Mammary Epithelial Cells

Ki-67 is a marker for cell proliferation. Participants underwent percutaneous core needle breast biopsies on Day 1 (Baseline, prior to treatment) and Day 28. Levels of Ki67 were measured using immunohistochemical staining and digital imaging. The proliferation index was calculated as the percentage of Ki-67 positive terminal ductal lobular unit (TDLU) and duct epithelial cells. The higher the percentage, the higher the rate of epithelial cell proliferation.

Pharmacodynamic analysis set with non-missing data

Posted

Mean

Standard Deviation

log ratio

Baseline and Day 28

ID	Title	Description
OG000	No Treatment	Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment A No Treatment	Participants in this group received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Injection site erythema	General disorders	MedDRA 17.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Study Director	Amgen Inc.	866-572-6436

Intervention Browse Module

ID	Term
D000069448	Denosumab

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG0000 BG0010 BG0021 BG0031

Black (or African American)

Title	Measurements
	BG0004 BG0018 BG00210 BG003

Multiple

Title	Measurements
	BG0001 BG0010 BG0020 BG003

Native Hawaiian or Other Pacific Islander

Title	Measurements
	BG0001 BG0010 BG0021 BG003

Whte

Title	Measurements
	BG00021 BG00119 BG00216 BG003

Group IDs	Group Description	Statistical Method	P-Value	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000	An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.	ANCOVA	0.2966	LS Mean	0.15	2-Sided	95	-0.136	0.441		No	Superiority or Other
OG001	An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.	ANCOVA	0.2769	LS Mean	-0.16	2-Sided	95	-0.447	0.130		No	Superiority or Other
OG002	An ANCOVA analysis was performed on the log ratio of post-baseline to baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.	ANCOVA	0.5238	LS Mean	-0.09	2-Sided	95	-0.373	0.191		No	Superiority or Other
OG000 OG001	An ANCOVA analysis was performed on the log ratio of post-baseline to Baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.	ANCOVA	0.1343	LS Mean Difference	-0.31	2-Sided	95	-0.720	0.098	Denosumab 60 mg - Placebo	No	Superiority or Other
OG000 OG002	An ANCOVA analysis was performed on the log ratio of post-baseline to Baseline Ki-67 index. Independent variables included treatment, stratification factor, and log transformed baseline Ki-67 index.	ANCOVA	0.2345	LS Mean Difference	-0.24	2-Sided	95	-0.646	0.161	Denosumab 120 mg - Placebo	No	Superiority or Other