A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer (MONARCH 3)

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ClinicalTrials.gov Identifier: NCT02246621

Recruitment Status : Active, not recruiting

First Posted : September 23, 2014

Results First Posted : March 23, 2018

Last Update Posted : March 18, 2024

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Sponsor:

Information provided by (Responsible Party):

Eli Lilly and Company

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
Condition	Breast Cancer
Interventions	Drug: Abemaciclib Drug: Anastrozole Drug: Letrozole Drug: Placebo
Enrollment	493

Participant Flow

Recruitment Details
Pre-assignment Details	Completers are participants who died.


Arm/Group Title	Abemaciclib + NSAI (Nonsteroidal Aromatase Inhibitors)	Placebo + NSAI
Arm/Group Description	150 milligrams (mg) Abemaciclib ora...	Placebo orally every 12 hours plus ...
Arm/Group Description	150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).	Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Period Title: Overall Study
Started	328	165
Received At Least One Dose of Study Drug	327	161
Completed	63	30
Not Completed	265	135
Reason Not Completed
Withdrawal by Subject	28	16
Lost to Follow-up	1	0
On Study Treatment/ Follow Up	236	119

Baseline Characteristics

Arm/Group Title		Abemaciclib + NSAI	Placebo + NSAI	Total
Arm/Group Description		150 milligrams (mg) Abemaciclib ora...	Placebo orally every 12 hours plus ...	Total of all reporting groups
Arm/Group Description		150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).	Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).	Total of all reporting groups
Overall Number of Baseline Participants		328	165	493
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All randomized participants.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	328 participants	165 participants	493 participants
		63.13 (9.92)	62.92 (9.96)	63.05 (9.92)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	328 participants	165 participants	493 participants
	Female	328	165	493
	Male	0	0	0
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	328 participants	165 participants	493 participants
	Hispanic or Latino	32	12	44
	Not Hispanic or Latino	230	125	355
	Unknown or Not Reported	66	28	94
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	328 participants	165 participants	493 participants
	American Indian or Alaska Native	4	3	7
	Asian	103	45	148
	Native Hawaiian or Other Pacific Islander	0	1	1
	Black or African American	5	3	8
	White	186	102	288
	More than one race	2	0	2
	Unknown or Not Reported	28	11	39
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	328 participants	165 participants	493 participants
Australia		9	6	15
Austria		10	3	13
Belgium		14	7	21
Canada		14	11	25
Germany		11	5	16
Spain		16	14	30
France		30	11	41
United Kingdom		7	2	9
Greece		0	1	1
Israel		28	19	47
Italy		11	11	22
Japan		38	15	53
South Korea		41	18	59
Mexico		22	7	29
Netherlands		2	4	6
New Zealand		1	0	1
Russia		13	6	19
Slovakia		2	0	2
Sweden		3	1	4
Turkey		9	3	12
Taiwan		23	9	32
United States		24	12	36

Outcome Measures

1.Primary Outcome


Title	Progression Free Survival (PFS)
Description	PFS defined as the time from the first day of therapy to the first evi...
Description	PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Time Frame	Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants who had evaluable data. Censored participants: Abemaciclib + NSAI = 190 and Placebo + NSAI =57.


Arm/Group Title	Abemaciclib + NSAI	Placebo + NSAI
Arm/Group Description:	150 mg Abemaciclib orally every 12 ...	Placebo orally every 12 hours plus ...
Arm/Group Description:	150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).	Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed	328	165
Median (95% Confidence Interval) Unit of Measure: Months
	28.18 ^[1] (23.51 to NA)	14.76 (11.24 to 19.20)

[1]

The upper limit of the 95% CI was not evaluable due to the high censoring rate.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib + NSAI, Placebo + NSAI
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.000002
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.54
	Confidence Interval	(2-Sided) 95% 0.418 to 0.698
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Overall Survival (OS)
Description	OS defined as the time from first dose date to the date of death due t...
Description	OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Time Frame	Randomization to Progressive Disease or Death Due to Any Cause (Estimated Up to 82 Months)

Outcome Measure Data Not Reported

3.Secondary Outcome


Title	Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Description	ORR was the percentage of participants achieving a best overall respon...
Description	ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
Time Frame	Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants.


Arm/Group Title	Abemaciclib + NSAI	Placebo + NSAI
Arm/Group Description:	150 mg Abemaciclib orally every 12 ...	Placebo orally every 12 hours plus ...
Arm/Group Description:	150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).	Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed	328	165
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of Participants
	49.7 (44.3 to 55.1)	37 (29.6 to 44.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib + NSAI, Placebo + NSAI
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.005
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

4.Secondary Outcome


Title	Duration of Response (DoR)
Description	DOR was the time from the date of first evidence of complete response ...
Description	DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.
Time Frame	CR or PR to Disease Progression or Death Due to Any Cause (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants who had evaluable data. Censored participants: Abemaciclib + NSAI = 112 and Placebo + NSAI =28.


Arm/Group Title	Abemaciclib + NSAI	Placebo + NSAI
Arm/Group Description:	150 mg Abemaciclib orally every 12 ...	Placebo orally every 12 hours plus ...
Arm/Group Description:	150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).	Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed	163	61
Median (95% Confidence Interval) Unit of Measure: Months
	27.39 ^[1] (25.74 to NA)	17.46 (11.21 to 22.19)

[1]

The upper limit of the 95% CI was not evaluable due to the high censoring rate.

5.Secondary Outcome


Title	Percentage of Participants With CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])
Description	DCR was the percentage of participants with a best overall response of...
Description	DCR was the percentage of participants with a best overall response of CR, PR, or SD as per response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Time Frame	Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants.


Arm/Group Title	Abemaciclib + NSAI	Placebo + NSAI
Arm/Group Description:	150 mg Abemaciclib orally every 12 ...	Placebo orally every 12 hours plus ...
Arm/Group Description:	150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).	Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed	328	165
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of Participants
	88.7 (85.3 to 92.1)	86.7 (81.5 to 91.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib + NSAI, Placebo + NSAI
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.501
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

6.Secondary Outcome


Title	Percentage of Participants With Tumor Response of SD for at Least 6 Months, PR, or CR (Clinical Benefit Rate [CBR])
Description	CBR defined as percentage of participants with best overall response o...
Description	CBR defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months / number of participants enrolled) * 100.
Time Frame	Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants.


Arm/Group Title	Abemaciclib + NSAI	Placebo + NSAI
Arm/Group Description:	150 mg Abemaciclib orally every 12 ...	Placebo orally every 12 hours plus ...
Arm/Group Description:	150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).	Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed	328	165
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of Participants
	78.0 (73.6 to 82.5)	71.5 (64.6 to 78.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib + NSAI, Placebo + NSAI
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.101
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

7.Secondary Outcome


Title	Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores
Description	EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidime...
Description	EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains(physical,role,cognitive,emotional, and social),global health status, and symptom scales of fatigue, pain, nausea and vomiting,dyspnea,loss of appetite,insomnia,constipation and diarrhea, and financial difficulties.Functional scale options are defined on a 7-point scale ranging from 1, "Very poor" to 7, "Excellent". A linear transformation is applied to standardize the raw scores to range between 0 and 100 with higher score indicating better functioning. For functional domains and global health status, higher scores represent a better level of functioning. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment*Visit and Baseline.
Time Frame	Baseline, End of Study (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants.


Arm/Group Title	Abemaciclib + NSAI	Placebo + NSAI
Arm/Group Description:	150 mg Abemaciclib orally every 12 ...	Placebo orally every 12 hours plus ...
Arm/Group Description:	150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).	Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed	328	165
Least Squares Mean (Standard Error) Unit of Measure: score on a scale
Physical	-1.0 (0.9)	1.7 (1.2)
Role	-1.4 (1.1)	2.9 (1.6)
Emotional	4.7 (0.9)	4.0 (1.3)
Cognitive	-4.0 (0.9)	-4.0 (1.3)
Social	-0.1 (1.0)	3.3 (1.4)

8.Secondary Outcome


Title	Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores
Description	EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidime...
Description	EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. Symptom scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much." A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For symptoms scales, higher scores indicated greater symptom burden. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment*Visit and Baseline. Small changes are generally defined as at least a 3, 4 or 5 point change from baseline.
Time Frame	Baseline, End of Study (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants.


Arm/Group Title	Abemaciclib + NSAI	Placebo + NSAI
Arm/Group Description:	150 mg Abemaciclib orally every 12 ...	Placebo orally every 12 hours plus ...
Arm/Group Description:	150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).	Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed	328	165
Least Squares Mean (Standard Error) Unit of Measure: score on a scale
Fatigue	2.4 (1.0)	-2.6 (1.4)
Nausea and Vomiting	2.4 (0.6)	-0.4 (0.9)
Pain	-4.8 (1.0)	-5.7 (1.5)
Dyspnea	0.9 (1.0)	-1.6 (1.4)
Insomnia	-1.7 (1.2)	-4.1 (1.7)
Appetite loss	0.2 (1.1)	-3.9 (1.6)
Constipation	-0.8 (0.9)	1.6 (1.3)
Diarrhea	18.2 (1.0)	-0.5 (1.5)
Financial difficulties	-0.7 (1.1)	-1.2 (1.6)

9.Secondary Outcome


Title	Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire
Description	The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion modul...
Description	The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much". All scores are converted to a 0 to 100 scale. A higher score representing a higher ("better") level of functioning (BR23: body image, sexual functioning, future perspective), or a higher ("worse") level of symptoms. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment*Visit and Baseline.
Time Frame	Baseline, End of Study (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants.


Arm/Group Title		Abemaciclib + NSAI	Placebo + NSAI
Arm/Group Description:		150 mg Abemaciclib orally every 12 ...	Placebo orally every 12 hours plus ...
Arm/Group Description:		150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).	Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed		328	165
Least Squares Mean (Standard Error) Unit of Measure: score on a scale
Body image	Number Analyzed	328 participants	165 participants
Body image		-4.5 (1.1)	0.6 (1.6)
Sexual functioning	Number Analyzed	328 participants	165 participants
Sexual functioning		-0.2 (0.7)	-0.1 (1.0)
Future perspective	Number Analyzed	328 participants	165 participants
Future perspective		12.7 (1.3)	11.9 (1.9)
sexual enjoyment	Number Analyzed	0 participants	0 participants
Systemic therapy side effects	Number Analyzed	328 participants	165 participants
Systemic therapy side effects		8.15 (0.68)	3.68 (0.98)
Breast symptoms	Number Analyzed	328 participants	165 participants
Breast symptoms		-6.12 (0.64)	-6.23 (0.93)
Arm symptoms	Number Analyzed	328 participants	165 participants
Arm symptoms		-1.14 (0.87)	-2.23 (1.27)
upset by hair loss	Number Analyzed	0 participants	0 participants

10.Secondary Outcome


Title	Change From Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L) Index Value
Description	The EuroQol-5D (version 5L) is a brief self-administered, validated in...
Description	The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts.The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a five level scale (no problem, slight problem, moderate problem, severe problem and extreme problem) with higher levels indicating greater severity/ impairment. Published weights are available that allow for the creation of a single summary score called the EQ-5D index that ranges from 0 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health. Minimally important differences in the EQ-5D index score are 0.06 or greater in cancer patients. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment*Visit and Baseline.
Time Frame	Baseline, End of Study (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants.


Arm/Group Title	Abemaciclib + NSAI	Placebo + NSAI
Arm/Group Description:	150 mg Abemaciclib orally every 12 ...	Placebo orally every 12 hours plus ...
Arm/Group Description:	150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).	Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed	328	165
Least Squares Mean (Standard Error) Unit of Measure: units on a scale
	0.01 (0.01)	0.01 (0.01)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib + NSAI, Placebo + NSAI
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.688
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.02
	Estimation Comments	[Not Specified]

11.Secondary Outcome


Title	Change From Baseline to End of Study in Health Status on the EuroQol-5D 5L Visual Analog Scale (VAS) Scores Scale
Description	The EuroQol-5D (version 5L) is a brief self-administered, validated in...
Description	The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). Minimally important differences in the EQ-5D VAS score are 7 or greater in cancer patients. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment*Visit and Baseline.
Time Frame	Baseline, End of Study (Up to 32 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants.


Arm/Group Title	Abemaciclib + NSAI	Placebo + NSAI
Arm/Group Description:	150 mg Abemaciclib orally every 12 ...	Placebo orally every 12 hours plus ...
Arm/Group Description:	150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).	Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed	328	165
Least Squares Mean (Standard Error) Unit of Measure: millimeter (mm)
	0.49 (0.78)	1.51 (1.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib + NSAI, Placebo + NSAI
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.466
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.01
	Parameter Dispersion	Type: Standard Error of the Mean Value: 1.39
	Estimation Comments	[Not Specified]

12.Secondary Outcome


Title	Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Abemaciclib and Its Metabolites M2 and M20
Description	Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve ...
Description	Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Abemaciclib and Its Metabolites M2 and M20
Time Frame	Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with evaluable PK data.


Arm/Group Title	Abemaciclib + NSAI
Arm/Group Description:	150 mg Abemaciclib orally every 12 ...
Arm/Group Description:	150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed	322
Geometric Mean (Geometric Coefficient of Variation) Unit of Measure: nanogramhours/milliliter (ngh/mL)
Abemaciclib	3360 (36.6%)
M2	1290 (75.8%)
M20	2300 (74.4%)

13.Secondary Outcome


Title	PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20
Description	PK: Hepatic Clearance of Abemaciclib, and apparent hepatic clearance o...
Description	PK: Hepatic Clearance of Abemaciclib, and apparent hepatic clearance of its Metabolites M2 and M20
Time Frame	Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with evaluable PK data.


Arm/Group Title	Abemaciclib + NSAI
Arm/Group Description:	150 mg Abemaciclib orally every 12 ...
Arm/Group Description:	150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Overall Number of Participants Analyzed	322
Geometric Mean (Geometric Coefficient of Variation) Unit of Measure: liters/hour (L/h)
Abemaciclib	23.0 (26.7%)
M2	21.6 (50.4%)
M20	26.0 (46.4%)

Adverse Events

Time Frame	Baseline Up to 32 Months
Adverse Event Reporting Description	Serious Adverse Events and Other Adverse Events: All participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants.

Arm/Group Title	Abemaciclib + NSAI		Placebo + NSAI
Arm/Group Description	150 milligrams (mg) Abemaciclib ora...		Placebo orally every 12 hours plus ...
Arm/Group Description	150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).		Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
All-Cause Mortality
	Abemaciclib + NSAI		Placebo + NSAI
	Affected / at Risk (%)		Affected / at Risk (%)
Total	63/328 (19.21%)		30/165 (18.18%)
Serious Adverse Events Serious Adverse Events
	Abemaciclib + NSAI		Placebo + NSAI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	102/327 (31.19%)		27/161 (16.77%)
Blood and lymphatic system disorders
Anaemia ^† 1	6/327 (1.83%)	6	0/161 (0.00%)	0
Disseminated intravascular coagulation ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Neutropenia ^† 1	2/327 (0.61%)	2	0/161 (0.00%)	0
Cardiac disorders
Acute coronary syndrome ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	1
Angina pectoris ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Atrial fibrillation ^† 1	2/327 (0.61%)	3	0/161 (0.00%)	0
Atrial tachycardia ^† 1	1/327 (0.31%)	2	0/161 (0.00%)	0
Cardiac failure ^† 1	2/327 (0.61%)	2	0/161 (0.00%)	0
Myocardial infarction ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	1
Pericardial effusion ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Stress cardiomyopathy ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	1
Supraventricular tachycardia ^† 1	2/327 (0.61%)	2	0/161 (0.00%)	0
Ventricular arrhythmia ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Ear and labyrinth disorders
Vertigo ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	1
Vertigo positional ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Gastrointestinal disorders
Abdominal pain ^† 1	1/327 (0.31%)	1	2/161 (1.24%)	2
Colitis ^† 1	1/327 (0.31%)	2	0/161 (0.00%)	0
Constipation ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Diarrhoea ^† 1	5/327 (1.53%)	7	0/161 (0.00%)	0
Enterocolitis ^† 1	2/327 (0.61%)	2	0/161 (0.00%)	0
Food poisoning ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Gastritis ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Ileus ^† 1	1/327 (0.31%)	1	1/161 (0.62%)	1
Intestinal obstruction ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Nausea ^† 1	1/327 (0.31%)	2	0/161 (0.00%)	0
Oesophagitis ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Pancreatitis ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Periodontal disease ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Rectal haemorrhage ^† 1	1/327 (0.31%)	1	1/161 (0.62%)	1
Vomiting ^† 1	2/327 (0.61%)	3	2/161 (1.24%)	2
General disorders
General physical health deterioration ^† 1	2/327 (0.61%)	2	1/161 (0.62%)	2
Inflammation ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Non-cardiac chest pain ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	1
Pyrexia ^† 1	1/327 (0.31%)	1	1/161 (0.62%)	1
Sudden death ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	1
Ulcer haemorrhage ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Hepatobiliary disorders
Bile duct stone ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Cholecystitis ^† 1	2/327 (0.61%)	2	1/161 (0.62%)	1
Hepatitis toxic ^† 1	1/327 (0.31%)	2	0/161 (0.00%)	0
Immune system disorders
Anaphylactic reaction ^† 1	1/327 (0.31%)	1	1/161 (0.62%)	1
Infections and infestations
Appendicitis ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Bacteraemia ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Cellulitis ^† 1	2/327 (0.61%)	2	0/161 (0.00%)	0
Diverticulitis ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Erysipelas ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Gastroenteritis ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	1
Kidney infection ^† 1	2/327 (0.61%)	2	0/161 (0.00%)	0
Lung infection ^† 1	13/327 (3.98%)	17	0/161 (0.00%)	0
Mastitis ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Sepsis ^† 1	2/327 (0.61%)	2	1/161 (0.62%)	1
Skin infection ^† 1	1/327 (0.31%)	2	1/161 (0.62%)	1
Urinary tract infection ^† 1	4/327 (1.22%)	4	1/161 (0.62%)	1
Wound infection ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	1
Injury, poisoning and procedural complications
Ankle fracture ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Fall ^† 1	2/327 (0.61%)	3	1/161 (0.62%)	1
Fracture ^† 1	3/327 (0.92%)	3	1/161 (0.62%)	1
Hip fracture ^† 1	3/327 (0.92%)	3	0/161 (0.00%)	0
Spinal fracture ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Wound dehiscence ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Wrist fracture ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	1
Investigations
Alanine aminotransferase increased ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Aspartate aminotransferase increased ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Blood bilirubin increased ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Blood creatinine increased ^† 1	3/327 (0.92%)	3	0/161 (0.00%)	0
Ejection fraction decreased ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	1
Gamma-glutamyltransferase increased ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	1
Metabolism and nutrition disorders
Cachexia ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	1
Decreased appetite ^† 1	1/327 (0.31%)	1	1/161 (0.62%)	1
Dehydration ^† 1	4/327 (1.22%)	5	2/161 (1.24%)	2
Hypercalcaemia ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Hyperkalaemia ^† 1	2/327 (0.61%)	2	0/161 (0.00%)	0
Hypokalaemia ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Hyponatraemia ^† 1	3/327 (0.92%)	4	0/161 (0.00%)	0
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Arthritis ^† 1	2/327 (0.61%)	2	0/161 (0.00%)	0
Back pain ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Bone pain ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Muscular weakness ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Breast cancer metastatic ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	1
Endometrial cancer ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Tumour haemorrhage ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	1
Nervous system disorders
Cerebral ischaemia ^† 1	1/327 (0.31%)	2	0/161 (0.00%)	0
Cerebrovascular accident ^† 1	3/327 (0.92%)	3	1/161 (0.62%)	1
Headache ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Presyncope ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Spinal cord compression ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	2
Syncope ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Renal and urinary disorders
Acute kidney injury ^† 1	5/327 (1.53%)	6	0/161 (0.00%)	0
Chronic kidney disease ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Nephrolithiasis ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Urinary tract obstruction ^† 1	1/327 (0.31%)	2	0/161 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea ^† 1	3/327 (0.92%)	5	0/161 (0.00%)	0
Pharyngeal inflammation ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Pleural effusion ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	2
Pneumonitis ^† 1	4/327 (1.22%)	5	0/161 (0.00%)	0
Pulmonary fibrosis ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Respiratory failure ^† 1	2/327 (0.61%)	3	0/161 (0.00%)	0
Skin and subcutaneous tissue disorders
Rash ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Skin ulcer ^† 1	0/327 (0.00%)	0	1/161 (0.62%)	1
Vascular disorders
Embolism ^† 1	8/327 (2.45%)	10	1/161 (0.62%)	1
Haematoma ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Hypertension ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Pelvic venous thrombosis ^† 1	1/327 (0.31%)	1	0/161 (0.00%)	0
Peripheral ischaemia ^† 1	1/327 (0.31%)	2	0/161 (0.00%)	0
1 Term from vocabulary, MedDRA 20.1 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Abemaciclib + NSAI		Placebo + NSAI
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	322/327 (98.47%)		141/161 (87.58%)
Blood and lymphatic system disorders
Anaemia ^† 1	102/327 (31.19%)	328	13/161 (8.07%)	21
Leukopenia ^† 1	72/327 (22.02%)	293	4/161 (2.48%)	6
Lymphopenia ^† 1	24/327 (7.34%)	67	6/161 (3.73%)	6
Neutropenia ^† 1	143/327 (43.73%)	625	3/161 (1.86%)	20
Thrombocytopenia ^† 1	41/327 (12.54%)	91	5/161 (3.11%)	12
Eye disorders
Dry eye ^† 1	17/327 (5.20%)	19	1/161 (0.62%)	1
Lacrimation increased ^† 1	23/327 (7.03%)	30	1/161 (0.62%)	1
Gastrointestinal disorders
Abdominal pain ^† 1	102/327 (31.19%)	158	20/161 (12.42%)	24
Constipation ^† 1	57/327 (17.43%)	81	23/161 (14.29%)	29
Diarrhoea ^† 1	267/327 (81.65%)	984	52/161 (32.30%)	97
Dyspepsia ^† 1	26/327 (7.95%)	33	5/161 (3.11%)	5
Nausea ^† 1	135/327 (41.28%)	239	33/161 (20.50%)	44
Stomatitis ^† 1	41/327 (12.54%)	55	17/161 (10.56%)	25
Vomiting ^† 1	98/327 (29.97%)	146	20/161 (12.42%)	31
General disorders
Fatigue ^† 1	135/327 (41.28%)	255	54/161 (33.54%)	79
Influenza like illness ^† 1	39/327 (11.93%)	54	15/161 (9.32%)	19
Oedema peripheral ^† 1	33/327 (10.09%)	41	10/161 (6.21%)	11
Pain ^† 1	27/327 (8.26%)	35	11/161 (6.83%)	14
Pyrexia ^† 1	33/327 (10.09%)	40	16/161 (9.94%)	19
Infections and infestations
Upper respiratory tract infection ^† 1	33/327 (10.09%)	48	9/161 (5.59%)	15
Urinary tract infection ^† 1	34/327 (10.40%)	46	16/161 (9.94%)	31
Injury, poisoning and procedural complications
Fall ^† 1	17/327 (5.20%)	24	3/161 (1.86%)	3
Investigations
Alanine aminotransferase increased ^† 1	57/327 (17.43%)	143	12/161 (7.45%)	17
Aspartate aminotransferase increased ^† 1	55/327 (16.82%)	119	12/161 (7.45%)	14
Blood alkaline phosphatase increased ^† 1	19/327 (5.81%)	25	6/161 (3.73%)	7
Blood creatinine increased ^† 1	67/327 (20.49%)	174	7/161 (4.35%)	8
Weight decreased ^† 1	36/327 (11.01%)	65	5/161 (3.11%)	8
Metabolism and nutrition disorders
Decreased appetite ^† 1	86/327 (26.30%)	140	17/161 (10.56%)	23
Hypokalaemia ^† 1	28/327 (8.56%)	48	2/161 (1.24%)	2
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	56/327 (17.13%)	91	33/161 (20.50%)	50
Back pain ^† 1	52/327 (15.90%)	67	26/161 (16.15%)	33
Bone pain ^† 1	33/327 (10.09%)	42	14/161 (8.70%)	20
Muscular weakness ^† 1	17/327 (5.20%)	27	6/161 (3.73%)	10
Myalgia ^† 1	34/327 (10.40%)	38	12/161 (7.45%)	15
Pain in extremity ^† 1	35/327 (10.70%)	50	19/161 (11.80%)	26
Nervous system disorders
Dizziness ^† 1	44/327 (13.46%)	57	18/161 (11.18%)	20
Dysgeusia ^† 1	31/327 (9.48%)	37	5/161 (3.11%)	5
Headache ^† 1	64/327 (19.57%)	102	26/161 (16.15%)	37
Neuropathy ^† 1	35/327 (10.70%)	42	16/161 (9.94%)	17
Psychiatric disorders
Anxiety ^† 1	11/327 (3.36%)	16	9/161 (5.59%)	11
Insomnia ^† 1	24/327 (7.34%)	28	16/161 (9.94%)	17
Reproductive system and breast disorders
Breast pain ^† 1	14/327 (4.28%)	20	10/161 (6.21%)	13
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	48/327 (14.68%)	69	20/161 (12.42%)	27
Dyspnoea ^† 1	40/327 (12.23%)	56	11/161 (6.83%)	15
Skin and subcutaneous tissue disorders
Alopecia ^† 1	90/327 (27.52%)	95	18/161 (11.18%)	19
Dry skin ^† 1	31/327 (9.48%)	39	4/161 (2.48%)	4
Nail ridging ^† 1	17/327 (5.20%)	20	2/161 (1.24%)	2
Pruritus ^† 1	47/327 (14.37%)	68	15/161 (9.32%)	19
Rash ^† 1	50/327 (15.29%)	72	8/161 (4.97%)	14
Vascular disorders
Hot flush ^† 1	33/327 (10.09%)	34	28/161 (17.39%)	35
Hypertension ^† 1	24/327 (7.34%)	46	10/161 (6.21%)	24
1 Term from vocabulary, MedDRA 20.1 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Chief Medical Officer
Organization:	Eli Lilly and Company
Phone:	800-545-5979
EMail:	clinicaltrials.gov@lilly.com

Publications of Results:

Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Tredan O, Chen SC, Manso L, Freedman OC, Garnica Jaliffe G, Forrester T, Frenzel M, Barriga S, Smith IC, Bourayou N, Di Leo A. MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. doi: 10.1200/JCO.2017.75.6155. Epub 2017 Oct 2.

Johnston S, Martin M, Di Leo A, Im SA, Awada A, Forrester T, Frenzel M, Hardebeck MC, Cox J, Barriga S, Toi M, Iwata H, Goetz MP. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer. 2019 Jan 17;5:5. doi: 10.1038/s41523-018-0097-z. eCollection 2019.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Takahashi M, Tokunaga E, Mori J, Tanizawa Y, van der Walt JS, Kawaguchi T, Goetz MP, Toi M. Japanese subgroup analysis of the phase 3 MONARCH 3 study of abemaciclib as initial therapy for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Breast Cancer. 2022 Jan;29(1):174-184. doi: 10.1007/s12282-021-01295-0. Epub 2021 Oct 18.

Goetz MP, Okera M, Wildiers H, Campone M, Grischke EM, Manso L, Andre VAM, Chouaki N, San Antonio B, Toi M, Sledge GW Jr. Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. Breast Cancer Res Treat. 2021 Apr;186(2):417-428. doi: 10.1007/s10549-020-06029-y. Epub 2021 Jan 3.

Layout table for additonal information

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT02246621
Other Study ID Numbers:	15417 I3Y-MC-JPBM ( Other Identifier: Eli Lilly and Company ) 2014-001502-18 ( EudraCT Number )
First Submitted:	September 18, 2014
First Posted:	September 23, 2014
Results First Submitted:	January 31, 2018
Results First Posted:	March 23, 2018
Last Update Posted:	March 18, 2024

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