A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer (MONARCH 2)

• ClinicalTrials.gov Identifier: NCT02107703
• Recruitment Status: Active, not recruiting
• First Posted: April 8, 2014
• Results First Posted: March 13, 2018
• Last Update Posted: April 16, 2024
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Breast Neoplasms
• Interventions: Drug: Abemaciclib; Drug: Fulvestrant; Drug: Placebo
• Enrollment: 669

Participant Flow

Recruitment Details
Pre-assignment Details	With Overall Survival (OS) as a key outcome, participants who completed included those who died due to any cause and those who were off treatment, alive and in follow-up at the time of the final OS analysis.

Arm/Group Title	Abemaciclib + Fulvestrant	Placebo + Fulvestrant
Arm/Group Description	Abemaciclib 150 milligram (mg) administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.	Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Period Title: Overall Study
Started	446	223
Received at Least 1 Dose of Study Drug	441	223
Completed	332	188
Not Completed	114	35
Reason Not Completed
Withdrawal by Subject	46	21
Lost to Follow-up	20	9
On study treatment/follow up	48	5

Baseline Characteristics

Arm/Group Title		Abemaciclib + Fulvestrant	Placebo + Fulvestrant	Total
Arm/Group Description		Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.	Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.	Total of all reporting groups
Overall Number of Baseline Participants		446	223	669
Baseline Analysis Population Description		All randomized participants.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	446 participants	223 participants	669 participants
		59.3 (11.2)	61.1 (11.7)	59.9 (11.4)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	446 participants	223 participants	669 participants
	Female	446	223	669
	Male	0	0	0
Ethnicity (NIH/OMB) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	443 participants	223 participants	666 participants
	Hispanic or Latino	57	25	82
	Not Hispanic or Latino	303	162	465
	Unknown or Not Reported	83	36	119
		[1] Measure Analysis Population Description: All randomized participants who had baseline Ethnicity data.
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	446 participants	223 participants	669 participants
	American Indian or Alaska Native	18	8	26
	Asian	149	65	214
	Native Hawaiian or Other Pacific Islander	0	0	0
	Black or African American	9	5	14
	White	237	136	373
	More than one race	0	0	0
	Unknown or Not Reported	33	9	42
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
North America	Number Analyzed	446 participants	223 participants	669 participants
		120	58	178
Europe	Number Analyzed	446 participants	223 participants	669 participants
		179	100	279
Taiwan	Number Analyzed	446 participants	223 participants	669 participants
		25	14	39
Japan	Number Analyzed	446 participants	223 participants	669 participants
		64	31	95
South Korea	Number Analyzed	446 participants	223 participants	669 participants
		58	20	78

Outcome Measures

1. Primary Outcome

Title	Progression-Free Survival (PFS)
Description	PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (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	From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants. Censored participants: Abemaciclib=224.

Arm/Group Title	Abemaciclib + Fulvestrant	Placebo + Fulvestrant
Arm/Group Description:	Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.	Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Overall Number of Participants Analyzed	446	223
Median (95% Confidence Interval); Unit of Measure: Months
	16.4; (14.4 to 19.3)	9.3; (7.4 to 11.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Abemaciclib + Fulvestrant, Placebo + Fulvestrant
	Comments	The final analysis was planned at 378 PFS events, which would provide approximately 90% power assuming a hazard ratio (HR) of 0.703 at a one-sided α of 0.025.
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.0000001
	Comments	This is two sided P value and it is statistically significant.
	Method	Log Rank
	Comments	Log rank test is stratified by endocrine sensitivity and natural of disease by interactive web response system (IWRS).
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.553
	Confidence Interval	(2-Sided) 95%; 0.449 to 0.681
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Overall Survival (OS)
Description	OS defined as the time from the date of randomization 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. The final analysis of the OS outcome was conducted after 440 OS events had been observed.
Time Frame	From Date of Randomization until Death Due to Any Cause (Up To 72 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants. Censored participants: Abemaciclib=163 (36.5%), Placebo = 66 (29.6).

Arm/Group Title	Abemaciclib + Fulvestrant	Placebo + Fulvestrant
Arm/Group Description:	Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.	Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Overall Number of Participants Analyzed	446	223
Median (95% Confidence Interval); Unit of Measure: Months
	45.80; (38.96 to 52.64)	37.25; (34.36 to 43.20)

3. Secondary Outcome

Title	Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
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. 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.
Time Frame	From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	Abemaciclib + Fulvestrant	Placebo + Fulvestrant
Arm/Group Description:	Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.	Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Overall Number of Participants Analyzed	446	223
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	35.2; (30.8 to 39.6)	16.1; (11.3 to 21.0)

4. Secondary Outcome

Title	Duration of Response (DOR)
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. 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.
Time Frame	From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 31 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants with response.

Arm/Group Title	Abemaciclib + Fulvestrant	Placebo + Fulvestrant
Arm/Group Description:	Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.	Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Overall Number of Participants Analyzed	157	36
Median (95% Confidence Interval); Unit of Measure: Months
	NA [1]; (18.05 to NA)	25.6; (11.9 to 25.6)

[1]

The median DoR for participants has not been reached.

5. Secondary Outcome

Title	Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])
Description	Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (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. 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.
Time Frame	From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	Abemaciclib + Fulvestrant	Placebo + Fulvestrant
Arm/Group Description:	Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.	Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Overall Number of Participants Analyzed	446	223
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	83.0; (79.5 to 86.4)	75.8; (70.2 to 81.4)

6. Secondary Outcome

Title	Percentage of Participants With CR, PR or SD With a Duration of At Least 6 Months (Clinical Benefit Rate [CBR])
Description	Clinical benefit rate defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months.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.PD was at least a 20% increase in 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.
Time Frame	From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	Abemaciclib + Fulvestrant	Placebo + Fulvestrant
Arm/Group Description:	Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.	Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Overall Number of Participants Analyzed	446	223
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	72.2; (68.0 to 76.4)	56.1; (49.5 to 62.6)

7. Secondary Outcome

Title	Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf)
Description	A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. Least square (LS) Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.
Time Frame	Baseline, End of Study (Up To 31 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with a baseline and at least 1 post-baseline result.

Arm/Group Title	Abemaciclib + Fulvestrant	Placebo + Fulvestrant
Arm/Group Description:	Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.	Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Overall Number of Participants Analyzed	441	223
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-0.06 (0.07)	0.00 (0.10)

8. Secondary Outcome

Title	Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20
Description	Area Under the Plasma Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20.
Time Frame	Cycle 1 Day 1 2-4 hours (h) post dose, Cycle 1 Day 15 4 and 7h post dose, Cycle 2 Day 1 pre dose and 3h post dose, Cycle 3 Day1 pre dose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of 150 mg study drug (Abemaciclib) with evaluable Abemaciclib, M2 and M20 PK data.

Arm/Group Title	Abemaciclib + Fulvestrant
Arm/Group Description:	Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Overall Number of Participants Analyzed	326
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: Nanograms*hour/milliliters (ng*h/mL)
Abemaciclib	2960; (32.2%)
M2	1640; (70.2%)
M20	2870; (69.6%)

9. Secondary Outcome

Title	Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L)
Description	European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The EQ-5D-5L is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. A higher score indicates better health state. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.
Time Frame	Baseline, End of Study (Up To 31 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline EQ-5D 5L data.

Arm/Group Title	Abemaciclib + Fulvestrant	Placebo + Fulvestrant
Arm/Group Description:	Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.	Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Overall Number of Participants Analyzed	441	223
Least Squares Mean (Standard Error); Unit of Measure: mm
	0.12 (0.65)	1.16 (0.92)

10. Secondary Outcome

Title	Change From Baseline to Short Term Follow up in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Description	EORTC QLQ-C30 v3.0 was 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. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 110 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline.
Time Frame	Baseline, Short Term Follow Up (Up To 31 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 data at short term follow up for each EORTC QLQ-C30 items.

Arm/Group Title		Abemaciclib + Fulvestrant	Placebo + Fulvestrant
Arm/Group Description:		Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.	Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Overall Number of Participants Analyzed		180	126
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
Global health status	Number Analyzed	179 participants	126 participants
		-4.57 (1.55)	-8.15 (1.87)
Functional scale: Physical functioning	Number Analyzed	179 participants	126 participants
		-3.76 (1.29)	-7.59 (1.59)
Functional scale: Role functioning	Number Analyzed	179 participants	124 participants
		-4.87 (1.73)	-9.58 (2.12)
Functional scale: Emotional functioning	Number Analyzed	179 participants	125 participants
		2.38 (1.38)	-2.44 (1.70)
Functional scale: Cognitive functioning	Number Analyzed	180 participants	125 participants
		-3.16 (1.29)	-2.96 (1.58)
Functional scale: Social functioning	Number Analyzed	180 participants	126 participants
		-4.62 (1.61)	-4.78 (1.97)
Symptom scale: Fatigue	Number Analyzed	180 participants	125 participants
		5.01 (1.45)	7.83 (1.78)
Symptom scale: Nausea and vomiting	Number Analyzed	180 participants	125 participants
		2.81 (1.35)	6.49 (1.64)
Symptom scale: Pain	Number Analyzed	180 participants	126 participants
		-0.47 (1.82)	4.38 (2.21)
Symptom scale: Dyspnoea	Number Analyzed	180 participants	123 participants
		5.21 (1.70)	5.39 (2.10)
Symptom scale: Insomnia	Number Analyzed	180 participants	126 participants
		-0.04 (1.86)	3.76 (2.27)
Symptom scale: Appetite loss	Number Analyzed	180 participants	125 participants
		2.06 (1.85)	6.40 (2.23)
Symptom scale: Constipation	Number Analyzed	179 participants	125 participants
		-0.15 (1.59)	3.79 (1.92)
Symptom scale: Diarrhoea	Number Analyzed	179 participants	125 participants
		4.14 (1.66)	2.67 (1.99)
Symptom scale: Financial difficulties	Number Analyzed	179 participants	124 participants
		0.34 (1.60)	2.85 (1.96)

11. Secondary Outcome

Title	Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire
Description	EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms and arm symptoms. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline.
Time Frame	Baseline, Short Term Follow Up (Up To 31 Months)

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-BR23 data at short term follow up for each BR23 items.

Arm/Group Title		Abemaciclib + Fulvestrant	Placebo + Fulvestrant
Arm/Group Description:		Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.	Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Overall Number of Participants Analyzed		182	126
Least Squares Mean (Standard Error); Unit of Measure: Units on a scale
Functional scale: Body image	Number Analyzed	179 participants	125 participants
		-2.20 (1.46)	-3.27 (1.83)
Functional scale:Sexual functioning	Number Analyzed	171 participants	116 participants
		0.41 (1.00)	-1.60 (1.25)
Functional scale: Future perspective	Number Analyzed	179 participants	126 participants
		6.06 (2.06)	10.05 (2.51)
Symptom scale: Systemic therapy side effects	Number Analyzed	182 participants	125 participants
		7.23 (1.00)	6.98 (1.22)
Symptom scale: Breast symptoms	Number Analyzed	181 participants	126 participants
		-2.10 (0.89)	-0.96 (1.09)
Symptom scale: Arm symptoms	Number Analyzed	182 participants	125 participants
		-0.45 (1.29)	0.10 (1.59)

Adverse Events

Time Frame	Up To 7 years 7.7 Months
Adverse Event Reporting Description	Adverse Events: All randomized participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants. Analyses presented in this report are based on a database lock for the pre-planned final OS analysis of 22 April 2022.
Arm/Group Title	Abemaciclib + Fulvestrant		Placebo + Fulvestrant
Arm/Group Description	150 mg Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.		Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
All-Cause Mortality
	Abemaciclib + Fulvestrant		Placebo + Fulvestrant
	Affected / at Risk (%)		Affected / at Risk (%)
Total	283/446 (63.45%)		157/223 (70.40%)
Serious Adverse Events
	Abemaciclib + Fulvestrant		Placebo + Fulvestrant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	129/441 (29.25%)		33/223 (14.80%)
Blood and lymphatic system disorders
Anaemia † 1	3/441 (0.68%)	3	0/223 (0.00%)	0
Disseminated intravascular coagulation † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Febrile neutropenia † 1	3/441 (0.68%)	3	0/223 (0.00%)	0
Neutropenia † 1	1/441 (0.23%)	1	1/223 (0.45%)	1
Pancytopenia † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Cardiac disorders
Atrial fibrillation † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
Atrioventricular block first degree † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Cardiac arrest † 1	0/441 (0.00%)	0	1/223 (0.45%)	2
Cardiac failure † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
Myocardial infarction † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Restrictive cardiomyopathy † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Sinus tachycardia † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Supraventricular tachycardia † 1	2/441 (0.45%)	2	1/223 (0.45%)	1
Ventricular tachycardia † 1	1/441 (0.23%)	1	1/223 (0.45%)	1
Ear and labyrinth disorders
Middle ear inflammation † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Endocrine disorders
Adrenal insufficiency † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Eye disorders
Macular hole † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Gastrointestinal disorders
Abdominal pain † 1	5/441 (1.13%)	6	1/223 (0.45%)	1
Ascites † 1	1/441 (0.23%)	1	1/223 (0.45%)	2
Diarrhoea † 1	9/441 (2.04%)	9	0/223 (0.00%)	0
Enterocolitis † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
Gastritis † 1	1/441 (0.23%)	1	1/223 (0.45%)	1
Gastrointestinal amyloidosis † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Intestinal obstruction † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Nausea † 1	5/441 (1.13%)	5	2/223 (0.90%)	2
Oesophageal pain † 1	0/441 (0.00%)	0	1/223 (0.45%)	1
Pancreatitis † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Small intestinal perforation † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Volvulus † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Vomiting † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
General disorders
Injection site reaction † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
Localised oedema † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Malaise † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Multiple organ dysfunction syndrome † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Non-cardiac chest pain † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
Oedema peripheral † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
Pain † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Pyrexia † 1	3/441 (0.68%)	3	0/223 (0.00%)	0
Surgical failure † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Hepatobiliary disorders
Cholangitis † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Cholecystitis † 1	4/441 (0.91%)	4	0/223 (0.00%)	0
Drug-induced liver injury † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
Hepatic failure † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
Hepatic function abnormal † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
Immune system disorders
Autoimmune disorder † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Hypersensitivity † 1	1/441 (0.23%)	1	1/223 (0.45%)	1
Sarcoidosis † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Infections and infestations
Bartholin's abscess † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Bronchitis † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Cellulitis † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Covid-19 † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Enterocolitis infectious † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
Gastroenteritis † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Kidney infection † 1	0/441 (0.00%)	0	1/223 (0.45%)	1
Lower respiratory tract infection † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Lymph gland infection † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Mastitis † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Osteomyelitis † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Periorbital cellulitis † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Pneumonia † 1	13/441 (2.95%)	13	0/223 (0.00%)	0
Pyelonephritis acute † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Salmonella bacteraemia † 1	0/441 (0.00%)	0	1/223 (0.45%)	1
Sepsis † 1	6/441 (1.36%)	6	1/223 (0.45%)	1
Skin infection † 1	6/441 (1.36%)	6	1/223 (0.45%)	1
Upper respiratory tract infection † 1	0/441 (0.00%)	0	1/223 (0.45%)	1
Urinary tract infection † 1	2/441 (0.45%)	2	1/223 (0.45%)	1
Injury, poisoning and procedural complications
Ankle fracture † 1	2/441 (0.45%)	2	1/223 (0.45%)	1
Fall † 1	3/441 (0.68%)	4	0/223 (0.00%)	0
Fracture † 1	8/441 (1.81%)	8	1/223 (0.45%)	1
Hip fracture † 1	0/441 (0.00%)	0	1/223 (0.45%)	1
Limb injury † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Spinal fracture † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
Wound complication † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
Wrist fracture † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Investigations
Alanine aminotransferase increased † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Aspartate aminotransferase increased † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Blood alkaline phosphatase increased † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Blood bilirubin increased † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Blood creatinine increased † 1	4/441 (0.91%)	4	0/223 (0.00%)	0
Blood follicle stimulating hormone abnormal † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Electrocardiogram qt prolonged † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
General physical condition abnormal † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Hormone level abnormal † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Oestradiol abnormal † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Metabolism and nutrition disorders
Decreased appetite † 1	1/441 (0.23%)	1	1/223 (0.45%)	1
Dehydration † 1	3/441 (0.68%)	3	1/223 (0.45%)	1
Hypercalcaemia † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
Hyperglycaemia † 1	1/441 (0.23%)	1	1/223 (0.45%)	1
Hypocalcaemia † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Hypokalaemia † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Hyponatraemia † 1	0/441 (0.00%)	0	1/223 (0.45%)	2
Musculoskeletal and connective tissue disorders
Arthralgia † 1	0/441 (0.00%)	0	1/223 (0.45%)	1
Arthritis † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Back pain † 1	2/441 (0.45%)	2	2/223 (0.90%)	2
Bone pain † 1	1/441 (0.23%)	1	1/223 (0.45%)	1
Muscular weakness † 1	5/441 (1.13%)	5	0/223 (0.00%)	0
Musculoskeletal pain † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Myositis † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Osteoarthritis † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Osteonecrosis of jaw † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma † 1	0/441 (0.00%)	0	1/223 (0.45%)	1
Benign bone neoplasm † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Colon cancer † 1	1/441 (0.23%)	1	1/223 (0.45%)	1
Myelodysplastic syndrome † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Tumour pain † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
Nervous system disorders
Cerebrovascular accident † 1	4/441 (0.91%)	4	0/223 (0.00%)	0
Depressed level of consciousness † 1	1/441 (0.23%)	1	2/223 (0.90%)	2
Dizziness † 1	3/441 (0.68%)	3	0/223 (0.00%)	0
Headache † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Neuropathy † 1	0/441 (0.00%)	0	1/223 (0.45%)	1
Syncope † 1	2/441 (0.45%)	2	1/223 (0.45%)	1
Psychiatric disorders
Confusional state † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Psychotic disorder † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Suicidal ideation † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Renal and urinary disorders
Acute kidney injury † 1	3/441 (0.68%)	3	0/223 (0.00%)	0
Chronic kidney disease † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Nephrolithiasis † 1	2/441 (0.45%)	2	0/223 (0.00%)	0
Urinary retention † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Reproductive system and breast disorders
Pelvic pain † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Atelectasis † 1	0/441 (0.00%)	0	1/223 (0.45%)	1
Chronic obstructive pulmonary disease † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Cough † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Dyspnoea † 1	6/441 (1.36%)	7	2/223 (0.90%)	3
Pleural effusion † 1	2/441 (0.45%)	2	6/223 (2.69%)	6
Pneumonitis † 1	3/441 (0.68%)	3	0/223 (0.00%)	0
Skin and subcutaneous tissue disorders
Rash † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Surgical and medical procedures
Fracture treatment † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Internal fixation of fracture † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Leg amputation † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Medical device implantation † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Vascular disorders
Embolism † 1	9/441 (2.04%)	11	1/223 (0.45%)	1
Hypertension † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
Lymphoedema † 1	1/441 (0.23%)	1	1/223 (0.45%)	1
Vasculitis † 1	1/441 (0.23%)	1	0/223 (0.00%)	0
1 Term from vocabulary, MedDRA 25.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Abemaciclib + Fulvestrant		Placebo + Fulvestrant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	432/441 (97.96%)		194/223 (87.00%)
Blood and lymphatic system disorders
Anaemia † 1	155/441 (35.15%)	313	11/223 (4.93%)	15
Leukopenia † 1	148/441 (33.56%)	500	4/223 (1.79%)	10
Lymphopenia † 1	45/441 (10.20%)	113	2/223 (0.90%)	9
Neutropenia † 1	219/441 (49.66%)	760	8/223 (3.59%)	15
Thrombocytopenia † 1	79/441 (17.91%)	135	6/223 (2.69%)	7
Eye disorders
Lacrimation increased † 1	34/441 (7.71%)	44	3/223 (1.35%)	3
Gastrointestinal disorders
Abdominal distension † 1	24/441 (5.44%)	28	5/223 (2.24%)	6
Abdominal pain † 1	166/441 (37.64%)	320	36/223 (16.14%)	65
Constipation † 1	73/441 (16.55%)	96	36/223 (16.14%)	47
Diarrhoea † 1	384/441 (87.07%)	1205	62/223 (27.80%)	104
Dry mouth † 1	35/441 (7.94%)	40	15/223 (6.73%)	15
Dyspepsia † 1	33/441 (7.48%)	43	12/223 (5.38%)	15
Gastrooesophageal reflux disease † 1	25/441 (5.67%)	27	5/223 (2.24%)	5
Nausea † 1	218/441 (49.43%)	367	55/223 (24.66%)	72
Stomatitis † 1	82/441 (18.59%)	119	24/223 (10.76%)	30
Vomiting † 1	130/441 (29.48%)	253	26/223 (11.66%)	43
General disorders
Chills † 1	26/441 (5.90%)	30	1/223 (0.45%)	1
Fatigue † 1	192/441 (43.54%)	294	64/223 (28.70%)	81
Influenza like illness † 1	41/441 (9.30%)	71	16/223 (7.17%)	23
Injection site reaction † 1	48/441 (10.88%)	66	22/223 (9.87%)	40
Oedema peripheral † 1	62/441 (14.06%)	83	16/223 (7.17%)	21
Pain † 1	30/441 (6.80%)	42	11/223 (4.93%)	14
Pyrexia † 1	62/441 (14.06%)	99	16/223 (7.17%)	18
Infections and infestations
Sinusitis † 1	24/441 (5.44%)	36	6/223 (2.69%)	7
Skin infection † 1	25/441 (5.67%)	36	6/223 (2.69%)	7
Upper respiratory tract infection † 1	88/441 (19.95%)	159	19/223 (8.52%)	32
Urinary tract infection † 1	46/441 (10.43%)	76	10/223 (4.48%)	18
Investigations
Alanine aminotransferase increased † 1	79/441 (17.91%)	138	12/223 (5.38%)	15
Aspartate aminotransferase increased † 1	81/441 (18.37%)	132	16/223 (7.17%)	25
Blood alkaline phosphatase increased † 1	27/441 (6.12%)	47	7/223 (3.14%)	10
Blood creatinine increased † 1	63/441 (14.29%)	134	1/223 (0.45%)	1
Weight decreased † 1	54/441 (12.24%)	65	7/223 (3.14%)	10
Metabolism and nutrition disorders
Decreased appetite † 1	127/441 (28.80%)	162	30/223 (13.45%)	31
Hypokalaemia † 1	41/441 (9.30%)	77	7/223 (3.14%)	7
Musculoskeletal and connective tissue disorders
Arthralgia † 1	78/441 (17.69%)	154	34/223 (15.25%)	47
Back pain † 1	62/441 (14.06%)	100	30/223 (13.45%)	40
Bone pain † 1	29/441 (6.58%)	36	21/223 (9.42%)	25
Muscular weakness † 1	53/441 (12.02%)	90	15/223 (6.73%)	19
Myalgia † 1	44/441 (9.98%)	57	14/223 (6.28%)	17
Pain in extremity † 1	52/441 (11.79%)	119	11/223 (4.93%)	13
Nervous system disorders
Dizziness † 1	67/441 (15.19%)	111	16/223 (7.17%)	18
Dysgeusia † 1	82/441 (18.59%)	106	6/223 (2.69%)	7
Headache † 1	108/441 (24.49%)	203	36/223 (16.14%)	67
Neuropathy † 1	42/441 (9.52%)	51	21/223 (9.42%)	26
Psychiatric disorders
Anxiety † 1	23/441 (5.22%)	26	5/223 (2.24%)	6
Depression † 1	26/441 (5.90%)	28	10/223 (4.48%)	12
Insomnia † 1	42/441 (9.52%)	53	21/223 (9.42%)	24
Respiratory, thoracic and mediastinal disorders
Cough † 1	78/441 (17.69%)	114	30/223 (13.45%)	35
Dyspnoea † 1	51/441 (11.56%)	58	23/223 (10.31%)	28
Oropharyngeal pain † 1	28/441 (6.35%)	32	14/223 (6.28%)	15
Skin and subcutaneous tissue disorders
Alopecia † 1	76/441 (17.23%)	88	4/223 (1.79%)	4
Dermatitis acneiform † 1	23/441 (5.22%)	29	5/223 (2.24%)	6
Dry skin † 1	48/441 (10.88%)	61	5/223 (2.24%)	7
Pruritus † 1	64/441 (14.51%)	82	16/223 (7.17%)	18
Rash † 1	54/441 (12.24%)	75	11/223 (4.93%)	13
Vascular disorders
Embolism † 1	26/441 (5.90%)	31	1/223 (0.45%)	1
Hot flush † 1	51/441 (11.56%)	71	25/223 (11.21%)	28
Lymphoedema † 1	23/441 (5.22%)	25	4/223 (1.79%)	5
1 Term from vocabulary, MedDRA 25.0; † 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

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

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

Neven P, Rugo HS, Tolaney SM, Iwata H, Toi M, Goetz MP, Kaufman PA, Lu Y, Haddad N, Hurt KC, Sledge GW Jr. Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial. Breast Cancer Res. 2021 Aug 23;23(1):87. doi: 10.1186/s13058-021-01463-2.

Inoue K, Masuda N, Iwata H, Takahashi M, Ito Y, Miyoshi Y, Nakayama T, Mukai H, van der Walt JS, Mori J, Sakaguchi S, Kawaguchi T, Tanizawa Y, Llombart-Cussac A, Sledge GW Jr, Toi M. Japanese subpopulation analysis of MONARCH 2: phase 3 study of abemaciclib plus fulvestrant for treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that progressed on endocrine therapy. Breast Cancer. 2021 Sep;28(5):1038-1050. doi: 10.1007/s12282-021-01239-8. Epub 2021 Apr 1.

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.

Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Conte P, Lu Y, Barriga S, Hurt K, Frenzel M, Johnston S, Llombart-Cussac A. The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy-MONARCH 2: A Randomized Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):116-124. doi: 10.1001/jamaoncol.2019.4782.

Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Frenzel M, Lin Y, Barriga S, Smith IC, Bourayou N, Llombart-Cussac A. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol. 2017 Sep 1;35(25):2875-2884. doi: 10.1200/JCO.2017.73.7585. Epub 2017 Jun 3.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02107703
• Other Study ID Numbers: 15362; I3Y-MC-JPBL ( Other Identifier: Eli Lilly and Company ); 2013-004728-13 ( EudraCT Number )
• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Results First Submitted: February 12, 2018
• Results First Posted: March 13, 2018
• Last Update Posted: April 16, 2024