A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (monarcHER)

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ClinicalTrials.gov Identifier: NCT02675231

Recruitment Status : Completed

First Posted : February 5, 2016

Results First Posted : May 26, 2020

Last Update Posted : March 19, 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: None (Open Label); Primary Purpose: Treatment
Conditions	Hormone Receptor Positive Breast Cancer HER-2 Positive Breast Cancer
Interventions	Drug: Abemaciclib Drug: Trastuzumab Drug: Fulvestrant Drug: Standard of Care Single Agent Chemotherapy
Enrollment	237

Participant Flow

Recruitment Details
Pre-assignment Details	In the Participant Flow, participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment.


Arm/Group Title	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant	150 mg Abemaciclib + 8 mg/kg Trastuzumab	8 mg/kg Trastuzumab + Standard of Care Chemotherapy
Arm/Group Description	150 milligram (mg) abemaciclib give...	150 mg abemaciclib given orally Q12...	8 mg/kg trastuzumab IV infusion on ...
Arm/Group Description	150 milligram (mg) abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 milligram per kilogram (mg/kg) trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.	150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.	8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
Period Title: Overall Study
Started	79	79	79
Received at Least One Dose of Drug	78	77	72
Completed	53	43	53
Not Completed	26	36	26
Reason Not Completed
Withdrawal by Subject	1	3	1
Lost to Follow-up	2	2	2
On study treatment/follow up	23	31	23

Baseline Characteristics

Arm/Group Title		150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant	150 mg Abemaciclib + 8 mg/kg Trastuzumab	8 mg/kg Trastuzumab + Standard of Care Chemotherapy	Total
Arm/Group Description		150 mg abemaciclib given orally eve...	150 mg abemaciclib given orally Q12...	8 mg/kg trastuzumab IV infusion on ...	Total of all reporting groups
Arm/Group Description		150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.	150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.	8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.	Total of all reporting groups
Overall Number of Baseline Participants		79	79	79	237
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All enrolled participants.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	79 participants	79 participants	79 participants	237 participants
		54.34 (10.25)	54.99 (11.08)	56.77 (12.37)	55.37 (11.27)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	79 participants	79 participants	79 participants	237 participants
	Female	79	79	79	237
	Male	0	0	0	0
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	79 participants	79 participants	79 participants	237 participants
	Hispanic or Latino	14	11	12	37
	Not Hispanic or Latino	58	52	56	166
	Unknown or Not Reported	7	16	11	34
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	79 participants	79 participants	79 participants	237 participants
	American Indian or Alaska Native	0	1	1	2
	Asian	15	10	10	35
	Native Hawaiian or Other Pacific Islander	0	0	0	0
	Black or African American	3	2	4	9
	White	55	53	55	163
	More than one race	0	0	1	1
	Unknown or Not Reported	6	13	8	27
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	79 participants	79 participants	79 participants	237 participants
Argentina		9	7	3	19
United States		20	8	17	45
United Kingdom		9	9	10	28
Spain		6	8	3	17
Greece		1	1	2	4
Canada		2	4	4	10
South Korea		11	9	10	30
Belgium		5	7	7	19
Brazil		3	1	4	8
Italy		2	5	2	9
Mexico		2	1	3	6
Australia		2	4	2	8
France		6	13	8	27
Germany		1	2	4	7

Outcome Measures

1.Primary Outcome


Title	Progression Free Survival (PFS)
Description	PFS time was measured from the date of randomization to the date of in...
Description	PFS time was measured from the date of randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, 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 first dose, 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	Baseline to Progressive Disease or Death from Any Cause (Up To 36 Months)

Outcome Measure Data

Analysis Population Description

All enrolled participants. Censored participants: Abemaciclib + Trastuzumab + Fulvestrant=23; Abemaciclib + Trastuzumab = 18 and Trastuzumab + Standard of Care Chemotherapy = 27.


Arm/Group Title	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant	150 mg Abemaciclib + 8 mg/kg Trastuzumab	8 mg/kg Trastuzumab + Standard of Care Chemotherapy
Arm/Group Description:	150 mg abemaciclib given orally eve...	150 mg abemaciclib given orally Q12...	8 mg/kg trastuzumab IV infusion on ...
Arm/Group Description:	150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.	150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.	8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
Overall Number of Participants Analyzed	79	79	79
Median (95% Confidence Interval) Unit of Measure: Months
	8.3 (5.9 to 12.6)	5.7 (4.2 to 7.2)	5.7 (5.4 to 6.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	PFS analysis was planned after approximately 165 PFS events occurred in the enrolled population, yielding greater than or equal to (≥) 80% power assuming a Hazard ration (HR) of 0·667 at an experiment-wise 2-sided alpha level of 0·2.
	Type of Statistical Test	Superiority
	Comments	The abemaciclib plus trastuzumab plus fulvestrant arm will be compared to the standard of care (SOC) chemotherapy plus trastuzumab arm first, and the abemaciclib doublet arm will be compared to the SOC chemotherapy plus trastuzumab arm only if the test for the triplet vs the SOC chemotherapy plus trastuzumab arm is significant.

Statistical Test of Hypothesis	P-Value	0.0506
	Comments	[Not Specified]
	Method	Log Rank
	Comments	Stratified by number of prior systemic regimens for advanced breast cancer (2 to 3 versus(vs) >3) and status of disease(measurable vs non-measurable).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	PFS analysis was planned after approximately 165 PFS events occurred in the enrolled population, yielding greater than or equal to (≥) 80% power assuming a Hazard ration (HR) of 0·667 at an experiment-wise 2-sided alpha level of 0·2.
	Type of Statistical Test	Superiority
	Comments	The abemaciclib plus trastuzumab plus fulvestrant arm will be compared to the standard of care (SOC) chemotherapy plus trastuzumab arm first, and the abemaciclib doublet arm will be compared to the SOC chemotherapy plus trastuzumab arm only if the test for the triplet vs the SOC chemotherapy plus trastuzumab arm is significant.

Statistical Test of Hypothesis	P-Value	0.7695
	Comments	[Not Specified]
	Method	Log Rank
	Comments	Stratified by number of prior systemic regimens for advanced breast cancer (2 to 3 versus(vs) >3) and status of disease(measurable vs non-measurable).

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	Baseline to Death from Any Cause (Estimated up to 48 Months)

Outcome Measure Data Not Reported

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 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	Baseline to Objective Disease Progression (Up To 36 Months)

Outcome Measure Data

Analysis Population Description

All enrolled participants.


Arm/Group Title	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant	150 mg Abemaciclib + 8 mg/kg Trastuzumab	8 mg/kg Trastuzumab + Standard of Care Chemotherapy
Arm/Group Description:	150 mg abemaciclib given orally eve...	150 mg abemaciclib given orally Q12...	8 mg/kg trastuzumab IV infusion on ...
Arm/Group Description:	150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.	150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.	8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
Overall Number of Participants Analyzed	79	79	79
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of participants
	32.9 (22.5 to 43.3)	13.9 (6.3 to 21.6)	13.9 (6.3 to 21.6)

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	Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Up To 36 Months)

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and achieved CR or PR.Censored participants = 12 in 150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant

; 3 participants in 150 mg Abemaciclib + 8 mg/kg Trastuzumab and 11 participants in 8 mg/kg Trastuzumab + Standard of Care Chemotherapy.


Arm/Group Title	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant	150 mg Abemaciclib + 8 mg/kg Trastuzumab	8 mg/kg Trastuzumab + Standard of Care Chemotherapy
Arm/Group Description:	150 mg abemaciclib given orally eve...	150 mg abemaciclib given orally Q12...	8 mg/kg trastuzumab IV infusion on ...
Arm/Group Description:	150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.	150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.	8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
Overall Number of Participants Analyzed	26	11	11
Median (95% Confidence Interval) Unit of Measure: Months
	12.5 (6.5 to 23.5)	9.5 (2.8 to 22.7)	NA ^[1] (4.1 to NA)

[1]

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

5.Secondary Outcome


Title	Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD): Disease Control Rate (DCR)
Description	Disease Control Rate (DCR) was the percentage of participants with a b...
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.
Time Frame	Baseline to Objective Disease Progression (Up To 36 Months)

Outcome Measure Data

Analysis Population Description

All enrolled participants.


Arm/Group Title	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant	150 mg Abemaciclib + 8 mg/kg Trastuzumab	8 mg/kg Trastuzumab + Standard of Care Chemotherapy
Arm/Group Description:	150 mg abemaciclib given orally eve...	150 mg abemaciclib given orally Q12...	8 mg/kg trastuzumab IV infusion on ...
Arm/Group Description:	150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.	150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.	8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
Overall Number of Participants Analyzed	79	79	79
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of participants
	78.5 (69.4 to 87.5)	74.7 (65.1 to 84.3)	67.1 (56.7 to 77.5)

6.Secondary Outcome


Title	Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months: Clinical Benefit Rate (CBR)
Description	Clinical benefit rate defined as percentage of participants with best ...
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, 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	Date of CR, PR or SD to 6 Months Post CR, PR or SD (Up To 36 Months)

Outcome Measure Data

Analysis Population Description

All enrolled participants.


Arm/Group Title	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant	150 mg Abemaciclib + 8 mg/kg Trastuzumab	8 mg/kg Trastuzumab + Standard of Care Chemotherapy
Arm/Group Description:	150 mg abemaciclib given orally eve...	150 mg abemaciclib given orally Q12...	8 mg/kg trastuzumab IV infusion on ...
Arm/Group Description:	150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.	150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.	8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
Overall Number of Participants Analyzed	79	79	79
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of participants
	58.2 (47.4 to 69.1)	45.6 (34.6 to 56.6)	38.0 (27.3 to 48.7)

7.Secondary Outcome


Title	Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
Description	The mBPI-sf is an 11-item instrument used as a multiple-item measure o...
Description	The mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours and typical completion time for this instrument is less than 5 minutes. Mean Interference Score data is reported here. Least square (LS) Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.
Time Frame	Baseline, 30 Days After Treatment Discontinuation (Up To 36 Months)

Outcome Measure Data

Analysis Population Description

All enrolled participants.


Arm/Group Title	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant	150 mg Abemaciclib + 8 mg/kg Trastuzumab	8 mg/kg Trastuzumab + Standard of Care Chemotherapy
Arm/Group Description:	150 mg abemaciclib given orally eve...	150 mg abemaciclib given orally Q12...	8 mg/kg trastuzumab IV infusion on ...
Arm/Group Description:	150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.	150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.	8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
Overall Number of Participants Analyzed	79	79	79
Least Squares Mean (Standard Error) Unit of Measure: units on a scale
	0 (0.18)	0.20 (0.18)	0.31 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.232
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.31
	Estimation Comments	[Not Specified]

8.Secondary Outcome


Title	Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Description	EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidim...
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, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.
Time Frame	Baseline, 30 Days After Treatment Discontinuation (Up To 36 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 for each EORTC QLQ-C30 items.


Arm/Group Title		150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant	150 mg Abemaciclib + 8 mg/kg Trastuzumab	8 mg/kg Trastuzumab + Standard of Care Chemotherapy
Arm/Group Description:		150 mg abemaciclib given orally eve...	150 mg abemaciclib given orally Q12...	8 mg/kg trastuzumab IV infusion on ...
Arm/Group Description:		150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.	150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.	8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
Overall Number of Participants Analyzed		72	72	69
Least Squares Mean (Standard Error) Unit of Measure: units on a scale
Global health status	Number Analyzed	72 participants	72 participants	69 participants
Global health status		-2.9 (1.6)	-5.9 (1.7)	-1.9 (1.8)
Functional scale: Physical functioning	Number Analyzed	72 participants	72 participants	69 participants
Functional scale: Physical functioning		-1.0 (1.6)	-4.4 (1.6)	-4.5 (1.7)
Functional scale: Role functioning	Number Analyzed	72 participants	72 participants	69 participants
Functional scale: Role functioning		-2.7 (2.2)	-5.0 (2.3)	-8.2 (2.4)
Functional scale: Emotional functioning	Number Analyzed	72 participants	71 participants	69 participants
Functional scale: Emotional functioning		2.4 (1.7)	-0.4 (1.8)	1.1 (1.8)
Functional scale: Cognitive functioning	Number Analyzed	72 participants	72 participants	69 participants
Functional scale: Cognitive functioning		-1.8 (1.4)	-1.1 (1.5)	-1.6 (1.6)
Functional scale: Social functioning	Number Analyzed	72 participants	71 participants	69 participants
Functional scale: Social functioning		-0.9 (1.9)	-0.9 (1.9)	-2.4 (2.0)
Symptom scale: Fatigue	Number Analyzed	72 participants	72 participants	69 participants
Symptom scale: Fatigue		1.8 (1.9)	7.0 (2.0)	4.7 (2.1)
Symptom scale: Nausea and vomiting	Number Analyzed	72 participants	72 participants	69 participants
Symptom scale: Nausea and vomiting		6.3 (1.4)	5.6 (1.4)	2.2 (1.5)
Symptom scale: Pain	Number Analyzed	72 participants	72 participants	69 participants
Symptom scale: Pain		-2.5 (2.1)	3.1 (2.1)	4.3 (2.2)
Symptom scale: Dyspnoea	Number Analyzed	72 participants	72 participants	69 participants
Symptom scale: Dyspnoea		0.7 (1.9)	2.9 (2.0)	3.7 (2.1)
Symptom scale: Insomnia	Number Analyzed	72 participants	72 participants	69 participants
Symptom scale: Insomnia		-4.4 (2.1)	-1.6 (2.2)	2.0 (2.3)
Symptom scale: Appetite loss	Number Analyzed	72 participants	72 participants	69 participants
Symptom scale: Appetite loss		6.3 (2.3)	5.5 (2.4)	2.4 (2.5)
Symptom scale: Constipation	Number Analyzed	72 participants	71 participants	69 participants
Symptom scale: Constipation		-6.3 (1.9)	-10.5 (1.9)	-3.4 (2.0)
Symptom scale: Diarrhoea	Number Analyzed	72 participants	72 participants	69 participants
Symptom scale: Diarrhoea		21.5 (2.2)	25.3 (2.3)	2.2 (2.4)
Symptom scale: Financial difficulties	Number Analyzed	72 participants	71 participants	68 participants
Symptom scale: Financial difficulties		0.8 (2.0)	-1.9 (2.1)	-3.2 (2.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	Global health status
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.689
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Least Square (LS) Mean Difference
	Estimated Value	-1.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	Functional scales: Physical functioning
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.141
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	3.4
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.3
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	Functional scale: Role functioning
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.095
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	5.5
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.3
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	Functional scale: Emotional functioning
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.591
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.3
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.5
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	Functional scale: Cognitive functioning
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.935
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-0.2
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.1
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	Functional scale: Social functioning
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.578
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.5
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.7
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	Symptom scale: Fatigue
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.308
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-2.9
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.8
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	Symptom scale: Nausea and vomiting
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.043
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	4.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.0
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	Symptom scale: Pain
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.026
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-6.8
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.0
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	Symptom scale: Dyspnoea
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.276
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-3.1
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.8
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	Symptom scale: Insomnia
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.041
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-6.4
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.1
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	Symptom scale: Appetite loss
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.262
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	3.9
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.4
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	Symptom scale: Constipation
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.285
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-2.9
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.7
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	Symptom scale: Diarrhoea
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	19.3
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.2
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	Symptom scale: Financial difficulties
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.180
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model (MMRM): Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	4.0
	Parameter Dispersion	Type: Standard Error of the Mean Value: 3.0
	Estimation Comments	[Not Specified]

9.Secondary Outcome


Title	Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
Description	The EQ-5D-5L is a standardized instrument for use as a measure of self...
Description	The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status.LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline.
Time Frame	Baseline, 30 Days After Treatment Discontinuation (Up To 36 Months)

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant	150 mg Abemaciclib + 8 mg/kg Trastuzumab	8 mg/kg Trastuzumab + Standard of Care Chemotherapy
Arm/Group Description:	150 mg abemaciclib given orally eve...	150 mg abemaciclib given orally Q12...	8 mg/kg trastuzumab IV infusion on ...
Arm/Group Description:	150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.	150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.	8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
Overall Number of Participants Analyzed	72	72	68
Least Squares Mean (Standard Error) Unit of Measure: units on a scale
	0.01 (0.02)	-0.01 (0.02)	-0.04 (0.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.033
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model: Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.05
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.02
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.275
	Comments	p-values are from Type 3 sums of squares mixed models repeated measures model: Change from baseline = Treatment + Visit + Treatment*Visit + Baseline.
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	0.03
	Parameter Dispersion	Type: Standard Error of the Mean Value: 0.02
	Estimation Comments	[Not Specified]

10.Secondary Outcome


Title	Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)
Description	European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standard...
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 100 millimeter (mm), 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, 30 Days After Treatment Discontinuation (Up To 36 Months)

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant	150 mg Abemaciclib + 8 mg/kg Trastuzumab	8 mg/kg Trastuzumab + Standard of Care Chemotherapy
Arm/Group Description:	150 mg abemaciclib given orally eve...	150 mg abemaciclib given orally Q12...	8 mg/kg trastuzumab IV infusion on ...
Arm/Group Description:	150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.	150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.	8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
Overall Number of Participants Analyzed	72	71	70
Least Squares Mean (Standard Error) Unit of Measure: millimeter (mm)
	0.61 (1.4)	-1.64 (1.4)	-0.61 (1.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.546
	Comments	[Not Specified]
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	1.22
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.02
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	150 mg Abemaciclib + 8 mg/kg Trastuzumab, 8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.620
	Comments	[Not Specified]
	Method	MMRM Model
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.02
	Parameter Dispersion	Type: Standard Error of the Mean Value: 2.1
	Estimation Comments	[Not Specified]

11.Secondary Outcome


Title	Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib and Its Metabolites (M2 and M20)
Description	Minimum Steady State Concentration (Cmin,ss) of Abemaciclib and Its Me...
Description	Minimum Steady State Concentration (Cmin,ss) of Abemaciclib and Its Metabolites (M2 and M20) was evaluated. M2 and M20 are 2 major active metabolites of abemaciclib.
Time Frame	Cycle(C)1 Day(D)1,C1D15, C2D1, C2D8, C3D1,C3D15, C4D1, C5D1:pre-dose; C1D1, C2D1, C3D1, C4D1, C5D1:post-dose

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug and had evaluable PK data.


Arm/Group Title	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant	150 mg Abemaciclib + 8 mg/kg Trastuzumab
Arm/Group Description:	150 mg abemaciclib given orally eve...	150 mg abemaciclib given orally Q12...
Arm/Group Description:	150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8 mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500 mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.	150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.
Overall Number of Participants Analyzed	77	71
Geometric Mean (Geometric Coefficient of Variation) Unit of Measure: nanogram/milliliter (ng/mL)
Abemaciclib	134 (77%)	155 (53%)
M2	72.0 (120%)	96.5 (120%)
M20	136 (120%)	181 (130%)

Adverse Events

Time Frame	Up To 36 Months
Adverse Event Reporting Description	All enrolled participants who received at least one dose of study drug.

Arm/Group Title	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant		150 mg Abemaciclib + 8 mg/kg Trastuzumab		8 mg/kg Trastuzumab + Standard of Care Chemotherapy
Arm/Group Description	150 mg abemaciclib given orally eve...		150 mg abemaciclib given orally Q12...		8 mg/kg trastuzumab IV infusion on ...
Arm/Group Description	150 mg abemaciclib given orally every 12 hours (Q12H) of a 21-day cycle; plus 8mg/kg trastuzumab intravenous (IV) infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle; plus 500mg fulvestrant intramuscularly (IM) on day 1, 15 and 29 and then once every 4 weeks thereafter.		150 mg abemaciclib given orally Q12H of a 21-day cycle; plus 8 mg/kg trastuzumab IV infusion on Day 1 of the cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle.		8 mg/kg trastuzumab IV infusion on Day 1 of a 21-day cycle then a 6 mg/kg maintenance dose IV infusion on Day 1 of each subsequent cycle plus standard of care single agent chemotherapy of physician's choice administered according to product label.
All-Cause Mortality
	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant		150 mg Abemaciclib + 8 mg/kg Trastuzumab		8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	31/78 (39.74%)		29/77 (37.66%)		31/72 (43.06%)
Serious Adverse Events Serious Adverse Events
	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant		150 mg Abemaciclib + 8 mg/kg Trastuzumab		8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/78 (26.92%)		15/77 (19.48%)		11/72 (15.28%)
Blood and lymphatic system disorders
Anaemia ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	3	0/72 (0.00%)	0
Febrile neutropenia ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	3/72 (4.17%)	4
Cardiac disorders
Cardio-respiratory arrest ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Pericardial effusion ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	1/72 (1.39%)	1
Gastrointestinal disorders
Abdominal pain ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Ascites ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	1	0/72 (0.00%)	0
Diarrhoea ^† 1	1/78 (1.28%)	1	2/77 (2.60%)	2	0/72 (0.00%)	0
Faecaloma ^† 1	0/78 (0.00%)	0	0/77 (0.00%)	0	1/72 (1.39%)	1
Ileus ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	1	0/72 (0.00%)	0
Intestinal obstruction ^† 1	1/78 (1.28%)	2	0/77 (0.00%)	0	0/72 (0.00%)	0
Nausea ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Stomatitis ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Vomiting ^† 1	1/78 (1.28%)	1	1/77 (1.30%)	1	0/72 (0.00%)	0
General disorders
Pain ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	1	0/72 (0.00%)	0
Pyrexia ^† 1	3/78 (3.85%)	5	1/77 (1.30%)	1	0/72 (0.00%)	0
Hepatobiliary disorders
Bile duct stone ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	1	0/72 (0.00%)	0
Cholangitis ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Immune system disorders
Drug hypersensitivity ^† 1	0/78 (0.00%)	0	0/77 (0.00%)	0	1/72 (1.39%)	1
Infections and infestations
Cellulitis ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Fungal infection ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Gastroenteritis ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Gastroenteritis viral ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Herpes zoster ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	1	0/72 (0.00%)	0
Influenza ^† 1	0/78 (0.00%)	0	0/77 (0.00%)	0	1/72 (1.39%)	1
Lower respiratory tract infection ^† 1	1/78 (1.28%)	2	0/77 (0.00%)	0	0/72 (0.00%)	0
Lung infection ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	1	0/72 (0.00%)	0
Lymphangitis ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Otitis media ^† 1	0/78 (0.00%)	0	0/77 (0.00%)	0	1/72 (1.39%)	1
Pneumonia ^† 1	1/78 (1.28%)	2	1/77 (1.30%)	1	1/72 (1.39%)	1
Sepsis ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	1/72 (1.39%)	1
Soft tissue infection ^† 1	0/78 (0.00%)	0	0/77 (0.00%)	0	1/72 (1.39%)	1
Urinary tract infection ^† 1	2/78 (2.56%)	2	1/77 (1.30%)	1	0/72 (0.00%)	0
Injury, poisoning and procedural complications
Femur fracture ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	1	0/72 (0.00%)	0
Hip fracture ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Radiation pneumonitis ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	1	0/72 (0.00%)	0
Investigations
Neutrophil count decreased ^† 1	0/78 (0.00%)	0	0/77 (0.00%)	0	1/72 (1.39%)	2
White blood cell count decreased ^† 1	0/78 (0.00%)	0	0/77 (0.00%)	0	1/72 (1.39%)	2
Metabolism and nutrition disorders
Decreased appetite ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	1	0/72 (0.00%)	0
Hypokalaemia ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Musculoskeletal and connective tissue disorders
Back pain ^† 1	0/78 (0.00%)	0	0/77 (0.00%)	0	1/72 (1.39%)	1
Musculoskeletal chest pain ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Musculoskeletal pain ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	1	0/72 (0.00%)	0
Osteonecrosis of jaw ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	1	0/72 (0.00%)	0
Nervous system disorders
Cerebral haemorrhage ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Dizziness ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Headache ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Psychiatric disorders
Confusional state ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Renal and urinary disorders
Acute kidney injury ^† 1	2/78 (2.56%)	2	1/77 (1.30%)	1	0/72 (0.00%)	0
Urinary retention ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Urinary tract obstruction ^† 1	0/78 (0.00%)	0	0/77 (0.00%)	0	1/72 (1.39%)	1
Reproductive system and breast disorders
Vaginal haemorrhage ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	2	0/72 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Dyspnoea ^† 1	1/78 (1.28%)	2	1/77 (1.30%)	1	0/72 (0.00%)	0
Epistaxis ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	1	0/72 (0.00%)	0
Interstitial lung disease ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	1	0/72 (0.00%)	0
Pleural effusion ^† 1	0/78 (0.00%)	0	0/77 (0.00%)	0	2/72 (2.78%)	2
Pneumonitis ^† 1	0/78 (0.00%)	0	0/77 (0.00%)	0	1/72 (1.39%)	1
Pneumothorax ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Pulmonary embolism ^† 1	1/78 (1.28%)	1	0/77 (0.00%)	0	0/72 (0.00%)	0
Respiratory failure ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	2	0/72 (0.00%)	0
1 Term from vocabulary, MedDRA 22.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	150 mg Abemaciclib + 8 mg/kg Trastuzumab + 500 mg Fulvestrant		150 mg Abemaciclib + 8 mg/kg Trastuzumab		8 mg/kg Trastuzumab + Standard of Care Chemotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	76/78 (97.44%)		75/77 (97.40%)		68/72 (94.44%)
Blood and lymphatic system disorders
Anaemia ^† 1	27/78 (34.62%)	85	20/77 (25.97%)	43	16/72 (22.22%)	42
Leukopenia ^† 1	6/78 (7.69%)	16	2/77 (2.60%)	2	3/72 (4.17%)	24
Neutropenia ^† 1	17/78 (21.79%)	54	9/77 (11.69%)	28	15/72 (20.83%)	51
Thrombocytopenia ^† 1	3/78 (3.85%)	6	8/77 (10.39%)	13	0/72 (0.00%)	0
Eye disorders
Lacrimation increased ^† 1	6/78 (7.69%)	12	4/77 (5.19%)	6	2/72 (2.78%)	2
Vision blurred ^† 1	4/78 (5.13%)	4	3/77 (3.90%)	3	1/72 (1.39%)	1
Gastrointestinal disorders
Abdominal distension ^† 1	5/78 (6.41%)	5	3/77 (3.90%)	3	0/72 (0.00%)	0
Abdominal pain ^† 1	16/78 (20.51%)	21	13/77 (16.88%)	14	12/72 (16.67%)	14
Abdominal pain upper ^† 1	10/78 (12.82%)	12	3/77 (3.90%)	7	4/72 (5.56%)	4
Constipation ^† 1	9/78 (11.54%)	11	8/77 (10.39%)	10	14/72 (19.44%)	18
Diarrhoea ^† 1	61/78 (78.21%)	191	60/77 (77.92%)	179	18/72 (25.00%)	40
Dry mouth ^† 1	4/78 (5.13%)	5	4/77 (5.19%)	5	4/72 (5.56%)	6
Dyspepsia ^† 1	8/78 (10.26%)	15	6/77 (7.79%)	9	5/72 (6.94%)	5
Gastrooesophageal reflux disease ^† 1	5/78 (6.41%)	5	1/77 (1.30%)	1	1/72 (1.39%)	1
Nausea ^† 1	36/78 (46.15%)	58	32/77 (41.56%)	47	25/72 (34.72%)	36
Stomatitis ^† 1	3/78 (3.85%)	6	7/77 (9.09%)	10	8/72 (11.11%)	17
Vomiting ^† 1	20/78 (25.64%)	31	22/77 (28.57%)	29	11/72 (15.28%)	13
General disorders
Asthenia ^† 1	11/78 (14.10%)	17	12/77 (15.58%)	16	7/72 (9.72%)	14
Fatigue ^† 1	33/78 (42.31%)	58	29/77 (37.66%)	52	26/72 (36.11%)	30
Influenza like illness ^† 1	2/78 (2.56%)	2	6/77 (7.79%)	12	0/72 (0.00%)	0
Mucosal inflammation ^† 1	1/78 (1.28%)	1	3/77 (3.90%)	4	4/72 (5.56%)	6
Non-cardiac chest pain ^† 1	5/78 (6.41%)	6	0/77 (0.00%)	0	1/72 (1.39%)	1
Oedema peripheral ^† 1	4/78 (5.13%)	6	6/77 (7.79%)	9	7/72 (9.72%)	9
Pyrexia ^† 1	11/78 (14.10%)	15	4/77 (5.19%)	7	10/72 (13.89%)	16
Infections and infestations
Gastroenteritis ^† 1	5/78 (6.41%)	5	0/77 (0.00%)	0	2/72 (2.78%)	3
Influenza ^† 1	4/78 (5.13%)	6	5/77 (6.49%)	6	2/72 (2.78%)	2
Nasopharyngitis ^† 1	5/78 (6.41%)	5	3/77 (3.90%)	3	2/72 (2.78%)	2
Rhinitis ^† 1	4/78 (5.13%)	4	2/77 (2.60%)	2	1/72 (1.39%)	1
Upper respiratory tract infection ^† 1	8/78 (10.26%)	15	2/77 (2.60%)	2	8/72 (11.11%)	12
Urinary tract infection ^† 1	6/78 (7.69%)	9	8/77 (10.39%)	21	5/72 (6.94%)	8
Investigations
Alanine aminotransferase increased ^† 1	6/78 (7.69%)	12	6/77 (7.79%)	12	8/72 (11.11%)	20
Aspartate aminotransferase increased ^† 1	9/78 (11.54%)	13	7/77 (9.09%)	12	8/72 (11.11%)	24
Blood alkaline phosphatase increased ^† 1	6/78 (7.69%)	11	1/77 (1.30%)	1	2/72 (2.78%)	4
Blood bilirubin increased ^† 1	5/78 (6.41%)	6	2/77 (2.60%)	3	4/72 (5.56%)	8
Blood creatinine increased ^† 1	10/78 (12.82%)	14	11/77 (14.29%)	16	0/72 (0.00%)	0
Lymphocyte count decreased ^† 1	2/78 (2.56%)	2	4/77 (5.19%)	5	4/72 (5.56%)	26
Neutrophil count decreased ^† 1	24/78 (30.77%)	65	19/77 (24.68%)	73	13/72 (18.06%)	61
Platelet count decreased ^† 1	19/78 (24.36%)	58	16/77 (20.78%)	42	5/72 (6.94%)	36
Weight decreased ^† 1	6/78 (7.69%)	7	5/77 (6.49%)	5	1/72 (1.39%)	1
White blood cell count decreased ^† 1	12/78 (15.38%)	32	7/77 (9.09%)	26	8/72 (11.11%)	46
Metabolism and nutrition disorders
Decreased appetite ^† 1	16/78 (20.51%)	27	16/77 (20.78%)	24	13/72 (18.06%)	15
Dehydration ^† 1	3/78 (3.85%)	4	2/77 (2.60%)	2	4/72 (5.56%)	4
Hyperglycaemia ^† 1	1/78 (1.28%)	1	1/77 (1.30%)	3	4/72 (5.56%)	9
Hyperkalaemia ^† 1	5/78 (6.41%)	6	3/77 (3.90%)	3	1/72 (1.39%)	1
Hypokalaemia ^† 1	6/78 (7.69%)	16	7/77 (9.09%)	15	4/72 (5.56%)	4
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	10/78 (12.82%)	13	8/77 (10.39%)	9	8/72 (11.11%)	9
Back pain ^† 1	5/78 (6.41%)	6	11/77 (14.29%)	12	5/72 (6.94%)	7
Bone pain ^† 1	1/78 (1.28%)	1	3/77 (3.90%)	3	7/72 (9.72%)	7
Musculoskeletal pain ^† 1	2/78 (2.56%)	2	5/77 (6.49%)	7	3/72 (4.17%)	3
Myalgia ^† 1	7/78 (8.97%)	9	7/77 (9.09%)	7	10/72 (13.89%)	12
Pain in extremity ^† 1	1/78 (1.28%)	2	5/77 (6.49%)	7	8/72 (11.11%)	9
Nervous system disorders
Dizziness ^† 1	4/78 (5.13%)	6	8/77 (10.39%)	10	2/72 (2.78%)	2
Dysgeusia ^† 1	4/78 (5.13%)	4	4/77 (5.19%)	4	2/72 (2.78%)	2
Headache ^† 1	12/78 (15.38%)	17	10/77 (12.99%)	14	13/72 (18.06%)	15
Neuropathy peripheral ^† 1	3/78 (3.85%)	3	0/77 (0.00%)	0	4/72 (5.56%)	4
Peripheral sensory neuropathy ^† 1	2/78 (2.56%)	2	5/77 (6.49%)	6	9/72 (12.50%)	15
Psychiatric disorders
Anxiety ^† 1	2/78 (2.56%)	2	3/77 (3.90%)	3	4/72 (5.56%)	4
Insomnia ^† 1	4/78 (5.13%)	5	6/77 (7.79%)	12	5/72 (6.94%)	5
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	18/78 (23.08%)	25	11/77 (14.29%)	14	8/72 (11.11%)	12
Dyspnoea ^† 1	14/78 (17.95%)	21	7/77 (9.09%)	9	12/72 (16.67%)	14
Epistaxis ^† 1	6/78 (7.69%)	8	7/77 (9.09%)	11	5/72 (6.94%)	5
Skin and subcutaneous tissue disorders
Alopecia ^† 1	6/78 (7.69%)	6	7/77 (9.09%)	8	8/72 (11.11%)	10
Dry skin ^† 1	5/78 (6.41%)	5	4/77 (5.19%)	4	4/72 (5.56%)	4
Nail disorder ^† 1	2/78 (2.56%)	3	4/77 (5.19%)	4	1/72 (1.39%)	2
Onychoclasis ^† 1	4/78 (5.13%)	4	1/77 (1.30%)	1	0/72 (0.00%)	0
Palmar-plantar erythrodysaesthesia syndrome ^† 1	0/78 (0.00%)	0	1/77 (1.30%)	2	12/72 (16.67%)	19
Pruritus ^† 1	11/78 (14.10%)	18	9/77 (11.69%)	10	3/72 (4.17%)	3
Rash ^† 1	5/78 (6.41%)	7	8/77 (10.39%)	12	6/72 (8.33%)	8
Rash maculo-papular ^† 1	5/78 (6.41%)	6	6/77 (7.79%)	9	2/72 (2.78%)	4
Vascular disorders
Hot flush ^† 1	5/78 (6.41%)	7	3/77 (3.90%)	4	2/72 (2.78%)	2
Hypertension ^† 1	3/78 (3.85%)	4	4/77 (5.19%)	7	2/72 (2.78%)	3
1 Term from vocabulary, MedDRA 22.0 † 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 NOT 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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tolaney SM, Wardley AM, Zambelli S, Hilton JF, Troso-Sandoval TA, Ricci F, Im SA, Kim SB, Johnston SR, Chan A, Goel S, Catron K, Chapman SC, Price GL, Yang Z, Gainford MC, Andre F. Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial. Lancet Oncol. 2020 Jun;21(6):763-775. doi: 10.1016/S1470-2045(20)30112-1. Epub 2020 Apr 27. Erratum In: Lancet Oncol. 2021 Mar;22(3):e92. Lancet Oncol. 2021 Nov;22(11):e472.

Layout table for additonal information

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT02675231
Other Study ID Numbers:	15804 I3Y-MC-JPBZ ( Other Identifier: Eli Lilly and Company ) 2015-003400-24 ( EudraCT Number )
First Submitted:	February 3, 2016
First Posted:	February 5, 2016
Results First Submitted:	April 8, 2020
Results First Posted:	May 26, 2020
Last Update Posted:	March 19, 2024

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