MONARCH 1: A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02102490
• Collaborator: (none)
• Enrollment: 132
• Locations: 36
• Arm: 1
• Actual Duration (Months): 52.4
• Patients Per Site: 3.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer	Drug: Abemaciclib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 132 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
• Actual Study Start Date: Jun 10, 2014
• Actual Primary Completion Date: Apr 30, 2016
• Actual Study Completion Date: Oct 22, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abemaciclib 200 milligrams (mg) abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.	Drug: Abemaciclib; Administered orally; Other Names: LY2835219

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) [From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)]

   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.

Secondary Outcome Measures

1. Overall Survival (OS) [From Date of First Dose until Death Due to Any Cause (Up To 27 Months)]

   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.

2. Duration of Response (DOR) [From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)]

   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.

3. Progression Free Survival (PFS) [From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)]

   PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of 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.

4. Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR]) [From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)]

   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.

5. Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate) [From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)]

   Clinical benefit rate defined as percentage of patients 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.

6. Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score [Cycle 6 Day 1]

   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).

7. Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20 [Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose]

   Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20

8. Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score [Cycle 6 Day 1]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria.

• Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.

• Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.

• Prior treatment with at least 2 chemotherapy regimens:

• At least 1 of these regimens must have been administered in the metastatic setting.

• At least 1 of these regimens must have contained a taxane.

• No more than 2 prior chemotherapy regimens in the metastatic setting.

• Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale.

• Have discontinued all previous therapies for cancer.

• Have the presence of measureable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1.

Exclusion Criteria:

• Have either a history of central nervous system (CNS) metastasis or evidence of CNS metastasis on the magnetic resonance image of brain obtained at baseline.

• Received prior therapy with another cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.

• Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug.

• Have had major surgery within 14 days of the initial dose of study drug.

• Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northern Arizona Hematology & Oncology Associates	Sedona	Arizona	United States	86336
2	HOPE Hematology Oncology Physicians and Extenders	Tucson	Arizona	United States	85704
3	Arizona Clinical Research Center	Tucson	Arizona	United States	85715
4	Univ of California San Francisco	San Francisco	California	United States	94115
5	Sansum Medical Research Foundation	Santa Barbara	California	United States	93105
6	Rocky Mountain Cancer Center	Denver	Colorado	United States	80220
7	Washington Hospital Center	Washington	District of Columbia	United States	20010
8	Florida Cancer Specialists	Fort Myers	Florida	United States	33916
9	Advanced Medical Specialties	Miami	Florida	United States	33176
10	Florida Cancer Specialists	Saint Petersburg	Florida	United States	33705
11	Maryland Oncology Hematology, P.A.	Columbia	Maryland	United States	21044
12	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
13	Minnesota Oncology/Hematology PA	Minneapolis	Minnesota	United States	55404
14	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
15	Oncology Hematology Care Inc	Cincinnati	Ohio	United States	45242
16	Sarah Cannon Research Institute SCRI	Nashville	Tennessee	United States	37203
17	Texas Oncology Cancer Center	Austin	Texas	United States	78731
18	Texas Oncology - Bedford	Bedford	Texas	United States	76022
19	Presbyterian Hospital Dallas	Dallas	Texas	United States	75231
20	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas	United States	75246
21	The Center for Cancer and Blood Disorders	Fort Worth	Texas	United States	76104
22	Texas Oncology-Memorial City	Houston	Texas	United States	77024
23	Texas Oncology-Plano West	Plano	Texas	United States	75093
24	Texas Oncology-Sherman	Sherman	Texas	United States	75090-0504
25	US Oncology	The Woodlands	Texas	United States	77380
26	Tyler Cancer Center	Tyler	Texas	United States	75702
27	Northwest Cancer Specialists PC	Vancouver	Washington	United States	98684
28	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Brussel		Belgium	1000
29	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Charleroi		Belgium	6000
30	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Leuven		Belgium	3000
31	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Liège		Belgium	4000
32	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Dijon		France	21034
33	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Paris		France	75248
34	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Barcelona		Spain	08035
35	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Madrid		Spain	28007
36	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Valencia		Spain	46015

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02102490
• Other Study ID Numbers: 15419; I3Y-MC-JPBN; 2013-005548-27
• First Posted: Apr 3, 2014
• Last Update Posted: Jan 21, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Eli Lilly and Company: Endocrine Therapy, Taxane, MONARCH 1
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Pre-assignment Detail	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	Abemaciclib
Arm/Group Description	200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Period Title: Overall Study
STARTED	132
Received at Least 1 Dose of Study Drug	132
COMPLETED	125
NOT COMPLETED	7

Baseline Characteristics

Arm/Group Title	Abemaciclib
Arm/Group Description	200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Overall Participants	132
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	59.13 (10.33)
Sex: Female, Male (Count of Participants)
Female	132 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	8 6.1%
Not Hispanic or Latino	112 84.8%
Unknown or Not Reported	12 9.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 1.5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	6 4.5%
White	112 84.8%
More than one race	0 0%
Unknown or Not Reported	12 9.1%
Region of Enrollment (Count of Participants)
Belgium	28 21.2%
United States	70 53%
France	11 8.3%
Spain	23 17.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Description	ORR was the percentage of participants achieving a best overall 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	From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug.

Arm/Group Title	Abemaciclib
Arm/Group Description	200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Measure Participants	132
Number (95% Confidence Interval) [Percentage of participants]	19.7 14.9%

2. Secondary Outcome

Title	Overall Survival (OS)
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	From Date of First Dose until Death Due to Any Cause (Up To 27 Months)

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug. Censored participants: Abemaciclib=70.

Arm/Group Title	Abemaciclib
Arm/Group Description	200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Measure Participants	132
Median (95% Confidence Interval) [Months]	22.32

3. 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.
Time Frame	From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug.

Arm/Group Title	Abemaciclib
Arm/Group Description	200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Measure Participants	132
Median (95% Confidence Interval) [Months]	8.6

4. Secondary Outcome

Title	Progression Free Survival (PFS)
Description	PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of 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	From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug. Censored participants: Abemaciclib=35.

Arm/Group Title	Abemaciclib
Arm/Group Description	200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Measure Participants	132
Median (95% Confidence Interval) [Months]	6.0

5. Secondary Outcome

Title	Percentage of Participants With CR, PR or 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.
Time Frame	From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of study drug.

Arm/Group Title	Abemaciclib
Arm/Group Description	200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Measure Participants	132
Number (95% Confidence Interval) [Percentage of participants]	67.4 51.1%

6. Secondary Outcome

Title	Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate)
Description	Clinical benefit rate defined as percentage of patients 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	From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)

Outcome Measure Data

Analysis Population Description

All enrolled participants who received at least one dose of the study drug.

Arm/Group Title	Abemaciclib
Arm/Group Description	200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Measure Participants	132
Number (95% Confidence Interval) [Percentage of participants]	42.4 32.1%

7. Secondary Outcome

Title	Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score
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).
Time Frame	Cycle 6 Day 1

Outcome Measure Data

Analysis Population Description

All randomized participants with a baseline and at least 1 post-baseline mBPI-sf data.

Arm/Group Title	Abemaciclib
Arm/Group Description	200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Measure Participants	59
Better	18 13.6%
No Change	21 15.9%
Worse	20 15.2%

8. Secondary Outcome

Title	Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) for Abemaciclib and Metabolites M2 and M20
Description	Area Under the 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 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Abemaciclib
Arm/Group Description	200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Measure Participants	132
Abemaciclib	3510 (38.0)
M2	1620 (55.0)
M20	2750 (55.0)

9. Secondary Outcome

Title	Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score
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.
Time Frame	Cycle 6 Day 1

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.

Arm/Group Title	Abemaciclib
Arm/Group Description	200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
Measure Participants	59
Better	17 12.9%
No Change	16 12.1%
Worse	26 19.7%

Adverse Events

Time Frame	Up To 45.57 Months
Adverse Event Reporting Description	All enrolled participants who received at least one dose of study drug.
Arm/Group Title	Abemaciclib
Arm/Group Description	200 mg abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met.
All Cause Mortality
	Abemaciclib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Abemaciclib
	Affected / at Risk (%)	# Events
Total	33/132 (25%)
Blood and lymphatic system disorders
Febrile neutropenia	1/132 (0.8%)	1
Haematotoxicity	1/132 (0.8%)	1
Neutropenia	1/132 (0.8%)	2
Cardiac disorders
Sinus bradycardia	1/132 (0.8%)	1
Tachycardia	1/132 (0.8%)	1
Gastrointestinal disorders
Abdominal pain	2/132 (1.5%)	2
Abdominal pain upper	1/132 (0.8%)	1
Constipation	1/132 (0.8%)	1
Large intestinal obstruction	1/132 (0.8%)	1
Nausea	3/132 (2.3%)	3
Pancreatic enzyme abnormality	1/132 (0.8%)	1
Pancreatitis	1/132 (0.8%)	1
Varices oesophageal	1/132 (0.8%)	1
Vomiting	1/132 (0.8%)	1
General disorders
Asthenia	1/132 (0.8%)	1
Pyrexia	1/132 (0.8%)	1
Infections and infestations
Atypical pneumonia	1/132 (0.8%)	2
Cellulitis	2/132 (1.5%)	5
Gastroenteritis viral	1/132 (0.8%)	1
Lung infection	1/132 (0.8%)	1
Respiratory tract infection	1/132 (0.8%)	1
Sepsis	1/132 (0.8%)	1
Injury, poisoning and procedural complications
Fall	1/132 (0.8%)	1
Hip fracture	1/132 (0.8%)	1
Investigations
Blood creatinine increased	3/132 (2.3%)	4
Electrocardiogram abnormal	1/132 (0.8%)	1
Liver function test abnormal	1/132 (0.8%)	1
Neutrophil count decreased	1/132 (0.8%)	1
Renal function test abnormal	1/132 (0.8%)	1
White blood cell count decreased	1/132 (0.8%)	1
Metabolism and nutrition disorders
Decreased appetite	1/132 (0.8%)	1
Dehydration	3/132 (2.3%)	3
Hypokalaemia	1/132 (0.8%)	1
Musculoskeletal and connective tissue disorders
Back pain	1/132 (0.8%)	1
Bone pain	1/132 (0.8%)	1
Muscular weakness	1/132 (0.8%)	1
Nervous system disorders
Epilepsy	1/132 (0.8%)	1
Renal and urinary disorders
Acute kidney injury	1/132 (0.8%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	2/132 (1.5%)	2
Pleural effusion	2/132 (1.5%)	2
Pneumonitis	1/132 (0.8%)	1
Pneumothorax	1/132 (0.8%)	1
Pulmonary embolism	1/132 (0.8%)	1
Skin and subcutaneous tissue disorders
Rash	1/132 (0.8%)	1
Vascular disorders
Arterial thrombosis	1/132 (0.8%)	1
Other (Not Including Serious) Adverse Events
	Abemaciclib
	Affected / at Risk (%)	# Events
Total	132/132 (100%)
Blood and lymphatic system disorders
Anaemia	35/132 (26.5%)	96
Neutropenia	24/132 (18.2%)	88
Thrombocytopenia	11/132 (8.3%)	21
Eye disorders
Lacrimation increased	11/132 (8.3%)	12
Gastrointestinal disorders
Abdominal pain	34/132 (25.8%)	54
Abdominal pain upper	16/132 (12.1%)	19
Constipation	27/132 (20.5%)	33
Diarrhoea	120/132 (90.9%)	370
Dry mouth	18/132 (13.6%)	18
Dyspepsia	14/132 (10.6%)	16
Flatulence	9/132 (6.8%)	11
Gastrooesophageal reflux disease	7/132 (5.3%)	13
Nausea	89/132 (67.4%)	141
Stomatitis	12/132 (9.1%)	17
Vomiting	46/132 (34.8%)	91
General disorders
Asthenia	31/132 (23.5%)	85
Chills	8/132 (6.1%)	8
Fatigue	63/132 (47.7%)	129
Oedema peripheral	14/132 (10.6%)	16
Pain	13/132 (9.8%)	19
Pyrexia	14/132 (10.6%)	17
Infections and infestations
Upper respiratory tract infection	9/132 (6.8%)	13
Urinary tract infection	9/132 (6.8%)	9
Investigations
Alanine aminotransferase increased	11/132 (8.3%)	15
Aspartate aminotransferase increased	12/132 (9.1%)	16
Blood creatinine increased	15/132 (11.4%)	41
Neutrophil count decreased	31/132 (23.5%)	105
Platelet count decreased	18/132 (13.6%)	42
Weight decreased	18/132 (13.6%)	22
White blood cell count decreased	24/132 (18.2%)	69
Metabolism and nutrition disorders
Decreased appetite	60/132 (45.5%)	76
Dehydration	11/132 (8.3%)	15
Hypokalaemia	9/132 (6.8%)	17
Musculoskeletal and connective tissue disorders
Arthralgia	25/132 (18.9%)	32
Back pain	16/132 (12.1%)	18
Musculoskeletal chest pain	8/132 (6.1%)	9
Musculoskeletal pain	8/132 (6.1%)	9
Myalgia	7/132 (5.3%)	8
Nervous system disorders
Dizziness	16/132 (12.1%)	18
Dysgeusia	18/132 (13.6%)	19
Headache	26/132 (19.7%)	40
Psychiatric disorders
Anxiety	8/132 (6.1%)	8
Respiratory, thoracic and mediastinal disorders
Cough	28/132 (21.2%)	42
Dyspnoea	17/132 (12.9%)	23
Skin and subcutaneous tissue disorders
Alopecia	20/132 (15.2%)	21
Dry skin	11/132 (8.3%)	13
Pruritus	11/132 (8.3%)	13
Rash	7/132 (5.3%)	9

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.