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A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer (Next MONARCH 1)

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ClinicalTrials.gov Identifier: NCT02747004
Recruitment Status : Active, not recruiting
First Posted : April 21, 2016
Results First Posted : July 12, 2019
Last Update Posted : October 30, 2019
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
Condition Metastatic Breast Cancer
Interventions Drug: Abemaciclib
Drug: Tamoxifen
Drug: Prophylactic Loperamide
Enrollment 234
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 150mg Abemaciclib + 20mg Tamoxifen 150mg Abemaciclib 200mg Abemaciclib + 2mg Prophylactic Loperamide
Hide Arm/Group Description Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle. Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle. Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.
Period Title: Overall Study
Started 78 79 77
Received at Least One Dose of Study Drug 78 79 77
Completed 21 30 30
Not Completed 57 49 47
Reason Not Completed
Withdrawal by Subject             8             5             4
Lost to Follow-up             1             2             2
on study treatment/follow-up             48             42             41
Arm/Group Title 150mg Abemaciclib + 20mg Tamoxifen 150mg Abemaciclib 200mg Abemaciclib + 2mg Prophylactic Loperamide Total
Hide Arm/Group Description Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle. Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle. Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle. Total of all reporting groups
Overall Number of Baseline Participants 78 79 77 234
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 79 participants 77 participants 234 participants
54.28  (12.47) 56.18  (12.24) 55.86  (11.03) 55.44  (11.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 79 participants 77 participants 234 participants
Female 78 79 77 234
Male 0 0 0 0
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 79 participants 77 participants 234 participants
Hispanic or Latino 16 20 21 57
Not Hispanic or Latino 55 45 46 146
Unknown or Not Reported 7 14 10 31
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 79 participants 77 participants 234 participants
American Indian or Alaska Native 4 3 4 11
Asian 8 6 10 24
Native Hawaiian or Other Pacific Islander 0 0 0 0
Black or African American 2 1 2 5
White 63 64 60 187
More than one race 0 1 0 1
Unknown or Not Reported 1 4 1 6
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression-free survival time was measured from the date of randomization to the date of investigator-determined objective progression as defined by RECIST v1.1, or death from any cause, whichever occurred first. Progressive disease (PD) is defined as 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. Participants who have neither progressed nor died were censored at the day of their last radiographic tumor assessment (if available) or date of randomization if no post baseline radiographic assessment is available.
Time Frame Baseline to Objective Disease Progression or Death from Any Cause (Up to 21 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug. Censored participants: 21 in Abemaciclib 150 mg + Tamoxifen 20mg; 25 in Abemaciclib 150 mg; 22 in Abemaciclib 200mg.
Arm/Group Title 150mg Abemaciclib + 20mg Tamoxifen 150mg Abemaciclib 200mg Abemaciclib + 2mg Prophylactic Loperamide
Hide Arm/Group Description:
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.
Overall Number of Participants Analyzed 78 79 77
Median (95% Confidence Interval)
Unit of Measure: Months
9.07
(6.90 to 10.95)
6.48
(4.77 to 9.21)
7.43
(5.42 to 9.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 150mg Abemaciclib + 20mg Tamoxifen, 200mg Abemaciclib + 2mg Prophylactic Loperamide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2930
Comments Two-sided P-value.
Method Log Rank
Comments Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 150mg Abemaciclib, 200mg Abemaciclib + 2mg Prophylactic Loperamide
Comments [Not Specified]
Type of Statistical Test Other
Comments Informal phase 2 non-inferiority.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Log Rank
Comments Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.045
Confidence Interval (2-Sided) 95%
0.711 to 1.535
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
Hide Description Objective response rate was defined as the percentage of participants with CR or PR according to RECIST v1.1. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the LD (longest diameter) 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 21 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had PR/CR data.
Arm/Group Title 150mg Abemaciclib + 20mg Tamoxifen 150mg Abemaciclib 200mg Abemaciclib + 2mg Prophylactic Loperamide
Hide Arm/Group Description:
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.
Overall Number of Participants Analyzed 78 79 77
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
34.6
(24.1 to 45.2)
24.1
(14.6 to 33.5)
32.5
(22 to 42.9)
3.Secondary Outcome
Title Duration of Response (DoR)
Hide Description DoR is defined as the time from the date of first evidence of a CR or PR to the date of objective progression or death from any cause, whichever is earlier as defined by Recist v1.1. CR was defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR was 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.
Time Frame Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 21 Months)
Hide Outcome Measure Data
Hide Analysis Population Description

All randomized participants who received at least one dose of study drug and achieved CR or PR.

Censored participants: 9 in Abemaciclib 150 mg + Tamoxifen 20mg; 9 in Abemaciclib 150 mg; 11 in Abemaciclib 200mg.

Arm/Group Title 150mg Abemaciclib + 20mg Tamoxifen 150mg Abemaciclib 200mg Abemaciclib + 2mg Prophylactic Loperamide
Hide Arm/Group Description:
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.
Overall Number of Participants Analyzed 27 19 25
Median (95% Confidence Interval)
Unit of Measure: Months
7.40
(3.88 to 9.27)
9.21 [1] 
(3.72 to NA)
7.46
(5.56 to 10.92)
[1]
Upper bound not estimable.
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame Baseline to Death from Any Cause (Approximately 36 Months)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites
Hide Description Mean single dose concentrations of Abemaciclib and its metabolites (M2 & M20) are reported.
Time Frame Cycle (C) 1 Day (D) 1 post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable PK samples.
Arm/Group Title 150mg Abemaciclib + 20mg Tamoxifen 150mg Abemaciclib 200mg Abemaciclib + 2mg Prophylactic Loperamide
Hide Arm/Group Description:
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.
Overall Number of Participants Analyzed 19 13 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per Millilitre (ng/mL)
Abemaciclib (C1D1) Number Analyzed 17 participants 10 participants 15 participants
10.9
(231%)
3.05
(95.4%)
8.59
(440%)
M2 (C1D1) Number Analyzed 18 participants 9 participants 13 participants
6.05
(123%)
2.14
(60.1%)
6.85
(237%)
M20 (C1D1) Number Analyzed 19 participants 13 participants 20 participants
6.50
(132%)
2.54
(54.5%)
7.91
(220%)
6.Secondary Outcome
Title Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites
Hide Description

Mean steady state concentrations of Abemaciclib and its metabolites (M2 & M20) are reported.

C=Cycle D= Day

Time Frame Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had evaluable PK samples.
Arm/Group Title 150mg Abemaciclib + 20mg Tamoxifen 150mg Abemaciclib 200mg Abemaciclib + 2mg Prophylactic Loperamide
Hide Arm/Group Description:
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.
Overall Number of Participants Analyzed 55 56 46
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram per Millilitre (ng/mL)
Abemaciclib (C1D15) Number Analyzed 55 participants 56 participants 46 participants
214
(66.4%)
256
(58.8%)
314
(74.3%)
M2 (C1D15) Number Analyzed 55 participants 56 participants 46 participants
96.5
(53.9%)
108
(45.6%)
147
(47.1%)
M20 (C1D15) Number Analyzed 55 participants 56 participants 46 participants
180
(51.1%)
199
(41.0%)
251
(48.5%)
Abemaciclib (C2D1) Number Analyzed 55 participants 48 participants 30 participants
98.9
(196%)
182
(129%)
220
(154%)
M2 (C2D1) Number Analyzed 54 participants 48 participants 30 participants
56.1
(88.0%)
85.4
(62.1%)
105
(98.5%)
M20 (C2D1) Number Analyzed 55 participants 48 participants 29 participants
100
(103%)
149
(78.9%)
164
(171%)
Abemaciclib (C2D15) Number Analyzed 49 participants 39 participants 27 participants
135
(115%)
157
(173%)
175
(136%)
M2 (C2D15) Number Analyzed 48 participants 39 participants 27 participants
62.3
(79.0%)
71.7
(97.9%)
95.4
(73.9%)
M20 (C2D15) Number Analyzed 48 participants 39 participants 27 participants
120
(76.2%)
128
(121%)
154
(101%)
Abemaciclib (C3D1) Number Analyzed 43 participants 32 participants 22 participants
125
(64.3%)
177
(42.0%)
207
(49%)
M2 (C3D1) Number Analyzed 43 participants 32 participants 22 participants
60.6
(39.6%)
78.4
(38.2%)
95.8
(44.2%)
M20 (C3D1) Number Analyzed 43 participants 32 participants 22 participants
109
(39.4%)
146
(37.7%)
171
(36.6%)
7.Secondary Outcome
Title PK: Mean Single Dose Concentration of Tamoxifen and Endoxifen
Hide Description Mean single dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported.
Time Frame Cycle 1 Day 1 post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug along with Tamoxifen and had evaluable PK samples.
Arm/Group Title 150mg Abemaciclib + 20mg Tamoxifen
Hide Arm/Group Description:
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.
Overall Number of Participants Analyzed 21
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Tamoxifen (C1D1) Number Analyzed 21 participants
7.47
(116%)
Endoxifen (C1D1) Number Analyzed 2 participants
NA [1] 
(NA%)
[1]
Geometric Mean was not able to be calculated due to small sample size (2 Participants)
8.Secondary Outcome
Title PK: Multiple Dose Concentration of Tamoxifen and Endoxifen
Hide Description Mean multiple dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported.
Time Frame Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug along with Tamoxifen and had evaluable PK samples.
Arm/Group Title 150mg Abemaciclib + 20mg Tamoxifen
Hide Arm/Group Description:
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.
Overall Number of Participants Analyzed 48
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Tamoxifen (C1D15) Number Analyzed 48 participants
84.5
(41.6%)
Endoxifen (C1D15) Number Analyzed 48 participants
4.76
(99.7%)
Tamoxifen (C2D1) Number Analyzed 45 participants
98.7
(50.2%)
Endoxifen (C2D1) Number Analyzed 45 participants
7.41
(89.5%)
Tamoxifen (C2D15) Number Analyzed 44 participants
109
(51.9%)
Endoxifen (C2D15) Number Analyzed 44 participants
9.17
(73.7%)
Tamoxifen (C3D1) Number Analyzed 34 participants
112
(60.2%)
Endoxifen (C3D1) Number Analyzed 34 participants
10.3
(84.8%)
9.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)
Hide Description

The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 items covered by 1 of 3 dimensions:

  1. Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent).
  2. Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much)
  3. Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much).

Raw scores are linearly converted to a 0–100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden.

Time Frame Baseline, 21 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 score.
Arm/Group Title 150mg Abemaciclib + 20mg Tamoxifen 150mg Abemaciclib 200mg Abemaciclib + 2mg Prophylactic Loperamide
Hide Arm/Group Description:
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.
Overall Number of Participants Analyzed 77 75 76
Least Squares Mean (Standard Deviation)
Unit of Measure: score on a scale
Global Health Status Number Analyzed 76 participants 75 participants 76 participants
1.56  (1.83) 4.56  (1.90) -2.77  (1.91)
Functional Scales (Physical Functioning) Number Analyzed 77 participants 75 participants 76 participants
-2.01  (1.59) -1.05  (1.68) -2.65  (1.68)
Functional Scales (Role Functioning) Number Analyzed 77 participants 75 participants 76 participants
-0.44  (2.18) -3.95  (2.30) -5.87  (2.29)
Functional Scales (Emotional Functioning) Number Analyzed 76 participants 75 participants 76 participants
4.40  (1.88) 2.58  (1.95) 1.86  (1.95)
Functional Scale (Cognitive Functioning) Number Analyzed 76 participants 75 participants 76 participants
0.14  (1.37) -1.31  (1.44) -2.39  (1.43)
Functional Scales (Social Functioning) Number Analyzed 76 participants 75 participants 76 participants
3.23  (2.08) -0.53  (2.16) -0.94  (2.16)
Symptom Scales (Fatigue) Number Analyzed 77 participants 75 participants 76 participants
2.39  (2.05) 2.77  (2.15) 4.0  (2.16)
Symptom Scales (Nausea and Vomiting) Number Analyzed 77 participants 75 participants 76 participants
5.59  (1.63) 5.30  (1.73) 5.09  (1.71)
Symptom Scales (Pain) Number Analyzed 76 participants 75 participants 76 participants
-3.09  (2.20) -1.43  (2.30) -2.01  (2.29)
Symptom Scales (Dyspnoea) Number Analyzed 77 participants 75 participants 76 participants
4.21  (1.79) -3.49  (1.89) -2.0  (1.87)
Symptom Scales (Insomnia) Number Analyzed 77 participants 75 participants 76 participants
-5.02  (2.21) -3.43  (2.36) -2.98  (2.35)
Symptom Scales (Appetite Loss) Number Analyzed 77 participants 75 participants 76 participants
5.82  (2.38) 1.87  (2.50) 7.76  (2.50)
Symptom Scales (Constipation) Number Analyzed 76 participants 74 participants 76 participants
-0.28  (1.57) -6.29  (1.71) 0.08  (1.67)
Symptom Scales (Diarrhoea) Number Analyzed 76 participants 75 participants 76 participants
13.31  (1.97) 20.17  (2.10) 17.43  (2.09)
Symptom Scales (Functional Difficulties) Number Analyzed 76 participants 75 participants 76 participants
-7.56  (2.00) -3.81  (2.08) -0.09  (2.07)
10.Secondary Outcome
Title Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
Hide Description 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.
Time Frame Baseline, 21 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least one dose of study drug and had baselines and post baseline mBPI-sf measurement.
Arm/Group Title 150mg Abemaciclib + 20mg Tamoxifen 150mg Abemaciclib 200mg Abemaciclib + 2mg Prophylactic Loperamide
Hide Arm/Group Description:
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle.
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.
Overall Number of Participants Analyzed 78 76 75
Least Squares Mean (Standard Deviation)
Unit of Measure: score on a scale
Pain at its Worst in Last 24 Hours Number Analyzed 78 participants 76 participants 75 participants
-0.53  (0.20) -0.43  (0.21) -0.43  (0.21)
Pain at its Least in Last 24 Hours Number Analyzed 78 participants 76 participants 75 participants
-0.09  (0.15) -0.01  (0.16) 0.14  (0.16)
Pain on the Average Number Analyzed 78 participants 75 participants 75 participants
-0.34  (0.16) -0.20  (0.17) -0.11  (0.17)
Pain Right Now Number Analyzed 78 participants 76 participants 75 participants
-0.28  (0.17) -0.18  (0.17) -0.04  (0.17)
Mean Interference Score Number Analyzed 77 participants 76 participants 75 participants
-0.09  (0.18) 0.03  (0.18) 0.16  (0.18)
Time Frame Up to 21 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 150mg Abemaciclib + 20mg Tamoxifen 150mg Abemaciclib 200mg Abemaciclib + 2mg Prophylactic Loperamide
Hide Arm/Group Description Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 20mg Tamoxifen every 24 hours (QD) on days 1 to days 28 of a 28 day cycle. Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle. Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle.
All-Cause Mortality
150mg Abemaciclib + 20mg Tamoxifen 150mg Abemaciclib 200mg Abemaciclib + 2mg Prophylactic Loperamide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   18/78 (23.08%)      28/79 (35.44%)      29/77 (37.66%)    
Show Serious Adverse Events Hide Serious Adverse Events
150mg Abemaciclib + 20mg Tamoxifen 150mg Abemaciclib 200mg Abemaciclib + 2mg Prophylactic Loperamide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/78 (20.51%)      16/79 (20.25%)      21/77 (27.27%)    
Blood and lymphatic system disorders       
Anaemia  1  1/78 (1.28%)  1 1/79 (1.27%)  1 0/77 (0.00%)  0
Disseminated intravascular coagulation  1  1/78 (1.28%)  1 0/79 (0.00%)  0 1/77 (1.30%)  1
Haemolytic anaemia  1  0/78 (0.00%)  0 1/79 (1.27%)  1 0/77 (0.00%)  0
Leukopenia  1  0/78 (0.00%)  0 3/79 (3.80%)  4 0/77 (0.00%)  0
Neutropenia  1  0/78 (0.00%)  0 2/79 (2.53%)  2 0/77 (0.00%)  0
Pancytopenia  1  1/78 (1.28%)  1 0/79 (0.00%)  0 0/77 (0.00%)  0
Thrombocytopenia  1  0/78 (0.00%)  0 2/79 (2.53%)  3 0/77 (0.00%)  0
Cardiac disorders       
Acute coronary syndrome  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
Cardiac arrest  1  1/78 (1.28%)  1 0/79 (0.00%)  0 1/77 (1.30%)  1
Cardio-respiratory arrest  1  0/78 (0.00%)  0 1/79 (1.27%)  1 0/77 (0.00%)  0
Gastrointestinal disorders       
Constipation  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
Diarrhoea  1  1/78 (1.28%)  1 1/79 (1.27%)  1 1/77 (1.30%)  1
Dyspepsia  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
Gastrointestinal toxicity  1  1/78 (1.28%)  1 0/79 (0.00%)  0 0/77 (0.00%)  0
Intestinal obstruction  1  1/78 (1.28%)  4 0/79 (0.00%)  0 1/77 (1.30%)  1
Nausea  1  0/78 (0.00%)  0 1/79 (1.27%)  1 2/77 (2.60%)  2
Vomiting  1  1/78 (1.28%)  1 1/79 (1.27%)  1 2/77 (2.60%)  3
General disorders       
Asthenia  1  2/78 (2.56%)  2 0/79 (0.00%)  0 1/77 (1.30%)  1
Fatigue  1  0/78 (0.00%)  0 1/79 (1.27%)  1 1/77 (1.30%)  1
Multiple organ dysfunction syndrome  1  0/78 (0.00%)  0 1/79 (1.27%)  1 0/77 (0.00%)  0
Pain  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
Pyrexia  1  1/78 (1.28%)  1 2/79 (2.53%)  2 1/77 (1.30%)  1
Hepatobiliary disorders       
Cholangitis  1  1/78 (1.28%)  1 0/79 (0.00%)  0 0/77 (0.00%)  0
Hepatic failure  1  1/78 (1.28%)  1 1/79 (1.27%)  1 0/77 (0.00%)  0
Infections and infestations       
Influenza  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
Lung infection  1  0/78 (0.00%)  0 1/79 (1.27%)  1 1/77 (1.30%)  1
Pharyngitis  1  0/78 (0.00%)  0 1/79 (1.27%)  1 1/77 (1.30%)  1
Pneumonia  1  1/78 (1.28%)  1 0/79 (0.00%)  0 1/77 (1.30%)  1
Respiratory tract infection  1  0/78 (0.00%)  0 1/79 (1.27%)  1 0/77 (0.00%)  0
Sepsis  1  0/78 (0.00%)  0 1/79 (1.27%)  1 0/77 (0.00%)  0
Upper respiratory tract infection  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
Urinary tract infection  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
Viral infection  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
Investigations       
Alanine aminotransferase increased  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
Aspartate aminotransferase increased  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
Blood creatinine increased  1  1/78 (1.28%)  1 0/79 (0.00%)  0 0/77 (0.00%)  0
Haemoglobin decreased  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
Neutrophil count decreased  1  1/78 (1.28%)  1 0/79 (0.00%)  0 0/77 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  0/78 (0.00%)  0 1/79 (1.27%)  1 0/77 (0.00%)  0
Hypercalcaemia  1  1/78 (1.28%)  1 0/79 (0.00%)  0 0/77 (0.00%)  0
Hyponatraemia  1  0/78 (0.00%)  0 1/79 (1.27%)  1 0/77 (0.00%)  0
Nervous system disorders       
Cerebral ischaemia  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
Ischaemic stroke  1  0/78 (0.00%)  0 1/79 (1.27%)  1 0/77 (0.00%)  0
Monoparesis  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
Paraesthesia  1  0/78 (0.00%)  0 1/79 (1.27%)  1 0/77 (0.00%)  0
Spinal cord compression  1  1/78 (1.28%)  1 0/79 (0.00%)  0 0/77 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury  1  1/78 (1.28%)  1 1/79 (1.27%)  1 1/77 (1.30%)  1
Glomerulonephritis  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  1/78 (1.28%)  1 2/79 (2.53%)  3 0/77 (0.00%)  0
Pleural effusion  1  1/78 (1.28%)  1 0/79 (0.00%)  0 0/77 (0.00%)  0
Pneumonia aspiration  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  2
Pneumonitis  1  0/78 (0.00%)  0 1/79 (1.27%)  1 0/77 (0.00%)  0
Pneumothorax  1  0/78 (0.00%)  0 1/79 (1.27%)  1 1/77 (1.30%)  1
Pulmonary embolism  1  2/78 (2.56%)  2 2/79 (2.53%)  2 1/77 (1.30%)  1
Pulmonary oedema  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
Vascular disorders       
Deep vein thrombosis  1  1/78 (1.28%)  1 0/79 (0.00%)  0 1/77 (1.30%)  1
Hypertensive crisis  1  0/78 (0.00%)  0 0/79 (0.00%)  0 1/77 (1.30%)  1
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
150mg Abemaciclib + 20mg Tamoxifen 150mg Abemaciclib 200mg Abemaciclib + 2mg Prophylactic Loperamide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   73/78 (93.59%)      77/79 (97.47%)      75/77 (97.40%)    
Blood and lymphatic system disorders       
Anaemia  1  30/78 (38.46%)  63 24/79 (30.38%)  36 31/77 (40.26%)  68
Leukopenia  1  9/78 (11.54%)  24 10/79 (12.66%)  23 6/77 (7.79%)  9
Neutropenia  1  21/78 (26.92%)  64 20/79 (25.32%)  46 18/77 (23.38%)  51
Thrombocytopenia  1  8/78 (10.26%)  18 1/79 (1.27%)  1 5/77 (6.49%)  5
Eye disorders       
Dry eye  1  0/78 (0.00%)  0 4/79 (5.06%)  4 0/77 (0.00%)  0
Lacrimation increased  1  2/78 (2.56%)  2 6/79 (7.59%)  7 4/77 (5.19%)  5
Gastrointestinal disorders       
Abdominal distension  1  4/78 (5.13%)  5 4/79 (5.06%)  5 3/77 (3.90%)  3
Abdominal pain  1  16/78 (20.51%)  21 11/79 (13.92%)  17 19/77 (24.68%)  21
Abdominal pain upper  1  6/78 (7.69%)  7 8/79 (10.13%)  10 6/77 (7.79%)  7
Constipation  1  10/78 (12.82%)  16 9/79 (11.39%)  13 25/77 (32.47%)  28
Diarrhoea  1  41/78 (52.56%)  161 53/79 (67.09%)  244 47/77 (61.04%)  140
Dyspepsia  1  7/78 (8.97%)  7 3/79 (3.80%)  3 4/77 (5.19%)  6
Flatulence  1  4/78 (5.13%)  5 1/79 (1.27%)  1 3/77 (3.90%)  4
Haemorrhoids  1  4/78 (5.13%)  5 1/79 (1.27%)  1 1/77 (1.30%)  2
Nausea  1  24/78 (30.77%)  48 26/79 (32.91%)  47 33/77 (42.86%)  50
Stomatitis  1  5/78 (6.41%)  5 4/79 (5.06%)  7 4/77 (5.19%)  6
Toothache  1  4/78 (5.13%)  4 0/79 (0.00%)  0 0/77 (0.00%)  0
Vomiting  1  14/78 (17.95%)  34 20/79 (25.32%)  62 20/77 (25.97%)  34
General disorders       
Asthenia  1  14/78 (17.95%)  26 14/79 (17.72%)  20 6/77 (7.79%)  7
Fatigue  1  22/78 (28.21%)  32 17/79 (21.52%)  30 21/77 (27.27%)  41
Mucosal inflammation  1  5/78 (6.41%)  8 3/79 (3.80%)  4 2/77 (2.60%)  2
Oedema peripheral  1  3/78 (3.85%)  4 6/79 (7.59%)  8 7/77 (9.09%)  7
Pyrexia  1  7/78 (8.97%)  8 5/79 (6.33%)  7 8/77 (10.39%)  8
Infections and infestations       
Upper respiratory tract infection  1  10/78 (12.82%)  11 4/79 (5.06%)  6 4/77 (5.19%)  5
Urinary tract infection  1  7/78 (8.97%)  8 5/79 (6.33%)  6 5/77 (6.49%)  5
Investigations       
Alanine aminotransferase increased  1  6/78 (7.69%)  10 4/79 (5.06%)  6 5/77 (6.49%)  8
Aspartate aminotransferase increased  1  8/78 (10.26%)  12 4/79 (5.06%)  5 7/77 (9.09%)  8
Blood alkaline phosphatase increased  1  4/78 (5.13%)  10 3/79 (3.80%)  4 4/77 (5.19%)  4
Blood creatinine increased  1  14/78 (17.95%)  35 7/79 (8.86%)  15 8/77 (10.39%)  11
Gamma-glutamyltransferase increased  1  3/78 (3.85%)  5 5/79 (6.33%)  13 3/77 (3.90%)  7
Lymphocyte count decreased  1  1/78 (1.28%)  1 5/79 (6.33%)  20 3/77 (3.90%)  4
Neutrophil count decreased  1  11/78 (14.10%)  22 21/79 (26.58%)  71 22/77 (28.57%)  81
Platelet count decreased  1  8/78 (10.26%)  14 9/79 (11.39%)  22 22/77 (28.57%)  49
Weight decreased  1  5/78 (6.41%)  9 9/79 (11.39%)  10 5/77 (6.49%)  6
White blood cell count decreased  1  12/78 (15.38%)  26 18/79 (22.78%)  56 15/77 (19.48%)  52
Metabolism and nutrition disorders       
Decreased appetite  1  20/78 (25.64%)  29 12/79 (15.19%)  21 17/77 (22.08%)  27
Dehydration  1  1/78 (1.28%)  1 0/79 (0.00%)  0 5/77 (6.49%)  6
Hyperglycaemia  1  1/78 (1.28%)  1 5/79 (6.33%)  6 3/77 (3.90%)  3
Hypertriglyceridaemia  1  10/78 (12.82%)  22 3/79 (3.80%)  3 2/77 (2.60%)  4
Hypoalbuminaemia  1  6/78 (7.69%)  9 3/79 (3.80%)  3 6/77 (7.79%)  11
Hypocalcaemia  1  4/78 (5.13%)  5 2/79 (2.53%)  2 1/77 (1.30%)  1
Hypokalaemia  1  3/78 (3.85%)  4 8/79 (10.13%)  11 9/77 (11.69%)  10
Hyponatraemia  1  4/78 (5.13%)  7 1/79 (1.27%)  1 2/77 (2.60%)  2
Hypophosphataemia  1  5/78 (6.41%)  5 0/79 (0.00%)  0 1/77 (1.30%)  1
Musculoskeletal and connective tissue disorders       
Arthralgia  1  6/78 (7.69%)  8 5/79 (6.33%)  7 1/77 (1.30%)  1
Back pain  1  8/78 (10.26%)  9 11/79 (13.92%)  14 2/77 (2.60%)  3
Bone pain  1  4/78 (5.13%)  8 7/79 (8.86%)  12 0/77 (0.00%)  0
Musculoskeletal pain  1  2/78 (2.56%)  2 4/79 (5.06%)  4 4/77 (5.19%)  5
Myalgia  1  5/78 (6.41%)  7 2/79 (2.53%)  2 2/77 (2.60%)  2
Nervous system disorders       
Dizziness  1  2/78 (2.56%)  2 5/79 (6.33%)  7 2/77 (2.60%)  2
Dysgeusia  1  4/78 (5.13%)  5 4/79 (5.06%)  4 3/77 (3.90%)  3
Headache  1  7/78 (8.97%)  11 6/79 (7.59%)  7 7/77 (9.09%)  7
Paraesthesia  1  3/78 (3.85%)  5 4/79 (5.06%)  5 3/77 (3.90%)  3
Psychiatric disorders       
Anxiety  1  0/78 (0.00%)  0 5/79 (6.33%)  5 2/77 (2.60%)  2
Insomnia  1  3/78 (3.85%)  3 2/79 (2.53%)  2 5/77 (6.49%)  5
Respiratory, thoracic and mediastinal disorders       
Cough  1  7/78 (8.97%)  8 7/79 (8.86%)  7 10/77 (12.99%)  14
Dyspnoea  1  8/78 (10.26%)  9 12/79 (15.19%)  15 5/77 (6.49%)  10
Skin and subcutaneous tissue disorders       
Alopecia  1  5/78 (6.41%)  5 8/79 (10.13%)  9 3/77 (3.90%)  3
Pruritus  1  8/78 (10.26%)  8 6/79 (7.59%)  7 4/77 (5.19%)  4
Vascular disorders       
Hot flush  1  6/78 (7.69%)  9 2/79 (2.53%)  2 1/77 (1.30%)  2
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02747004     History of Changes
Other Study ID Numbers: 16339
I3Y-MC-JPCG ( Other Identifier: Eli Lilly and Company )
2016-000288-18 ( EudraCT Number )
First Submitted: April 19, 2016
First Posted: April 21, 2016
Results First Submitted: June 14, 2019
Results First Posted: July 12, 2019
Last Update Posted: October 30, 2019