Trial Outcomes & Findings for A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer (NCT NCT02747004)

Last Updated: 2025-04-20

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

234 participants

Primary outcome timeframe

Baseline to Objective Disease Progression or Death from Any Cause (Up to 21 Months)

Results posted on

2025-04-20

Participant Flow

Participant milestones

Participant milestones
Measure	150mg Abemaciclib + 20mg Tamoxifen 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.	150mg Abemaciclib Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.	200mg Abemaciclib + 2mg Prophylactic Loperamide Participants received oral dose of 200 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle. Note: During Cycle 1, 2mg prophylactic loperamide was administered orally with the first dose of abemaciclib daily. During Cycle 2 and beyond, loperamide was administered at investigator's discretion and/or if clinically indicated.
Overall Study STARTED	78	79	77
Overall Study Received at Least One Dose of Study Drug	78	79	77
Overall Study COMPLETED	21	30	30
Overall Study NOT COMPLETED	57	49	47

Reasons for withdrawal

Reasons for withdrawal
Measure	150mg Abemaciclib + 20mg Tamoxifen 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.	150mg Abemaciclib Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.	200mg Abemaciclib + 2mg Prophylactic Loperamide Participants received oral dose of 200 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle. Note: During Cycle 1, 2mg prophylactic loperamide was administered orally with the first dose of abemaciclib daily. During Cycle 2 and beyond, loperamide was administered at investigator's discretion and/or if clinically indicated.
Overall Study Withdrawal by Subject	8	5	4
Overall Study Lost to Follow-up	1	2	2
Overall Study on study treatment/follow-up	48	42	41

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	150mg Abemaciclib + 20mg Tamoxifen n=78 Participants 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.	150mg Abemaciclib n=79 Participants Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.	200mg Abemaciclib + 2mg Prophylactic Loperamide n=77 Participants Participants received oral dose of 200 milligrams (mg) Abemaciclib every 12 hours (Q12H) along with 2mg Prophylactic Loperamide on days 1 to days 28 of a 28 day cycle. Note: During Cycle 1, 2mg prophylactic loperamide was administered orally with the first dose of abemaciclib daily. During Cycle 2 and beyond, loperamide was administered at investigator's discretion and/or if clinically indicated.	Total n=234 Participants Total of all reporting groups
Age, Continuous	54.28 years STANDARD_DEVIATION 12.47 • n=93 Participants	56.18 years STANDARD_DEVIATION 12.24 • n=4 Participants	55.86 years STANDARD_DEVIATION 11.03 • n=27 Participants	55.44 years STANDARD_DEVIATION 11.91 • n=483 Participants
Sex: Female, Male Female	78 Participants n=93 Participants	79 Participants n=4 Participants	77 Participants n=27 Participants	234 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=93 Participants	20 Participants n=4 Participants	21 Participants n=27 Participants	57 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=93 Participants	45 Participants n=4 Participants	46 Participants n=27 Participants	146 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=93 Participants	14 Participants n=4 Participants	10 Participants n=27 Participants	31 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants	11 Participants n=483 Participants
Race (NIH/OMB) Asian	8 Participants n=93 Participants	6 Participants n=4 Participants	10 Participants n=27 Participants	24 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	5 Participants n=483 Participants
Race (NIH/OMB) White	63 Participants n=93 Participants	64 Participants n=4 Participants	60 Participants n=27 Participants	187 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	4 Participants n=4 Participants	1 Participants n=27 Participants	6 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline to Objective Disease Progression or Death from Any Cause (Up to 21 Months)

Population: 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.

Outcome measures

Outcome measures
Measure	150mg Abemaciclib + 20mg Tamoxifen n=78 Participants 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.	150mg Abemaciclib n=79 Participants Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.	200mg Abemaciclib + 2mg Prophylactic Loperamide n=77 Participants 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.
Progression Free Survival (PFS)	9.07 Months Interval 6.9 to 10.95	6.48 Months Interval 4.77 to 9.21	7.43 Months Interval 5.42 to 9.17

SECONDARY outcome

Timeframe: Baseline to Objective Disease Progression (Up to 21 Months)

Population: All randomized participants who received at least one dose of study drug and had PR/CR data.

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.

Outcome measures

Outcome measures
Measure	150mg Abemaciclib + 20mg Tamoxifen n=78 Participants 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.	150mg Abemaciclib n=79 Participants Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.	200mg Abemaciclib + 2mg Prophylactic Loperamide n=77 Participants 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.
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)	34.6 Percentage of participants Interval 24.1 to 45.2	24.1 Percentage of participants Interval 14.6 to 33.5	32.5 Percentage of participants Interval 22.0 to 42.9

SECONDARY outcome

Timeframe: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 21 Months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	150mg Abemaciclib + 20mg Tamoxifen n=27 Participants 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.	150mg Abemaciclib n=19 Participants Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.	200mg Abemaciclib + 2mg Prophylactic Loperamide n=25 Participants 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.
Duration of Response (DoR)	7.40 Months Interval 3.88 to 9.27	9.21 Months Interval 3.72 to Upper bound not estimable.	7.46 Months Interval 5.56 to 10.92

SECONDARY outcome

Timeframe: Baseline to Death from Any Cause (Approximately 36 Months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle (C) 1 Day (D) 1 post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable PK samples.

Mean single dose concentrations of Abemaciclib and its metabolites (M2 \& M20) are reported.

Outcome measures

Outcome measures
Measure	150mg Abemaciclib + 20mg Tamoxifen n=19 Participants 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.	150mg Abemaciclib n=13 Participants Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.	200mg Abemaciclib + 2mg Prophylactic Loperamide n=20 Participants 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.
Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites Abemaciclib (C1D1)	10.9 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 231	3.05 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 95.4	8.59 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 440
Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites M2 (C1D1)	6.05 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 123	2.14 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 60.1	6.85 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 237
Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites M20 (C1D1)	6.50 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 132	2.54 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 54.5	7.91 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 220

SECONDARY outcome

Timeframe: Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose

Population: All randomized participants who received at least one dose of study drug and had evaluable PK samples.

Mean steady state concentrations of Abemaciclib and its metabolites (M2 \& M20) are reported. C=Cycle D= Day

Outcome measures

Outcome measures
Measure	150mg Abemaciclib + 20mg Tamoxifen n=55 Participants 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.	150mg Abemaciclib n=56 Participants Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.	200mg Abemaciclib + 2mg Prophylactic Loperamide n=46 Participants 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.
Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites Abemaciclib (C1D15)	214 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 66.4	256 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 58.8	314 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 74.3
Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites M2 (C1D15)	96.5 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 53.9	108 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 45.6	147 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 47.1
Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites M20 (C1D15)	180 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 51.1	199 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 41.0	251 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 48.5
Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites Abemaciclib (C2D1)	98.9 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 196	182 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 129	220 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 154
Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites M2 (C2D1)	56.1 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 88.0	85.4 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 62.1	105 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 98.5
Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites M20 (C2D1)	100 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 103	149 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 78.9	164 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 171
Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites Abemaciclib (C2D15)	135 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 115	157 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 173	175 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 136
Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites M2 (C2D15)	62.3 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 79.0	71.7 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 97.9	95.4 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 73.9
Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites M20 (C2D15)	120 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 76.2	128 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 121	154 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 101
Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites Abemaciclib (C3D1)	125 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 64.3	177 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 42.0	207 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 49
Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites M2 (C3D1)	60.6 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 39.6	78.4 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 38.2	95.8 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 44.2
Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites M20 (C3D1)	109 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 39.4	146 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 37.7	171 Nanogram per Millilitre (ng/mL) Geometric Coefficient of Variation 36.6

SECONDARY outcome

Timeframe: Cycle 1 Day 1 post dose

Population: All randomized participants who received at least one dose of study drug along with Tamoxifen and had evaluable PK samples.

Mean single dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported.

Outcome measures

Outcome measures
Measure	150mg Abemaciclib + 20mg Tamoxifen n=21 Participants 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.	150mg Abemaciclib Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.	200mg Abemaciclib + 2mg Prophylactic Loperamide 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.
PK: Mean Single Dose Concentration of Tamoxifen and Endoxifen Tamoxifen (C1D1)	7.47 ng/mL Geometric Coefficient of Variation 116	—	—
PK: Mean Single Dose Concentration of Tamoxifen and Endoxifen Endoxifen (C1D1)	NA ng/mL Geometric Coefficient of Variation NA Geometric Mean was not able to be calculated due to small sample size (2 Participants). Individual values = 0.653 ng/mL, 3.8 ng/mL.	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose

Population: All randomized participants who received at least one dose of study drug along with Tamoxifen and had evaluable PK samples.

Mean multiple dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported.

Outcome measures

Outcome measures
Measure	150mg Abemaciclib + 20mg Tamoxifen n=48 Participants 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.	150mg Abemaciclib Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.	200mg Abemaciclib + 2mg Prophylactic Loperamide 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.
PK: Multiple Dose Concentration of Tamoxifen and Endoxifen Endoxifen (C1D15)	4.76 ng/mL Geometric Coefficient of Variation 99.7	—	—
PK: Multiple Dose Concentration of Tamoxifen and Endoxifen Tamoxifen (C1D15)	84.5 ng/mL Geometric Coefficient of Variation 41.6	—	—
PK: Multiple Dose Concentration of Tamoxifen and Endoxifen Tamoxifen (C2D1)	98.7 ng/mL Geometric Coefficient of Variation 50.2	—	—
PK: Multiple Dose Concentration of Tamoxifen and Endoxifen Endoxifen (C2D1)	7.41 ng/mL Geometric Coefficient of Variation 89.5	—	—
PK: Multiple Dose Concentration of Tamoxifen and Endoxifen Tamoxifen (C2D15)	109 ng/mL Geometric Coefficient of Variation 51.9	—	—
PK: Multiple Dose Concentration of Tamoxifen and Endoxifen Endoxifen (C2D15)	9.17 ng/mL Geometric Coefficient of Variation 73.7	—	—
PK: Multiple Dose Concentration of Tamoxifen and Endoxifen Tamoxifen (C3D1)	112 ng/mL Geometric Coefficient of Variation 60.2	—	—
PK: Multiple Dose Concentration of Tamoxifen and Endoxifen Endoxifen (C3D1)	10.3 ng/mL Geometric Coefficient of Variation 84.8	—	—

SECONDARY outcome

Timeframe: Baseline, 21 Months

Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 score.

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.

Outcome measures

Outcome measures
Measure	150mg Abemaciclib + 20mg Tamoxifen n=77 Participants 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.	150mg Abemaciclib n=75 Participants Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.	200mg Abemaciclib + 2mg Prophylactic Loperamide n=76 Participants 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.
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales (Insomnia)	-5.02 score on a scale Standard Deviation 2.21	-3.43 score on a scale Standard Deviation 2.36	-2.98 score on a scale Standard Deviation 2.35
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Global Health Status	1.56 score on a scale Standard Deviation 1.83	4.56 score on a scale Standard Deviation 1.90	-2.77 score on a scale Standard Deviation 1.91
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Functional Scales (Physical Functioning)	-2.01 score on a scale Standard Deviation 1.59	-1.05 score on a scale Standard Deviation 1.68	-2.65 score on a scale Standard Deviation 1.68
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Functional Scales (Role Functioning)	-0.44 score on a scale Standard Deviation 2.18	-3.95 score on a scale Standard Deviation 2.30	-5.87 score on a scale Standard Deviation 2.29
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Functional Scales (Emotional Functioning)	4.40 score on a scale Standard Deviation 1.88	2.58 score on a scale Standard Deviation 1.95	1.86 score on a scale Standard Deviation 1.95
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Functional Scale (Cognitive Functioning)	0.14 score on a scale Standard Deviation 1.37	-1.31 score on a scale Standard Deviation 1.44	-2.39 score on a scale Standard Deviation 1.43
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Functional Scales (Social Functioning)	3.23 score on a scale Standard Deviation 2.08	-0.53 score on a scale Standard Deviation 2.16	-0.94 score on a scale Standard Deviation 2.16
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales (Fatigue)	2.39 score on a scale Standard Deviation 2.05	2.77 score on a scale Standard Deviation 2.15	4.0 score on a scale Standard Deviation 2.16
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales (Nausea and Vomiting)	5.59 score on a scale Standard Deviation 1.63	5.30 score on a scale Standard Deviation 1.73	5.09 score on a scale Standard Deviation 1.71
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales (Pain)	-3.09 score on a scale Standard Deviation 2.20	-1.43 score on a scale Standard Deviation 2.30	-2.01 score on a scale Standard Deviation 2.29
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales (Dyspnoea)	4.21 score on a scale Standard Deviation 1.79	-3.49 score on a scale Standard Deviation 1.89	-2.0 score on a scale Standard Deviation 1.87
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales (Appetite Loss)	5.82 score on a scale Standard Deviation 2.38	1.87 score on a scale Standard Deviation 2.50	7.76 score on a scale Standard Deviation 2.50
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales (Constipation)	-0.28 score on a scale Standard Deviation 1.57	-6.29 score on a scale Standard Deviation 1.71	0.08 score on a scale Standard Deviation 1.67
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales (Diarrhoea)	13.31 score on a scale Standard Deviation 1.97	20.17 score on a scale Standard Deviation 2.10	17.43 score on a scale Standard Deviation 2.09
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales (Functional Difficulties)	-7.56 score on a scale Standard Deviation 2.00	-3.81 score on a scale Standard Deviation 2.08	-0.09 score on a scale Standard Deviation 2.07

SECONDARY outcome

Timeframe: Baseline, 21 Months

Population: All randomized participants who received at least one dose of study drug and had baselines and post baseline mBPI-sf measurement.

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.

Outcome measures

Outcome measures
Measure	150mg Abemaciclib + 20mg Tamoxifen n=78 Participants 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.	150mg Abemaciclib n=76 Participants Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle.	200mg Abemaciclib + 2mg Prophylactic Loperamide n=75 Participants 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.
Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) Pain at its Worst in Last 24 Hours	-0.53 score on a scale Standard Deviation 0.20	-0.43 score on a scale Standard Deviation 0.21	-0.43 score on a scale Standard Deviation 0.21
Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) Pain at its Least in Last 24 Hours	-0.09 score on a scale Standard Deviation 0.15	-0.01 score on a scale Standard Deviation 0.16	0.14 score on a scale Standard Deviation 0.16
Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) Pain on the Average	-0.34 score on a scale Standard Deviation 0.16	-0.20 score on a scale Standard Deviation 0.17	-0.11 score on a scale Standard Deviation 0.17
Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) Pain Right Now	-0.28 score on a scale Standard Deviation 0.17	-0.18 score on a scale Standard Deviation 0.17	-0.04 score on a scale Standard Deviation 0.17
Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) Mean Interference Score	-0.09 score on a scale Standard Deviation 0.18	0.03 score on a scale Standard Deviation 0.18	0.16 score on a scale Standard Deviation 0.18

Adverse Events

150mg Abemaciclib + 20mg Tamoxifen

Serious events: 16 serious events

Other events: 73 other events

Deaths: 18 deaths

150mg Abemaciclib

Serious events: 16 serious events

Other events: 77 other events

Deaths: 28 deaths

200mg Abemaciclib + 2mg Prophylactic Loperamide

Serious events: 21 serious events

Other events: 75 other events

Deaths: 29 deaths

Serious adverse events

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place