Trial Outcomes & Findings for A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer (NCT NCT02763566)

Last Updated: 2026-02-05

Results Overview

Progression-free survival time was measured from randomization until the date of objective progression as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), or death from any cause. 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. Patients 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

PHASE3

Target enrollment

463 participants

Primary outcome timeframe

Randomization to Measured Progressive Disease or Death (up to 26 Months)

Results posted on

2026-02-05

Participant Flow

Participants who died due to any cause or disease progression or alive and on study at conclusion but off treatment are considered as completed.

Participant milestones

Participant milestones
Measure	Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI) Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.	Placebo + NSAI Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle.	Abemaciclib + Fulvestrant Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Placebo + Fulvestrant Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
Overall Study STARTED	207	99	104	53
Overall Study COMPLETED	89	60	50	39
Overall Study NOT COMPLETED	118	39	54	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI) Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.	Placebo + NSAI Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle.	Abemaciclib + Fulvestrant Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Placebo + Fulvestrant Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
Overall Study Lost to Follow-up	1	4	0	1
Overall Study On study treatment at study conclusion	114	34	54	13
Overall Study Withdrawal by Subject	3	1	0	0

Baseline Characteristics

A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI) n=207 Participants Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.	Placebo + NSAI n=99 Participants Participants received Placebo orally Q12H plus anastrozole or letrozole given orally Q24H on days 1 to 28 of a 28 day cycle.	Abemaciclib + Fulvestrant n=104 Participants Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Placebo + Fulvestrant n=53 Participants Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Total n=463 Participants Total of all reporting groups
Age, Continuous	56.4 years STANDARD_DEVIATION 10.8 • n=25 Participants	55.5 years STANDARD_DEVIATION 9.8 • n=26 Participants	59.7 years STANDARD_DEVIATION 8.5 • n=51 Participants	58.2 years STANDARD_DEVIATION 10.3 • n=27 Participants	57.1 years STANDARD_DEVIATION 10.1 • n=3 Participants
Sex: Female, Male Female	207 Participants n=25 Participants	99 Participants n=26 Participants	104 Participants n=51 Participants	53 Participants n=27 Participants	463 Participants n=3 Participants
Sex: Female, Male Male	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants	0 Participants n=27 Participants	0 Participants n=3 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants	0 Participants n=27 Participants	0 Participants n=3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants	0 Participants n=27 Participants	0 Participants n=3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	207 Participants n=25 Participants	99 Participants n=26 Participants	104 Participants n=51 Participants	53 Participants n=27 Participants	463 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants	0 Participants n=27 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Asian	182 Participants n=25 Participants	89 Participants n=26 Participants	94 Participants n=51 Participants	48 Participants n=27 Participants	413 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants	0 Participants n=27 Participants	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	1 Participants n=25 Participants	2 Participants n=26 Participants	1 Participants n=51 Participants	1 Participants n=27 Participants	5 Participants n=3 Participants
Race (NIH/OMB) White	24 Participants n=25 Participants	8 Participants n=26 Participants	8 Participants n=51 Participants	4 Participants n=27 Participants	44 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants	0 Participants n=26 Participants	1 Participants n=51 Participants	0 Participants n=27 Participants	1 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	0 Participants n=26 Participants	0 Participants n=51 Participants	0 Participants n=27 Participants	0 Participants n=3 Participants
Region of Enrollment China	164 Participants n=25 Participants	82 Participants n=26 Participants	89 Participants n=51 Participants	45 Participants n=27 Participants	380 Participants n=3 Participants
Region of Enrollment Brazil	21 Participants n=25 Participants	8 Participants n=26 Participants	10 Participants n=51 Participants	5 Participants n=27 Participants	44 Participants n=3 Participants
Region of Enrollment South Africa	4 Participants n=25 Participants	2 Participants n=26 Participants	0 Participants n=51 Participants	1 Participants n=27 Participants	7 Participants n=3 Participants
Region of Enrollment India	18 Participants n=25 Participants	7 Participants n=26 Participants	5 Participants n=51 Participants	2 Participants n=27 Participants	32 Participants n=3 Participants

PRIMARY outcome

Timeframe: Randomization to Measured Progressive Disease or Death (up to 26 Months)

Population: All randomized participants in Abemaciclib + NSAI \& Placebo NSAI arms. Censored participants: 141 in Abemaciclib + NSAI, 46 in Placebo + NSAI.

Outcome measures

Outcome measures
Measure	Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI) n=207 Participants Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.	Abemaciclib + Fulvestrant n=99 Participants Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Abemaciclib + Fulvestrant Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Placebo + Fulvestrant Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
Progression Free Survival (PFS) (Abemaciclib + NSAI & Placebo NSAI)	NA Months Interval 22.32 to Median and Upper bound were not estimable due to Immature data.	14.73 Months Interval 11.21 to 18.87	—	—

SECONDARY outcome

Timeframe: Randomization to Measured Progressive Disease or Death (up to 26 Months)

Population: All randomized participants in Abemaciclib + Fulvestrant and Placebo + Fulvestrant arms. Censored participants: 58 in Abemaciclib + Fulvestrant, 17 in Placebo + Fulvestrant.

Outcome measures

Outcome measures
Measure	Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI) n=104 Participants Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.	Abemaciclib + Fulvestrant n=53 Participants Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Abemaciclib + Fulvestrant Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Placebo + Fulvestrant Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
Progression Free Survival (PFS) (Abemaciclib + Fulvestrant and Placebo + Fulvestrant Arms)	11.47 Months Interval 9.53 to Upper bound was not estimable due to Immature data.	5.59 Months Interval 3.65 to 7.69	—	—

SECONDARY outcome

Timeframe: Randomization to Date of Death from Any Cause (Estimated up to 38 Months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Randomization to Measured Progressive Disease (up to 26 Months)

Population: All randomized participants.

Objective response rate is the percentage of participants with a BOR of CR or PR as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is 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	Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI) n=207 Participants Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.	Abemaciclib + Fulvestrant n=99 Participants Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Abemaciclib + Fulvestrant n=104 Participants Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Placebo + Fulvestrant n=53 Participants Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]	56.0 percentage of participants Interval 49.3 to 62.8	30.3 percentage of participants Interval 21.3 to 39.4	38.5 percentage of participants Interval 29.1 to 47.8	7.5 percentage of participants Interval 0.4 to 14.7

SECONDARY outcome

Timeframe: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 38 Months)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Randomization to Measured Progressive Disease (up to 26 Months)

Population: All randomized participants.

Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. 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.

Outcome measures

Outcome measures
Measure	Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI) n=207 Participants Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.	Abemaciclib + Fulvestrant n=99 Participants Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Abemaciclib + Fulvestrant n=104 Participants Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Placebo + Fulvestrant n=53 Participants Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
Percentage of Participants Who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)]	91.3 percentage of participants Interval 87.5 to 95.1	82.8 percentage of participants Interval 75.4 to 90.3	92.3 percentage of participants Interval 87.2 to 97.4	69.8 percentage of participants Interval 57.5 to 82.2

SECONDARY outcome

Timeframe: Randomization to Measured Progressive Disease (up to 26 Months)

Population: All randomized participants

Clinical benefit rate (CBR) is the percentage of participants with a BOR of CR or PR, or SD for at least 6 months. CR is defined as the disappearance of all target and non-target lesions \& no appearance of new lesions. PR is 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 is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD 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.

Outcome measures

Outcome measures
Measure	Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI) n=207 Participants Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.	Abemaciclib + Fulvestrant n=99 Participants Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Abemaciclib + Fulvestrant n=104 Participants Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Placebo + Fulvestrant n=53 Participants Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months [Clinical Benefit Rate (CBR)]	82.6 percentage of participants Interval 77.4 to 87.8	62.6 percentage of participants Interval 53.1 to 72.2	77.9 percentage of participants Interval 69.9 to 85.9	45.3 percentage of participants Interval 31.9 to 58.7

SECONDARY outcome

Timeframe: Baseline through 19 Months

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

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	Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI) n=202 Participants Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.	Abemaciclib + Fulvestrant n=97 Participants Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Abemaciclib + Fulvestrant n=97 Participants Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Placebo + Fulvestrant n=51 Participants Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
Change From Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Global Health Status	2.38 score on a scale Standard Error 0.99	4.26 score on a scale Standard Error 1.47	-0.35 score on a scale Standard Error 1.41	3.12 score on a scale Standard Error 2.07
Change From Randomization 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	-0.78 score on a scale Standard Error 0.82	-0.01 score on a scale Standard Error 1.21	-1.11 score on a scale Standard Error 1.06	-2.70 score on a scale Standard Error 1.54
Change From Randomization 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	-1.69 score on a scale Standard Error 1.20	-1.38 score on a scale Standard Error 1.79	-3.76 score on a scale Standard Error 1.35	-2.04 score on a scale Standard Error 1.95
Change From Randomization 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	1.57 score on a scale Standard Error 0.98	-0.10 score on a scale Standard Error 1.44	0.43 score on a scale Standard Error 1.27	0.18 score on a scale Standard Error 1.85
Change From Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Functional Scales - Cognitive Functioning	-2.89 score on a scale Standard Error 0.90	-0.72 score on a scale Standard Error 1.35	-3.52 score on a scale Standard Error 1.35	-1.10 score on a scale Standard Error 1.96
Change From Randomization 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	-2.45 score on a scale Standard Error 1.19	-1.57 score on a scale Standard Error 1.75	-2.03 score on a scale Standard Error 1.71	-2.67 score on a scale Standard Error 2.44
Change From Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales - Fatigue	1.63 score on a scale Standard Error 0.95	0.06 score on a scale Standard Error 1.40	4.19 score on a scale Standard Error 1.44	1.46 score on a scale Standard Error 2.08
Change From Randomization 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	0.62 score on a scale Standard Error 0.60	-0.33 score on a scale Standard Error 0.88	4.26 score on a scale Standard Error 1.10	1.67 score on a scale Standard Error 1.65
Change From Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales - Pain	-5.44 score on a scale Standard Error 0.91	-4.90 score on a scale Standard Error 1.35	-2.82 score on a scale Standard Error 1.36	-0.17 score on a scale Standard Error 2.01
Change From Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales - Dyspnoea	2.51 score on a scale Standard Error 1.02	0.35 score on a scale Standard Error 1.53	-1.66 score on a scale Standard Error 1.27	0.83 score on a scale Standard Error 1.92
Change From Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales - Insomnia	-0.87 score on a scale Standard Error 1.07	-0.05 score on a scale Standard Error 1.60	1.53 score on a scale Standard Error 1.59	-0.44 score on a scale Standard Error 2.42
Change From Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales - Appetite	4.19 score on a scale Standard Error 0.97	-1.47 score on a scale Standard Error 1.44	8.67 score on a scale Standard Error 1.63	1.21 score on a scale Standard Error 2.42
Change From Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales - Constipation	-3.05 score on a scale Standard Error 0.98	-1.49 score on a scale Standard Error 1.46	-1.63 score on a scale Standard Error 1.31	0.65 score on a scale Standard Error 1.88
Change From Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales - Diarrhoea	15.72 score on a scale Standard Error 0.85	-0.10 score on a scale Standard Error 1.27	16.03 score on a scale Standard Error 1.26	-1.80 score on a scale Standard Error 1.95
Change From Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Symptom Scales - Financial Difficulties	-3.02 score on a scale Standard Error 1.65	-1.27 score on a scale Standard Error 2.46	-6.36 score on a scale Standard Error 1.76	-9.35 score on a scale Standard Error 2.59

SECONDARY outcome

Timeframe: C1D1 post dose, C2D1 post dose, C3D1 predose, C4D1 predose

Population: All randomized participants who received at least one dose of Abemaciclib and had evaluable PK data.

Pharmacokinetics (PK): Area Under the Concentration Curve of Abemaciclib and its Metabolites LSN2839567 (M2) \& LSN3106726 (M20) was reported. C=Cycle, D=day;

Outcome measures

Outcome measures
Measure	Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI) n=204 Participants Participants received Abemaciclib orally every 12 hours (Q12H) plus anastrozole or letrozole given orally every 24 hours (Q24H) on days 1 to 28 of a 28 day cycle.	Abemaciclib + Fulvestrant n=101 Participants Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Abemaciclib + Fulvestrant Participants received Abemaciclib orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant intramuscularly (IM) on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.	Placebo + Fulvestrant Participants received Placebo orally Q12H on days 1 to 28 of a 28 day cycle plus fulvestrant IM on days 1 and 15 of cycle 1, then on day 1 of cycle 2 and beyond.
Pharmacokinetics (PK): Area Under the Concentration Curve of Abemaciclib, Its Metabolites (M2 & M20) Abemaciclib	2720 Nanogramhour per Millilitre (ngh/mL) Geometric Coefficient of Variation 40	2740 Nanogramhour per Millilitre (ngh/mL) Geometric Coefficient of Variation 57	—	—
Pharmacokinetics (PK): Area Under the Concentration Curve of Abemaciclib, Its Metabolites (M2 & M20) LSN2839567 (M2)	1080 Nanogramhour per Millilitre (ngh/mL) Geometric Coefficient of Variation 84	861 Nanogramhour per Millilitre (ngh/mL) Geometric Coefficient of Variation 120	—	—
Pharmacokinetics (PK): Area Under the Concentration Curve of Abemaciclib, Its Metabolites (M2 & M20) LSN3106726 (M20)	1970 Nanogramhour per Millilitre (ngh/mL) Geometric Coefficient of Variation 81	1570 Nanogramhour per Millilitre (ngh/mL) Geometric Coefficient of Variation 110	—	—

Adverse Events

Abemaciclib + Nonsteroidal Aromatase Inhibitor (NSAI)

Serious events: 40 serious events

Other events: 204 other events

Deaths: 20 deaths

Placebo + NSAI

Serious events: 9 serious events

Other events: 85 other events

Deaths: 10 deaths

Abemaciclib + Fulvestrant

Serious events: 16 serious events

Other events: 103 other events

Deaths: 8 deaths

Placebo + Fulvestrant

Serious events: 4 serious events

Other events: 39 other events

Deaths: 9 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

Restriction type: GT60