Metastatic Breast Cancer
Conditions
Brief summary
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.
Interventions
DRUGAbemaciclib
Administered orally
DRUGTamoxifen
Administered orally
DRUGProphylactic Loperamide
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of HR+, HER2- breast cancer. * Relapsed or progressed following endocrine therapy. * Have received prior treatment with at least 2 chemotherapy regimens, of which at least 1 but no more than 2 have been administered in the metastatic setting. * Have the presence of measureable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). * Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale. * Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy. * Have adequate organ function. * Have negative serum pregnancy test within 7 days prior to the first dose of study treatment and agree to use highly effective precautions to prevent pregnancy during the study and for 3 weeks following last dose of study treatment. * Are able to swallow oral medication.
Exclusion criteria
* Have clinical evidence or history of central nervous system metastasis. * Have a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest. * Have active bacterial or fungal infection (that is, requiring intravenous antibiotics at the time of initiating study treatment) and/or detectable viral infection. * Have received treatment with a prior cyclin-dependent kinase (CDK4) and CDK 6 inhibitor. * Have a preexisting chronic condition resulting in persistent diarrhea. * Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Baseline to Objective Disease Progression or Death from Any Cause (Up to 21 Months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | Baseline to Objective Disease Progression (Up to 21 Months) | 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. |
| Duration of Response (DoR) | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 21 Months) | 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. |
| Overall Survival (OS) | Baseline to Death from Any Cause (Approximately 36 Months) | — |
| Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites | Cycle (C) 1 Day (D) 1 post dose | Mean single dose concentrations of Abemaciclib and its metabolites (M2 \& M20) are reported. |
| Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose | Mean steady state concentrations of Abemaciclib and its metabolites (M2 \& M20) are reported. C=Cycle D= Day |
| PK: Mean Single Dose Concentration of Tamoxifen and Endoxifen | Cycle 1 Day 1 post dose | Mean single dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported. |
| PK: Multiple Dose Concentration of Tamoxifen and Endoxifen | Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose | Mean multiple dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported. |
| Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) | Baseline, 21 Months | 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. |
| Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Baseline, 21 Months | 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. |
Countries
Argentina, Austria, Belgium, Brazil, Czechia, France, Germany, Italy, Mexico, Russia, Spain, Taiwan, Turkey (Türkiye), United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 78 |
| 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. | 79 |
| 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. | 77 |
| Total | 234 |
Baseline characteristics
| Characteristic | 150mg Abemaciclib + 20mg Tamoxifen | 150mg Abemaciclib | 200mg Abemaciclib + 2mg Prophylactic Loperamide | Total |
|---|---|---|---|---|
| Age, Continuous | 54.28 years STANDARD_DEVIATION 12.47 | 56.18 years STANDARD_DEVIATION 12.24 | 55.86 years STANDARD_DEVIATION 11.03 | 55.44 years STANDARD_DEVIATION 11.91 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 16 Participants | 20 Participants | 21 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 45 Participants | 46 Participants | 146 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 14 Participants | 10 Participants | 31 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 3 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 6 Participants | 10 Participants | 24 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 63 Participants | 64 Participants | 60 Participants | 187 Participants |
| Sex: Female, Male Female | 78 Participants | 79 Participants | 77 Participants | 234 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 18 / 78 | 28 / 79 | 29 / 77 |
| other Total, other adverse events | 73 / 78 | 77 / 79 | 75 / 77 |
| serious Total, serious adverse events | 16 / 78 | 16 / 79 | 21 / 77 |
Outcome results
Primary
Progression Free Survival (PFS)
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)
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 150mg Abemaciclib + 20mg Tamoxifen | Progression Free Survival (PFS) | 9.07 Months |
| 150mg Abemaciclib | Progression Free Survival (PFS) | 6.48 Months |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Progression Free Survival (PFS) | 7.43 Months |
p-value: 0.293Log Rank
95% CI: [0.711, 1.535]Log Rank
Secondary
Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
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
Population: All randomized participants who received at least one dose of study drug and had baselines and post baseline mBPI-sf measurement.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 0.2 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib | Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain on the Average | -0.20 score on a scale | Standard Deviation 0.17 |
| 150mg Abemaciclib | 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 | -0.43 score on a scale | Standard Deviation 0.21 |
| 150mg Abemaciclib | 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 | -0.01 score on a scale | Standard Deviation 0.16 |
| 150mg Abemaciclib | Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Right Now | -0.18 score on a scale | Standard Deviation 0.17 |
| 150mg Abemaciclib | Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Mean Interference Score | 0.03 score on a scale | Standard Deviation 0.18 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Mean Interference Score | 0.16 score on a scale | Standard Deviation 0.18 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain Right Now | -0.04 score on a scale | Standard Deviation 0.17 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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 | -0.43 score on a scale | Standard Deviation 0.21 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf) | Pain on the Average | -0.11 score on a scale | Standard Deviation 0.17 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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 | 0.14 score on a scale | Standard Deviation 0.16 |
Secondary
Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
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
Population: All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 score.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 2.2 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib | 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) | 1.87 score on a scale | Standard Deviation 2.5 |
| 150mg Abemaciclib | 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 | 4.56 score on a scale | Standard Deviation 1.9 |
| 150mg Abemaciclib | 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) | -1.05 score on a scale | Standard Deviation 1.68 |
| 150mg Abemaciclib | 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) | -3.95 score on a scale | Standard Deviation 2.3 |
| 150mg Abemaciclib | 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) | 2.58 score on a scale | Standard Deviation 1.95 |
| 150mg Abemaciclib | 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) | -1.31 score on a scale | Standard Deviation 1.44 |
| 150mg Abemaciclib | 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) | -0.53 score on a scale | Standard Deviation 2.16 |
| 150mg Abemaciclib | 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) | 2.77 score on a scale | Standard Deviation 2.15 |
| 150mg Abemaciclib | 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) | 5.30 score on a scale | Standard Deviation 1.73 |
| 150mg Abemaciclib | 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) | -1.43 score on a scale | Standard Deviation 2.3 |
| 150mg Abemaciclib | 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) | -3.49 score on a scale | Standard Deviation 1.89 |
| 150mg Abemaciclib | 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) | -3.43 score on a scale | Standard Deviation 2.36 |
| 150mg Abemaciclib | 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) | -6.29 score on a scale | Standard Deviation 1.71 |
| 150mg Abemaciclib | 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) | 20.17 score on a scale | Standard Deviation 2.1 |
| 150mg Abemaciclib | 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) | -3.81 score on a scale | Standard Deviation 2.08 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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) | -0.94 score on a scale | Standard Deviation 2.16 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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) | 17.43 score on a scale | Standard Deviation 2.09 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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) | -2.98 score on a scale | Standard Deviation 2.35 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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) | -2.39 score on a scale | Standard Deviation 1.43 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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) | 1.86 score on a scale | Standard Deviation 1.95 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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) | 7.76 score on a scale | Standard Deviation 2.5 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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) | -5.87 score on a scale | Standard Deviation 2.29 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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 | -2.77 score on a scale | Standard Deviation 1.91 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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) | 0.08 score on a scale | Standard Deviation 1.67 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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) | 5.09 score on a scale | Standard Deviation 1.71 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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) | -2.65 score on a scale | Standard Deviation 1.68 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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) | -2.01 score on a scale | Standard Deviation 2.29 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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) | 4.0 score on a scale | Standard Deviation 2.16 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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) | -0.09 score on a scale | Standard Deviation 2.07 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | 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) | -2.0 score on a scale | Standard Deviation 1.87 |
Secondary
Duration of Response (DoR)
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)
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 150mg Abemaciclib + 20mg Tamoxifen | Duration of Response (DoR) | 7.40 Months |
| 150mg Abemaciclib | Duration of Response (DoR) | 9.21 Months |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Duration of Response (DoR) | 7.46 Months |
Secondary
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)
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)
Population: All randomized participants who received at least one dose of study drug and had PR/CR data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 150mg Abemaciclib + 20mg Tamoxifen | Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | 34.6 Percentage of participants |
| 150mg Abemaciclib | Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | 24.1 Percentage of participants |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR) | 32.5 Percentage of participants |
Secondary
Overall Survival (OS)
Time frame: Baseline to Death from Any Cause (Approximately 36 Months)
Secondary
Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites
Mean single dose concentrations of Abemaciclib and its metabolites (M2 & M20) are reported.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib | Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites | M2 (C1D1) | 2.14 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 60.1 |
| 150mg Abemaciclib | Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites | Abemaciclib (C1D1) | 3.05 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 95.4 |
| 150mg Abemaciclib | Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites | M20 (C1D1) | 2.54 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 54.5 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites | Abemaciclib (C1D1) | 8.59 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 440 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites | M20 (C1D1) | 7.91 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 220 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites | M2 (C1D1) | 6.85 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 237 |
Secondary
Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites
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
Population: All randomized participants who received at least one dose of study drug and had evaluable PK samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 150mg Abemaciclib + 20mg Tamoxifen | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M20 (C1D15) | 180 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 51.1 |
| 150mg Abemaciclib + 20mg Tamoxifen | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | Abemaciclib (C2D1) | 98.9 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 196 |
| 150mg Abemaciclib + 20mg Tamoxifen | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M2 (C2D1) | 56.1 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 88 |
| 150mg Abemaciclib + 20mg Tamoxifen | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M20 (C2D1) | 100 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 103 |
| 150mg Abemaciclib + 20mg Tamoxifen | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | Abemaciclib (C2D15) | 135 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 115 |
| 150mg Abemaciclib + 20mg Tamoxifen | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M2 (C2D15) | 62.3 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 79 |
| 150mg Abemaciclib + 20mg Tamoxifen | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M20 (C2D15) | 120 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 76.2 |
| 150mg Abemaciclib + 20mg Tamoxifen | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | Abemaciclib (C3D1) | 125 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 64.3 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib + 20mg Tamoxifen | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M20 (C3D1) | 109 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 39.4 |
| 150mg Abemaciclib + 20mg Tamoxifen | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | Abemaciclib (C1D15) | 214 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 66.4 |
| 150mg Abemaciclib + 20mg Tamoxifen | 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 |
| 150mg Abemaciclib | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M2 (C1D15) | 108 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 45.6 |
| 150mg Abemaciclib | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M20 (C1D15) | 199 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 41 |
| 150mg Abemaciclib | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M20 (C2D15) | 128 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 121 |
| 150mg Abemaciclib | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M2 (C3D1) | 78.4 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 38.2 |
| 150mg Abemaciclib | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | Abemaciclib (C2D1) | 182 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 129 |
| 150mg Abemaciclib | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M2 (C2D15) | 71.7 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 97.9 |
| 150mg Abemaciclib | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | Abemaciclib (C1D15) | 256 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 58.8 |
| 150mg Abemaciclib | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M2 (C2D1) | 85.4 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 62.1 |
| 150mg Abemaciclib | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | Abemaciclib (C3D1) | 177 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 42 |
| 150mg Abemaciclib | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | Abemaciclib (C2D15) | 157 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 173 |
| 150mg Abemaciclib | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M20 (C2D1) | 149 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 78.9 |
| 150mg Abemaciclib | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M20 (C3D1) | 146 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 37.7 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M20 (C2D1) | 164 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 171 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | Abemaciclib (C2D15) | 175 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 136 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M20 (C3D1) | 171 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 36.6 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M2 (C2D15) | 95.4 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 73.9 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M20 (C2D15) | 154 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 101 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | Abemaciclib (C3D1) | 207 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 49 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | Abemaciclib (C1D15) | 314 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 74.3 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M20 (C1D15) | 251 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 48.5 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | Abemaciclib (C2D1) | 220 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 154 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M2 (C3D1) | 95.8 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 44.2 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M2 (C2D1) | 105 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 98.5 |
| 200mg Abemaciclib + 2mg Prophylactic Loperamide | Pharmacokinetics (PK): Steady State Concentration of Abemaciclib and Its Metabolites | M2 (C1D15) | 147 Nanogram per Millilitre (ng/mL) | Geometric Coefficient of Variation 47.1 |
Secondary
PK: Mean Single Dose Concentration of Tamoxifen and Endoxifen
Mean single dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported.
Time frame: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 150mg Abemaciclib + 20mg Tamoxifen | PK: Mean Single Dose Concentration of Tamoxifen and Endoxifen | Endoxifen (C1D1) | NA ng/mL | — |
| 150mg Abemaciclib + 20mg Tamoxifen | PK: Mean Single Dose Concentration of Tamoxifen and Endoxifen | Tamoxifen (C1D1) | 7.47 ng/mL | Geometric Coefficient of Variation 116 |
Secondary
PK: Multiple Dose Concentration of Tamoxifen and Endoxifen
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
Population: All randomized participants who received at least one dose of study drug along with Tamoxifen and had evaluable PK samples.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| 150mg Abemaciclib + 20mg Tamoxifen | PK: Multiple Dose Concentration of Tamoxifen and Endoxifen | Tamoxifen (C1D15) | 84.5 ng/mL | Geometric Coefficient of Variation 41.6 |
| 150mg Abemaciclib + 20mg Tamoxifen | PK: Multiple Dose Concentration of Tamoxifen and Endoxifen | Endoxifen (C1D15) | 4.76 ng/mL | Geometric Coefficient of Variation 99.7 |
| 150mg Abemaciclib + 20mg Tamoxifen | PK: Multiple Dose Concentration of Tamoxifen and Endoxifen | Tamoxifen (C2D1) | 98.7 ng/mL | Geometric Coefficient of Variation 50.2 |
| 150mg Abemaciclib + 20mg Tamoxifen | PK: Multiple Dose Concentration of Tamoxifen and Endoxifen | Endoxifen (C2D1) | 7.41 ng/mL | Geometric Coefficient of Variation 89.5 |
| 150mg Abemaciclib + 20mg Tamoxifen | PK: Multiple Dose Concentration of Tamoxifen and Endoxifen | Tamoxifen (C2D15) | 109 ng/mL | Geometric Coefficient of Variation 51.9 |
| 150mg Abemaciclib + 20mg Tamoxifen | PK: Multiple Dose Concentration of Tamoxifen and Endoxifen | Endoxifen (C2D15) | 9.17 ng/mL | Geometric Coefficient of Variation 73.7 |
| 150mg Abemaciclib + 20mg Tamoxifen | PK: Multiple Dose Concentration of Tamoxifen and Endoxifen | Tamoxifen (C3D1) | 112 ng/mL | Geometric Coefficient of Variation 60.2 |
| 150mg Abemaciclib + 20mg Tamoxifen | PK: Multiple Dose Concentration of Tamoxifen and Endoxifen | Endoxifen (C3D1) | 10.3 ng/mL | Geometric Coefficient of Variation 84.8 |