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| ID | Type | Description | Link |
|---|---|---|---|
| I3Y-MC-JPCG | Other Identifier | Eli Lilly and Company | |
| 2016-000288-18 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abemaciclib + Tamoxifen | Experimental | Abemaciclib given orally every 12 hours (Q12H) in combination with tamoxifen given orally every day. Participants may continue to receive treatment until discontinuation criteria are met. |
|
| Abemaciclib | Experimental | Abemaciclib given orally Q12H. Participants may continue to receive treatment until discontinuation criteria are met. |
|
| Abemaciclib + Prophylactic Loperamide | Experimental | Abemaciclib given orally Q12H in combination with prophylactic loperamide given orally. Participants may continue to receive treatment until discontinuation criteria are met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Objective Disease Progression or Death from Any Cause (Up to 21 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona Cancer Center | Tucson | Arizona | 85724 | United States | ||
| Dartmouth Hitchcock Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35829935 | Derived | Hamilton E, Cortes J, Ozyilkan O, Chen SC, Petrakova K, Manikhas A, Jerusalem G, Hegg R, Huober J, Zhang W, Chen Y, Martin M. nextMONARCH Phase 2 randomized clinical trial: overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with endocrine-refractory HR + , HER2- metastatic breast cancer. Breast Cancer Res Treat. 2022 Aug;195(1):55-64. doi: 10.1007/s10549-022-06662-9. Epub 2022 Jul 12. |
| Label | URL |
|---|---|
| A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer (nextMONARCH 1) | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 150mg Abemaciclib |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 29, 2019 | Apr 2, 2019 |
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| Tamoxifen | Drug | Administered orally |
|
| Prophylactic Loperamide | Drug | Administered orally |
|
| Baseline to Objective Disease Progression (Up to 21 Months) |
| 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. | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 21 Months) |
| Overall Survival (OS) | Baseline to Death from Any Cause (Approximately 36 Months) |
| Pharmacokinetics (PK): Mean Single Dose Concentration of Abemaciclib and Its Metabolites | Mean single dose concentrations of Abemaciclib and its metabolites (M2 & M20) are reported. | Cycle (C) 1 Day (D) 1 post dose |
| 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 | Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose |
| PK: Mean Single Dose Concentration of Tamoxifen and Endoxifen | Mean single dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported. | Cycle 1 Day 1 post dose |
| PK: Multiple Dose Concentration of Tamoxifen and Endoxifen | Mean multiple dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported. | Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose |
| 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:
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. | Baseline, 21 Months |
| 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. | Baseline, 21 Months |
| Lebanon |
| New Hampshire |
| 03766 |
| United States |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37203 | United States |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | United States |
| University of Wisconsin Clinical Research Center | Madison | Wisconsin | 53705 | United States |
| CENIT Centro de Neurociencias, Investigación y Tratamiento | CABA | Buenos Aires | C1125ABD | Argentina |
| Fundacion Ars Medica | San Salvador de Jujuy | Jujuy Province | Y4600APW | Argentina |
| Clinica Viedma | Viedma | Río Negro Province | R8500ACE | Argentina |
| Instituto de Oncología de Rosario | Rosario | Santa Fe Province | S2000KZE | Argentina |
| Centro Para la Atención Integral del Paciente Oncologico (CAIPO) | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Sanatorio Parque | Salta | 4400 | Argentina |
| Medizinische Universitaet Graz | Graz | Styria | 8036 | Austria |
| Universitätsklinik Innsbruck | Innsbruck | Tyrol | 6020 | Austria |
| AKH | Vienna | 1090 | Austria |
| Universitair Ziekenhuis Gent | Ghent | Oost-Vlaanderen | 9000 | Belgium |
| VITAZ | Sint-Niklaas | Oost-Vlaanderen | 9100 | Belgium |
| Grand Hopital de Charleroi-Site Notre-Dame | Charleroi | 6000 | Belgium |
| Centre Hospitalier Universitaire Sart Tilman | Liège | 4000 | Belgium |
| Hospital São Lucas - PUCRS - ONCOLOGY | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | São Paulo | 14784400 | Brazil |
| Icesp - Instituto Do Câncer Do Estado de São Paulo | São Paulo | 01246000 | Brazil |
| Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária LTDA | São Paulo | 01317-000 | Brazil |
| Masarykuv onkologicky ustav | Brno | Czech Republic | 656 53 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Fakultni Poliklinika VFN | Prague | 128 08 | Czechia |
| Fakultni Nemocnice v Motole | Prague | 150 06 | Czechia |
| Thomayerova nemocnice | Praha 4 - Krc | 140 59 | Czechia |
| Centre Oscar Lambret | Lille | Hauts-de-France | 59020 | France |
| Institut Paoli-Calmettes | Marseille | Provence-Alpes-Côte d'Azur Region | 13273 | France |
| Universitätsklinikum Ulm | Ulm | Baden-Wurttemberg | 89081 | Germany |
| Kath. Marienkrankenhaus gGmbH | Hamburg | 22087 | Germany |
| Polic.Umberto I -Univ. La Sapienza | Roma | Rome | 00161 | Italy |
| Ospedale Sacro Cuore Don G. Calabria | Negrar | Verona | 37024 | Italy |
| Ospedale Bellaria - Azienda USL di Bologna | Bologna | 40139 | Italy |
| Azienda Ospedaliera Universitaria Federico II | Naples | 80131 | Italy |
| Neurociencias Estudios Clinicos | Culiacán | Sinaloa | 80020 | Mexico |
| Centro Hemato Oncologico Privado | San Bernardino | Toluca | 50080 | Mexico |
| Grupo Medico Camino Sc | Mexico City | 03310 | Mexico |
| Oaxaca Site Management Organization | Oaxaca City | 68000 | Mexico |
| Republic Oncology Dispensary of MoH of Republic Tatarstan | Kazan' | 420029 | Russia |
| St-Petersburg scientifical practical center of specialized medical care | Saint Petersburg | 197758 | Russia |
| Saint-Petersburg city clinical oncology dispensary | Saint Petersburg | 198255 | Russia |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | Madrid, Comunidad de | 28034 | Spain |
| Hospital Clinic I Provincial | Barcelona | 08036 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | 46010 | Spain |
| Taipei Medical University Shuang Ho Hospital | New Taipei City | 235 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Chang Gung Memorial Hospital - Linkou | Taoyuan City | 33305 | Taiwan |
| Erciyes University Faculty of Medicine | Kayseri | Melikgazi | 38039 | Turkey (Türkiye) |
| Baskent University Dr. Turgut Noyan Research and Training Center | Adana | 1250 | Turkey (Türkiye) |
| Hacettepe University Faculty of Medicine | Ankara | 06100 | Turkey (Türkiye) |
| Medipol Mega University Hospital | Istanbul | 34214 | Turkey (Türkiye) |
| Marmara University Medical Faculty | Istanbul | 34668 | Turkey (Türkiye) |
Participants received oral dose of 150 milligrams (mg) Abemaciclib every 12 hours (Q12H) on days 1 to days 28 of a 28 day cycle. |
| FG002 | 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. |
| Received at Least One Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | 95% Confidence Interval | Months | Baseline to Objective Disease Progression or Death from Any Cause (Up to 21 Months) |
|
|
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| 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. | All randomized participants who received at least one dose of study drug and had PR/CR data. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to Objective Disease Progression (Up to 21 Months) |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Months | Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up to 21 Months) |
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| Secondary | Overall Survival (OS) | Not Posted | Baseline to Death from Any Cause (Approximately 36 Months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | All randomized participants who received at least one dose of study drug and had evaluable PK samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per Millilitre (ng/mL) | Cycle (C) 1 Day (D) 1 post dose |
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| 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 | All randomized participants who received at least one dose of study drug and had evaluable PK samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanogram per Millilitre (ng/mL) | Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose |
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| Secondary | PK: Mean Single Dose Concentration of Tamoxifen and Endoxifen | Mean single dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported. | All randomized participants who received at least one dose of study drug along with Tamoxifen and had evaluable PK samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1 Day 1 post dose |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK: Multiple Dose Concentration of Tamoxifen and Endoxifen | Mean multiple dose concentrations of Tamoxifen and its metabolite (Endoxifen) were reported. | All randomized participants who received at least one dose of study drug along with Tamoxifen and had evaluable PK samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1 post dose |
|
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| 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:
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. | All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 score. | Posted | Least Squares Mean | Standard Deviation | score on a scale | Baseline, 21 Months |
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| 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. | All randomized participants who received at least one dose of study drug and had baselines and post baseline mBPI-sf measurement. | Posted | Least Squares Mean | Standard Deviation | score on a scale | Baseline, 21 Months |
|
Up to 21 Months
All randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 18 | 78 | 16 | 78 | 73 | 78 |
| EG001 | 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. | 28 | 79 | 16 | 79 | 77 | 79 |
| EG002 | 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. | 29 | 77 | 21 | 77 | 75 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 20.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 29, 2016 | Apr 2, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000590451 | abemaciclib |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Stratified by the randomization factors of presence of liver metastases and prior use of Tamoxifen in the advanced/metastatic setting. |
| Hazard Ratio (HR) |
| 1.045 |
| 2-Sided |
| 95 |
| 0.711 |
| 1.535 |
| Other |
Informal phase 2 non-inferiority. |
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.
|
|
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. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| OG002 | 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. |
|
|
| OG002 | 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. |
|
|