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| ID | Type | Description | Link |
|---|---|---|---|
| I3Y-MC-JPBL | Other Identifier | Eli Lilly and Company | |
| 2013-004728-13 | EudraCT Number |
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The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant.
For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abemaciclib + Fulvestrant | Experimental | Abemaciclib 150 milligram (mg) administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met. |
|
| Placebo + Fulvestrant | Placebo Comparator | Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib | Drug | Administered Orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was 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. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS defined as the time from the date of randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. The final analysis of the OS outcome was conducted after 440 OS events had been observed. |
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Inclusion Criteria
Have a diagnosis of HR+, HER2- breast cancer
Have locally advanced disease not amenable to curative treatment by surgery or metastatic disease. In addition, participants must fulfill 1 of the following criteria:
Have postmenopausal status due to either surgical/natural menopause or ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin
Have a negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression with a GnRH agonist
Have either measurable disease or nonmeasurable bone only disease
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
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 |
|---|---|---|---|---|---|---|
| St. Bernards Medical Center | Jonesboro | Arkansas | 72401 | United States | ||
| Highlands Oncology Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34425869 | Derived | Neven P, Rugo HS, Tolaney SM, Iwata H, Toi M, Goetz MP, Kaufman PA, Lu Y, Haddad N, Hurt KC, Sledge GW Jr. Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial. Breast Cancer Res. 2021 Aug 23;23(1):87. doi: 10.1186/s13058-021-01463-2. | |
| 33797023 |
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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 European Union (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.
With Overall Survival (OS) as a key outcome, participants who completed included those who died due to any cause and those who were off treatment, alive and in follow-up at the time of the final OS analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abemaciclib + Fulvestrant | Abemaciclib 150 milligram (mg) administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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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: JPBL 05 Protocol_Redacted | Apr 1, 2014 |
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| Fulvestrant | Drug | Administered IM |
|
| Placebo | Drug | Administered Orally |
|
| From Date of Randomization until Death Due to Any Cause (Up To 72 Months) |
| Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was 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. | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months) |
| Duration of Response (DOR) | DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR 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. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was 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. | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 31 Months) |
| Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR]) | Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR 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 was 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 was 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. | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months) |
| Percentage of Participants With CR, PR or SD With a Duration of At Least 6 Months (Clinical Benefit Rate [CBR]) | Clinical benefit rate defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months.CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.PR 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 was 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. Percentage of participants=(participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100.PD was at least a 20% increase in 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. | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months) |
| Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf) | A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. Least square (LS) Mean value was controlled for Treatment, visit, Treatment*Visit and baseline. | Baseline, End of Study (Up To 31 Months) |
| Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20 | Area Under the Plasma Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20. | Cycle 1 Day 1 2-4 hours (h) post dose, Cycle 1 Day 15 4 and 7h post dose, Cycle 2 Day 1 pre dose and 3h post dose, Cycle 3 Day1 pre dose |
| Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L) | European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The EQ-5D-5L is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. A higher score indicates better health state. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline. | Baseline, End of Study (Up To 31 Months) |
| Change From Baseline to Short Term Follow up in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 110 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline. | Baseline, Short Term Follow Up (Up To 31 Months) |
| Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire | EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms and arm symptoms. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline. | Baseline, Short Term Follow Up (Up To 31 Months) |
| Springdale |
| Arkansas |
| 72762 |
| United States |
| University of California - San Diego | La Jolla | California | 92037-0845 | United States |
| Kaiser Permanente | Riverside | California | 92505 | United States |
| Univ of California San Francisco | San Francisco | California | 94115 | United States |
| Stanford University Clinic | Stanford | California | 94305 | United States |
| Palm Beach Cancer Institue | Atlantis | Florida | 33462 | United States |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States |
| Florida Cancer Specialists - South | Fort Myers | Florida | 33901 | United States |
| Palm Beach Cancer Institue | Palm Beach Gardens | Florida | 33410 | United States |
| Florida Cancer Specialists - North | St. Petersburg | Florida | 33705 | United States |
| Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center | Tampa | Florida | 33612 | United States |
| Palm Beach Cancer Institue | Wellington | Florida | 33414 | United States |
| Palm Beach Cancer Institue | West Palm Beach | Florida | 33401 | United States |
| University Cancer & Blood Center, LLC | Athens | Georgia | 30607 | United States |
| Harbin Clinic | Rome | Georgia | 30165 | United States |
| Quincy Medical Group | Quincy | Illinois | 62301 | United States |
| Pharmasite Research, Inc. | Baltimore | Maryland | 21208 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Breslin Cancer Center | Lansing | Michigan | 48910 | United States |
| Minnesota Oncology/Hematology PA | Minneapolis | Minnesota | 55404 | United States |
| Washington University Medical School | City of Saint Peters | Missouri | 63376 | United States |
| Washington University Medical School | Creve Coeur | Missouri | 63141 | United States |
| Freeman Cancer Institute | Joplin | Missouri | 64804 | United States |
| St Lukes Hospital | Kansas City | Missouri | 64111 | United States |
| Washington University Medical School | St Louis | Missouri | 63110 | United States |
| Washington University Medical School | St Louis | Missouri | 63129 | United States |
| Billings Clinic | Billings | Montana | 59101 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0001 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Rochester General Hospital | Rochester | New York | 14621 | United States |
| Rochester General Hospital | Rochester | New York | 14625 | United States |
| Novant Health, Oncology Research Institute | Winston-Salem | North Carolina | 27103 | United States |
| Oklahoma Cancer Specialists & Research Institute, LLC | Tulsa | Oklahoma | 74146 | United States |
| Sanford Research/USD | Sioux Falls | South Dakota | 57104 | United States |
| The Boston Baskin Cancer Group | Memphis | Tennessee | 38120 | United States |
| SMO Sarah Cannon Research Inst. | Nashville | Tennessee | 37203 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Oncology Consultants P.A. | Houston | Texas | 77030 | United States |
| Utah Cancer Specialists | Salt Lake City | Utah | 84106 | United States |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | 99336 | United States |
| St Mary Regional Cancer Center | Walla Walla | Washington | 99362 | United States |
| Icon Cancer Centre South Brisbane | South Brisbane | Queensland | 4101 | Australia |
| Gold Coast University Hospital | Southport | Queensland | 4215 | Australia |
| Ashford Cancer Centre Research | Kurralta Park | South Australia | 5037 | Australia |
| Monash Cancer Centre | East Bentleigh | Victoria | 3165 | Australia |
| St. John of God Subiaco Hospital | Subiaco | Western Australia | 6008 | Australia |
| Antwerp University Hospital | Edegem | Antwerpen | 2650 | Belgium |
| UZ Brussel | Brussels | Bruxelles-Capitale, Région de | 1090 | Belgium |
| UZ Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman | Liège | 4000 | Belgium |
| Tom Baker Cancer Center | Calgary | Alberta | T2N 4N2 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 5W9 | Canada |
| Humber River Hospital | Toronto | Ontario | M3M 0B2 | Canada |
| Unity Health Toronto, St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Herlev and Gentofte Hospital | Copenhagen | Capital Region | 2730 | Denmark |
| Aalborg Universitets hospital | Aalborg | 9000 | Denmark |
| Roskilde Sygehus | Roskilde | 4000 | Denmark |
| Tampereen yliopistollinen sairaala | Tampere | Pirkanmaa | 33520 | Finland |
| Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) | Helsinki | Uusimaa | 00029 | Finland |
| Turun Yliopistollinen Keskussairaala | Turku | 20520 | Finland |
| CHU Besançon | Besançon | Doubs | 25000 | France |
| Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne | Clermont-Ferrand | Puy-de-Dôme | 63011 | France |
| Polyclinique De Blois | La Chaussée-Saint-Victor | 41260 | France |
| Clinique Victor Hugo - Centre Jean Bernard | Le Mans | 72000 | France |
| Klinikum Ludwigsburg | Ludwigsburg | Baden-Wurttemberg | 71640 | Germany |
| Universitaetsklinikum Tuebingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Gemeinschaftspraxis hop-augsburg | Augsburg | Bavaria | 86150 | Germany |
| Klinikum der Ludwig-Maximilians-Universitaet Muenchen | München | Bavaria | 80336 | Germany |
| Facharztzentrum Eppendorf | Hamburg | 20249 | Germany |
| University Hospital of Patras | Pátrai | Achaḯa | 26504 | Greece |
| Agios Savvas Regional Cancer Hospital | Athens | Attikí | 11522 | Greece |
| University General Hospital of Heraklion | Heraklion | Krítí | 71110 | Greece |
| Chania General Hospital 'Agios Georgios' | Chania | 73300 | Greece |
| Azienda Ospedaliero Universitaria S.Anna | Cona | Emilia-Romagna | 44124 | Italy |
| Istituto Nazionale Tumori Regina Elena | Rome | Roma | 00144 | Italy |
| Ospedale Bellaria - Azienda USL di Bologna | Bologna | 40139 | Italy |
| Istituto Oncologico Veneto IRCCS | Padova | 35128 | Italy |
| Aichi Cancer Center Hospital | Nagoya | Aichi-ken | 464-8681 | Japan |
| Chiba cancer center | Chiba | Chiba | 260-8717 | Japan |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| National Hospital Organization Shikoku Cancer Center | Matsuyama | Ehime | 791-0280 | Japan |
| Kurume General Hospital | Kurume | Fukuoka | 830-0013 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Sapporo | Hokkaido | 003-0804 | Japan |
| Hyogo College of Medicine | Nishinomiya | Hyōgo | 663-8501 | Japan |
| St. Marianna University School of Medicine Hospital | Kawasaki | Kanagawa | 216-8511 | Japan |
| Niigata Cancer Center Hospital | Niigata | Niigata | 951-8566 | Japan |
| Saitama Prefectural Cancer Center | Ina-machi | Saitama | 362-0806 | Japan |
| Jichi Medical University Hospital | Shimotsuke | Tochigi | 329- 0498 | Japan |
| Tokyo Met Cancer & Infectious Diseases Center Komagome Hp | Bunkyo-ku | Tokyo | 113-8677 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| Japanese Foundation for Cancer Research | Koto | Tokyo | 135-8550 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 811-1395 | Japan |
| Sagara Hospital | Kagoshima | 892-0833 | Japan |
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| National Hospital Organization Osaka Medical Center | Osaka | 540-0006 | Japan |
| Osaka International Cancer Institute | Osaka | 541-8567 | Japan |
| Hospital Angeles | Tijuana | Estado de Baja California | 22010 | Mexico |
| Preparaciones Oncológicas S.C. | León | Guanajuato | 37178 | Mexico |
| Centro Oncológico Internacional (COI) | Guadalajara | Jalisco | 45647 | Mexico |
| Grupo Medico Camino Sc | Mexico City | Mexico City | 03310 | Mexico |
| Instituto Nacional de Cancerologia | Mexico City | Mexico City | 14070 | Mexico |
| OCA Hospital | Monterrey | Nuevo León | 64000 | Mexico |
| Tecnologico de Monterrey | Monterrey | Nuevo León | 64710 | Mexico |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Pomeranian Voivodeship | 80-214 | Poland |
| Bialostockie Centrum Onkologii, Oddzial Onkologii Klinicznej | Bialystok | 15-027 | Poland |
| Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | Łódź Voivodeship | Poland |
| Puerto Rico Hematology/Oncology Group | Bayamón | PR | 00959 | Puerto Rico |
| S.C. MedisProf SRL | Cluj-Napoca | Cluj | 400058 | Romania |
| Centrul de Oncologie "Sfântul Nectarie" | Craiova | Dolj | 200347 | Romania |
| Ianuli Med Consult SRL | Bucharest | 010976 | Romania |
| Arkhangelsk Clinical Oncological Dispensary | Arkhangelsk | Arkhangelskaya oblast | 163045 | Russia |
| Regional Budgetary Healthcare Institution 'Ivanovo Regional Oncology Dispensary' | Ivanovo | Ivanovo Oblast | 153040 | Russia |
| Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF | Moscow | Moscow | 115478 | Russia |
| Kursk Regional Oncology Dispensary | Kursk | Russian Federation | 305035 | Russia |
| N.N.Petrov Research Institute of Oncology | Saint Petersburg | Sankt-Peterburg | 197758 | Russia |
| Saint-Petersburg City Clinical Oncology Dispensary | Saint Petersburg | Sankt-Peterburg | 198255 | Russia |
| Chungbuk National University Hospital | Cheongju-si | Chungcheongbuk-do [Chungbuk] | 28644 | South Korea |
| Inha University Hospital | Incheon | Incheon-gwangyeoksi [Incheon] | 22332 | South Korea |
| Gachon University Gil Medical Center | Namdong-gu | Incheon-gwangyeoksi [Incheon] | 21565 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | Kyǒnggi-do | 13620 | South Korea |
| Seoul National University Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | 3080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | Seoul-teukbyeolsi [Seoul] | 3722 | South Korea |
| Asan Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | 5505 | South Korea |
| Samsung Medical Center | Seoul | Seoul-teukbyeolsi [Seoul] | 6351 | South Korea |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital | Seoul | Seoul-teukbyeolsi [Seoul] | 6591 | South Korea |
| Ulsan University Hospital | Ulsan | Ulsan-Kwangyǒkshi | 44033 | South Korea |
| Hospital General Universitario de Elche | Elche | Alicante | 03202 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | 08035 | Spain |
| Hospital Universitario Arnau de Vilanova de Lleida | Lleida | Lleida [Lérida] | 25198 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid, Comunidad de | 28041 | Spain |
| Hospital General Universitario Morales Meseguer | Murcia | Murcia, Región de | 30008 | Spain |
| Hospital Quirónsalud Valencia | Valencia | València | 46010 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Universitätsspital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
| Spital Thun | Thun | Canton of Bern | 3600 | Switzerland |
| HUG-Hôpitaux Universitaires de Genève | Geneva | 1211 | Switzerland |
| Chang Gung Memorial Hospital at Kaohsiung | Kaohsiung Niao Sung Dist | Kaohsiung | 83301 | Taiwan |
| Kaohsiung Medical University Hospital | Kaohsiung City | 80756 | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | 81362 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 407 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Chang Gung Medical Foundation-Linkou Branch | Taoyuan | 333 | Taiwan |
| Derived |
| Inoue K, Masuda N, Iwata H, Takahashi M, Ito Y, Miyoshi Y, Nakayama T, Mukai H, van der Walt JS, Mori J, Sakaguchi S, Kawaguchi T, Tanizawa Y, Llombart-Cussac A, Sledge GW Jr, Toi M. Japanese subpopulation analysis of MONARCH 2: phase 3 study of abemaciclib plus fulvestrant for treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that progressed on endocrine therapy. Breast Cancer. 2021 Sep;28(5):1038-1050. doi: 10.1007/s12282-021-01239-8. Epub 2021 Apr 1. |
| 33392835 | Derived | Goetz MP, Okera M, Wildiers H, Campone M, Grischke EM, Manso L, Andre VAM, Chouaki N, San Antonio B, Toi M, Sledge GW Jr. Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. Breast Cancer Res Treat. 2021 Apr;186(2):417-428. doi: 10.1007/s10549-020-06029-y. Epub 2021 Jan 3. |
| 31563959 | Derived | Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Conte P, Lu Y, Barriga S, Hurt K, Frenzel M, Johnston S, Llombart-Cussac A. The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy-MONARCH 2: A Randomized Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):116-124. doi: 10.1001/jamaoncol.2019.4782. |
| 28580882 | Derived | Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Frenzel M, Lin Y, Barriga S, Smith IC, Bourayou N, Llombart-Cussac A. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol. 2017 Sep 1;35(25):2875-2884. doi: 10.1200/JCO.2017.73.7585. Epub 2017 Jun 3. |
| Placebo + Fulvestrant |
Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Abemaciclib + Fulvestrant | Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met. |
| BG001 | Placebo + Fulvestrant | Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met. |
| BG002 | 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) | All randomized participants who had baseline Ethnicity data. | Count of Participants | Participants | No |
| ||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | 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) | PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was 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. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. | All randomized participants. Censored participants: Abemaciclib=224. | Posted | Median | 95% Confidence Interval | Months | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months) |
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| Secondary | Overall Survival (OS) | OS defined as the time from the date of randomization to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. The final analysis of the OS outcome was conducted after 440 OS events had been observed. | All randomized participants. Censored participants: Abemaciclib=163 (36.5%), Placebo = 66 (29.6). | Posted | Median | 95% Confidence Interval | Months | From Date of Randomization until Death Due to Any Cause (Up To 72 Months) |
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| Secondary | Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was 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. | All randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months) |
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| Secondary | Duration of Response (DOR) | DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR 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. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was 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. | All randomized participants with response. | Posted | Median | 95% Confidence Interval | Months | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 31 Months) |
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| Secondary | Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR]) | Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR 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 was 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 was 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. | All randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months) |
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| Secondary | Percentage of Participants With CR, PR or SD With a Duration of At Least 6 Months (Clinical Benefit Rate [CBR]) | Clinical benefit rate defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months.CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions.PR 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 was 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. Percentage of participants=(participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100.PD was at least a 20% increase in 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. | All randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months) |
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| Secondary | Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf) | A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. Least square (LS) Mean value was controlled for Treatment, visit, Treatment*Visit and baseline. | All randomized participants who received at least one dose of study drug with a baseline and at least 1 post-baseline result. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, End of Study (Up To 31 Months) |
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| Secondary | Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20 | Area Under the Plasma Concentration versus Time Curve from Time Zero to Infinity (AUC[0-∞]) was evaluated for Abemaciclib and Metabolites M2 and M20. | All randomized participants who received at least one dose of 150 mg study drug (Abemaciclib) with evaluable Abemaciclib, M2 and M20 PK data. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms*hour/milliliters (ng*h/mL) | Cycle 1 Day 1 2-4 hours (h) post dose, Cycle 1 Day 15 4 and 7h post dose, Cycle 2 Day 1 pre dose and 3h post dose, Cycle 3 Day1 pre dose |
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| Secondary | Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L) | European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The EQ-5D-5L is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. A higher score indicates better health state. LS Mean value was controlled for Treatment, visit, Treatment*Visit and baseline. | All randomized participants who received at least one dose of study drug with baseline and post-baseline EQ-5D 5L data. | Posted | Least Squares Mean | Standard Error | mm | Baseline, End of Study (Up To 31 Months) |
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| Secondary | Change From Baseline to Short Term Follow up in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 110 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline. | All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-C30 data at short term follow up for each EORTC QLQ-C30 items. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Short Term Follow Up (Up To 31 Months) |
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| Secondary | Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire | EORTC-QLQ-BR23 measured multi-item functional scales for body image, sexual functioning and future perspective and measured single item symptoms scales which assessed systemic therapy side effects, breast symptoms and arm symptoms. For functional scales, scores ranged from 0 to 100 where higher scores represented a better level of functioning. For symptoms scales, scores ranged from 0 to 100 where higher scores represented a greater degree of symptoms. LS Mean value of changing from baseline to short follow up was estimated from the mixed model that was controlled for Treatment, visit, Treatment*Visit and baseline. | All randomized participants who received at least one dose of study drug with baseline and post-baseline EORTC QLQ-BR23 data at short term follow up for each BR23 items. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline, Short Term Follow Up (Up To 31 Months) |
|
Up To 7 years 7.7 Months
Adverse Events: All randomized participants who received at least one dose of study drug; All-Cause Mortality: All randomized participants. Analyses presented in this report are based on a database lock for the pre-planned final OS analysis of 22 April 2022.
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 | Abemaciclib + Fulvestrant | 150 mg Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met. | 283 | 446 | 129 | 441 | 432 | 441 |
| EG001 | Placebo + Fulvestrant | Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met. | 157 | 223 | 33 | 223 | 194 | 223 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Atrioventricular block first degree | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Restrictive cardiomyopathy | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Middle ear inflammation | Ear and labyrinth disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Macular hole | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Enterocolitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrointestinal amyloidosis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oesophageal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Surgical failure | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Autoimmune disorder | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bartholin's abscess | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Covid-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Mastitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Salmonella bacteraemia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood follicle stimulating hormone abnormal | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Electrocardiogram qt prolonged | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| General physical condition abnormal | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Hormone level abnormal | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Oestradiol abnormal | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Adrenal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Benign bone neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fracture treatment | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
| |
| Internal fixation of fracture | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
| |
| Leg amputation | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
| |
| Medical device implantation | Surgical and medical procedures | MedDRA 25.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Neuropathy | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Jan 29, 2018 |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: JPBL 05 Protocol (a)_Redacted | Jan 12, 2015 | Jan 29, 2018 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: JPBL 05 Protocol (b)_Redacted | Mar 30, 2015 | Jan 29, 2018 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: JPBL 05 Protocol (c)_Redacted | Oct 27, 2015 | Jan 29, 2018 | Prot_003.pdf |
| Prot | Yes | No | No | Study Protocol: JPBL 05 Protocol (d)_Redacted | Apr 26, 2016 | Jan 29, 2018 | Prot_004.pdf |
| Prot | Yes | No | No | Study Protocol: JPBL 05 Protocol (g)_Redacted | Feb 17, 2021 | Aug 17, 2023 | Prot_007.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: version 4 | Jul 8, 2016 | Jan 29, 2018 | SAP_005.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Addendum for Overall Survival Analyses | Aug 25, 2017 | Jan 31, 2018 | SAP_006.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 |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
|
|
|
|
| Europe |
|
|
| Taiwan |
|
|
| Japan |
|
|
| South Korea |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met. |
|
|
Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met. |
|
|
| OG001 |
| Placebo + Fulvestrant |
Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 | Placebo + Fulvestrant | Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met. |
|
|
|
|