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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02107703
Other study ID # 15362
Secondary ID I3Y-MC-JPBL2013-
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date July 22, 2014
Est. completion date December 30, 2024

Study information

Verified date May 2024
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 669
Est. completion date December 30, 2024
Est. primary completion date February 14, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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: - relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression - relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression - relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease - presented de novo with metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease - for the endocrine naïve cohort: Must not have received prior endocrine therapy in current or prior disease setting - 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 - Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study - Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease - Have clinical evidence or history of central nervous system metastasis - Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, everolimus, or any CDK4/6 inhibitor. For the endocrine naïve cohort: In addition, have received treatment with any prior endocrine therapy - Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively - Have received recent (within 28 days prior to randomization) yellow fever vaccination - Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s) - Have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest - Have inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years - Have received an autologous or allogeneic stem-cell transplant - Have active bacterial or fungal infection, or detectable viral infection - Have initiated bisphosphonates or approved Receptor activator of nuclear factor kappa-B (RANK) ligand targeted agents <7 days prior to randomization

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Abemaciclib
Administered Orally
Fulvestrant
Administered IM
Placebo
Administered Orally

Locations

Country Name City State
Australia Monash Cancer Centre East Bentleigh Victoria
Australia Ashford Cancer Centre Research Kurralta Park South Australia
Australia Icon Cancer Centre South Brisbane South Brisbane Queensland
Australia Gold Coast University Hospital Southport Queensland
Australia St. John of God Subiaco Hospital Subiaco Western Australia
Belgium UZ Brussel Brussel Bruxelles-Capitale, Région De
Belgium Antwerp University Hospital Edegem Antwerpen
Belgium UZ Leuven Leuven Vlaams-Brabant
Belgium Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman Liège
Canada Tom Baker Cancer Center Calgary Alberta
Canada London Regional Cancer Program London Ontario
Canada Humber River Hospital Toronto Ontario
Canada Unity Health Toronto, St. Michael's Hospital Toronto Ontario
Denmark Aalborg Universitets hospital Aalborg
Denmark Herlev and Gentofte Hospital Copenhagen Hovedstaden
Denmark Roskilde Sygehus Roskilde
Finland Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) Helsinki Uusimaa
Finland Tampereen yliopistollinen sairaala Tampere Pirkanmaa
Finland Turun Yliopistollinen Keskussairaala Turku
France CHU Besançon Besancon Doubs
France Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne Clermont-Ferrand Puy-de-Dôme
France Polyclinique De Blois La Chaussee Saint Victor
France Clinique Victor Hugo - Centre Jean Bernard Le Mans
Germany Gemeinschaftspraxis hop-augsburg Augsburg Bayern
Germany Facharztzentrum Eppendorf Hamburg
Germany Klinikum Ludwigsburg Ludwigsburg Baden-Württemberg
Germany Klinikum der Ludwig-Maximilians-Universitaet Muenchen München Bayern
Germany Universitaetsklinikum Tuebingen Tübingen Baden-Württemberg
Greece Agios Savvas Regional Cancer Hospital Athens Attikí
Greece Chania General Hospital 'Agios Georgios' Chania
Greece University General Hospital of Heraklion Heraklion Krítí
Greece University Hospital of Patras Patras Acha?a
Italy Ospedale Bellaria - Azienda USL di Bologna Bologna
Italy Azienda Ospedaliero Universitaria S.Anna Cona Emilia-Romagna
Italy Istituto Oncologico Veneto IRCCS Padova
Italy Istituto Nazionale Tumori Regina Elena Rome Roma
Japan Tokyo Met Cancer & Infectious Diseases Center Komagome Hp Bunkyo-ku Tokyo
Japan Chiba cancer center Chiba-shi Chiba
Japan National Cancer Center Hospital Chuo-ku Tokyo
Japan National Hospital Organization Kyushu Cancer Center Fukuoka
Japan Saitama Prefectural Cancer Center Ina-machi Saitama
Japan Sagara Hospital Kagoshima
Japan National Cancer Center Hospital East Kashiwa Chiba
Japan St. Marianna University School of Medicine Hospital Kawasaki Kanagawa
Japan Japanese Foundation for Cancer Research Koto Tokyo
Japan Kurume General Hospital Kurume Fukuoka
Japan Kyoto University Hospital Kyoto
Japan National Hospital Organization Shikoku Cancer Center Matsuyama Ehime
Japan Aichi Cancer Center Hospital Nagoya Aichi
Japan Niigata Cancer Center Hospital Niigata-shi Niigata
Japan Hyogo College of Medicine Nishinomiya Hyogo
Japan National Hospital Organization Osaka Medical Center Osaka
Japan Osaka International Cancer Institute Osaka
Japan National Hospital Organization Hokkaido Cancer Center Sapporo Hokkaido
Japan Jichi Medical University Hospital Shimotsuke Tochigi
Korea, Republic of Chungbuk National University Hospital Cheongju-si Chungcheongbuk-do [Chungbuk]
Korea, Republic of Inha University Hospital Incheon Incheon-gwangyeoksi [Incheon]
Korea, Republic of Gachon University Gil Medical Center Namdong-gu Incheon-gwangyeoksi [Incheon]
Korea, Republic of Seoul National University Bundang Hospital Seongnam Kyonggi-do
Korea, Republic of Asan Medical Center Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Samsung Medical Center Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Seoul National University Hospital Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of The Catholic Univ. of Korea Seoul St. Mary's Hospital Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Ulsan University Hospital Ulsan Ulsan-Kwangyokshi
Mexico Centro Oncológico Internacional (COI) Guadalajara Jalisco
Mexico Preparaciones Oncológicas S.C. Leon Guanajuato
Mexico Grupo Medico Camino Sc Mexico City Distrito Federal
Mexico Instituto Nacional de Cancerologia Mexico City Distrito Federal
Mexico OCA Hospital Monterrey Nuevo León
Mexico Tecnologico de Monterrey Monterrey Nuevo León
Mexico Hospital Angeles Tijuana Baja California
Poland Bialostockie Centrum Onkologii, Oddzial Onkologii Klinicznej Bialystok
Poland Uniwersyteckie Centrum Kliniczne Gdansk Pomorskie
Poland Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna Lodz Lódzkie
Puerto Rico Puerto Rico Hematology/Oncology Group Bayamon
Romania Ianuli Med Consult SRL Bucharest
Romania S.C. MedisProf SRL Cluj-Napoca Cluj
Romania Centrul de Oncologie "Sfântul Nectarie" Craiova Dolj
Russian Federation Arkhangelsk Clinical Oncological Dispensary Arkhangelsk Arkhangel'skaya Oblast'
Russian Federation Regional Budgetary Healthcare Institution 'Ivanovo Regional Oncology Dispensary' Ivanovo Ivanovskaya Oblast'
Russian Federation Kursk Regional Oncology Dispensary Kursk
Russian Federation Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF Moscow Moskva
Russian Federation N.N.Petrov Research Institute of Oncology Saint Petersburg Sankt-Peterburg
Russian Federation Saint-Petersburg City Clinical Oncology Dispensary Saint Petersburg Sankt-Peterburg
Spain Hospital Universitari Vall d'Hebron Barcelona Barcelona [Barcelona]
Spain Hospital General Universitario de Elche Elche Alicante
Spain Hospital Universitario Arnau de Vilanova de Lleida Lleida Lleida [Lérida]
Spain Hospital Clinico San Carlos Madrid
Spain Hospital Universitario 12 de Octubre Madrid Madrid, Comunidad De
Spain Hospital General Universitario Morales Meseguer Murcia Murcia, Región De
Spain Hospital Quirónsalud Valencia Valencia València
Switzerland Universitätsspital Basel Basel Basel Stadt
Switzerland HUG-Hôpitaux Universitaires de Genève Genève
Switzerland Spital Thun Thun Berne
Taiwan Kaohsiung Medical University Hospital Kaohsiung
Taiwan Kaohsiung Veterans General Hospital Kaohsiung
Taiwan Chang Gung Memorial Hospital at Kaohsiung Kaohsiung Niao Sung Dist Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan Taichung Veterans General Hospital Taichung
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Chang Gung Medical Foundation-Linkou Branch Taoyuan
United States University Cancer & Blood Center, LLC Athens Georgia
United States Palm Beach Cancer Institue Atlantis Florida
United States Pharmasite Research, Inc. Baltimore Maryland
United States Billings Clinic Billings Montana
United States Dana Farber Cancer Institute Boston Massachusetts
United States Washington University Medical School Creve Coeur Missouri
United States Holy Cross Hospital Fort Lauderdale Florida
United States Florida Cancer Specialists - South Fort Myers Florida
United States Baylor College of Medicine Houston Texas
United States Oncology Consultants P.A. Houston Texas
United States St. Bernards Medical Center Jonesboro Arkansas
United States Freeman Cancer Institute Joplin Missouri
United States St Lukes Hospital Kansas City Missouri
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States University of California - San Diego La Jolla California
United States Breslin Cancer Center Lansing Michigan
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States The Boston Baskin Cancer Group Memphis Tennessee
United States Minnesota Oncology/Hematology PA Minneapolis Minnesota
United States SMO Sarah Cannon Research Inst. Nashville Tennessee
United States Columbia University Medical Center New York New York
United States Icahn School of Medicine at Mount Sinai New York New York
United States Palm Beach Cancer Institue Palm Beach Gardens Florida
United States Quincy Medical Group Quincy Illinois
United States Kaiser Permanente Riverside California
United States Rochester General Hospital Rochester New York
United States Rochester General Hospital Rochester New York
United States Harbin Clinic Rome Georgia
United States Washington University Medical School Saint Louis Missouri
United States Washington University Medical School Saint Louis Missouri
United States Washington University Medical School Saint Peters Missouri
United States Florida Cancer Specialists - North Saint Petersburg Florida
United States Utah Cancer Specialists Salt Lake City Utah
United States Univ of California San Francisco San Francisco California
United States Sanford Research/USD Sioux Falls South Dakota
United States Highlands Oncology Group Springdale Arkansas
United States Stanford University Clinic Stanford California
United States Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center Tampa Florida
United States Oklahoma Cancer Specialists & Research Institute, LLC Tulsa Oklahoma
United States St Mary Regional Cancer Center Walla Walla Washington
United States Palm Beach Cancer Institue Wellington Florida
United States Palm Beach Cancer Institue West Palm Beach Florida
United States Novant Health, Oncology Research Institute Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  Finland,  France,  Germany,  Greece,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Spain,  Switzerland,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
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. From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months)
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. From Date of Randomization until Death Due to Any Cause (Up To 72 Months)
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. From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)
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. From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 31 Months)
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. From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)
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. From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months)
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. Baseline, End of Study (Up To 31 Months)
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[0-8]) 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
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. Baseline, End of Study (Up To 31 Months)
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. Baseline, Short Term Follow Up (Up To 31 Months)
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. Baseline, Short Term Follow Up (Up To 31 Months)
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