A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT02246621
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 493
- Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer
- Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
- Have postmenopausal status
- Have either measurable disease or nonmeasurable bone-only disease
- Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Have adequate organ function
- Have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture prior to randomization and recovered from the acute effects of therapy
- Are able to swallow capsules
- Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
- Have inflammatory breast cancer
- Have clinical evidence or a history of central nervous system (CNS) metastasis
- Are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer
- Have received prior (neo)adjuvant endocrine therapy with a disease-free interval ≤12 months from completion of treatment
- Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer
- Have received prior treatment with everolimus
- Have received prior treatment with any cyclin-dependent kinase (CDK) 4/6 inhibitor (or participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded)
- Have initiated bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents <7 days prior to randomization
- 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 received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
- Have had major surgery within 14 days prior to randomization
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + NSAI Placebo Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles). Abemaciclib + NSAI Anastrozole 150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles). Abemaciclib + NSAI Abemaciclib 150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles). Abemaciclib + NSAI Letrozole 150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles). Placebo + NSAI Anastrozole Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles). Placebo + NSAI Letrozole Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months) PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by 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.
- Secondary Outcome Measures
Name Time Method PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20 Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose PK: Hepatic Clearance of Abemaciclib, and apparent hepatic clearance of its Metabolites M2 and M20
Overall Survival (OS) Randomization to Progressive Disease or Death Due to Any Cause (Estimated Up to 82 Months) OS defined as the time from first dose date 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.
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months) 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.
Duration of Response (DoR) CR or PR to Disease Progression or Death Due to Any Cause (Up to 32 Months) 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.
Percentage of Participants With CR, PR or Stable Disease (SD) (Disease Control Rate [DCR]) Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months) DCR was the percentage of participants with a best overall response of CR, PR, or 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.
Percentage of Participants With Tumor Response of SD for at Least 6 Months, PR, or CR (Clinical Benefit Rate [CBR]) Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months) CBR defined as percentage of participants with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined 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. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months / number of participants enrolled) \* 100.
Change From Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Functional Scale Scores Baseline, End of Study (Up to 32 Months) EORTC QLQ-C30 v3.0 is 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.Functional scale options are defined on a 7-point scale ranging from 1, "Very poor" to 7, "Excellent". A linear transformation is applied to standardize the raw scores to range between 0 and 100 with higher score indicating better functioning. For functional domains and global health status, higher scores represent a better level of functioning. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline.
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores Baseline, End of Study (Up to 32 Months) EORTC QLQ-C30 v3.0 is 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. Symptom scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much." A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For symptoms scales, higher scores indicated greater symptom burden. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline. Small changes are generally defined as at least a 3, 4 or 5 point change from baseline.
Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire Baseline, End of Study (Up to 32 Months) The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much". All scores are converted to a 0 to 100 scale. A higher score representing a higher ("better") level of functioning (BR23: body image, sexual functioning, future perspective), or a higher ("worse") level of symptoms. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline.
Change From Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L) Index Value Baseline, End of Study (Up to 32 Months) The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts.The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a five level scale (no problem, slight problem, moderate problem, severe problem and extreme problem) with higher levels indicating greater severity/ impairment. Published weights are available that allow for the creation of a single summary score called the EQ-5D index that ranges from 0 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health. Minimally important differences in the EQ-5D index score are 0.06 or greater in cancer patients. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline.
Change From Baseline to End of Study in Health Status on the EuroQol-5D 5L Visual Analog Scale (VAS) Scores Scale Baseline, End of Study (Up to 32 Months) The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts. The second part consists of the EQ-5D general health status as measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). Minimally important differences in the EQ-5D VAS score are 7 or greater in cancer patients. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline.
Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity [AUC(0-∞)] of Abemaciclib and Its Metabolites M2 and M20 Cycle 1 Day 1; 2 to 4 hours (h) post dose, Cycle 2 Day 1; 3 h post dose; 7 h post dose, Cycle 3 Day 1; pre dose, 3 h post dose Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve From Time 0 Hour to Infinity \[AUC(0-∞)\] of Abemaciclib and Its Metabolites M2 and M20
Trial Locations
- Locations (134)
Universitaetsklinikum Allgemeines Krankenhaus Wien
🇦🇹Vienna, Wien, Austria
Shizuoka Cancer Center
🇯🇵Nagaizumi, Shizuoka, Japan
Ironwood Cancer & Research Centers
🇺🇸Chandler, Arizona, United States
Highlands Oncology Group
🇺🇸Springdale, Arkansas, United States
CBCC Global Research, Inc.
🇺🇸Bakersfield, California, United States
California Cancer Associates Research and Excellence
🇺🇸Fresno, California, United States
TRIO-US (Translational Research in Oncology-US)
🇺🇸Los Angeles, California, United States
Central Coast Medical Oncology Corporation
🇺🇸Los Angeles, California, United States
Orlando Health, Inc
🇺🇸Los Angeles, California, United States
North Valley Hematology/Oncology Medical Group
🇺🇸Los Angeles, California, United States
UCLA Hematology/Oncology - Parkside
🇺🇸Santa Monica, California, United States
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
Lakes Research, LLC
🇺🇸Miami Lakes, Florida, United States
Candler Medical Oncology Practice - Statesboro
🇺🇸Savannah, Georgia, United States
Mayo Clinic in Rochester, Minnesota
🇺🇸Rochester, Minnesota, United States
Nebraska Hematology-Oncology, P.C.
🇺🇸Lincoln, Nebraska, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Mount Sinai Cancer Center
🇺🇸New York, New York, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Oncology Consultants P.A.
🇺🇸Houston, Texas, United States
Joe Arrington Cancer Center
🇺🇸Lubbock, Texas, United States
Chris O'Brien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
St Vincent's Hospital
🇦🇺Sydney, New South Wales, Australia
Sydney Adventist Hospital
🇦🇺Wahroonga, New South Wales, Australia
Mater Adult Hospital Brisbane
🇦🇺South Brisbane, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
The Queen Elizabeth Hospital
🇦🇺Woodville, South Australia, Australia
Barwon Health - The Geelong Hospital
🇦🇺Geelong, Victoria, Australia
St. John of God Murdoch Hospital
🇦🇺Murdoch, Western Australia, Australia
Ordensklinikum Linz
🇦🇹Linz, Oberösterreich, Austria
Medizinische Universitaet Graz
🇦🇹Graz, Steiermark, Austria
Medizinische Universitaet Innsbruck
🇦🇹Innsbruck, Tirol, Austria
Medizinische Universität Wien
🇦🇹Vienna, Wien, Austria
Iridium Kankernetwerk Wilrijk en Antwerp
🇧🇪Wilrijk, Antwerpen, Belgium
Cliniques universitaires Saint-Luc
🇧🇪Bruxelles, Brussel, Belgium
Institut Jules Bordet
🇧🇪Anderlecht, Bruxelles-Capitale, Région De, Belgium
Grand Hopital de Charleroi-Site Notre-Dame
🇧🇪Charleroi, Belgium
CHU UCL Namur/Site Sainte Elisabeth
🇧🇪Namur, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Lakeridge Health
🇨🇦Oshawa, Ontario, Canada
The Ottawa Hospital - General Campus
🇨🇦Ottawa, Ontario, Canada
Princess Margaret Hospital (Ontario)
🇨🇦Toronto, Ontario, Canada
Hopital Notre Dame
🇨🇦Montreal, Quebec, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - H -T
🇨🇦Montreal, Quebec, Canada
Hopital du Saint-Sacrement
🇨🇦Quebec, Canada
Polyclinique Bordeaux Nord
🇫🇷Bordeaux, Aquitaine, France
Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
🇫🇷Brest, Bretagne, France
Centre Georges François Leclerc
🇫🇷Dijon, Côte-d'Or, France
Centre Hospitalier de Saint-Brieuc - Hôpital Yves Le Foll
🇫🇷Saint-Brieuc, Côtes-d'Armor, France
Centre de Cancérologie du Grand Montpellier
🇫🇷Montpellier, Languedoc-Roussillon, France
Institut de Cancérologie de l'Ouest
🇫🇷Saint Herblain, Loire-Atlantique, France
Polyclinique de Gentilly
🇫🇷Nancy, Meurthe-et-Moselle, France
Centre Leon Berard
🇫🇷Lyon, Rhône-Alpes, France
CHD Vendee
🇫🇷La Roche Sur Yon, Vendée, France
CHU de Besancon Hopital Jean Minjoz
🇫🇷Besancon Cedex, France
Klinikum Ludwigsburg
🇩🇪Ludwigsburg, Baden-Württemberg, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Baden-Württemberg, Germany
Klinikum Rechts der Isar der TU München
🇩🇪München, Bayern, Germany
Helios Dr. Horst Schmidt Kliniken
🇩🇪Wiesbaden, Hessen, Germany
Marien-Hospital Düsseldorf
🇩🇪Düsseldorf, Nordrhein-Westfalen, Germany
Lübecker Onkologische Schwerpunktpraxis
🇩🇪Lubeck, Schleswig-Holstein, Germany
Facharztzentrum Eppendorf
🇩🇪Hamburg, Germany
Kath. Marienkrankenhaus gGmbH
🇩🇪Hamburg, Germany
Alexandra Hospital
🇬🇷Athens, Attikí, Greece
Rabin Medical Center
🇮🇱Petah-Tikva, HaMerkaz, Israel
Sheba Medical Center
🇮🇱Ramat Gan, HaMerkaz, Israel
Kaplan Medical Center
🇮🇱Rehovot, HaMerkaz, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
Soroka Medical Center
🇮🇱Beer Sheva, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Rambam Health Care Campus
🇮🇱Haifa, Ḥeifā, Israel
Ospedale Perrino
🇮🇹Brindisi, BR, Italy
Azienda Ospedaliero Universitaria di Ferrara
🇮🇹Cona, Ferrara, Italy
Ospedale San Martino
🇮🇹Genova, Liguria, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
🇮🇹Candiolo, Torino, Italy
Nuovo Ospedale di Prato-S.Stefano
🇮🇹Prato, Toscana, Italy
Ospedale Sacro Cuore Don G. Calabria
🇮🇹Negrar Di Valpolicella, Verona, Italy
Azienda Ospedaliera Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Ospedale Bellaria - Azienda USL di Bologna
🇮🇹Bologna, Italy
Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
🇮🇹Messina, Italy
Policlinico Ospedale S. Andrea
🇮🇹Roma, Italy
Azienda Ospedaliera Santa Maria Terni
🇮🇹Terni, Italy
Aichi Cancer Center Hospital
🇯🇵Nagoya, Aichi, Japan
Chiba cancer center
🇯🇵Chiba-shi, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Matsuyama, Ehime, Japan
National Hospital Organization Hokkaido Cancer Center
🇯🇵Sapporo, Hokkaido, Japan
Hyogo College of Medicine
🇯🇵Nishinomiya, Hyogo, Japan
Kanagawa cancer center
🇯🇵Yokohama, Kanagawa, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata-shi, Niigata, Japan
Kindai University Hospital- Osakasayama Campus
🇯🇵Osaka-sayama, Osaka, Japan
Saitama Prefectural Cancer Center
🇯🇵Kitaadachi-Gun, Saitama, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Tochigi, Japan
Tokyo Met Cancer & Infectious Diseases Center Komagome Hp
🇯🇵Bunkyo-ku, Tokyo, Japan
Japanese Foundation for Cancer Research
🇯🇵Koto, Tokyo, Japan
Tokyo Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Hiroshima City Hospital
🇯🇵Hiroshima, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
National Hospital Organization Osaka Medical Center
🇯🇵Osaka, Japan
Osaka International Cancer Institute
🇯🇵Osaka, Japan
Inha University Hospital
🇰🇷Incheon, Incheon-gwangyeoksi [Incheon], Korea, Republic of
National Cancer Center
🇰🇷Goyang-Si, Kyǒnggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Kyǒnggi-do, 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
Asan Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Taegu-Kwangyǒkshi, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Ulsan-Kwangyǒkshi, Korea, Republic of
Clinica Oncológica San Francisco
🇲🇽Torreon, Coahuila, Mexico
Hospital La Raza
🇲🇽Mexico City, Distrito Federal, Mexico
Grupo Medico Camino Sc
🇲🇽Mexico City, Distrito Federal, Mexico
Superare Centro de Infusion
🇲🇽Mexico, Federal District, Mexico
Fundacion Rodolfo Padilla AC
🇲🇽Leon, Guanajuato, Mexico
Hospital Civil Fray Antonio Alcalde
🇲🇽Guadalajara, Jalisco, Mexico
Centro Oncologico Belenus
🇲🇽Cuernavaca, Morelos, Mexico
Centro de Estudios Y Prevencion Del Cancer
🇲🇽Juchitan, Oaxaca, Mexico
Cancerología
🇲🇽Colinas Del Cimatario, Queretaro, Mexico
Haga Ziekenhuis locatie Leyweg
🇳🇱Den Haag, Zuid-Holland, Netherlands
Leids Universitair Medisch Centrum
🇳🇱Leiden, Netherlands
Auckland City Hospital
🇳🇿Auckland, New Zealand
Arkhangelsk Clinical Oncological Dispensary
🇷🇺Arkhangelsk, Arkhangel'skaya Oblast', Russian Federation
Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
🇷🇺Moscow, Moskva, Russian Federation
Republic Oncology Dispensary of MoH of Republic Tatarstan
🇷🇺Kaznan, Russia, Russian Federation
European Medical Center
🇷🇺Moscow, Russian Federation
Clinic Complex
🇷🇺Saint-Petersburg, Russian Federation
Saint-Petersburg City Clinical Oncology Dispensary
🇷🇺Saint-Petersburg, Russian Federation
Rosmedtech Scientific Research Institute of Oncology
🇷🇺St. Petersburg, Russian Federation
Onkologicky Ustav sv. Alzbety
🇸🇰Bratislava, Bratislavský Kraj, Slovakia
Vychodoslovensky Onkologicky ustav a.s.
🇸🇰Kosice, Košický Kraj, Slovakia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇬🇧Sutton, United Kingdom