MedPath

A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer

Phase 3
Active, not recruiting
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
Inclusion Criteria
  • 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
Read More
Exclusion Criteria
  • 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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo + NSAIPlaceboPlacebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Abemaciclib + NSAIAnastrozole150 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 + NSAIAbemaciclib150 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 + NSAILetrozole150 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 + NSAIAnastrozolePlacebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Placebo + NSAILetrozolePlacebo 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
NameTimeMethod
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
NameTimeMethod
PK: Hepatic Clearance of Abemaciclib, and Apparent Hepatic Clearance of Its Metabolites M2 and M20Cycle 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 ScoresBaseline, 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 ScoresBaseline, 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 QuestionnaireBaseline, 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 ValueBaseline, 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 ScaleBaseline, 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 M20Cycle 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

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