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Clinical Trial NCT05696626 (ELAINEIII) for Metastatic Breast Cancer is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (ELAINEIII) Phase 3 500

Recruiting
Clinical Trial NCT05696626 (ELAINEIII) is designed to study Treatment for Metastatic Breast Cancer. It is a Phase 3 interventional study that is recruiting, having started on 31 October 2023, with plans to enroll 500 participants. Led by Sermonix Pharmaceuticals Inc., it is expected to complete by 1 April 2028. The latest data from ClinicalTrials.gov was last updated on 26 January 2026.
Brief Summary
The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (H...Show More
Official Title

An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

Conditions
Metastatic Breast Cancer
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • ELAINEIII
  • SMX 22-002
NCT ID Number
Start Date (Actual)
2023-10-31
Last Update Posted
2026-01-26
Completion Date (Estimated)
2028-04
Enrollment (Estimated)
500
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTreatment
Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an ESR1 mutation.
Lasofoxifene in combination with abemaciclib
5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day
Active ComparatorReference Therapy
Pre- and Postmenopausal Women and Men with locally advanced or metastatic ER+/HER2- breast cancer who have disease progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease and who have an ESR1 mutation.
Fulvestrant in combination with abemaciclib
Fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Progression free survival (PFS)
PFS is defined as the time from the date of randomization \[Visit 0 (Day 1)\] to the earliest date of first documented progression per RECIST 1.1 or death due to any cause.
Within approximately 3 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Objective response rate (ORR)
ORR is defined as the percentage of subjects with measurable disease at baseline whose best overall response is either a confirmed CR or a confirmed PR according to RECIST 1.1.
Within approximately 3 years
Overall survival (OS)
Overall survival is defined as time from the date of Visit 0 (Day 1) to death due to any cause.
Within approximately 3 years
Clinical benefit rate (CBR)
CBR is defined as the percentage of subjects with best overall response of confirmed CR, confirmed PR, or stable disease (SD) with a duration of 24 weeks or longer according to RECIST 1.1. As used in this calculation, stable disease is defined as stable disease in those subjects with measurable disease plus nonPR/non progressive disease (PD) in subjects with non-measurable disease.
Within approximately 3 years
Duration of response (DoR) in subjects with an objective response
DoR is from the date of first documented confirmed response (CR or PR) to the date of first documented progression of disease or death due to any cause, whichever is earlier.
Within approximately 3 years
Time to response (TTR) in subjects with an objective response
TTR is from the date of randomization to the date of first documented confirmed response (CR or PR).
Within approximately 3 years
Time to cytotoxic chemotherapy
From the date of randomization to the date of first documented use of cytotoxic chemotherapy.
Within approximately 3 years
Quality of Life (QoL) evaluated using the Functional Assessment of Cancer Therapy-Breast Cancer-Endocrine Subscale (FACT B-ES)
Scale ranges from 'Not at all' to 'Very much'
Within approximately 3 years
Incidence of Adverse Events (AEs) and Serious AEs
The type, severity (graded by Common Terminology Criteria for Adverse Events \[CTCAE version 5.0\]), course, duration, seriousness, and relationship to study treatment will be assessed at each visit
Within approximately 3 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Pre- or postmenopausal women or men.

  2. Locally advanced and/or metastatic ER+ breast cancer with radiological or clinical evidence of progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease.

  3. Histological or cytological confirmation of ER+/HER2 - disease

  4. No evidence of progression for at least 6 months on an AI/CDKi combination for advanced breast cancer.

  5. At least 1 or more ESR1 point mutations in the ESR1 ligand binding domain as assessed in cell- free ctDNA obtained from a blood or breast cancer tissue.

  6. Locally advanced or metastatic breast cancer with either measurable (according to RECIST 1.1) or non-measurable lesions.

  7. Subjects may have received 1 cytotoxic chemotherapy regimen in the metastatic disease setting prior to study entry, but must have recovered from chemotherapy acute toxicity excluding alopecia and Grade 2 peripheral neuropathy.

  8. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1

  9. Adequate organ function

  10. Able to swallow tablets

  11. Brain metastases are allowed only if the following 4 parameters hold:

    1. Asymptomatic,
    2. Definitively treated (e.g., radiotherapy, surgery),
    3. Not requiring steroids up to 4 weeks before study treatment initiation, AND
    4. Central nervous system disease stable for >3 months prior to registration as documented by magnetic resonance imagining (MRI).
  12. Able to understand and voluntarily sign a written informed consent before any screening procedures.

  13. Every attempt should be made to obtain a biopsy of metastatic breast cancer tissue, when safe and feasible, to provide histological or cytological confirmation of ER+/HER2- disease as assessed by a local laboratory, according to American Society of Clinical Oncology/College of American Pathologists guidelines, using slides, paraffin blocks, or paraffin samples. If a biopsy is done, it may undergo genomic testing at some point to assess for ESR1 mutations and correlation with ctDNA results. If a biopsy is not possible or inappropriate from a clinical standpoint, the ER and HER2 status from the subject's most recent biopsy must confirm that the subject is ER+ and HER2

  1. Lymphangitic carcinomatosis involving the lung.
  2. History of Grade 3 or Grade 4 interstitial lung disease (ILD) on previous therapy.
  3. Visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator.
  4. Prior progression of disease on abemaciclib, fulvestrant, or other selective estrogen receptor degrader (SERD) therapy.
  5. Subjects with a known hypersensitivity to fulvestrant or to any of the excipients
  6. Radiotherapy within 30 days prior to Visit 0 (Day 1) except in case of localized radiotherapy for analgesic purposes or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to Visit 0 (Day 1). Subjects must have recovered from radiotherapy toxicities prior to Visit 0 (Day 1).
  7. Known RB1 mutations or deletions that in the opinion of the investigator confer resistance to CDK4/6i. (Screening for RB1 mutation is not required for entry.)
  8. History of long QTc (Q-T interval corrected for heart rate) syndrome or a QTc of >480 msec.
  9. History of a pulmonary embolus (PE), deep vein thrombosis (DVT), or any known thrombophilia, unless the event occurred greater than 6 months prior to screening and the subject is treated with chronic anticoagulant therapy such as apixaban (Eliquis) or rivaroxaban (Xarelto).
  10. Lasofoxifene is not recommended for use in subjects with conditions that place them at increased risk for VTEs (such as severe congestive heart failure \[CHF\] or prolonged immobilization).
  11. On concomitant strong CYP3A4 inhibitors.
  12. On strong and moderate CYP3A4 inducers.
  13. Any significant co-morbidity that would impact the study or the subject's safety, including subjects with significant malabsorption.
  14. Active systemic bacterial or fungal infection (requiring intravenous \[IV\] antibiotics or antifungals at the time of initiating study treatment).
  15. Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
  16. History of malignancy within the past 5 years (excluding breast cancer), except basal cell or squamous cell carcinoma of the skin curatively treated by surgery.
  17. Positive serum pregnancy test (only if premenopausal).
  18. Sexually active premenopausal women and men unwilling to use double-barrier contraception.
  19. Women who are breast feeding
  20. History of non-compliance to medical regimens.
  21. Unwilling or unable to comply with the protocol.
  22. Current participation in any clinical research trial involving an investigational drug or device within the last 30 days.
Sermonix Pharmaceuticals Inc. logoSermonix Pharmaceuticals Inc.
Study Central Contact
Contact: Sermonix Pharmaceuticals Study Inquiry, 614-864-4919, [email protected]
222 Study Locations in 17 Countries
Blacktown Hospital, Blacktown, Australia
Jennifer Man, Contact, [email protected]
Recruiting
Concord Repatriation General Hospital, Concord, Australia
Belinda Kiely, Contact, +61 02 9767 6354, [email protected]
Recruiting
Mater Misericordiae Ltd, South Brisbane, South Brisbane, Australia
Kathryn Middleton, Contact, +61 07 31632531, [email protected]
Recruiting

Arizona

Mayo Clinic - Scottsdale, Scottsdale, Arizona, 85259, United States
Clinical Trials Office - All Mayo Clinic Locations, Contact, 855-776-0015
Recruiting
University of Arizona - Cancer Center, Tucson, Arizona, 85719, United States
Carissa Ganzer, Contact, [email protected]
Recruiting

California

Providence Medical Foundation - Santa Rosa, CA, Santa Rosa, California, 95403, United States
Jarrod Holmes, Contact, [email protected]
Recruiting

Florida

Mayo Clinic - Jacksonville, Jacksonville, Florida, 32224, United States
Clinical Trials Office - All Mayo Clinic Locations, Contact, 855-776-0015
Recruiting
Miami Cancer Institute, Miami, Florida, 33143, United States
Ana Sandoval Leon, Contact, [email protected]
Recruiting
Miami Cancer Institute Plantation, Plantation, Florida, 33324, United States
Ana Sandoval Leon, Contact, [email protected]
Recruiting

Georgia

Emory University School of Medicine, Atlanta, Georgia, 30322, United States
Jane Meisel, Contact, [email protected]
Recruiting

Kentucky

Norton Cancer Institute, Louisville, Kentucky, 40202, United States
Laila Agrawal, Contact, [email protected]
Recruiting

Maryland

Johns Hopkins Kimmel Cancer Center, Baltimore, Maryland, 21231, United States
Jessica Tao, Contact, [email protected]
Recruiting

Massachusetts

Massachusetts General Hospital, Boston, Massachusetts, 02114, United States
Seth Wander, Contact, [email protected]
Recruiting
Dana-Farber Cancer Institute, Boston, Massachusetts, 02115, United States
Sarah Sammons, Contact, [email protected]
Recruiting
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States
S Berwick, Contact, [email protected]
Recruiting

Michigan

Cancer and Hematology Centers of Western Michigan, Grand Rapids, Michigan, 49503, United States
Amy Vander Woude, Contact, [email protected]
Recruiting

Minnesota

Allina Health System DBA Virginia Piper Cancer Institute, Minneapolis, Minnesota, 55407, United States
Domingo Perez, Contact, [email protected]
Recruiting
Mayo Clinic - Rochester, Rochester, Minnesota, 55905, United States
Clinical Trials Office - All Mayo Clinic Locations, Contact, 855-776-0015
Recruiting

Missouri

Saint Luke's Cancer Institute, Kansas City, Missouri, 64111, United States
Timothy Pluard, Contact, 816-932-3300, [email protected]
Recruiting
Washington University School of Medicine, St Louis, Missouri, 63110, United States
Nusayba Bagegni, Contact, [email protected]
Recruiting

Nevada

Renown Regional Medical Centre, Reno, Nevada, 89502, United States
Lee Schwartzberg, Contact, [email protected]
Recruiting
Cancer Care Specialists, Reno, Nevada, 89511-2250, United States
Sowjanya Reganti, Contact, [email protected]
Recruiting

New Jersey

New Jersey Cancer Care, PA, Belleville, New Jersey, 07109, United States
James Orsini, Contact, 973-751-8880, [email protected]
Not yet recruiting
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, 08901, United States
Coral Omene, Contact, [email protected]
Not yet recruiting

New Mexico

Presbyterian Rust Cancer Center, Rio Rancho, New Mexico, 87124, United States
Ethan Binder, Contact, [email protected]
Recruiting

New York

The Blavatnik Family - Chelsea Medical Center at Mount Sinai, New York, New York, 10011, United States
Amy Tiersten, Contact, (212) 241-3300, [email protected]
Recruiting
Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States
Amy Tiersten, Contact, [email protected]
Recruiting
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States
Sherry Shen, Contact, [email protected]
Recruiting

North Carolina

Duke University Medical Center, Durham, North Carolina, 27705, United States
Rani Bansal, Contact, [email protected]
Recruiting

North Dakota

Altru Health Systems, Grand Forks, North Dakota, 58201, United States
Completed

Ohio

University Hospitals Seidman Cancer Center, Cleveland, Ohio, 44106, United States
Takae Mizukami, Contact, [email protected]
Not yet recruiting
Cleveland Clinic, Cleveland, Ohio, 44119, United States
Withdrawn
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James), Columbus, Ohio, 42112, United States
Daniel Stover, Contact, [email protected]
Recruiting

Pennsylvania

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15232, United States
Completed

Texas

Baylor College of Medicine, Houston, Texas, 77030, United States
Ahmed Elkhanany, Contact, [email protected]
Recruiting
MD Anderson Cancer Center, Houston, Texas, 77030, United States
Senthil Damodaran, Contact, [email protected]
Recruiting
Harris Health System - Smith Clinic, Houston, Texas, 77054, United States
Ahmed Elkhanany, Contact, [email protected]
Ahmed Elkhanany, Principal Investigator
Recruiting

Washington

Swedish Cancer Institute (SCI), Seattle, Washington, 98104, United States
Withdrawn
Cliniques Universitaires Saint-Luc, Brussels, Belgium
Francois Duhoux, Contact, +32 2 764 51 06, [email protected]
Not yet recruiting
Antwerp University Hospital (UZA), Edegem, Belgium
Sevilay Altintas, Contact, +32 3 821 49 73, [email protected]
Not yet recruiting
Universitaire Ziekenhuizen Leuven, Leuven, Belgium
Patrick Neven, Contact, [email protected]
Recruiting
CHU UCL Namur - Site De Sainte-Elisabeth, Namur, Belgium
Donatienne Taylor, Contact, 003281720524, [email protected]; [email protected]
Recruiting

Ontario

The Ottawa General Hospital, Ottawa, Ontario, Canada
Terry Ng, Contact, [email protected]
Recruiting
Sunnybrook Health Sciences Centre -Bayview Campus, Toronto, Ontario, Canada
Rossanna Pezo, Contact, 416-480-4757, [email protected]
Recruiting

Quebec

Hospital Maisonneuve-Rosemont, Montreal, Quebec, Canada
Jonathan Noujaim, Contact, [email protected]
Recruiting
Lady Davis Institute for Medical Research Jewish General Hospital, Montreal, Quebec, Canada
Parvaneh Fallah, Contact, [email protected]
Recruiting
CIUSSS du Saguenay-Lac-Saint-Jean, Saguenay, Quebec, Canada
Withdrawn
Anhui Provincial Cancer Hospital, Anhui, China
Yueyin Pan, Contact, 13805695536, [email protected]
Recruiting
Anyang Tumour Hospital, Anyang, China
Junlan Guo, Contact, [email protected]
Recruiting
Beijing Cancer Hospital, Beijing, China
Huiping Li, Contact, 86 13811012595, [email protected]
Recruiting
Peking Union Medical College Hospital, Beijing, China
Hongyan Ying, Contact, 15901226215, [email protected]
Recruiting
The First Affiliated Hospital of Bengbu Medical University, Bengbu, China
Jinhai Zhu, Contact, 13956331545, [email protected]
Recruiting
The First Hospital of Jilin University, Changchun, China
Dong Song, Contact, 13943189777, [email protected]
Recruiting
The Second Xiangya Hospital of Central South University, Changsha, China
Wenjun Yi, Contact, 18608403318, [email protected]
Recruiting
Sichuan Provincial People's Hospital, Chengdu, China
Jing Luo, Contact, 18981838521, [email protected]
Recruiting
West China Hospital, Sichuan University, Chengdu, China
Ting Luo, Contact, 18602866299, [email protected]
Recruiting
The First Affiliated Hospital, Chongqing Medical University, Chongqicun, China
Lu Gan, Contact, 18602320222, [email protected]
Recruiting
The Second Hospital of Dalian Medical University, Dalian, China
Man Li, Contact, 17709873580, [email protected]
Recruiting
Deyang People's Hospital, Deyang, China
Ying Yi, Contact, 8618908103891, [email protected]
Recruiting
Fuyang Cancer Hosptial, Fuyang, China
Hesheng Qian, Contact, 13956814015, [email protected]
Recruiting
Fujian Cancer Hospital, Fuzhou, China
Yi Zeng, Contact, 13905916886, [email protected]
Recruiting
Fujian Medical University Union Hospital, Fuzhou, China
Xiaoyan Lin, Contact, 13365910793, [email protected]
Recruiting
Zhujiang Hospital of Nanfang Medical University, Guandong, China
Guangyu Yao, Contact, 18675835626, [email protected]
Recruiting
Guangdong Provincial People's Hospital, Guangdong, China
Kun Wang, Contact, 13922118086, [email protected]
Recruiting
Meizhou People's Hospital, Guangdong, China
Jingna Wu, Contact, 13431819838, [email protected]
Recruiting
Peking University Shenzhen Hospital, Guangdong, China
Xiaoling Liu, Contact
Recruiting
Sun Yat-Sen University- Cancer Center, Guangdong, China
Shusen Wang, Contact, 13926168469, [email protected]
Recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China
Yaping Yang, Contact, 13602409759, [email protected]
Recruiting
The First Affiliated Hospital of Hainan Medical University, Haikou, China
Jinsheng Wu, Contact, 13707599070, [email protected]
Recruiting
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China
Xian Wang, Contact, 15857121122, [email protected]
Recruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
Peifen Fu, Contact, 13958161556, [email protected]
Recruiting
Zhejiang Provincial Hospital of Chinese Medicine, Hangzhou, China
Xiaohong Xie, Contact, 13957101427, [email protected]
Recruiting
Hebei Medical University - The Fourth Hospital - Hebei Provincial Tumor Hospital, Hebei, China
Yunjiang Liu, Contact, 13703297890, [email protected]
Recruiting
Xiangyang Central Hospital, Hubei, China
Yuehua Wang, Contact, 13995777482, [email protected]
Recruiting
Xiangya Hospital Central South University, Hunan, China
Juan Huang, Contact, 13469081784, [email protected]
Recruiting
Jieyang People's Hospital, Jieyang, China
Zhenhai Cai, Contact, 13502606100, [email protected]
Recruiting
Shandong Province Tumor Hospital, Jinan, China
Yongqing Li, Contact, 15553115677, [email protected]
Recruiting
Yunnan Cancer Hospital, Kunming, China
Wenlin Chen, Contact, 138 88087395, [email protected]
Recruiting
Gansu Provincial Hospital, Lanzhou, China
Jie Hao, Contact, 13099203178, [email protected]
Recruiting
The First Hospital of Lanzhou University, Lanzhou, China
Xiaoling Ling, Contact, 18693165668, [email protected]
Recruiting
Linyi Cancer Hospital, Linyi, China
Jingfen Wang, Contact, 15963976026, [email protected]
Recruiting
Luoyang Central Hospital, Luoyang, China
Mingli Ni, Contact, 15803795310, [email protected]
Recruiting
The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China
Xinshuai Wang, Contact, 13837986128, [email protected]
Recruiting
The Affiliated Hospital of Southwest Medical University (Luzhou Medical College), Luzhou, China
Lijia He, Contact, 13619042857, [email protected]
Recruiting
Jiangxi Cancer Hospital, Nanchang, China
Zhengkui Sun, Contact, 13907000210, [email protected]
Recruiting
Nanchang People's Hospital, Nanchang, China
Chunwei Xie, Contact, 13006218563, [email protected]
Recruiting
Jiangsu Province Hospital - The First Affiliated Hospital with Nanjing Medical University, Nanjing, China
Yongmei Yin, Contact, 86 13951842727, [email protected]
Recruiting
Nanjing Drum Tower Hospital, Nanjing, China
Li Xie, Contact, 13605169652, [email protected]
Recruiting
Guangxi Medical University Cancer Hospital, Nanning, China
Yan Liu, Contact, 15877129696, [email protected]
Recruiting
Nanyang Central Hospital, Nanyang, China
Hao Zhang, Contact, 13703772883, [email protected]
Recruiting
The Second People's Hospital of Neijiang, Neijiang, China
Xujuan Wang, Contact, 13696038558, [email protected]
Recruiting
Ningbo Medical Center Li Huili Hospital, Ningbo, China
WeiZhu Wu, Contact, 13957402451, [email protected]
Recruiting
The First People'S Hospital of Ping Ding Shan, Pingdingshan, China
Xiaohui Jing, Contact, [email protected]
Recruiting
Qingdao Central Hospital, University of Health and Rehabilitation Sciences, Qingdao, China
Qiang Mu, Contact, 18561858307, [email protected]
Recruiting
The Affiliated Hospital of Qingdao University, Qingdao, China
Haibo Wang, Contact, 18661805787, [email protected]
Recruiting
Quanzhou First Hospital, Quanzhou, China
Xiaofeng Li, Contact, 18965658239, [email protected]
Recruiting
Huashan Hospital, Fudan University, Shanghai, China
Xiaohua Liang, Contact, 18121186232, [email protected]
Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
GU Jianchun, Contact, 13764074162, [email protected]
Recruiting
Fudan University Cancer Center, Shang’ai, China
Zhimin Shao, Contact, 18017312288, [email protected]
Recruiting
First Affiliated Hospital of Xi'an Jiaotong University, Shanxi, China
Jin Yang, Contact, 18991232383, [email protected]
Recruiting
The Central Hospital of Shaoyang, Shaoyang, China
Bin Dai, Contact, 15243901393, [email protected]
Recruiting
Liaoning Cancer Hospital & Institute, Shenyang, China
Tao Sun, Contact, 18900917877, [email protected]
Recruiting
Yuebei People's Hospital, Shouguang, China
Ruiwen Lei, Contact, 13826351682, [email protected]
Recruiting
University of Electonic Science & Technology (UESTC) - Sichuan Cancer Hospital & Institute, Sichuan, China
Hao Wang, Contact, 13518204307, [email protected]
Recruiting
Tianjin Cancer Hospital Airport Hospital, Tianjin, China
Chunfang Hao, Contact, 13602031629, [email protected]
Recruiting
Tianjin Medical University Cancer Institute & Hospital, Tianjin, China
Yehui Shi, Contact, 18622221183, [email protected]
Recruiting
The Affiliated Cancer Hospital of Xinjiang Medical University, Ürümqi, China
Bing Zhao, Contact, 13899908184, [email protected]
Recruiting
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
Ouchen Wang, Contact, 13957706099, [email protected]
Recruiting
Hubei Cancer Hospital, Wuhan, China
Xinhong Wu, Contact, 86 18602726300, [email protected]
Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technolog, Wuhan, China
Jing Yao, Contact, 13971139665, [email protected]
Recruiting
The Second People's Hospital of WuHu, Wuhu, China
Hu Qin, Contact, 18055316155, [email protected]
Recruiting
The First Affiliated Hospital of Air Force Medical University, Xi Ail, China
Jing Fan, Contact, 13572961081, [email protected]
Recruiting
The first affiliated hospital of Xiamen University, Xiamen, China
Zhong Ouyang, Contact, 18205962909, [email protected]
Recruiting
Zhongshang Hospital Xiamen University, Xiamen, China
Minjun Meng, Contact, [email protected]
Recruiting
The Second Affiliated Hospital Of Xi'an Jiaotong University, Xinzheng, China
Shuqun Zhang, Contact, 13891841249, [email protected]
Not yet recruiting
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China
Hongbing Wang, Contact, 15996969368, [email protected]
Recruiting
Xuzhou Central Hospital, Xuzhou, China
Li Sun, Contact, 18052230275, [email protected]
Recruiting
Yuncheng Central Hospital, Yuncheng, China
Xiaoke Hou, Contact, 17703591026, [email protected]
Recruiting
Zhejiang cancer hospital, Zhejiang, China
Junqing Chen, Contact, 18658840965, [email protected]
Recruiting
Zhejiang Provincial People's Hospital, Zhejiang, China
Xuli Meng, Contact, 13757128803, [email protected]
Recruiting
Henan Cancer Hospital, Zhengzhou, China
Zhenzhen Liu, Contact, 13603862755, [email protected]
Recruiting
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
Jingruo Li, Contact, 13939021305, [email protected]
Recruiting
Zhongshan City People's Hospital, Zhongshan, China
Shihui Ma, Contact, 13620394254, [email protected]
Recruiting
Zhumadian Central Hospital, Zhumadian, China
Sen Xiang, Contact, 13839928053, [email protected]
Recruiting
Institut Sainte Catherine, Avignon, 84000, France
Julien Grenier, Contact, [email protected]
Not yet recruiting
Service d'Oncologie Medicale - CHRU Besancon, Besançon, France
Laura Mansi, Contact, [email protected]
Recruiting
Institut Bergonie, Bordeaux, France
Marc Debled, Contact, +33 (0)5 56 33 04 77, [email protected]
Recruiting
Centre Francois Baclesse, Caen, France
George Emile, Contact, [email protected]
Recruiting
Groupement de Cooperation Sanitaire (GCS) ELSAN - Clinique Victor Hugo, Le Mans, 72015, France
Sophie Roche, Contact, [email protected]
Not yet recruiting
Centre Oscar Lambret, Lille, France
Charlotte Bellier, Contact, +33 (0)3.20.29.59.59, [email protected];[email protected]
Recruiting
Centre Leon Berard, Lyon, France
Thomas Bachelot, Contact, +33 4 78 78 26 54, [email protected]
Recruiting
Institut Paoli-Calmettes, Marseille, France
Alexandre Tassin de Nonneville, Contact, +33491223789, [email protected]
Recruiting
HCL Centre Hospitalier Lyon Sud, Pierre-Bénite, 69310, France
Julien Peron, Contact, [email protected]
Not yet recruiting
CHU Poitiers - Pole Regional de Cancerologie de Poitiers (PRC), Poitiers, France
Nicolas Isambert, Contact, [email protected]
Recruiting
Centre Henri Becquerel, Rouen, France
Marianne Leheurteur, Contact, [email protected]
Recruiting
Institut Claudius Regaud, Toulouse, France
Florence Dalenc, Contact, (+33) 5 31 15 51 22, [email protected]
Recruiting
Institut Gustave Roussy, Villejuif, 94800, France
Alessandro Viansone, Contact
Not yet recruiting
Universitaetsklinikum Carl Gustav Carus Dresden, Dresden, Germany
Pauline Wimberger, Contact, +49 (0)351 458-6728, [email protected]
Not yet recruiting
Klinikum rechts der Isar der Technischen Universitaet Muenchen, München, Germany
Evelyn Klein, Contact, 089 4140 2433, [email protected]
Not yet recruiting
Haemek Medical Center, Afula, 1834111, Israel
Gil Bar, Contact, [email protected]
Not yet recruiting
Soroka Medical Center, Beersheba, 8486614, Israel
Wael Hozaeel, Contact, [email protected]
Not yet recruiting
Rambam Health Care Campus, Haifa, Israel
Ayelet Shai, Contact, [email protected]
Recruiting
Hadassah Ein-Karem Medical Center, Jerusalem, Israel
Ofra Maimon, Contact, +972505172570, [email protected]
Recruiting
Shaare Zedek Medical Center, Jerusalem, Israel
Ora Solange Rosengarten, Contact, [email protected]
Recruiting
Meir Medical Center, Kfar Saba, 4428164, Israel
Iryna Kuchuk, Contact, [email protected]
Not yet recruiting
Rabin MC, Petah Tikva, Israel
Rinat Yerushalmi, Contact, [email protected]
Recruiting
Kaplan Medical Center, Rehovot, Israel
Ella Evron, Contact, [email protected]
Recruiting
Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
Amir Sonnenblick, Contact, [email protected]
Recruiting
Sheba Medical Center, Tel Litwinsky, Israel
Einav Nili Gal-Yam, Contact, +972-3-5302243, [email protected]
Recruiting
Azienda Ospedaliero-Universitaria delle Marche, Ancona, Italy
Rossana Berardi, Contact, [email protected]
Not yet recruiting
Centro Riferimento Oncologico - Aviano, Aviano, Italy
Lorenzo Gerratana, Contact, (+39) 0434 659254, [email protected]; [email protected]
Recruiting
La Fondazione e l'Istituto di Candiolo, Candiolo, 10060, Italy
Vanesa Gregorc, Contact, [email protected]
Not yet recruiting
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l., Meldola, Italy
Michela Palleschi, Contact, +39 0543 739100, [email protected]
Recruiting
Istituto Europeo di Oncologia, Milan, Italy
Marco Angelo Colleoni, Contact, 02-57489.970, [email protected]; [email protected]
Recruiting
Humanitas Istituto Clinico Catanese, Misterbianco, Italy
Maria Vita Sanò, Contact, 09573390197, [email protected]
Recruiting
Azienda Ospedaliero-Universitaria di Modena, Modena, Italy
Luca Moscetti, Contact, +390594223244, [email protected]
Not yet recruiting
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy
Michelino De Laurentiis, Contact, +3908117770442, [email protected]; [email protected]
Recruiting
Azienda Ospedaliero Universitaria Maggiore Della Carita, Novara, 28100, Italy
Alessandra Gennari, Contact, [email protected]
Not yet recruiting
Istituto Oncologico Veneto-I.R.C.C.S. - Ospedale Busonera, Padua, 35128, Italy
Valentina Guarneri, Contact, [email protected]
Not yet recruiting
Azienda Ospedaliero Universitaria di Parma, Parma, Italy
Benedetta Pellegrino, Contact, [email protected]
Not yet recruiting
Fondazione IRCCS Policlinico San Matteo, Pavia, Italy
Gianpiero Rizzo, Contact, [email protected]
Gianpiero Rizzo, Principal Investigator
Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore, Roma, Italy
Emilio Bria, Contact, +390630155202, [email protected]; [email protected]
Recruiting
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento, Verona, Italy
Elena Fiorio, Contact, 0458122769, [email protected]; [email protected];
Recruiting
KO - MED Centra Kliniczne Sp. z o.o., Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej, Biała Podlaska, Poland
Withdrawn
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Oddzial w Gliwicach, I Klinika Radioterapii i Chemioterapii, Gliwice, Poland
Michal Jarzab, Contact, 48 32 2788721, [email protected]
Not yet recruiting
SP ZOZ Szpital Uniwersytecki w Krakowie, Oddzial Onkologii Klinicznej, Krakow, Poland
Piotr Wysocki, Contact, 48 12 424-89-12, [email protected]; [email protected]
Not yet recruiting
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie - Oddzial Onkologii Klinicznej z Pododdzialem Dziennym, Krakow, Poland
Anna Kowalczyk-Tekiela, Contact, +48 502 315 790, [email protected]
Recruiting
Instytut Centrum Zdrowia Matki Polki - Klinika Onkologii, Lodz, Poland
Completed
Uniwersytecki Szpital Kliniczny w Poznaniu, Oddzial Chemioterapii, Poznan, Poland
Rodryg Ramlau, Contact, +48513155613, [email protected]
Not yet recruiting
Wielkopolskie Centrum Onkologii (WCO) / The Greater Poland Cancer Center, Poznan, Poland
Anna Szafryna-Kliwicka, Contact, +48618850620, [email protected]
Not yet recruiting
Mazowiecki Szpital Onkologiczny, Wieliszew, Poland
Sylwina Socha, Contact, +48 22 766 15 00, [email protected]
Not yet recruiting
Centrul Medical Focus, Bucharest, Romania
Ingrid Iordan, Contact, 0721298677, [email protected]
Not yet recruiting
Radiotherapy Center Cluj, Cluj-Napoca, Romania
Andrei Ungureanu, Contact, +40742206212, [email protected]
Recruiting
Onco Clinic Consult SA, Craiova, Romania
Completed
Oncology Center Sfantul Nectarie, Craiova, Romania
Michael Schenker, Contact, +40351401336, [email protected]
Recruiting
Gral Medical SRL, Piteşti, Romania
Adela-Luiza Chirila, Contact, +40766442720, [email protected]
Recruiting
OncoMed Oncology Center, Timișoara, Romania
Daniela Sirbu, Contact, +40 0744571617, [email protected]
Recruiting
Curie Oncology, Singapore, 329563, Singapore
Su-Mien Lynette Ngo, Contact, +6562595538, [email protected]
Not yet recruiting
National Cancer Center, Gyeonggi-do, South Korea
Keun Seok Lee, Contact, [email protected]
Not yet recruiting
Chonnam National University Hwasun Hospital, Jeollanam-do, 58128, South Korea
Hyun Jeong Shim, Contact, 82-61-379-7634, [email protected]
Recruiting
Asan Medical Center, Seoul, South Korea
Sung-Bae Kim, Contact, 82-2-3010-3217, [email protected]
Not yet recruiting
Korea University Anam Hospital, Seoul, South Korea
Kyong Hwa Park, Contact, 82-2-920-6841, [email protected]
Recruiting
Severance Hospital, Yonsei University Health System, Seoul, South Korea
Joo Hyuk Sohn, Contact, 82-2-2228-8135, [email protected]
Not yet recruiting
Hospital Clinic Barcelona, Barcelona, Spain
Tomas Pascual, Contact, [email protected]
Recruiting
Hospital Universitario Vall d'Hebron, Barcelona, Spain
Miriam Arumi de Dios, Contact, +34600240679, [email protected]
Recruiting
Hospital Universitario Reina Sofia, Córdoba, Spain
Juan de la Haba, Contact, [email protected]
Recruiting
Hospital Universitario Ramon y Cajal, Madrid, 28034, Spain
Noelia Martinez Jañez, Contact, [email protected]
Not yet recruiting
Hospital Fundacion Jimenez Diaz, Madrid, 28040, Spain
Yann Izarzugaza, Contact, [email protected]
Not yet recruiting
Clinica Universidad de Navarra - Madrid, Madrid, Spain
Jaime Espinos Jimenez, Contact, [email protected]
Recruiting
Hospital Beata Maria Ana, Madrid, Spain
Javier Cortes Castan, Contact, +34 935 460 139, [email protected]
Recruiting
Hospital General Universitario Gregorio Maranon, Madrid, Spain
Sara Lopez- Tarruella Cobo, Contact, [email protected]
Recruiting
Hospital Universitario 12 de Octubre, Madrid, Spain
Eva Ciruelos Gil, Contact, +34913908000, [email protected]
Recruiting
Hospital Universitario de La Princesa, Madrid, Spain
Ana Isabel Ballesteros, Contact, +34915202200, [email protected]
Recruiting
Hospital Regional Universitario de Malaga, Málaga, Spain
Begoña Jimenez Rodríguez, Contact, [email protected]
Recruiting
Clinica Universidad de Navarra - Pamplona, Pamplona, Spain
Jaime Espinos Jimenez, Contact, [email protected]
Recruiting
Instituto Valenciano de Oncologia, Valencia, Spain
Angel Guerrero Zotano, Contact, +34 96 111 4051, [email protected]
Recruiting
Changhua Christian Hospital (CCH), Changhua, Taiwan
Shou-Tung Chen, Contact, [email protected]
Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH), Kaohsiung City, Taiwan
Ming-Feng Hou, Contact, [email protected]
Recruiting
National Cheng Kung University Hospital, Tainan, Taiwan
Wei-Pang Chung, Contact, +886975014242, [email protected]
Recruiting
Koo Foundation Sun Yat-Sen Cancer Center, Taipei, Taiwan
Chi-Feng Chung, Contact, [email protected]
Recruiting
National Taiwan University Hospital, Taipei, Taiwan
Chiun-Sheng Huang, Contact, [email protected]
Recruiting
Tri-Service General Hospital, Taipei, Taiwan
Ming-Shen Dai, Contact, +886-2-87927208, [email protected]
Recruiting
Linkou Chang Gung Memorial Hospital (CGMHLK), Taoyuan, Taiwan
Shin-Cheh Chen, Contact, [email protected]
Recruiting

Ankara

Liv Hospital Ankara, Çankaya, Ankara, Turkey (Türkiye)
Sadettin Kilickap, Contact, [email protected]
Not yet recruiting

Istanbul

Istanbul University CAPA Medical Faculty, Çapa, Istanbul, Turkey (Türkiye)
Meltem Ekenel, Contact, [email protected]
Not yet recruiting
Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Kadiköy, Istanbul, Turkey (Türkiye)
Mahmut Gumus, Contact, [email protected]
Not yet recruiting

İzmir

Ege University Medical Faculty Hospital, Bornova, İzmir, Turkey (Türkiye)
Burcu Cakar, Contact, [email protected]
Not yet recruiting
Suat Seren Training and Research Hospital, Konak, İzmir, Turkey (Türkiye)
Sema Erturk, Contact, [email protected]
Not yet recruiting

Kocaeli

Kocaeli University Research and Application Hospital, İzmit, Kocaeli, Turkey (Türkiye)
Devrim Cabuk, Contact, [email protected]
Not yet recruiting
Ankara University Medical Faculty Medical Oncology Department, Ankara, Turkey (Türkiye)
Arzu Yasar, Contact, [email protected]
Not yet recruiting
Uludag University Faculty of Medicine Hospital, Bursa, Turkey (Türkiye)
Turkkan Evrensel, Contact, [email protected]
Not yet recruiting
Trakya University Medical Faculty Hospital, Edirne, Turkey (Türkiye)
Sernaz Topaloglu, Contact, [email protected]
Not yet recruiting
Medical Point Izmir Hospital, Izmir, Turkey (Türkiye)
Cagatay Arslan, Contact, [email protected]
Not yet recruiting
Velindre Cancer Center, Cardiff, CF14 2TL, United Kingdom
Simon Waters, Contact
Not yet recruiting
Princess Alexandra Hospital - Harlow, Harlow, CM20 1QX, United Kingdom
Apostolos Konstantis, Contact, [email protected]
Not yet recruiting
Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom
Chris Twelves, Contact, [email protected]
Recruiting
Royal Free London NHS Foundation Trust, London, NW3 2, United Kingdom
Judy King, Contact, [email protected]
Not yet recruiting
Charing Cross Hospital, London, United Kingdom
Farah Rehman, Contact, [email protected]
Recruiting
The Christie NHS Foundation Trust, Manchester, United Kingdom
Anne Armstrong, Contact, [email protected]
Recruiting
Milton Keynes Hospital, Milton Keynes, MK6 5LD, United Kingdom
Azhar Rizvi, Contact, [email protected]
Not yet recruiting
Nottingham City Hospital, Nottingham, United Kingdom
Sarah Khan, Contact, [email protected]
Not yet recruiting
University Hospital of North Tees, Stockton-on-Tees, TS198PE, United Kingdom
Janine Graham, Contact, [email protected]
Not yet recruiting