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A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer (IMpassion030)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03498716
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Breast International Group
Alliance Foundation Trials (AFT)
Institut Jules Bordet/Clinical Trials Support Unit (IJB/CTSU)
Frontier Science and Technology Research Foundation Inc (FS)
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Drug: Atezolizumab Drug: Paclitaxel Drug: Dose-dense Doxorubicin or dose-dense Epirubicin Drug: Cyclophosphamide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Open-Label Study Comparing Atezolizumab (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone in Patients With Operable Triple Negative Breast Cancer
Actual Study Start Date : August 2, 2018
Estimated Primary Completion Date : January 15, 2022
Estimated Study Completion Date : December 29, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Atezolizumab + Chemotherapy

Participants will receive atezolizumab (in combination with chemotherapy as described below) every 2 weeks for 10 doses, followed by atezolizumab maintenance therapy every 3 weeks to complete 1 year of treatment from the first dose

Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)

Drug: Atezolizumab

Atezolizumab will be administered by IV, 840 mg every 2 weeks, for 10 doses.

Atezolizumab maintenance will be administered by IV, 1200 mg every 3 weeks to complete 1 year


Drug: Paclitaxel
Paclitaxel will be administered by IV, 80 mg/m^2 every week for 12 weeks.

Drug: Dose-dense Doxorubicin or dose-dense Epirubicin

Dose-dense doxorubicin will be administered by IV, 60 mg/m^2 every 2 weeks for a total of 4 doses.

Or

Dose-dense epirubicin will be administered by IV, (90 mg/m^2) every 2 weeks for a total of 4 doses


Drug: Cyclophosphamide
Cyclophosphamide will be administered by IV, 600 mg/m^2 every 2 weeks for 4 doses

Active Comparator: Chemotherapy
Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
Drug: Paclitaxel
Paclitaxel will be administered by IV, 80 mg/m^2 every week for 12 weeks.

Drug: Dose-dense Doxorubicin or dose-dense Epirubicin

Dose-dense doxorubicin will be administered by IV, 60 mg/m^2 every 2 weeks for a total of 4 doses.

Or

Dose-dense epirubicin will be administered by IV, (90 mg/m^2) every 2 weeks for a total of 4 doses


Drug: Cyclophosphamide
Cyclophosphamide will be administered by IV, 600 mg/m^2 every 2 weeks for 4 doses




Primary Outcome Measures :
  1. Invasive Disease-Free Survival (iDFS) [ Time Frame: Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years). ]

    iDFS events are defined as follows:

    1. Ipsilateral invasive breast tumor recurrence
    2. Ipsilateral local-regional invasive breast cancer recurrence
    3. Ipsilateral second primary invasive breast cancer
    4. Contralateral invasive breast cancer
    5. Distant recurrence
    6. Death attributable to any cause


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Randomization to death from any cause through the end of study (approximately 7 years) ]
  2. Disease-Free Survival (DFS) [ Time Frame: Randomization until the first occurrence of an DFS event, through the end of study (approximately 7 years) ]
    DFS is defined as any event of the primary endpoint and new diagnosis of an ipsilateral or contralateral non-invasive breast cancer.

  3. Recurrence-Free Interval (RFI) [ Time Frame: Randomization until local, regional, or distant disease recurrence of breast cancer, through the end of study (approximately 7 years) ]
  4. Distant RFI [ Time Frame: Randomization until distant disease recurrence, through the end of study (approximately 7 years) ]
  5. Percentage of participants with adverse events [ Time Frame: Baseline to end of study (approximately 7 years) ]
    Safety Objective

  6. Serum concentration of Atezolizumab [ Time Frame: Pre-infusion (0 hour), 30 minutes post-infusion on Week 1 Day 1 (infusion length = 60 minutes); pre-infusion on Day 1 of Weeks 5, 9, 13, 21, 33 and 45; at treatment discontinuation (up to approximately 1 year), 120 days after last dose ]
  7. Invasive Disease-Free Survival (iDFS) in PDL1- Selected Patients [ Time Frame: Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years) ]
  8. Invasive Disease-Free Survival (iDFS) in Node- Positive Disease [ Time Frame: Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years) ]
  9. Invasive Disease Free Survival (iDFS) including second primary non-breast invasive cancer [ Time Frame: Randomization until the first occurrence of iDFS event or death, through the end of study (approximately 7 years) ]
  10. Percentage of Participants with Anti-Drug Antibodies (ADAs) to Atezolizumab [ Time Frame: Updated: Pre-infusion (0 hour) on Day 1 of Weeks 1, 5, 9, 13, 21, 33 and 45; at treatment discontinuation (up to Week 51), 120 days after last dose ]
  11. Mean changes from baseline in patient-reported function (role, physical) [ Time Frame: Baseline, Cycle 4 Day 1, Day 1 of every other cycle until Cycle 16 (cycle = 21 days), at the end of treatment/discontinuation visit ((up to approximately 1 year), and during Study Follow-up (up to approximately 7 years). ]
    Mean changes from baseline score in role, physical function will be assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - Core 30 (EORTC QLQ-C30)

  12. Mean changes from baseline in patient-reported health-related quality of life (HRQoL) [ Time Frame: Time Frame: Baseline, Cycle 4 Day 1, Day 1 of every other cycle until Cycle 16 (cycle = 21 days), at the end of treatment/discontinuation visit (up to approximately 1 year), and during Study Follow-up (up to approximately 7 years). ]
    Mean changes from baseline score in HRQoL will be assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - Core 30 (EORTC QLQ-C30).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-metastatic operable Stage II-III breast cancer
  • Histologically documented TNBC (Triple Negative Breast Cancer)
  • Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen
  • Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
  • Adequate hematologic and end-organ function
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
  • No more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization.
  • Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical resection in paraffin blocks (preferred) or at least 25 unstained slides.

Exclusion Criteria

  • Prior history of invasive breast cancer
  • For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy.
  • Previous therapy with anthracyclines or taxanes for any malignancy
  • Cardiopulmonary dysfunction
  • Prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Urinary outflow obstruction
  • Active tuberculosis
  • Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment or within 5 months following the last dose of Atezolizumab (for patients randomized to Atezolizumab)
  • Prior allogeneic stem cell or solid organ transplant
  • Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498716


Contacts
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Contact: Reference Study ID Number: WO39391 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

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Locations
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United States, California
John Muir Health Clinical Research Center Recruiting
Concord, California, United States, 94520
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Martin-O'Neil Cancer Center Recruiting
Saint Helena, California, United States, 94574
United States, Florida
Baptist - MD Anderson Cancer Center Recruiting
Jacksonville, Florida, United States, 32207
United States, Georgia
Northwest Georgia Oncology Centers PC - Marietta Recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
Advocate Illinois Masonic Outpatient Center for Advanced Care Recruiting
Chicago, Illinois, United States, 60657
United States, Iowa
Des Moines Oncology Research Association Recruiting
Des Moines, Iowa, United States, 50309
United States, Kansas
Cancer Center of Kansas Recruiting
Wichita, Kansas, United States, 67214-3728
United States, Louisiana
Christus Cabrini Cancer Center Withdrawn
Alexandria, Louisiana, United States, 71301
United States, Maryland
University of Maryland Greenebaum Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Mercy Medical Center Recruiting
Baltimore, Maryland, United States, 21202
University of Maryland; St. Joseph Medical Center Withdrawn
Towson, Maryland, United States, 21204
United States, Minnesota
Fairview Southdale Medical Oncology Clinic Recruiting
Edina, Minnesota, United States, 55435
United States, Missouri
Mercy Cancer Center - Joplin Recruiting
Joplin, Missouri, United States, 64804
HCA Midwest Division Recruiting
Kansas City, Missouri, United States, 64132
United States, Montana
MT Cancer Consortium Recruiting
Billings, Montana, United States, 59101
United States, New Hampshire
New Hampshire Hematology Oncology Recruiting
Hooksett, New Hampshire, United States, 03106
United States, New Jersey
The Valley Hospital Withdrawn
Paramus, New Jersey, United States, 07652
United States, New York
Monter Cancer Center Recruiting
Lake Success, New York, United States, 11042
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Rochester General Hospital; Lipson Cancer and Blood Center Recruiting
Rochester, New York, United States, 14621
United States, North Carolina
Southeastern Medical Oncology Center - Goldsboro Withdrawn
Goldsboro, North Carolina, United States, 27534
United States, Pennsylvania
Lancaster General Hospital Recruiting
Lancaster, Pennsylvania, United States, 17604
United States, South Dakota
Rapid City Regional Hospital/Regional Cancer Care Institute Recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
SCRI Recruiting
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37204
United States, Texas
The Center for Cancer and Blood Disorders - Fort Worth Recruiting
Fort Worth, Texas, United States, 76104
United States, Utah
Intermountain Medical Center Not yet recruiting
Murray, Utah, United States, 84107
Intermountain Precision Genomics Cancer Research Clinic-Dixie Not yet recruiting
Saint George, Utah, United States, 84770
United States, West Virginia
St. Mary's Medical Center Recruiting
Huntington, West Virginia, United States, 25702
Argentina
COIBA; Centro de Oncologia e; Investigacion Buenos Aires Not yet recruiting
Berazategui, Argentina, B1880BBF
Hospital Britanico de Buenos Aires Not yet recruiting
Ciudad Autonoma Buenos Aires, Argentina, C1284AEB
Clinica Universitaria Reina Fabiola Not yet recruiting
Cordoba, Argentina, X5004FHP
Centro Oncologico Riojano Integral (CORI) Not yet recruiting
La Rioja, Argentina, F5300COE
Instituto de Oncología de Rosario Not yet recruiting
Rosario, Argentina, S2000KZE
Centro Medico San Roque Not yet recruiting
San Miguel de Tucuman, Argentina, T4000IAK
Centro de Investigacion Clinica - Clinica Viedma S.A.; Oncology Department Not yet recruiting
Viedma, Argentina, R8500ACE
Australia, New South Wales
Bankstown-Lidcombe Hospital Not yet recruiting
Bankstown, New South Wales, Australia, 2200
Chris O'Brien Lifehouse Not yet recruiting
Camperdown, New South Wales, Australia, 2050
St Vincent's Hospital Sydney Not yet recruiting
Darlinghurst, New South Wales, Australia, 2010
Lismore Base Hospital Not yet recruiting
Lismore, New South Wales, Australia, 2480
Northern Cancer Institute Not yet recruiting
St Leonards, New South Wales, Australia, 2065
Macquarie University Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2109
Tweed Hospital Not yet recruiting
Tweed Heads, New South Wales, Australia, 2485
Sydney Adventist Hospital Not yet recruiting
Wahroonga, New South Wales, Australia, 2076
Australia, Queensland
Icon Cancer Care Wesley Not yet recruiting
Auchenflower, Queensland, Australia, 4066
Icon Cancer Foundation; Icon Cancer Care Chermside Not yet recruiting
Chermside, Queensland, Australia, 4032
Icon Cancer Care South Brisbane Not yet recruiting
South Brisbane, Queensland, Australia, 4101
Icon Cancer Foundation Not yet recruiting
South Brisbane, Queensland, Australia, 4101
Mater Hospital; Cancer Services Not yet recruiting
South Brisbane, Queensland, Australia, 4101
Icon Cancer Foundation; Icon Cancer Care Southport Not yet recruiting
Southport, Queensland, Australia, 4215
Princess Alexandra Hospital; Cancer Trials Unit Recruiting
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital; Cancer Centre Recruiting
Adelaide, South Australia, Australia, 5000
Ashford Cancer Center Research Recruiting
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Box Hill Hospital; Eastern Clinical Research Unit Not yet recruiting
Box Hill, Victoria, Australia, 3128
Monash Medical Centre Not yet recruiting
Clayton, Victoria, Australia, 3168
Peninsula and South Eastern Haematology and Oncology Group Not yet recruiting
Frankston, Victoria, Australia, 3199
Austin Hospital Olivia Newton John Cancer Centre Not yet recruiting
Heidelberg, Victoria, Australia, 3084
Maroondah Hospital; Breast Clinic Not yet recruiting
Ringwood East, Victoria, Australia, 3135
Austria
Medical University Innsbruck; Frauenklinik Innsbruck, Dept Gyn Not yet recruiting
Innsbruck, Austria, 6020
Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie Not yet recruiting
Linz, Austria, 4010
Uniklinikum Salzburg, LKH; Univ.Klinik f. Innere Medizin III der PMU Recruiting
Salzburg, Austria, 5020
AKH - Medizinische Universität Wien; Department of Oncology Not yet recruiting
Vienna, Austria, 1090
General Hospital Hietzing, KLI; Dept. Obstet&Gynecol Not yet recruiting
Vienna, Austria, 1130
Salzkammergut-Klinikum Voecklabruck Recruiting
Vöcklabruck, Austria, 4840
Klinikum Kreuzschwestern Wels; Iv. Interne Abt. Not yet recruiting
Wels, Austria, 4600
Belgium
AZ KLINA Recruiting
Brasschaat, Belgium, 2930
Institut Jules Bordet Recruiting
Bruxelles, Belgium, 1000
UZ Leuven Gasthuisberg Recruiting
Leuven, Belgium, 3000
Chr de La Citadelle Recruiting
Liège, Belgium, 4000
CHU de Liège Recruiting
Liège, Belgium, 4000
Clinique Saint-Joseph Recruiting
Liège, Belgium, 4000
CHU Ambroise Paré Recruiting
Mons, Belgium, 7000
Clinique Sainte-Elisabeth; Oncologie Recruiting
Namur, Belgium, 5000
AZ Nikolaas (Sint Niklaas) Recruiting
Sint Niklaas, Belgium, 9100
Brazil
Nucleo de Oncologia da Bahia - NOB Not yet recruiting
Salvador, Bahia, BA, Brazil, 40170-380
Clinica Amo - Assistencia Medica Em Oncologia Not yet recruiting
Salvador, BA, Brazil, 41950-610
Crio - Centro Regional Integrado de Oncologia Not yet recruiting
Fortaleza, CE, Brazil, 60336-550
Instituto Nacional do Cancer - INCA Not yet recruiting
Rio de Janeiro, RJ, Brazil, 20560-120
Hospital de Caridade de Ijuí Not yet recruiting
Ijuí, RO, Brazil, 98700-000
Hospital Moinhos de Vento; Instituto de Educação e Pesquisa Not yet recruiting
Porto Alegre, RO, Brazil, 90560-030
Hospital Mãe de Deus; Centro de Pesquisa Clínica - Instituto do Câncer Recruiting
Porto Alegre, RS, Brazil, 90470-340
Hospital Sao Lucas da PUCRS Not yet recruiting
Porto Alegre, RS, Brazil, 90610-000
Hospital de Clínicas de Porto Alegre Not yet recruiting
Porto Alegre, RS, Brazil
Clinica de Neoplasias Litoral Recruiting
Itajai, SC, Brazil, 88301-220
Fundação Pio XII Hospital de Câncer de Barretos Not yet recruiting
Barretos, SP, Brazil, 14784-400
Hospital Amaral Carvalho; Oncologia Clinica Not yet recruiting
Jau, SP, Brazil, 17210-080
CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia Not yet recruiting
Santo André, SP, Brazil, 09060-650
Hospital Sírio-Libanês Not yet recruiting
Sao Paulo, SP, Brazil, 01308-050
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda Recruiting
Sao Paulo, SP, Brazil, 01317-000
Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira Not yet recruiting
São Paulo, SP, Brazil, 01246 000
Instituto Brasileiro De Controle Do Câncer - IBCC; Laboratório De Patologia Recruiting
São Paulo, SP, Brazil, 03102-002
China
The 307th Hospital of Chinese People's Liberation Army Not yet recruiting
Beijing City, China, 100071
Peking University People's Hospital Recruiting
Beijing, China, 100044
Beijing Hospital of Ministry of Health Not yet recruiting
Beijing, China, 100730
Beijing Union Hospital Not yet recruiting
Beijing, China, 100730
Jilin Cancer Hospital Not yet recruiting
Changchun, China, 130012
the First Hospital of Jilin University Not yet recruiting
Changchun, China, 130021
West China Hospital, Sichuan University Not yet recruiting
Chengdu, China, 610041
Chongqing Cancer Hospital Recruiting
Chongqing, China, 400030
Fujian Medical University Union Hospital Not yet recruiting
Fujian, China, 350001
Fuzhou General Hospital, PLA Nanjing Military Area Command Not yet recruiting
Fuzhou, China, 110016
Sun Yat-sen Memorial Hospital Not yet recruiting
Guangzhou, China, 510000
Sun yat-sen University Cancer Center; Internal Medicine of Oncology Not yet recruiting
Guangzhou, China, 510060
Guangdong General Hospital Not yet recruiting
Guangzhou, China, 510080
The First Affiliated Hospital of College of Medicine, Zhejiang University Recruiting
Hangzhou, China, 310003
The Second Affiliated Hospital of Zhejiang University College Not yet recruiting
Hangzhou, China, 310009
Zhejiang Cancer Hospital Not yet recruiting
Hangzhou, China, 310022
Harbin Medical University Cancer Hospital Not yet recruiting
Harbin, China, 150081
Shandong Cancer Hospital Not yet recruiting
Jinan, China, 250117
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School Not yet recruiting
Nanjing, China, 210029
The Affiliated Hospital of Medical College Qingdao University Not yet recruiting
Qingdao, China, 266003
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital) Recruiting
Shanghai, China, 200025
Fudan University Shanghai Cancer Center Not yet recruiting
Shanghai, China, 200032
Zhongshan Hospital Fudan University Not yet recruiting
Shanghai, China, 200032
Changhai Hospital of Shanghai Not yet recruiting
Shanghai, China, 200433
The University of Hong Kong-Shenzhen Hospital Not yet recruiting
Shenzhen City, China, 518053
Hebei Medical University Fourth Hospital;(Tumor Hospital of Hebei Province) Not yet recruiting
Shijiazhuang, China, 050035
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan City, China, 430022
The First Affiliated Hospital of Xian Jiao Tong University Recruiting
Xi'an City, China, 710061
Henan Cancer Hospital Not yet recruiting
Zhengzhou, China, 450008
Czechia
Nemocnice Horovice, NH Hospital a.s.; Oncology Department Recruiting
Horovice, Czechia, 26831
Fakultni nemocnice Hradec Kralove Recruiting
Hradec Kralove, Czechia, 500 05
Fakultni nemocnice Olomouc; Onkologicka klinika Recruiting
Olomouc, Czechia, 779 00
Fakultni Nemocnice V Motole, S.P. Recruiting
Prague, Czechia, 15060
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika Recruiting
Praha 2, Czechia, 128 08
Krajska nemocnice T. Bati, a.s. Recruiting
Zlin, Czechia, 76001
Denmark
Herlev Hospital; Onkologisk afdeling Recruiting
Herlev, Denmark, 2730
Sjællands Universitetshospital, Næstved; Onkologisk Afdeling Recruiting
Naestved, Denmark, 4700
Odense Universitetshospital, Onkologisk Afdeling, Klinisk Forsknings Enhed Recruiting
Odense C, Denmark, 5000
Sygehus Lillebælt, Vejle Recruiting
Vejle, Denmark, 7100
France
Centre Hospitalier Regional Metz-Thionville - Hopital de Mercy Recruiting
Ars-Laquenexy, France, 57530
Institut Sainte Catherine Recruiting
Avignon, France, 84918
CH de Beauvais Recruiting
Beauvais, France, 60000
CHU Jean Minjoz Not yet recruiting
Besançon, France, 25030
Centre Hospitalier De Blois Recruiting
Blois, France, 41016
Clinique Tivoli; Sce Radiotherapie Recruiting
Bordeaux, France, 33000
Institut Bergonie Recruiting
Bordeaux, France, 33076
Polyclinique Bordeaux Nord Aquitaine Recruiting
Bordeaux, France, 33300
Centre Hospitalier Fleyriat Recruiting
Bourg-en- Bresse Cedex, France, 01012
CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie Recruiting
Brest, France, 29609
CRLCC-Francois Baclesse; Oncologie Médicale Recruiting
Caen, France, 14076
CH de Cholet; oncologie Recruiting
Cholet, France, 49325
Centre Jean Perrin Recruiting
Clermont Ferrand, France, 63011
Centre Hospitalier de Compiegne Recruiting
Compiegne, France, 60321
Centre Hospitalier Alpes Leman Recruiting
Contamine Sur Arve, France, 74130
Centre Georges Francois Leclerc Recruiting
Dijon, France, 21000
CHU de Grenoble - Hôpital André Michallon Recruiting
Grenoble Cedex 9, France, 38043
Centre Hospitalier Departemental de Vendee Recruiting
La Roche Sur Yon, France, 85925
Centre Hospitalier De Versailles Recruiting
Le Chesnay, France, 78157
Clinique des Ormeaux; Oncologie Recruiting
Le Havre, France, 76600
Hôpital Privé de l'Estuaire Recruiting
Le Havre, France, 76620
Clinique Chenieux; Oncology Recruiting
Limoges, France, 87039
Centre Hospitalier Bretagne Sud Recruiting
Lorient, France, 56100
Centre Leon Berard Recruiting
Lyon, France, 69008
Hopital Prive Jean Mermoz Recruiting
Lyon, France, 69373
Hopital Europeen Recruiting
Marseille, France, 13003
Hôpital Saint Joseph Recruiting
Marseille, France, 13008
Institut Paoli Calmettes Recruiting
Marseille, France, 13009
Centre Hospitalier de Mont de Marsan - Hopital Layne Recruiting
Mont De Marsan, France, 40024
Clinique Clémentville Recruiting
Montpellier, France, 34070
Institut régional du Cancer Montpellier Recruiting
Montpellier, France, 34298
l'Hôpital privé du Confluent SAS Recruiting
Nantes, France, 44202
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
CHR Orleans, Hopital Madeleine Recruiting
Orléans, France, 45067
Institut Curie Not yet recruiting
Paris, France, 75005
Polyclinique Francheville Recruiting
Perigueux, France, 24004
Centre Armoricain de Radiotherapie, de Imagerie Medicale et de Oncologie (CARIO) Recruiting
Plerin, France, 22190
CH Annecy Genevois site Annecy; Oncologie Recruiting
Pringy, France, 74374
Chi De Cornouaille; Oncologie Hospitalisation Recruiting
Quimper, France, 29107
Institut Jean Godinot Recruiting
Reims, France, 51056
Institut du Cancer Coulancy Reims Recruiting
Reims, France, 51100
Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer Withdrawn
Rennes, France, 35000
Centre Henri Becquerel Recruiting
Rouen, France, 76038
Institut De Cancerologie Lucien Newrth Recruiting
St Priest en Jarez CEDEX, France, 42271
Centre Paul Strauss Recruiting
Strasbourg, France, 67085
Hopitaux Du Leman - Site Georges Pianta Recruiting
Thonon Les Bains, France, 74200
Institut Claudius Régaud Recruiting
Toulouse, France, 31059
Clinique Pasteur Recruiting
Toulouse, France, 31076
Clinique Pasteur; Imagerie Medicale Recruiting
Toulouse, France, 31300
CHU Tours - Hôpital Bretonneau Recruiting
Tours, France, 37044
Hopital Prive Drome Ardeche; Hopital De Jour Recruiting
Valence, France, 26000
Institut de Cancérologie de Lorraine Recruiting
Vandoeuvre-Les-Nancy, France, 54519
Institut Gustave Roussy; Departement Oncologie Medicale Recruiting
Villejuif, France, 94805
Hopital Prive Villeneuve d Ascq;Chimiotherapie Radiotherapie Recruiting
Villeneuve D Ascq, France, 59657
Germany
Praxisklinik Krebsheilkunde für Frauen / Brustzentrum (Dres. Kittel/Klare) Not yet recruiting
Berlin, Germany, 10367
Studienzentrum Berlin City Not yet recruiting
Berlin, Germany, 14169
St. Johannes-Hospital Not yet recruiting
Dortmund, Germany, 44137
Onkozentrum Dres. Göhler Recruiting
Dresden, Germany, 01127
Praxis für Hamatologie und Onkologie Not yet recruiting
Erfurt, Germany, 99085
Klinikum Frankfurt Höchst GmbH Not yet recruiting
Frankfurt, Germany, 65929
Onkodok GmbH Recruiting
Gütersloh, Germany, 33332
Ärztehaus am Bahnhofsplatz; Praxis Uleer/Pourfard Recruiting
Hildesheim, Germany, 31134
St. Elisabeth-Krankenhaus Recruiting
Köln, Germany, 50935
Klinikum Ludwigsburg; Studiensekretariat Recruiting
Ludwigsburg, Germany, 71640
St. Vincenz-Elisabeth-Hospital; Katholisches Klinikum Mainz Not yet recruiting
Mainz, Germany, 55131
Uniklinik Mainz; I. Medizinische Klinik Not yet recruiting
Mainz, Germany, 55131
Universitaets Medizin Mannheim Not yet recruiting
Mannheim, Germany, 68167
Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller Not yet recruiting
Mayen, Germany, 56727
Johannes Wesling Klinikum Minden Not yet recruiting
Minden, Germany, 32429
Klinikum der Universität München; Frauenklinik - Onkologie II Not yet recruiting
München, Germany, 80337
Klinikum Neumarkt; Frauenklinik Not yet recruiting
Neumarkt i.d.OPf., Germany, 92318
Studienzentrum Onkologie Ravensburg; Onkologie Ravensburg Recruiting
Ravensburg, Germany, 88212
Johanniter Frauenklinik Stendal Germany Recruiting
Stendal, Germany, 39576
Universitätsklinik Tübingen; Frauenklinik Not yet recruiting
Tübingen, Germany, 72076
Marien-Hospital Witten, MVZ Witten Recruiting
Witten, Germany, 58452
Klinikum Worms; Frauenklinik; Klinik für Gynäkologie und Geburtshilfe Not yet recruiting
Worms, Germany, 67550
Hong Kong
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology Not yet recruiting
Hong Kong, Hong Kong
Queen Mary Hospital Not yet recruiting
Hong Kong, Hong Kong
Queen Elizabeth Hospital Department of Clinical Oncology Not yet recruiting
Kowloon, Hong Kong
Hungary
Szent Margit Hospital; Dept. of Oncology Not yet recruiting
Budapest, Hungary, 1032
National Institute of Oncology, A Dept of Internal Medicine Not yet recruiting
Budapest, Hungary, 1122
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktatókórház Not yet recruiting
Miskolc, Hungary, 3526
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet Not yet recruiting
Pecs, Hungary, 7624
Ireland
Mater Misecordiae University Hospital Recruiting
Dublin, Ireland, 7
Beaumont Hospital; Cancer Clinical Trials Unit Recruiting
Dublin, Ireland, 9
Galway University Hospital; Clinical Trials Department Not yet recruiting
Galway, Ireland, H91YR71
University Hospital Limerick - PIN Recruiting
Limerick, Ireland, V 94 F858
Israel
Rambam Health Care Campus; Hematology Recruiting
Haifa, Israel, 31096
Hadassah Med Org Kiryat; Oncology Institute Recruiting
Jerusalem, Israel, 0091120
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 9103102
Meir Medical center, Pediatrics Recruiting
Kfar Sava, Israel, 4428164
Rabin MC; Davidof Center - Oncology Institute Recruiting
Petach Tikva, Israel, 4941492
Kaplan Medical Center Recruiting
Rehovot, Israel, 7610001
Italy
Azienda Ospedaliera Papa Giovanni XXIII Recruiting
Bergamo, Abruzzo, Italy, 24060
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi; UO Farmacia Clinica Recruiting
Bologna, Emilia-Romagna, Italy, 40138
Ospedale Degli Infermi - Faenza; Oncologia Medica Recruiting
Faenza, Emilia-Romagna, Italy, 48018
Azienda Ospedaliero - Universitaria di Modena Policlinico Recruiting
Modena, Emilia-Romagna, Italy, 41110
Azienda Ospedaliero Universitaria di Parma Recruiting
Parma, Emilia-Romagna, Italy, 43100
Ospedale degli Infermi Recruiting
Rimini, Emilia-Romagna, Italy, 47923
Centro Di Riferimento Oncologico; SOC Oncologia Medica C Recruiting
Aviano, Friuli-Venezia Giulia, Italy, 33081
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia Recruiting
Udine, Friuli-Venezia Giulia, Italy, 33100
Policlinico Universitario Campus Biomedico Di Roma Not yet recruiting
Roma, Lazio, Italy, 00128
Ospedale Belcolle Di Viterbo; Oncologia Not yet recruiting
Viterbo, Lazio, Italy, 01100
Ente Ospedaliero Ospedali Galliera Not yet recruiting
Genova, Liguria, Italy, 16128
Azienda Ospedaliero Universitaria San Martino Recruiting
Genova, Liguria, Italy, 16132
ASST DI LECCO; Oncologia Medica Recruiting
Lecco, Lombardia, Italy, 23900
Ospedale Mater Salutis Recruiting
Legnago (VR), Lombardia, Italy, 37045
Istituto Europeo Di Oncologia Recruiting
Milano, Lombardia, Italy, 20141
Fondazione Salvatore Maugeri Recruiting
Pavia, Lombardia, Italy, 27100
Policlinico San Mattea Recruiting
Pavia, Lombardia, Italy, 27100
Istituto Clinico Humanitas Not yet recruiting
Rozzano (MI), Lombardia, Italy, 20089
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria Recruiting
Alessandria, Piemonte, Italy, 15121
Ospedale Degli Infermi Di Biella; Reparto Oncologia Medica Recruiting
Ponderano (BI), Piemonte, Italy, 13875
Nuovo Ospedale Di Prato Recruiting
Prato, Toscana, Italy, 50047
Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia Recruiting
Perugia, Umbria, Italy, 06100
Azienda Ospedaliero Universitaria di Ferrara - U.O. Di Oncologia Recruiting
Cona (FE), Veneto, Italy, 44124
Japan
Aichi Cancer Center Hospital Recruiting
Aichi, Japan, 464-8681
Chiba Cancer Center Recruiting
Chiba, Japan, 260-8717
Shikoku Cancer Center Recruiting
Ehime, Japan, 791-0280
National Hospital Organization Kyushu Cancer Center Recruiting
Fukuoka, Japan, 811-1395
Fukushima Medical University Hospital Recruiting
Fukushima, Japan, 960-1295
Hiroshima City Hiroshima Citizens Hospital Recruiting
Hiroshima, Japan, 730-8518
National Hospital Organization Hokkaido Cancer Center Recruiting
Hokkaido, Japan, 003-0804
Hyogo College of Medicine Hospital Recruiting
Hyogo, Japan, 663-8501
Sagara Hospital Recruiting
Kagoshima, Japan, 892-0833
Kanagawa Cancer Center Recruiting
Kanagawa, Japan, 241-8515
Tokai University Hospital Recruiting
Kanagawa, Japan, 259-1193
Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Naha-nishi Clinic Recruiting
Okinawa, Japan, 901-0154
National Hospital Organization Osaka National Hospital Recruiting
Osaka, Japan, 540-0006
Osaka International Cancer Institute Recruiting
Osaka, Japan, 541-8567
Saitama Medical University International Medical Center Recruiting
Saitama, Japan, 350-1298
Saitama Cancer Center Recruiting
Saitama, Japan, 362-0806
Shizuoka Cancer Center Recruiting
Shizuoka, Japan, 41109340
St. Luke's Internat. Hospital, Breast Surgical Oncology Recruiting
Tokyo, Japan, 104-8560
The Cancer Institute Hospital of JFCR Recruiting
Tokyo, Japan, 135-8550
Korea, Republic of
Chungbuk National University Hospital Recruiting
Cheongju-si, Korea, Republic of, 28644
Soon Chun Hyang University Cheonan Hospital Recruiting
Dongnam-gu, Cheonan-si, Korea, Republic of, 31151
National Cancer Center Recruiting
Gyeonggi-do, Korea, Republic of, 10408
CHA Bundang Medical Center Recruiting
Gyeonggi-do, Korea, Republic of, 13496
Seoul National University Bundang Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 13620
Ajou University Hospital Recruiting
Gyeonggi-do, Korea, Republic of, 443-380
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 21565
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 22332
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital; Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Asan Medical Center - Oncology Recruiting
Seoul, Korea, Republic of, 05505
Seoul St Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of, 07985
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 6351
Ulsan University Hosiptal Recruiting
Ulsan, Korea, Republic of, 44033
Wonju Christian Hospital Recruiting
Wonju, Korea, Republic of, 220-701
Mexico
Centro Médico Zambrano Hellion Recruiting
Monterrey, Nuevo LEON, Mexico, 66278
Oncologico Potosino Recruiting
San Luis Potosí, SAN LUIS Potosi, Mexico, 78250
Merida | Investigacion Clinica Recruiting
Mérida, Yucatan, Mexico, 97125
Iem-Fucam Recruiting
D.f., Mexico, 04980
Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios Not yet recruiting
Distrito Federal, Mexico, 14000
Consultorio de Medicina Especializada; Dentro de Condominio San Francisco Recruiting
Mexico City, Mexico, 03100
Centro Medico Dalinde Not yet recruiting
Mexico City, Mexico, 06700
Peru
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology Not yet recruiting
Arequipa, Peru, 04001
Instituto Nacional de Enfermedades Neoplasicas Not yet recruiting
Lima, Peru, 15038
Oncosalud Sac; Oncología Not yet recruiting
Lima, Peru, 41
Clinica San Felipe Not yet recruiting
Lima, Peru, Lima 11
Poland
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii Recruiting
Gdańsk, Poland, 80-214
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii Not yet recruiting
Krakow, Poland, 31-531
Wielkopolskie Centrum Onkologi Recruiting
Poznan, Poland, 61-866
Szpital Kliniczny Przemienienia Panskiego Uni. Medycznego im. Karola Marcinkowskiego; Chemotherapy Withdrawn
Poznań, Poland, 60-569
Wojskowy Inst.Medyczny Mon; Klinika Onkologii Recruiting
Warszawa, Poland, 00-909
Instytut MSF Sp. z o.o. Recruiting
Łódź, Poland, 90-302
Romania
"Filantropia" Clinical Hospital; Gynecological Oncology Recruiting
Bucharest, Romania, 011191
Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti Not yet recruiting
Bucuresti, Romania, 022328
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca; Oncologie Medicala Recruiting
Cluj Napoca, Romania, 400015
Centrul de Oncologie Sfantul Nectarie Recruiting
Craiova, Romania, 200347
Russian Federation
Regional Clinical Oncology Hospital Recruiting
Yaroslavl, Jaroslavl, Russian Federation, 150054
Federal State Institution Medical Radiology Research Center Recruiting
Obninsk, Kaluga, Russian Federation, 249036
Evimed Recruiting
Chelyabinsk, Kurgan, Russian Federation
Moscow Clinical Scientific Center Recruiting
Moscow, Moskovskaja Oblast, Russian Federation, 111123
LLC Strategic Medical Systems Recruiting
Sankt-peterburg, Sankt Petersburg, Russian Federation, 194291
EosMed LLC Recruiting
Sankt-peterburg, Sankt Petersburg, Russian Federation, 195197
LCC Center of Palliative Medicine - Devita Recruiting
Sankt-peterburg, Sankt Petersburg, Russian Federation, 197343
Arkhangelsk Regional Clinical Oncology Dispensary Recruiting
Arkhangelsk, Russian Federation, 163045
Belgorod Regional Oncology Dispensary; Chemotherapy Recruiting
Belgorod, Russian Federation, 308010
Regional Oncology Hospital Recruiting
Irkutsk, Russian Federation, 664035
Ivanovo Regional Oncology Dispensary Recruiting
Ivanovo, Russian Federation, 153040
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF Recruiting
Moscow, Russian Federation, 115478
Russian Scientific Center of Roentgenoradiology Recruiting
Moscow, Russian Federation, 117997
P.A. Herzen Oncological Inst. ; Oncology Recruiting
Moscow, Russian Federation, 125284
Moscow city oncology hospital #62 of Moscow Healthcare Department Recruiting
Moscow, Russian Federation, 143423
Regional Oncology Dispensary; Dept of Chemotherapy Recruiting
Novgorod Veliky, Russian Federation, 173016
BIH at Omsk Region "Clinical Oncology Dispensary", Outpatient clinic Recruiting
Omsk, Russian Federation, 644013
Pyatigorsky Oncologic Dispensary Recruiting
Pyatigorsk, Russian Federation, 357524
Rostov Scientific Research Inst. of Oncology; Chemotherapy Recruiting
Rostov-na-donu, Russian Federation, 344037
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) Recruiting
Saint-Petersburg, Russian Federation, 197758
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov" Not yet recruiting
Saint-Petersburg, Russian Federation
Multidisciplinary clinic Reaviz Recruiting
Samara, Russian Federation, 443011
Mordovia State University Recruiting
Saransk, Russian Federation, 430032
Regional Clinical Hospital Recruiting
Saratov, Russian Federation, 410053
Oncologica Dispensary #2 Recruiting
Sochi, Russian Federation, 354057
Non-state Healthcare Institution "Road Clinical Hospital of JSC Russian Railways" Recruiting
St. Petersburg, Russian Federation, 195271
Singapore
National University Hospital; Medical Oncology Recruiting
Singapore, Singapore, 119074
National Cancer Centre Not yet recruiting
Singapore, Singapore, 169610
Tan Tock Seng Hospital Not yet recruiting
Singapore, Singapore, 308433
Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia Not yet recruiting
Badalona, Barcelona, Spain, 08916
Hospital General De Catalunya; Servicio de Oncologia Recruiting
Sant Cugat Del Valles, Barcelona, Spain, 28981
Hospital Mutua de Terrassa; Servicio de Oncologia Recruiting
Terrassa, Barcelona, Spain, 08221
Consorci Hospitalari de Terrassa Recruiting
Terrassa, Barcelona, Spain, 08227
Hospital Provincial Castellón Recruiting
Castellon DE LA Plana/castello DE LA Plana, Castellon, Spain, 12002
Hospital de Donostia.; Servicio de Oncología Radioterápica Not yet recruiting
San Sebastián, Guipuzcoa, Spain, 20014
Hospital Son Llatzer Not yet recruiting
Palma de Mallorca, Islas Baleares, Spain, 07198
Centro Oncologico de Galicia COG; Medical Oncology Recruiting
A Coruna, LA Coruña, Spain, 15009
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia Recruiting
La Coruna, LA Coruña, Spain, 15006
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia Not yet recruiting
Santiago de Compostela, LA Coruña, Spain, 15706
Hospital Universitario Rey Juan Carlos de Móstoles; Servicio de Neurología Not yet recruiting
Móstoles, Madrid, Spain, 28933
Hospital Infanta Cristina; Servicio de Oncologia Not yet recruiting
Parla, Madrid, Spain, 28981
Hospital Infanta Sofia; Servico de Oncologia Not yet recruiting
San Sebastian de Los Reyes, Madrid, Spain, 28702
Complexo Hospitalario de Vigo. Hospital Álvaro Cunqueiro; Servicio de Oncología Recruiting
Vigo, Pontevedra, Spain, 36312
Hospital Universitari Sant Joan de Reus Recruiting
Reus, Tarragona, Spain, 43204
Hospital Universitario de Canarias;servicio de Oncologia Recruiting
La Laguna, Tenerife, Spain, 38320
Hospital General Univ. de Alicante; Servicio de Oncologia Not yet recruiting
Alicante, Spain, 3010
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Hospital Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Hospital Universitario de Burgos Not yet recruiting
Burgos, Spain, 09006
Hospital San Pedro De Alcantara; Servicio de Oncologia Recruiting
Caceres, Spain, 10003
Complejo Hospitalario de Jaen Recruiting
Jaen, Spain, 23007
Complejo Asistencial Universitario de Leon; Servicio de Oncologia Not yet recruiting
Leon, Spain, 24071
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia Recruiting
Madrid, Spain, 28007
MD Anderson Cancer Center Not yet recruiting
Madrid, Spain, 28033
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain, 28034
Hospital Universitario 12 de Octubre; Servicio de Oncologia Not yet recruiting
Madrid, Spain, 28041
Hospital Universitario La Paz; Servicio de Oncologia Recruiting
Madrid, Spain, 28046
Centro Integral Oncológico Clara Campal Ensayos Clínicos START Not yet recruiting
Madrid, Spain, 28050
Hospital Universitario Puerta de Hierro - Majadahonda Not yet recruiting
Madrid, Spain, 28222
Hosp Univ Fundacion Alcorcon Not yet recruiting
Madrid, Spain, 28922
Hospital Universitario de Fuenlabrada; Servicio de Oncologia Not yet recruiting
Madrid, Spain, 28943
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia Not yet recruiting
Malaga, Spain, 29010
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia Recruiting
Murcia, Spain, 30120
Hospital Quirón Sagrado Corazón Recruiting
Sevilla, Spain, 41013
Hospital Universitario Virgen de la Macarena; Not yet recruiting
Sevilla, Spain, 41071
Hospital General Universitario de Valencia; Servicio de oncologia Not yet recruiting
Valencia, Spain, 41014
Instituto Valenciano Oncologia; Oncologia Medica Not yet recruiting
Valencia, Spain, 46009
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Hospital Arnau de Vilanova (Valencia) Not yet recruiting
Valencia, Spain, 46015
Hospital Universitari i Politecnic La Fe; Oncologia Recruiting
Valencia, Spain, 46026
Hospital Clinico Universitario Lozano Blesa; Servicio de Oncologia Not yet recruiting
Zaragoza, Spain, 50009
Switzerland
Hirslanden Medical Center, Tumorzentrum Recruiting
Aarau, Switzerland, 5000
Inselspital Bern; Universitätsklinik für medizinische Onkologie Recruiting
Bern, Switzerland, 3010
Centre Hospitalier Universitaire Vaudois - Lausanne Recruiting
Lausanne, Switzerland, 1011
Kantonsspital Olten; Medizinische Klinik Recruiting
Olten, Switzerland, 4600
Brustzentrum Recruiting
Zürich, Switzerland, 8008
Taiwan
Chunghua Christian hospital Not yet recruiting
Changhua, Taiwan, 500
Kaohsiung Medical University Hospital; Chung-Ho Memorial Hospital Not yet recruiting
Kaoshiung City, Taiwan, 807
Chi Mei Medical Center Liou Ying Campus Not yet recruiting
Liuying Township, Taiwan, 736
China Medical University Hospital;Oncology and Hematology Office Critical Care Center, 14H Recruiting
Taichung, Taiwan, 404
National Cheng Kung University Hospital Not yet recruiting
Tainan, Taiwan, 70457
Taipei Veterans General Hospital Recruiting
Taipei City, Taiwan, 112
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Mackay Memorial Hospital - Taipei Branch Not yet recruiting
Taipei, Taiwan, 104
Tri-Service General Hospital Recruiting
Taipei, Taiwan, 11490
Chang Gung Medical Foundation Linkou Branch Recruiting
Taoyuan City, Taiwan, 333
Thailand
Bhumibol Adulyadej Hospital; Medicine Not yet recruiting
Bangkok, Thailand, 10220
Ramathibodi Hospital; Medicine/Oncology Not yet recruiting
Bangkok, Thailand, 10400
Siriraj Hospital; Clinical Research Center, Pharmacy Department Not yet recruiting
Bangkok, Thailand, 10700
Chiang Rai Prachanukroh Hospital; Department Of Medicine Not yet recruiting
Chiang Rai, Thailand, 57000
Songklanagarind Hospital Not yet recruiting
Hat Yai, Thailand, 90110
Srinagarind Hospital, Khon Kaen University Not yet recruiting
Khon Kaen, Thailand, 40002
Lampang Cancer Hospital Not yet recruiting
Muang Lampang, Thailand, 52000
Ukraine
MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department Recruiting
Dnipro, KIEV Governorate, Ukraine, 49100
Municipal Institution Odesa Regional Oncology Dispensary Recruiting
Odesa, KIEV Governorate, Ukraine, 65055
Vinnytsya Regional Clinical Oncology Dispensary Recruiting
Vinnytsya, Podolia Governorate, Ukraine, 21029
Regional Oncology Center; Department of Mammology Recruiting
Chernigiv, Ukraine, 14029
Chernivtsi Regional Clinical Oncology Dispensary Recruiting
Chernivtsi, Ukraine, 58013
City Clinical Hospital #4 Recruiting
Dnipropetrovsk, Ukraine, 49102
Municipal Institution Kirovograd Regional Oncology Dispensary Recruiting
Kirovograd, Ukraine, 25011
MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council; Chemotherapy Department Recruiting
Kryvyi Rih, Ukraine, 50048
Volyn Regional Oncology Dispensary Recruiting
Lutsk, Ukraine, 43018
Lviv State Oncological Regional Treatment and Diagnostic Center Recruiting
Lviv, Ukraine, 79031
Municipal Institution Odesa Regional Clinical Hospital Recruiting
Odesa, Ukraine, 65025
Sumy Reg. Clin. Oncological Dispensary; Thoracall Department Recruiting
Sumy, Ukraine, 40005
CCCH City Oncological Center SHEI Uzhgorod NU Recruiting
Uzhgorod, Ukraine, 88000
Transkarpathian Regional Oncology Clinic; Chemotherapy Recruiting
Uzhgorod, Ukraine, 88000
Zaporizhzhia Regional Clinical Oncology Dispensary; Zaporizhzhya State Medical University Recruiting
Zaporizhzhya, Ukraine, 69040
United Kingdom
NHS Lothian - Western General Hospital; NHS Lothian - Western General Hospital Not yet recruiting
Edinburgh, United Kingdom, EH4 2XU
NHS Greater Glasgow and Clyde; Beatson West of Scotland Cancer Centre Not yet recruiting
Glasgow, United Kingdom, G12 0YN
Calderdale and Huddersfield NHS Foundation Trust Recruiting
Huddersfield, United Kingdom, HD3 3EA
Leeds Teaching Hosp NHS Trust;St James's Institute of Onc Not yet recruiting
Leeds, United Kingdom, LS9 7TF
Guys and St Thomas NHS Foundation Trust, Guys Hospital Not yet recruiting
London, United Kingdom, SE1 9RT
Sarah Cannon Research Institute Recruiting
London, United Kingdom, W1G 6AD
The Christie NHS Foundation Trust Not yet recruiting
Manchester, United Kingdom, M20 4BX
Mount Vernon Cancer Centre Recruiting
Northwood, United Kingdom, HA6 2RN
Nottingham University Hospitals NHS Trust - City Hospital Recruiting
Nottingham, United Kingdom, NG5 1PB
North West Anglia NHS Foundation Trust Recruiting
Peterborough, United Kingdom, PE3 9GZ
University Hospitals of North Midlands NHS Trust-Royal Stoke University Hospital Recruiting
Stoke-On-Trent, United Kingdom, ST4 6QG
Sponsors and Collaborators
Hoffmann-La Roche
Breast International Group
Alliance Foundation Trials (AFT)
Institut Jules Bordet/Clinical Trials Support Unit (IJB/CTSU)
Frontier Science and Technology Research Foundation Inc (FS)
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03498716     History of Changes
Other Study ID Numbers: WO39391
2016-003695-47 ( EudraCT Number )
BIG 16-05 ( Other Identifier: Breast International Group (BIG) )
AFT-27 ( Other Identifier: Alliance Foundation Trials )
ALEXANDRA ( Other Identifier: Breast International Group (BIG) )
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Atezolizumab
Epirubicin
Taxane
Antibodies
Antibodies, Monoclonal
Sargramostim
Lenograstim
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents