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Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
NCT06393374 · Merck Sharp & Dohme LLC
In plain English
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Official title
A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery
About this study
This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.
Eligibility criteria
Inclusion Criteria:
* Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
* Has no evidence of locoregional or distant relapse, as assessed by the treating physician
* Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC
* Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery
* Has non-pathologic complete response at surgery
* Is able to continue on adjuvant pembrolizumab
* Randomization must be conducted within 16 weeks from surgical resection
* Completed adjuvant radiation therapy (if indicated) and recovered before randomization
* Has provided tissue from the surgical resection for central laboratory determination of trophoblast cell surface antigen 2 (TROP2) status
* If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (120 days for sacituzumab tirumotecan and 95 days for capecitabine \[no restriction for pembrolizumab\]): agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception
* For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for sacituzumab tirumotecan, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention
* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline (except alopecia)
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B birus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization
Exclusion Criteria:
* Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available
* Has Grade \>2 peripheral neuropathy
* History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention
* Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC
* Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy
* Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting sacituzumab tirumotecan is 2 weeks
* Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein-4 \[CTLA-4\], OX-40 \[cluster of differentiation (CD) 134\], or CD137)
* Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
* Received prior radiotherapy within 3 weeks of start of study intervention or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has known additional malignancy that is progressing or has required active treatment within the past 5 years
* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
* Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has active infection requiring systemic therapy
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has concurrent active hepatitis B and hepatitis C virus infection
* Has history of allogeneic tissue/solid organ transplant
Study design
Enrollment target: 1530 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-06-24
Estimated completion: 2037-12-14
Last updated: 2026-04-13
Interventions
Biological: PembrolizumabBiological: Sacituzumab tirumotecanDrug: Capecitabine
Primary outcomes
- • Invasive Disease-Free Survival (iDFS) (Up to ~77 months)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (286)
Infirmary Cancer Care ( Site 0001)Recruiting
Mobile, Alabama, United States
Ironwood Cancer & Research Centers-Research ( Site 0054)Recruiting
Chandler, Arizona, United States
MemorialCare Orange Coast Medical Center ( Site 9501)Recruiting
Fountain Valley, California, United States
Scripps Cancer Center ( Site 0052)Recruiting
La Jolla, California, United States
Cancer and Blood Specialty Clinic ( Site 0008)Completed
Los Alamitos, California, United States
Kaiser Permanente - Oakland ( Site 0079)Recruiting
Oakland, California, United States
Profound Research LLC ( Site 0105)Recruiting
Oceanside, California, United States
Kaiser Permanente - Roseville ( Site 0081)Recruiting
Roseville, California, United States
Kaiser Permanente - San Francisco ( Site 0080)Recruiting
San Francisco, California, United States
Kaiser Permanente - Santa Clara ( Site 0082)Recruiting
Santa Clara, California, United States
Providence Medical Foundation ( Site 9543)Recruiting
Santa Rosa, California, United States
Kaiser Permanente Vallejo Medical Center ( Site 0060)Recruiting
Vallejo, California, United States
Kaiser Permanente - Walnut Creek ( Site 0078)Recruiting
Walnut Creek, California, United States
Bass Medical Group ( Site 0089)Completed
Walnut Creek, California, United States
Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0046)Recruiting
Grand Junction, Colorado, United States
Yale Cancer Center ( Site 0053)Recruiting
New Haven, Connecticut, United States
Orlando Health Cancer Institute ( Site 0030)Recruiting
Orlando, Florida, United States
Comprehensive Hematology Oncology ( Site 0091)Recruiting
St. Petersburg, Florida, United States
Cleveland Clinic Martin North Hospital ( Site 0114)Recruiting
Stuart, Florida, United States
Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040)Completed
Thomasville, Georgia, United States
Illinois Cancer Specialists (ICS) ( Site 8010)Recruiting
Arlington Heights, Illinois, United States
Orchard Healthcare Research Inc. ( Site 0014)Recruiting
Skokie, Illinois, United States
Northwest Cancer Center - Dyer Clinic ( Site 0097)Recruiting
Dyer, Indiana, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0011)Recruiting
Fort Wayne, Indiana, United States
Cancer Center of Kansas ( Site 0004)Completed
Wichita, Kansas, United States
Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0044)Recruiting
Edgewood, Kentucky, United States
CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0109)Recruiting
Alexandria, Louisiana, United States
Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0063)Recruiting
Monroe, Louisiana, United States
Louisiana State University Health Sciences Shreveport ( Site 0029)Recruiting
Shreveport, Louisiana, United States
Holy Cross Hospital ( Site 0069)Recruiting
Silver Spring, Maryland, United States
University of Michigan ( Site 0103)Recruiting
Ann Arbor, Michigan, United States
Profound Research LLC ( Site 0074)Completed
Royal Oak, Michigan, United States
Metro-Minnesota Community Clinical Oncology ( Site 0031)Recruiting
Saint Louis Park, Minnesota, United States
The University of Mississippi Medical Center-Cancer Center and Research Institute ( Site 0043)Recruiting
Jackson, Mississippi, United States
SSM Health Cancer Care - Fenton ( Site 0088)Completed
Fenton, Missouri, United States
Lake Regional Hospital ( Site 0009)Recruiting
Osage Beach, Missouri, United States
Siteman Cancer Center ( Site 0099)Recruiting
St Louis, Missouri, United States
Optum Care Cancer Center ( Site 9535)Recruiting
Las Vegas, Nevada, United States
New Mexico Oncology Hematology Consultants Ltd. ( Site 0090)Recruiting
Albuquerque, New Mexico, United States
CHRISTUS St. Vincent Regional Cancer Center ( Site 0118)Recruiting
Santa Fe, New Mexico, United States
Memorial Sloan Kettering Cancer Center ( Site 0067)Recruiting
New York, New York, United States
Clinical Research Alliance ( Site 0086)Recruiting
Westbury, New York, United States
Levine Cancer Institute ( Site 0083)Recruiting
Charlotte, North Carolina, United States
Sanford Cancer Center Bismarck ( Site 0058)Recruiting
Bismarck, North Dakota, United States
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0056)Recruiting
Fargo, North Dakota, United States
Altru Cancer Center ( Site 0104)Recruiting
Grand Forks, North Dakota, United States
Cleveland Clinic - Mercy Hospital ( Site 0057)Recruiting
Canton, Ohio, United States
Tri-County Hematology & Oncology Associates, Inc. ( Site 0076)Recruiting
Massillon, Ohio, United States
Genesis Healthcare System ( Site 0025)Recruiting
Zanesville, Ohio, United States
Hightower Clinical, LLC ( Site 0085)Recruiting
Oklahoma City, Oklahoma, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0041)Recruiting
Tulsa, Oklahoma, United States
Providence Portland Medical Center ( Site 0116)Recruiting
Portland, Oregon, United States
Providence Oncology and Hematology Care Clinic - Westside ( Site 0126)Recruiting
Portland, Oregon, United States
Sidney Kimmel Cancer Center at Jefferson ( Site 0049)Recruiting
Philadelphia, Pennsylvania, United States
Cancer Care Associates Of York ( Site 9517)Recruiting
York, Pennsylvania, United States
Sanford Cancer Center ( Site 0059)Recruiting
Sioux Falls, South Dakota, United States
West Cancer Center and Research Institute ( Site 0084)Recruiting
Germantown, Tennessee, United States
Baptist Cancer Center ( Site 0101)Recruiting
Memphis, Tennessee, United States
One Oncology - Tennessee Oncology ( Site 0098)Recruiting
Nashville, Tennessee, United States
SCRI Oncology Partners ( Site 7000)Recruiting
Nashville, Tennessee, United States
Tennessee Oncology ( Site 0111)Recruiting
Nashville, Tennessee, United States
Nashville General Hospital ( Site 0072)Completed
Nashville, Tennessee, United States
Vanderbilt Health One Hundred Oaks ( Site 0042)Recruiting
Nashville, Tennessee, United States
Hendrick Medical Center ( Site 0117)Recruiting
Abilene, Texas, United States
Harrington Cancer Center ( Site 0061)Recruiting
Amarillo, Texas, United States
Texas Oncology - DFW ( Site 8000)Recruiting
Dallas, Texas, United States
Parkland Health & Hospital System ( Site 0096)Recruiting
Dallas, Texas, United States
University of Texas Southwestern Medical Center ( Site 0032)Recruiting
Dallas, Texas, United States
Texas Oncology - Northeast Texas ( Site 8005)Recruiting
Flower Mound, Texas, United States
John Peter Smith Hospital ( Site 0106)Recruiting
Fort Worth, Texas, United States
Oncology Consultants P.A. ( Site 0107)Recruiting
Houston, Texas, United States
Laguna Clinical Research Associates LLC ( Site 0068)Recruiting
Laredo, Texas, United States
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0055)Recruiting
Tyler, Texas, United States
Texas Oncology - Gulf Coast ( Site 8009)Recruiting
Webster, Texas, United States
Intermountain Medical Center ( Site 0113)Recruiting
Murray, Utah, United States
Hematology Oncology Associates of Fredericksburg ( Site 9550)Recruiting
Fredericksburg, Virginia, United States
Bon Secours Memorial Regional Medical Center-Oncology Research Department ( Site 0020)Recruiting
Midlothian, Virginia, United States
Virginia Cancer Institute ( Site 0034)Recruiting
Richmond, Virginia, United States
Northwest Medical Specialties, PLLC ( Site 0093)Recruiting
Tacoma, Washington, United States
SSM Health Dean Medical Group ( Site 0087)Recruiting
Madison, Wisconsin, United States
Hospital Aleman-Oncology ( Site 0501)Recruiting
Capital Federal, Buenos Aires, Argentina
Hospital Británico de Buenos Aires-Oncology ( Site 0502)Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Oncología Angel H. Roffo ( Site 0503)Recruiting
Buenos Aires, Buenos Aires F.D., Argentina
Instituto Alexander Fleming-Alexander Fleming ( Site 0509)Recruiting
Buenos Aires, Buenos Aires F.D., Argentina
Sanatorio Parque ( Site 0512)Recruiting
Rosario, Santa Fe Province, Argentina
Sanatorio Finochietto ( Site 0513)Recruiting
Buenos Aires, Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0508)Recruiting
Buenos Aires, Argentina
Macquarie University-MQ Health Clinical Trials Unit ( Site 2703)Recruiting
Macquarie University, New South Wales, Australia
Westmead Hospital ( Site 2700)Recruiting
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 2701)Recruiting
Brisbane, Queensland, Australia
Frankston Hospital-Oncology and Haematology ( Site 2704)Recruiting
Frankston, Victoria, Australia
Medizinische Universitaet Innsbruck ( Site 1200)Recruiting
Innsbruck, Tyrol, Austria
Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1206)Recruiting
Linz, Upper Austria, Austria
Klinikum Wels-Grieskirchen ( Site 1205)Recruiting
Wels, Upper Austria, Austria
Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis ( Site 1202)Recruiting
Salzburg, Austria
Medizinische Universität Wien-Universitätsklinik für Innere Medizin I, Klinische Abteilung für Onko ( Site 1201)Recruiting
Vienna, Austria
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0901)Recruiting
Brussels, Bruxelles-Capitale, Region de, Belgium
AZ Maria Middelares-IKG ( Site 0903)Recruiting
Ghent, Oost-Vlaanderen, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0902)Recruiting
Namur, Belgium
PRONUTRIR-CLINICAL RESEARCH ( Site 0609)Recruiting
Fortaleza, Ceará, Brazil
Oncoclínica Oncologistas Associados-Clinical Research ( Site 0607)Recruiting
Teresina, Piauí, Brazil
Hospital do Câncer Mãe de Deus ( Site 0604)Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Oncologia Saint Gallen ( Site 0614)Recruiting
Santa Cruz do Sul, Rio Grande do Sul, Brazil
Instituto do Câncer Brasil - Unidade Taubaté ( Site 0608)Recruiting
Taubaté, São Paulo, Brazil
IBCC - Núcleo de Pesquisa e Ensino ( Site 0601)Recruiting
São Paulo, Brazil
Cross Cancer Institute ( Site 0407)Recruiting
Edmonton, Alberta, Canada
BC Cancer Vancouver ( Site 0404)Recruiting
Vancouver, British Columbia, Canada
CancerCare Manitoba ( Site 0411)Recruiting
Winnipeg, Manitoba, Canada
The Moncton Hospital ( Site 0401)Recruiting
Moncton, New Brunswick, Canada
QEII Health Sciences Centre - Victoria General Site ( Site 0418)Recruiting
Halifax, Nova Scotia, Canada
Southlake Health ( Site 0413)Recruiting
Newmarket, Ontario, Canada
The Ottawa Hospital - General Campus ( Site 0414)Recruiting
Ottawa, Ontario, Canada
North York General Hospital ( Site 0415)Recruiting
Toronto, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0400)Recruiting
Toronto, Ontario, Canada
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0417)Recruiting
Greenfield Park, Quebec, Canada
CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0419)Recruiting
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal ( Site 0403)Recruiting
Montreal, Quebec, Canada
Jewish General Hospital ( Site 0416)Recruiting
Montreal, Quebec, Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0409)Recruiting
Rimouski, Quebec, Canada
Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0406)Recruiting
Trois-Rivières, Quebec, Canada
Clinica Somer ( Site 3704)Recruiting
Rionegro, Antioquia, Colombia
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 3700)Recruiting
Bogotá, Bogota D.C., Colombia
Instituto Nacional De Cancerologia ( Site 3701)Recruiting
Bogotá, Bogota D.C., Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 3705)Recruiting
Valledupar, Cesar Department, Colombia
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1005)Recruiting
Brno, Brno-mesto, Czechia
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1006)Recruiting
Olomouc, Olomouc Region, Czechia
Vseobecna fakultni nemocnice v Praze-Onkologická klinika VFN ( Site 1002)Recruiting
Prague, Praha 2, Czechia
Fakultni Thomayerova nemocnice - Onkologicka klinika 1. LF UK a FTN ( Site 1008)Recruiting
Prague, Praha 4, Czechia
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1000)Recruiting
Prague, Praha 5, Czechia
Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 1007)Recruiting
České Budějovice, South Bohemian Region, Czechia
Herlev og Gentofte Hospital. ( Site 3203)Recruiting
Herlev, Capital Region, Denmark
Aarhus Universitets hospital ( Site 3202)Recruiting
Aarhus N, Central Jutland, Denmark
Odense Universitetshospital ( Site 3201)Recruiting
Odense C, Region Syddanmark, Denmark
Sygehus Soenderjylland ( Site 3204)Recruiting
Sønderborg, Region Syddanmark, Denmark
Tampereen yliopistollinen sairaala ( Site 1102)Recruiting
Tampere, Pirkanmaa, Finland
Turku University Hospital-Department of Oncology ( Site 1103)Recruiting
Turku, Southwest Finland, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1100)Recruiting
Helsinki, Uusimaa, Finland
Centre Antoine-Lacassagne ( Site 1308)Recruiting
Nice, Alpes-Maritimes, France
Centre Hospitalier de la Côte Basque ( Site 1315)Recruiting
Bayonne, Aquitaine, France
CENTRE LEON BERARD ( Site 1300)Recruiting
Lyon Cedex08, Auvergne-Rhône-Alpes, France
Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1307)Recruiting
Clermont-Ferrand, Auvergne, France
Institut Paoli-Calmettes ( Site 1309)Recruiting
Marseille, Bouches-du-Rhone, France
Centre François Baclesse ( Site 1318)Recruiting
Caen, Calvados, France
Centre Georges François Leclerc ( Site 1312)Recruiting
Dijon, Cote-d Or, France
CHU Besançon ( Site 1311)Completed
Besançon, Doubs, France
Hôpital Privé Drôme-Ardèche ( Site 1301)Recruiting
Valence, Drome, France
CHRU Brest - Hopital Cavale Blanche ( Site 1304)Recruiting
Brest, Finistere, France
Clinique Tivoli Ducos ( Site 1322)Recruiting
Bordeaux, Gironde, France
Hôpital Franco-Britannique - Fondation Cognacq-Jay ( Site 1321)Recruiting
Levallois-Perret, Hauts-de-Seine, France
Institut de Cancérologie de l'Ouest ( Site 1305)Recruiting
Saint-Herblain, Loire-Atlantique, France
Institut de Cancérologie de l'Ouest ( Site 1316)Recruiting
Angers, Maine-et-Loire, France
Centre de Cancerologie Les Dentellieres ( Site 1306)Recruiting
Valenciennes, Nord, France
Centre Hospitalier de Pau ( Site 1302)Recruiting
Pau, Pyrenees-Atlantiques, France
Centre Henri Becquerel ( Site 1319)Recruiting
Rouen, Seine-Maritime, France
Hôpital Tenon ( Site 1303)Recruiting
Paris, France
Klinikum Ludwigsburg-Klinik für Geburtshilfe und Frauenheilkunde ( Site 1405)Recruiting
Ludwigsburg, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen-Frauenklinik ( Site 1415)Recruiting
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1400)Recruiting
Erlangen, Bavaria, Germany
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Frauenklinik Brustzentrum ( Site 1402)Recruiting
Munich, Bavaria, Germany
Klinikum Ernst von Bergmann-Frauenklinik ( Site 1408)Recruiting
Potsdam, Brandenburg, Germany
Franziskus-Hospital Harderberg ( Site 1404)Recruiting
Georgsmarienhütte, Lower Saxony, Germany
Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1409)Recruiting
Düsseldorf, North Rhine-Westphalia, Germany
Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 1401)Recruiting
Essen, North Rhine-Westphalia, Germany
Evangelisches Krankenhaus Bethesda Mönchengladbach-Brustzentrum Niederrhein ( Site 1406)Recruiting
Mönchengladbach, North Rhine-Westphalia, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz-Klinik und Poliklinik für Geburtshilfe und ( Site 1418)Recruiting
Mainz, Rhineland-Palatinate, Germany
CaritasKlinikum Saarbruecken St. Theresia ( Site 1410)Recruiting
Saarbrücken, Saarland, Germany
Universitätsklinikum Schleswig-Holstein ( Site 1411)Recruiting
Lübeck, Schleswig-Holstein, Germany
Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1413)Recruiting
Berlin, Germany
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1509)Recruiting
Pátrai, Achaia, Greece
Errikos Dunant Hospital Center-1st Medical Oncology Dept. ( Site 1508)Recruiting
Athens, Attica, Greece
Aretaieio Hospital Oncology Unit ( Site 1505)Recruiting
Athens, Attica, Greece
University General Hospital of Larissa ( Site 1503)Recruiting
Larissa, Thessaly, Greece
European Interbalkan Medical Center ( Site 1502)Recruiting
Thessaloniki, Greece
European Interbalkan Medical Center ( Site 1507)Recruiting
Thessaloniki, Greece
Queen Mary Hospital ( Site 3600)Recruiting
Hong Kong, Hong Kong
Hong Kong United Oncology Centre ( Site 3601)Recruiting
Kowloon, Hong Kong
Prince of Wales Hospital ( Site 3602)Recruiting
Shatin, Hong Kong
Bon Secours Cork Hospital ( Site 1600)Recruiting
Cork, Ireland
St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1601)Recruiting
Dublin, Ireland
University College Hospital - Galway ( Site 1602)Recruiting
Galway, Ireland
Soroka Medical Center-Oncology ( Site 1704)Recruiting
Beersheba, Israel
Shaare Zedek Medical Center ( Site 1706)Recruiting
Jerusalem, Israel
Hadassah Medical Center ( Site 1700)Recruiting
Jerusalem, Israel
Rabin Medical Center ( Site 1702)Recruiting
Petah Tikva, Israel
Sheba Medical Center-ONCOLOGY ( Site 1701)Recruiting
Ramat Gan, Israel
Sourasky Medical Center ( Site 1705)Recruiting
Tel Aviv, Israel
University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 1803)Recruiting
Naples, Campania, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Clinica Sperimentale di Senologia ( Site 1800)Recruiting
Naples, Campania, Italy
Humanitas Istituto Clinico Catanese ( Site 1811)Recruiting
Misterbianco, Catania, Italy
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1807)Recruiting
Meldola (FC), Forli-Cesena, Italy
CRO-IRCCS ( Site 1808)Recruiting
Aviano, Friuli Venezia Giulia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802)Recruiting
Rome, Lazio, Italy
Azienda Ospedaliera Spedali Civili di Brescia ( Site 1812)Recruiting
Brescia, Lombardy, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1801)Recruiting
Milan, Lombardy, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1809)Recruiting
Milan, Lombardy, Italy
Fondazione IRCCS San Gerardo dei Tintori ( Site 1813)Recruiting
Monza, Lombardy, Italy
Azienda Ospedaliera Universitaria Careggi ( Site 1805)Recruiting
Florence, Tuscany, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1810)Recruiting
Bologna, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 1814)Recruiting
Milan, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità-SCDU ONCOLOGIA ( Site 1804)Recruiting
Novara, Italy
Nagoya City University Hospital ( Site 3414)Recruiting
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 3403)Recruiting
Kashiwa, Chiba, Japan
Hokkaido University Hospital ( Site 3400)Recruiting
Sapporo, Hokkaido, Japan
Tokai University Hospital ( Site 3413)Recruiting
Isehara, Kanagawa, Japan
St. Marianna University Hospital ( Site 3405)Recruiting
Kawasaki, Kanagawa, Japan
Kitasato University Hospital ( Site 3411)Recruiting
Sagamihara, Kanagawa, Japan
Kanagawa Cancer Center ( Site 3412)Recruiting
Yokohama, Kanagawa, Japan
Mie University Hospital ( Site 3423)Recruiting
Tsu, Mie-ken, Japan
Tohoku University Hospital ( Site 3422)Recruiting
Sendai, Miyagi, Japan
The University of Osaka Hospital ( Site 3416)Recruiting
Suita, Osaka, Japan
Saitama Medical University International Medical Center ( Site 3402)Recruiting
Hidaka, Saitama, Japan
Juntendo University Hospital ( Site 3408)Recruiting
Bunkyo, Tokyo, Japan
Cancer Institute Hospital of JFCR ( Site 3404)Recruiting
Koto, Tokyo, Japan
Showa Medical University Hospital ( Site 3406)Recruiting
Shinagawa, Tokyo, Japan
Tokyo Medical University Hospital ( Site 3407)Recruiting
Shinjuku, Tokyo, Japan
National Center for Global Health and Medicine ( Site 3409)Recruiting
Shinjuku, Tokyo, Japan
Fukushima Medical University Hospital ( Site 3401)Recruiting
Fukushima, Japan
Gifu University Hospital ( Site 3426)Recruiting
Gifu, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 3418)Recruiting
Hiroshima, Japan
Social medical corporation Hakuaikai Sagara Hospital ( Site 3421)Recruiting
Kagoshima, Japan
Kumamoto University Hospital ( Site 3420)Recruiting
Kumamoto, Japan
Kyoto University Hospital ( Site 3415)Recruiting
Kyoto, Japan
Okayama University Hospital ( Site 3425)Recruiting
Okayama, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3417)Recruiting
Osaka, Japan
Prince Court Medical Centre ( Site 2802)Recruiting
Kuala Lumpur, Malaysia
Pantai Hospital Kuala Lumpur ( Site 2801)Recruiting
Kuala Lumpur, Malaysia
CENEIT Oncologicos ( Site 0706)Recruiting
Mexico City, Mexico City, Mexico
Grupo Médico ASSET ( Site 0705)Recruiting
Mexico City, Mexico City, Mexico
Health Pharma Professional Research S.A. de C.V: ( Site 0709)Recruiting
Mexico City, Mexico City, Mexico
COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 0712)Recruiting
Mexico City, Mexico City, Mexico
Oncare - Unidad Valle ( Site 0713)Recruiting
San Pedro Garza García, Nuevo León, Mexico
CENTRO MEDICO ZAMBRANO HELLION ( Site 0711)Recruiting
San Pedro Garza García, Nuevo León, Mexico
Drammen Sykehus, Vestre Viken HF ( Site 2001)Recruiting
Drammen, Buskerud, Norway
Stavanger Universitetssykehus ( Site 2004)Recruiting
Stavanger, Rogaland, Norway
Oslo universitetssykehus, Radiumhospitalet ( Site 2002)Recruiting
Oslo, Norway
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2102)Recruiting
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 2120)Recruiting
Krakow, Lesser Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 2100)Recruiting
Warsaw, Masovian Voivodeship, Poland
Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 2101)Recruiting
Wieliszew, Masovian Voivodeship, Poland
Bialostockie Centrum Onkologii ( Site 2105)Completed
Bialystok, Podlaskie Voivodeship, Poland
Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 2113)Recruiting
Gdynia, Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 2110)Recruiting
Gliwice, Silesian Voivodeship, Poland
Zachodniopomorskie Centrum Onkologii ( Site 2108)Recruiting
Szczecin, West Pomeranian Voivodeship, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 2118)Recruiting
Kielce, Świętokrzyskie Voivodeship, Poland
Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 2203)Recruiting
Amadora, Lisbon District, Portugal
Fundacao Champalimaud ( Site 2200)Recruiting
Lisbon, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2201)Recruiting
Lisbon, Portugal
Instituto Portugues de Oncologia do Porto ( Site 2202)Recruiting
Porto, Portugal
National Cancer Centre Singapore-Medical Oncology ( Site 3002)Recruiting
Singapore, Central Singapore, Singapore
Seoul National University Hospital-Internal Medicine ( Site 3102)Recruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3100)Recruiting
Seoul, South Korea
Asan Medical Center-Department of Oncology ( Site 3103)Recruiting
Seoul, South Korea
Gangnam Severance Hospital, Yonsei University Health System-Medical Oncology, Internal Medicine ( Site 3104)Recruiting
Seoul, South Korea
Samsung Medical Center-Division of Hematology/Oncology ( Site 3101)Recruiting
Seoul, South Korea
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2304)Recruiting
Seville, Andalusia, Spain
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2305)Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2307)Recruiting
A Coruña, La Coruna, Spain
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2301)Recruiting
Madrid, Madrid, Comunidad de, Spain
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2308)Recruiting
Majadahonda, Madrid, Comunidad de, Spain
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2303)Recruiting
Valencia, Valenciana, Comunitat, Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 2300)Recruiting
Barcelona, Spain
Hospital Beata María Ana-oncology ( Site 2309)Recruiting
Madrid, Spain
Hospital Clinico San Carlos-Oncology Department ( Site 2306)Recruiting
Madrid, Spain
HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 2302)Recruiting
Valencia, Spain
Gävle sjukhus ( Site 3504)Recruiting
Gävle, Gävleborg County, Sweden
Capio St. Gorans Sjukhus ( Site 3503)Recruiting
Stockholm, Stockholm County, Sweden
Karolinska Universitetssjukhuset Solna ( Site 3500)Recruiting
Stockholm, Stockholm County, Sweden
Akademiska Sjukhuset ( Site 3501)Recruiting
Uppsala, Uppsala County, Sweden
Södra Älvsborg Sjukhus ( Site 3502)Recruiting
Borås, Västra Götaland County, Sweden
Sahlgrenska Universitetssjukhuset. ( Site 3505)Recruiting
Gothenburg, Västra Götaland County, Sweden
Spital Thun ( Site 2400)Recruiting
Thun, Canton of Bern, Switzerland
Clinique Générale-Beaulieu ( Site 2406)Recruiting
Geneva, Canton of Geneva, Switzerland
Brust-Zentrum ( Site 2401)Recruiting
Zurich, Canton of Zurich, Switzerland
Kantonsspital Graubünden-Medizin ( Site 2404)Completed
Chur, Kanton Graubünden, Switzerland
HFR Fribourg - Hôpital Cantonal ( Site 2402)Recruiting
Fribourg, Switzerland
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2501)Recruiting
Adana, Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-oncology ( Site 2504)Recruiting
Ankara, Turkey (Türkiye)
Memorial Ankara Hastanesi-Medical Oncology ( Site 2502)Recruiting
Ankara, Turkey (Türkiye)
Medipol Mega Universite Hastanesi-oncology ( Site 2503)Recruiting
Istanbul, Turkey (Türkiye)
Samsun Medical Park Hastanesi-medical oncology ( Site 2500)Recruiting
Samsun, Turkey (Türkiye)
University Hospitals Bristol NHS Foundation Trust ( Site 2601)Recruiting
Bristol, Bristol, City of, United Kingdom
The Royal Cornwall Hospital ( Site 2603)Recruiting
Truro, England, United Kingdom
St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2602)Recruiting
London, London, City of, United Kingdom
University College London Hospital ( Site 2604)Recruiting
London, London, City of, United Kingdom
Western General Hospital ( Site 2607)Recruiting
Edinburgh, Midlothian, United Kingdom
St James's University Hospital-Leeds Cancer Centre ( Site 2608)Recruiting
Leeds, United Kingdom