Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

Phase 3

Recruiting

• Conditions: Triple-Negative Breast Cancer
• Interventions: Biological: Pembrolizumab; Biological: Sacituzumab tirumotecan; Drug: Capecitabine

• Registration Number: NCT06393374
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-26
• Study First Posted: 2024-05-01
• Study Start: 2024-06-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Primary Completion: 2030-12-16
• Study Completion: 2037-12-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1530

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pembrolizumab + sacituzumab tirumotecan	Pembrolizumab	Participants receive pembrolizumab every 6 weeks (q6w) in combination with sacituzumab tirumotecan every 2 weeks (q2w) for 24 weeks. In addition, participants receive an antihistamine, an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to sacituzumab tirumotecan infusions.
Pembrolizumab + sacituzumab tirumotecan	Sacituzumab tirumotecan	Participants receive pembrolizumab every 6 weeks (q6w) in combination with sacituzumab tirumotecan every 2 weeks (q2w) for 24 weeks. In addition, participants receive an antihistamine, an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to sacituzumab tirumotecan infusions.
Treatment of Physician's Choice	Pembrolizumab	Participants receive pembrolizumab q6w or pembrolizumab q6w in combination with capecitabine (twice daily \[BID\] on Days 1 to 14 and 22 to 35 every 42 days x 4 \[2 weeks 1, 1 week off\]) for 24 weeks.
Treatment of Physician's Choice	Capecitabine	Participants receive pembrolizumab q6w or pembrolizumab q6w in combination with capecitabine (twice daily \[BID\] on Days 1 to 14 and 22 to 35 every 42 days x 4 \[2 weeks 1, 1 week off\]) for 24 weeks.

Primary Outcome Measures

Name	Time	Method
Invasive Disease-Free Survival (iDFS)	Up to ~77 months	iDFS is the time from randomization to invasive local, regional, or distant recurrence, invasive contralateral breast cancer, or death due to any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to ~101 months	OS is the time from randomization to death due to any cause.
Distant recurrence-free survival (DRFS)	Up to ~101 months	DRFS is the time from randomization to distant recurrence or death due to any cause, whichever occurs first.
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score	Baseline and up to ~60 months	EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life in cancer patients. The overall functioning score is based on participant responses that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status.
Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score	Baseline and up to ~60 months	EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The physical functioning score is based on participant responses to questions that scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better physical functioning.
Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score	Baseline and up to ~60 months	EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The role functioning score is based on participant responses to questions that scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better role functioning.
Change from baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score	Baseline and up to ~60 months	EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. Participant responses to questions about their fatigue are scored on a 4-point scale (1 = "Not at All" to 4 = "Very Much"). Lower scores indicate a better level of fatigue.
Number of participants who experience one or more adverse events (AEs)	Up to ~42 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of participants who discontinue study intervention due to an AE	Up to 24 weeks	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Trial Locations

Locations (216)

HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 2302); 🇪🇸 Valencia, Spain

Infirmary Cancer Care ( Site 0001); 🇺🇸 Mobile, Alabama, United States

Ironwood Cancer & Research Centers-Research ( Site 0054); 🇺🇸 Chandler, Arizona, United States

Scripps Cancer Center ( Site 0052); 🇺🇸 La Jolla, California, United States

Cancer and Blood Specialty Clinic ( Site 0008); 🇺🇸 Los Alamitos, California, United States

Bass Medical Group ( Site 0089); 🇺🇸 Walnut Creek, California, United States

Yale Cancer Center ( Site 0053); 🇺🇸 New Haven, Connecticut, United States

Comprehensive Hematology Oncology ( Site 0091); 🇺🇸 Saint Petersburg, Florida, United States

Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040); 🇺🇸 Thomasville, Georgia, United States

Orchard Healthcare Research Inc. ( Site 0014); 🇺🇸 Skokie, Illinois, United States

Parkview Research Center at Parkview Regional Medical Center ( Site 0011); 🇺🇸 Fort Wayne, Indiana, United States

Cancer Center of Kansas ( Site 0004); 🇺🇸 Wichita, Kansas, United States

Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0063); 🇺🇸 Monroe, Louisiana, United States

Louisiana State University Health Sciences Shreveport ( Site 0029); 🇺🇸 Shreveport, Louisiana, United States

Profound Research LLC ( Site 0074); 🇺🇸 Royal Oak, Michigan, United States

SSM Health Cancer Care - Fenton ( Site 0088); 🇺🇸 Fenton, Missouri, United States

Lake Regional Hospital ( Site 0009); 🇺🇸 Osage Beach, Missouri, United States

New Mexico Oncology Hematology Consultants Ltd. ( Site 0090); 🇺🇸 Albuquerque, New Mexico, United States

Memorial Sloan Kettering Cancer Center ( Site 0067); 🇺🇸 New York, New York, United States

Clinical Research Alliance ( Site 0086); 🇺🇸 Westbury, New York, United States

Sanford Cancer Center Bismarck ( Site 0058); 🇺🇸 Bismarck, North Dakota, United States

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0056); 🇺🇸 Fargo, North Dakota, United States

Cleveland Clinic - Mercy Hospital ( Site 0057); 🇺🇸 Canton, Ohio, United States

Tri-County Hematology & Oncology Associates, Inc. ( Site 0076); 🇺🇸 Massillon, Ohio, United States

Genesis Healthcare System ( Site 0025); 🇺🇸 Zanesville, Ohio, United States

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0041); 🇺🇸 Tulsa, Oklahoma, United States

Sidney Kimmel Cancer Center at Jefferson ( Site 0049); 🇺🇸 Philadelphia, Pennsylvania, United States

Sanford Cancer Center ( Site 0059); 🇺🇸 Sioux Falls, South Dakota, United States

Nashville General Hospital ( Site 0072); 🇺🇸 Nashville, Tennessee, United States

Harrington Cancer Center ( Site 0061); 🇺🇸 Amarillo, Texas, United States

Parkland Health & Hospital System ( Site 0096); 🇺🇸 Dallas, Texas, United States

University of Texas Southwestern Medical Center ( Site 0032); 🇺🇸 Dallas, Texas, United States

The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0055); 🇺🇸 Tyler, Texas, United States

Bon Secours Memorial Regional Medical Center-Oncology Research Department ( Site 0020); 🇺🇸 Midlothian, Virginia, United States

Virginia Cancer Institute ( Site 0034); 🇺🇸 Richmond, Virginia, United States

Northwest Medical Specialties, PLLC ( Site 0093); 🇺🇸 Tacoma, Washington, United States

SSM Health Dean Medical Group ( Site 0087); 🇺🇸 Madison, Wisconsin, United States

Hospital Aleman-Oncology ( Site 0501); 🇦🇷 Capital Federal, Buenos Aires, Argentina

Hospital Británico de Buenos Aires-Oncology ( Site 0502); 🇦🇷 Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Oncología Angel H. Roffo ( Site 0503); 🇦🇷 Buenos Aires, Caba, Argentina

Instituto Alexander Fleming-Alexander Fleming ( Site 0509); 🇦🇷 Ciudad Autónoma de Buenos Aires, Caba, Argentina

Sanatorio Parque ( Site 0512); 🇦🇷 Rosario, Santa Fe, Argentina

Sanatorio Finochietto ( Site 0513); 🇦🇷 Buenos Aires, Argentina

Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0508); 🇦🇷 Buenos Aires, Argentina

Macquarie University-MQ Health Clinical Trials Unit ( Site 2703); 🇦🇺 Macquarie University, New South Wales, Australia

Westmead Hospital ( Site 2700); 🇦🇺 Westmead, New South Wales, Australia

Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 2701); 🇦🇺 Brisbane, Queensland, Australia

Frankston Hospital-Oncology and Haematology ( Site 2704); 🇦🇺 Frankston, Victoria, Australia

Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1206); 🇦🇹 Linz, Oberosterreich, Austria

Klinikum Wels-Grieskirchen GmbH ( Site 1205); 🇦🇹 Wels, Oberosterreich, Austria

Medizinische Universitaet Innsbruck ( Site 1200); 🇦🇹 Innsbruck, Tirol, Austria

Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis ( Site 1202); 🇦🇹 Salzburg, Austria

Medizinische Universität Wien-Universitätsklinik für Innere Medizin I, Klinische Abteilung für Onko ( Site 1201); 🇦🇹 Wien, Austria

Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0901); 🇧🇪 Brussels, Bruxelles-Capitale, Region De, Belgium

AZ Maria Middelares-IKG ( Site 0903); 🇧🇪 Gent, Oost-Vlaanderen, Belgium

Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0902); 🇧🇪 Namur, Belgium

PRONUTRIR-CLINICAL RESEARCH ( Site 0609); 🇧🇷 Fortaleza, Ceara, Brazil

Oncoclínica Oncologistas Associados-Clinical Research ( Site 0607); 🇧🇷 Teresina, Piaui, Brazil

Hospital do Câncer Mãe de Deus ( Site 0604); 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

Instituto de Oncologia Saint Gallen ( Site 0614); 🇧🇷 Santa Cruz do Sul, Rio Grande Do Sul, Brazil

Instituto do Câncer Brasil - Unidade Taubaté ( Site 0608); 🇧🇷 Taubaté, Sao Paulo, Brazil

IBCC - Núcleo de Pesquisa e Ensino ( Site 0601); 🇧🇷 Sao Paulo, Brazil

Cross Cancer Institute ( Site 0407); 🇨🇦 Edmonton, Alberta, Canada

BC Cancer Vancouver ( Site 0404); 🇨🇦 Vancouver, British Columbia, Canada

CancerCare Manitoba ( Site 0411); 🇨🇦 Winnipeg, Manitoba, Canada

The Moncton Hospital ( Site 0401); 🇨🇦 Moncton, New Brunswick, Canada

QEII Health Sciences Centre - Victoria General Site ( Site 0418); 🇨🇦 Halifax, Nova Scotia, Canada

Southlake Regional Health Centre ( Site 0413); 🇨🇦 Newmarket, Ontario, Canada

The Ottawa Hospital - General Campus ( Site 0414); 🇨🇦 Ottawa, Ontario, Canada

North York General Hospital ( Site 0415); 🇨🇦 Toronto, Ontario, Canada

Princess Margaret Cancer Centre ( Site 0400); 🇨🇦 Toronto, Ontario, Canada

Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0417); 🇨🇦 Greenfield Park, Quebec, Canada

CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0419); 🇨🇦 Montreal, Quebec, Canada

Jewish General Hospital ( Site 0416); 🇨🇦 Montreal, Quebec, Canada

Centre Hospitalier de l'Université de Montréal ( Site 0403); 🇨🇦 Montréal, Quebec, Canada

Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0409); 🇨🇦 Rimouski, Quebec, Canada

Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0406); 🇨🇦 Trois-Rivières, Quebec, Canada

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 1005); 🇨🇿 Brno, Brno-mesto, Czechia

Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 1007); 🇨🇿 Ceske Budejovice, Jihocesky Kraj, Czechia

Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1006); 🇨🇿 Olomouc, Olomoucky Kraj, Czechia

Vseobecna fakultni nemocnice v Praze-Onkologická klinika VFN ( Site 1002); 🇨🇿 Praha, Praha 2, Czechia

Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1000); 🇨🇿 Praha, Praha 5, Czechia

Tampereen yliopistollinen sairaala ( Site 1102); 🇫🇮 Tampere, Pirkanmaa, Finland

Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1100); 🇫🇮 Helsinki, Uusimaa, Finland

Turku University Hospital-Department of Oncology ( Site 1103); 🇫🇮 Turku, Varsinais-Suomi, Finland

Centre Antoine-Lacassagne ( Site 1308); 🇫🇷 Nice, Alpes-Maritimes, France

Centre Hospitalier de la Côte Basque ( Site 1315); 🇫🇷 Bayonne, Aquitaine, France

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1307); 🇫🇷 Clermont-Ferrand, Auvergne, France

Institut Paoli-Calmettes ( Site 1309); 🇫🇷 Marseille, Bouches-du-Rhone, France

Centre François Baclesse ( Site 1318); 🇫🇷 Caen, Calvados, France

Centre Georges François Leclerc ( Site 1312); 🇫🇷 Dijon, Cote-d Or, France

CHU Besançon ( Site 1311); 🇫🇷 Besançon, Doubs, France

Hôpital Privé Drôme-Ardèche ( Site 1301); 🇫🇷 Valence, Drome, France

CHRU Brest - Hopital Cavale Blanche ( Site 1304); 🇫🇷 Brest, Finistere, France

Clinique Tivoli Ducos ( Site 1322); 🇫🇷 Bordeaux, Gironde, France

Hôpital Franco-Britannique - Fondation Cognacq-Jay ( Site 1321); 🇫🇷 Levallois-Perret, Hauts-de-Seine, France

Institut de Cancérologie de l'Ouest ( Site 1305); 🇫🇷 Saint Herblain, Loire-Atlantique, France

Institut de Cancérologie de l'Ouest ( Site 1316); 🇫🇷 ANGERS cedex 02, Maine-et-Loire, France

Centre de Cancerologie Les Dentellieres ( Site 1306); 🇫🇷 Valenciennes, Nord, France

Centre Hospitalier de Pau ( Site 1302); 🇫🇷 Pau, Pyrenees-Atlantiques, France

CENTRE LEON BERARD ( Site 1300); 🇫🇷 Lyon Cedex08, Rhone-Alpes, France

Centre Henri Becquerel ( Site 1319); 🇫🇷 Rouen, Seine-Maritime, France

Hôpital Tenon ( Site 1303); 🇫🇷 Paris, France

Klinikum Ludwigsburg-Klinik für Geburtshilfe und Frauenheilkunde ( Site 1405); 🇩🇪 Ludwigsburg, Baden-Wurttemberg, Germany

Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1400); 🇩🇪 Erlangen, Bayern, Germany

Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Frauenklinik Brustzentrum ( Site 1402); 🇩🇪 Muenchen, Bayern, Germany

Klinikum Ernst von Bergmann-Frauenklinik ( Site 1408); 🇩🇪 Potsdam, Brandenburg, Germany

Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1409); 🇩🇪 Düsseldorf, Nordrhein-Westfalen, Germany

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 1401); 🇩🇪 Essen, Nordrhein-Westfalen, Germany

Evangelisches Krankenhaus Bethesda Mönchengladbach-Brustzentrum Niederrhein ( Site 1406); 🇩🇪 Mönchengladbach, Nordrhein-Westfalen, Germany

Universitätsmedizin Johannes Gutenberg Universität Mainz-Klinik und Poliklinik für Geburtshilfe und ( Site 1418); 🇩🇪 Mainz, Rheinland-Pfalz, Germany

CaritasKlinikum Saarbrücken St. Theresia ( Site 1410); 🇩🇪 Saarbrücken, Saarland, Germany

Universitätsklinikum Schleswig-Holstein ( Site 1411); 🇩🇪 Lübeck, Schleswig-Holstein, Germany

Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1413); 🇩🇪 Berlin, Germany

UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1509); 🇬🇷 Patras, Achaia, Greece

Errikos Dunant Hospital Center-1st Medical Oncology Dept. ( Site 1508); 🇬🇷 Athens, Attiki, Greece

Aretaieio Hospital Oncology Unit ( Site 1505); 🇬🇷 Athens, Attiki, Greece

Agios Loukas Clinic ( Site 1507); 🇬🇷 Thessaloniki, Kentriki Makedonia, Greece

University General Hospital of Larissa ( Site 1503); 🇬🇷 Larissa, Thessalia, Greece

Euromedica General Clinic of Thessaloniki-Oncology Unit ( Site 1502); 🇬🇷 Thessaloniki, Greece

Queen Mary Hospital ( Site 3600); 🇭🇰 Hong Kong, Hong Kong

Hong Kong United Oncology Centre ( Site 3601); 🇭🇰 Kowloon, Hong Kong

Bon Secours Cork Hospital ( Site 1600); 🇮🇪 Cork, Ireland

St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1601); 🇮🇪 Dublin, Ireland

Soroka Medical Center-Oncology ( Site 1704); 🇮🇱 Beer Sheva, Israel

Hadassah Medical Center ( Site 1700); 🇮🇱 Jerusalem, Israel

Rabin Medical Center ( Site 1702); 🇮🇱 Petah Tikva, Israel

Sheba Medical Center-ONCOLOGY ( Site 1701); 🇮🇱 Ramat Gan, Israel

Sourasky Medical Center ( Site 1705); 🇮🇱 Tel Aviv, Israel

University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 1803); 🇮🇹 Naples, Campania, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Clinica Sperimentale di Senologia ( Site 1800); 🇮🇹 Napoli, Campania, Italy

Humanitas Istituto Clinico Catanese ( Site 1811); 🇮🇹 Misterbianco, Catania, Italy

IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1807); 🇮🇹 Meldola (FC), Forli-Cesena, Italy

CRO-IRCCS ( Site 1808); 🇮🇹 Aviano, Friuli-Venezia Giulia, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802); 🇮🇹 Roma, Lazio, Italy

Azienda Ospedaliera Spedali Civili di Brescia ( Site 1812); 🇮🇹 Brescia, Lombardia, Italy

Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1809); 🇮🇹 Milano, Lombardia, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1801); 🇮🇹 Milan, Lombardia, Italy

Fondazione IRCCS San Gerardo dei Tintori ( Site 1813); 🇮🇹 Monza, Lombardia, Italy

Azienda Ospedaliera Universitaria Careggi ( Site 1805); 🇮🇹 Firenze, Toscana, Italy

IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1810); 🇮🇹 Bologna, Italy

Ospedale San Raffaele-Oncologia Medica ( Site 1814); 🇮🇹 Milano, Italy

Azienda Ospedaliero Universitaria Maggiore della Carità-SCDU ONCOLOGIA ( Site 1804); 🇮🇹 Novara, Italy

Nagoya City University Hospital ( Site 3414); 🇯🇵 Nagoya, Aichi, Japan

Hokkaido University Hospital ( Site 3400); 🇯🇵 Sapporo, Hokkaido, Japan

Tokai University Hospital ( Site 3413); 🇯🇵 Isehara, Kanagawa, Japan

St. Marianna University Hospital ( Site 3405); 🇯🇵 Kawasaki, Kanagawa, Japan

Kitasato University Hospital ( Site 3411); 🇯🇵 Sagamihara, Kanagawa, Japan

Kanagawa Cancer Center ( Site 3412); 🇯🇵 Yokohama, Kanagawa, Japan

Mie University Hospital ( Site 3423); 🇯🇵 Tsu, Mie, Japan

Tohoku University Hospital ( Site 3422); 🇯🇵 Sendai, Miyagi, Japan

The University of Osaka Hospital ( Site 3416); 🇯🇵 Suita, Osaka, Japan

Saitama Medical University International Medical Center ( Site 3402); 🇯🇵 Hidaka, Saitama, Japan

Juntendo University Hospital ( Site 3408); 🇯🇵 Bunkyo, Tokyo, Japan

Showa Medical University Hospital ( Site 3406); 🇯🇵 Shinagawa, Tokyo, Japan

Tokyo Medical University Hospital ( Site 3407); 🇯🇵 Shinjuku, Tokyo, Japan

National Center for Global Health and Medicine ( Site 3409); 🇯🇵 Shinjuku, Tokyo, Japan

Fukushima Medical University Hospital ( Site 3401); 🇯🇵 Fukushima, Japan

Gifu University Hospital ( Site 3426); 🇯🇵 Gifu, Japan

Hiroshima City Hiroshima Citizens Hospital ( Site 3418); 🇯🇵 Hiroshima, Japan

Social medical corporation Hakuaikai Sagara Hospital ( Site 3421); 🇯🇵 Kagoshima, Japan

Kumamoto University Hospital ( Site 3420); 🇯🇵 Kumamoto, Japan

Kyoto University Hospital ( Site 3415); 🇯🇵 Kyoto, Japan

Okayama University Hospital ( Site 3425); 🇯🇵 Okayama, Japan

Osaka International Cancer Institute ( Site 3417); 🇯🇵 Osaka, Japan

Seoul National University Hospital-Internal Medicine ( Site 3102); 🇰🇷 Seoul, Korea, Republic of

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3100); 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center-Department of Oncology ( Site 3103); 🇰🇷 Seoul, Korea, Republic of

Gangnam Severance Hospital, Yonsei University Health System-Medical Oncology, Internal Medicine ( Site 3104); 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center-Division of Hematology/Oncology ( Site 3101); 🇰🇷 Seoul, Korea, Republic of

Prince Court Medical Centre ( Site 2802); 🇲🇾 Kuala Lumpur, Malaysia

Pantai Hospital Kuala Lumpur ( Site 2801); 🇲🇾 Kuala Lumpur, Malaysia

CENEIT Oncologicos ( Site 0706); 🇲🇽 Ciudad de México, Distrito Federal, Mexico

Health Pharma Professional Research S.A. de C.V: ( Site 0709); 🇲🇽 Ciudad de México, Distrito Federal, Mexico

COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 0712); 🇲🇽 Mexico City, Distrito Federal, Mexico

CENTRO MEDICO ZAMBRANO HELLION ( Site 0711); 🇲🇽 San Pedro Garza Garcia, Nuevo Leon, Mexico

Drammen Sykehus, Vestre Viken HF ( Site 2001); 🇳🇴 Drammen, Buskerud, Norway

Stavanger Universitetssykehus ( Site 2004); 🇳🇴 Stavanger, Rogaland, Norway

Oslo universitetssykehus, Radiumhospitalet ( Site 2002); 🇳🇴 Oslo, Norway

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2102); 🇵🇱 Bydgoszcz, Kujawsko-pomorskie, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 2100); 🇵🇱 Warszawa, Mazowieckie, Poland

Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 2101); 🇵🇱 Wieliszew, Mazowieckie, Poland

Bialostockie Centrum Onkologii ( Site 2105); 🇵🇱 Bialystok, Podlaskie, Poland

Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 2113); 🇵🇱 Gdynia, Pomorskie, Poland

Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 2110); 🇵🇱 Gliwice, Slaskie, Poland

Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 2118); 🇵🇱 Kielce, Swietokrzyskie, Poland

Zachodniopomorskie Centrum Onkologii ( Site 2108); 🇵🇱 Szczecin, Zachodniopomorskie, Poland

Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 2203); 🇵🇹 Amadora, Lisboa, Portugal

Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2201); 🇵🇹 Lisboa, Portugal

Instituto Portugues de Oncologia do Porto ( Site 2202); 🇵🇹 Porto, Portugal

National Cancer Centre Singapore-Medical Oncology ( Site 3002); 🇸🇬 Singapore, Central Singapore, Singapore

HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2304); 🇪🇸 Sevilla, Andalucia, Spain

Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2305); 🇪🇸 L Hospitalet De Llobregat, Barcelona, Spain

CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2307); 🇪🇸 A Coruña, La Coruna, Spain

Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2301); 🇪🇸 Madrid, Madrid, Comunidad De, Spain

HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2308); 🇪🇸 Majadahonda, Madrid, Comunidad De, Spain

Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2303); 🇪🇸 Valencia, Valenciana, Comunitat, Spain

Hospital Universitari Vall d'Hebron-Oncology ( Site 2300); 🇪🇸 Barcelona, Spain

Hospital Beata María Ana-oncology ( Site 2309); 🇪🇸 Madrid, Spain

Hospital Clinico San Carlos-Oncology Department ( Site 2306); 🇪🇸 Madrid, Spain

Spital Thun ( Site 2400); 🇨🇭 Thun, Berne, Switzerland

Clinique Générale-Beaulieu ( Site 2406); 🇨🇭 Geneva, Geneve, Switzerland

Kantonsspital Graubünden-Medizin ( Site 2404); 🇨🇭 Chur, Grisons, Switzerland

Brust-Zentrum ( Site 2401); 🇨🇭 Zürich, Zurich, Switzerland

HFR Fribourg - Hôpital Cantonal ( Site 2402); 🇨🇭 Fribourg, Switzerland

Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2501); 🇹🇷 Adana, Turkey

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-oncology ( Site 2504); 🇹🇷 Ankara, Turkey

Memorial Ankara Hastanesi-Medical Oncology ( Site 2502); 🇹🇷 Ankara, Turkey

Medipol Mega Universite Hastanesi-oncology ( Site 2503); 🇹🇷 Istanbul, Turkey

Samsun Medical Park Hastanesi-medical oncology ( Site 2500); 🇹🇷 Samsun, Turkey

University Hospitals Bristol NHS Foundation Trust ( Site 2601); 🇬🇧 Bristol, Bristol, City Of, United Kingdom

The Royal Cornwall Hospital ( Site 2603); 🇬🇧 Truro, England, United Kingdom

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2602); 🇬🇧 London, London, City Of, United Kingdom

University College London Hospital ( Site 2604); 🇬🇧 London, London, City Of, United Kingdom

Western General Hospital ( Site 2607); 🇬🇧 Edinburgh, Midlothian, United Kingdom

St James's University Hospital-Leeds Cancer Centre ( Site 2608); 🇬🇧 Leeds, United Kingdom