AzTrials
AzTrials

Triple Negative Breast NeoplasmsPhase 3NCT06841354

A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)

A Phase 3 study testing Sacituzumab tirumotecan, Pembrolizumab and Rescue Medication in people with Triple Negative Breast Neoplasms, run by Merck Sharp & Dohme LLC at 283 sites in 35 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple Negative Breast Neoplasms
What is being tested?
Sacituzumab tirumotecan, Pembrolizumab and Rescue Medication
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
283 sitesin 35 countries
Study dates
16 Mar 2025to 18 May 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The main inclusion criteria include but are not limited to the following:
  • Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent
  • Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer
  • Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence
  • Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin
  • Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Has breast cancer amenable to treatment with curative intent
  • Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10
  • Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer
  • Has Grade ≥2 peripheral neuropathy
  • Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
Show all 18Show fewer
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has skin only metastatic disease
  • Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications
  • Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has known additional malignancy that is progressing or has required active treatment within the past 5 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable
  • Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
  • Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
  • History of stem cell/solid organ transplant
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Trial locations and contacts

283 sites in 35 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

283 sites in 35 countries

United States39 sites, 36 recruiting

  • New Mexico Oncology Hematology Consultants Ltd. ( Site 0019)

    Albuquerque, New Mexico, 87109

    Study Coordinator, 505-842-8171

    Recruiting

  • AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007)

    Altamonte Springs, Florida, 32701

    Study Coordinator, 407-303-2284

    Recruiting

  • University Cancer & Blood Center, LLC ( Site 0023)

    Athens, Georgia, 30607

    Study Coordinator, 706-353-2990

    Recruiting

  • MedStar Franklin Square Medical Center ( Site 0031)

    Baltimore, Maryland, 21237

    Study Coordinator, 443-777-7147

    Recruiting

  • MedStar Good Samaritan Hospital ( Site 0079)

    Baltimore, Maryland, 21239

    Study Coordinator, 443-777-7147

    Recruiting

  • St. Luke's Cancer Institute: Boise ( Site 0037)

    Boise, Idaho, 83712

    Study Coordinator, 208-381-2711

    Recruiting

  • Ironwood Cancer & Research Centers ( Site 0036)

    Chandler, Arizona, 85224

    Study Coordinator, 623-312-3000

    Recruiting

  • University of Illinois Cancer Center ( Site 0044)

    Chicago, Illinois, 60612

    Study Coordinator, 312-996-1581

    Recruiting

  • MedStar Southern Maryland Hospital Center ( Site 0100)

    Clinton, Maryland, 20735

    Study Coordinator, 301-877-4673

    Recruiting

  • Texas Oncology - DFW ( Site 8007)

    Dallas, Texas, 75231

    Study Coordinator, 214-739-4175

    Recruiting

  • City of Hope ( Site 0097)

    Duarte, California, 91010

    Study Coordinator, 626-218-9845

    Recruiting

  • Texas Oncology - West Texas ( Site 8004)

    El Paso, Texas, 79902

    Study Coordinator, 915-747-4835

    Recruiting

  • Rex Hematology Oncology Associates - Garner ( Site 0071)

    Garner, North Carolina, 27529

    Completed

  • Cancer & Hematology Centers of Western Michigan ( Site 0026)

    Grand Rapids, Michigan, 49503

    Study Coordinator, 616-954-9800

    Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0082)

    Hackensack, New Jersey, 07601

    Study Coordinator, 551-996-5900

    Recruiting

  • Hattiesburg Clinic Hematology/Oncology ( Site 0104)

    Hattiesburg, Mississippi, 39401

    Study Coordinator, 601-261-1700

    Recruiting

  • Kelsey-Seybold Clinic - North Houston Campus ( Site 0096)

    Houston, Texas, 77014

    Study Coordinator, 713-239-4510

    Recruiting

  • Kelsey-Seybold Clinic ( Site 0040)

    Houston, Texas, 77025

    Study Coordinator, 713-239-4510

    Recruiting

  • City of Hope Lennar Foundation Cancer Center ( Site 0099)

    Irvine, California, 92618

    Study Coordinator, 626-218-0720

    Recruiting

  • Comprehensive Cancer Centers of Nevada ( Site 0015)

    Las Vegas, Nevada, 89106

    Study Coordinator, 702-952-3350

    Recruiting

  • UCLA Department of Medicine - Hematology & Oncology ( Site 0047)

    Los Angeles, California, 90095

    Study Coordinator, 650-283-5067

    Recruiting

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0073)

    Mineola, New York, 11501

    Study Coordinator, 516-663-9500

    Recruiting

  • Allina Health Cancer Institute ( Site 0069)

    Minneapolis, Minnesota, 55407

    Completed

  • USA Mitchell Cancer Institute ( Site 0090)

    Mobile, Alabama, 36604

    Study Coordinator, 251-410-4924

    Recruiting

  • SCRI Oncology Partners ( Site 7004)

    Nashville, Tennessee, 37203

    Study Coordinator, 615-329-7274

    Recruiting

  • Tennessee Oncology ( Site 0018)

    Nashville, Tennessee, 37203

    Study Coordinator, 877-836-6662

    Recruiting

  • Yale New Haven Hospital ( Site 0001)

    New Haven, Connecticut, 06520

    Completed

  • Laura and Isaac Perlmutter Cancer Center ( Site 0003)

    New York, New York, 10016

    Study Coordinator, 212-731-6126

    Recruiting

  • Virginia Oncology Associates (VOA) ( Site 8002)

    Norfolk, Virginia, 23502

    Study Coordinator, 757-368-5033

    Recruiting

  • MedStar Montgomery Medical Center ( Site 0078)

    Olney, Maryland, 20832

    Study Coordinator, 301-774-8882

    Recruiting

  • Orlando Health Cancer Institute ( Site 0012)

    Orlando, Florida, 32806

    Study Coordinator, 321-841-8284

    Recruiting

  • Renown Regional Medical Center ( Site 0005)

    Reno, Nevada, 89502

    Study Coordinator, 775-982-5050

    Recruiting

  • University of Utah, Huntsman Cancer Institute ( Site 0056)

    Salt Lake City, Utah, 84112

    Study Coordinator, 801-587-7000

    Recruiting

  • Texas Oncology - San Antonio ( Site 8001)

    San Antonio, Texas, 78240

    Study Coordinator, 210-419-2608

    Recruiting

  • UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016)

    San Francisco, California, 94158

    Study Coordinator, 415-353-7070

    Recruiting

  • Fred Hutchinson Cancer Center ( Site 0042)

    Seattle, Washington, 98109

    Study Coordinator, 206-606-6329

    Recruiting

  • Holy Cross Hospital ( Site 0091)

    Silver Spring, Maryland, 20910

    Study Coordinator, 301-754-7552

    Recruiting

  • Washington Hospital Center ( Site 0098)

    Washington D.C., District of Columbia, 20010-2975

    Study Coordinator, 202-877-8839

    Recruiting

  • Florida Cancer Specialists - East ( Site 7000)

    West Palm Beach, Florida, 33401

    Study Coordinator, 561-366-4100

    Recruiting

Other trials in United States

Japan28 sites, 27 recruiting

  • Akita University Hospital ( Site 5115)

    Akita, 010-8543

    Study Coordinator, +81-18-834-1111

    Recruiting

  • Juntendo University Hospital ( Site 5104)

    Bunkyo, Tokyo, 113-8431

    Study Coordinator, +81-3-3813-3111

    Recruiting

  • National Hospital Organization Kyushu Cancer Center ( Site 5119)

    Fukuoka, 811-1395

    Study Coordinator, +81-92-541-3231

    Recruiting

  • Fukushima Medical University Hospital ( Site 5101)

    Fukushima, 960-1295

    Study Coordinator, +81-24-547-1772

    Recruiting

  • Saitama Medical University International Medical Center ( Site 5116)

    Hidaka, Saitama, 350-1298

    Study Coordinator, +81-42-984-4111

    Recruiting

  • Hiroshima City Hiroshima Citizens Hospital ( Site 5113)

    Hiroshima, 730-8518

    Study Coordinator, +81-81-221-2291

    Recruiting

  • Tokai University Hospital ( Site 5107)

    Isehara, Kanagawa, 259-1193

    Study Coordinator, +81-463-93-1121

    Recruiting

  • Social medical corporation Hakuaikai Sagara Hospital ( Site 5114)

    Kagoshima, 892-0833

    Study Coordinator, +81-99-224-1800

    Recruiting

  • Kanazawa Medical University Hospital ( Site 5127)

    Kahoku-gun, Ishikawa-ken, 920-0293

    Study Coordinator, +81-76-286-3511

    Recruiting

  • National Cancer Center Hospital East ( Site 5120)

    Kashiwa, Chiba, 277-8577

    Study Coordinator, +81-4-7133-1111

    Recruiting

  • St. Marianna University Hospital ( Site 5124)

    Kawasaki, Kanagawa, 216-8511

    Study Coordinator, +81-44-977-8111

    Recruiting

  • Cancer Institute Hospital of JFCR ( Site 5102)

    Koto, Tokyo, 135-8550

    Study Coordinator, +81-3-3520-0111

    Recruiting

  • Kyoto University Hospital ( Site 5110)

    Kyoto, 606-8507

    Study Coordinator, +81-75-751-3111

    Recruiting

  • National Hospital Organization Shikoku Cancer Center ( Site 5122)

    Matsuyama, Ehime, 791-0280

    Study Coordinator, +81-89-999-1111

    Recruiting

  • Toranomon Hospital ( Site 5126)

    Minato, Tokyo, 105-8470

    Study Coordinator, +81-3-3588-1111

    Recruiting

  • Aichi Cancer Center ( Site 5117)

    Nagoya, Aichi-ken, 464-8681

    Study Coordinator, +81-52-762-6111

    Recruiting

  • Nagoya City University Hospital ( Site 5108)

    Nagoya, Aichi-ken, 467-8602

    Study Coordinator, +81-52-851-5511

    Recruiting

  • Naha Nishi Clinic ( Site 5125)

    Naha, Okinawa, 901-0154

    Study Coordinator, +81-98-858-5557

    Recruiting

  • Okayama University Hospital ( Site 5118)

    Okayama, 700-8558

    Study Coordinator, +81-86-223-7151

    Recruiting

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 5112)

    Osaka, 541-8567

    Study Coordinator, +81-06-6945-1181

    Recruiting

  • Kitasato University Hospital ( Site 5123)

    Sagamihara, Kanagawa, 252-0375

    Study Coordinator, +81-42-778-8111

    Recruiting

  • Hokkaido University Hospital ( Site 5100)

    Sapporo, Hokkaido, 060-8648

    Study Coordinator, +81-11-716-1161

    Recruiting

  • Showa Medical University Hospital ( Site 5103)

    Shinagawa, Tokyo, 142-8666

    Study Coordinator, +81-3-3784-8000

    Recruiting

  • Tokyo Medical University Hospital ( Site 5121)

    Shinjuku, Tokyo, 160-0023

    Active, not recruiting

  • National Center for Global Health and Medicine ( Site 5105)

    Shinjuku, Tokyo, 162-8655

    Study Coordinator, +81-3-3202-7181

    Recruiting

  • The University of Osaka Hospital ( Site 5111)

    Suita, Osaka, 565-0871

    Study Coordinator, +81-6-6210-8290

    Recruiting

  • Mie University Hospital ( Site 5109)

    Tsu, Mie-ken, 514-8507

    Study Coordinator, +81-59-231-5246

    Recruiting

  • Kanagawa Cancer Center ( Site 5106)

    Yokohama, Kanagawa, 241-8515

    Study Coordinator, +81-45-520-2222

    Recruiting

Other trials in Japan

China25 sites, 24 recruiting

  • The First Afflilated Hospital of Bengbu Medical College ( Site 5022)

    Bengbu, Anhui, 233004

    Study Coordinator, 0552-3085746

    Recruiting

  • Jilin Province Tumor Hospital ( Site 5040)

    Changchun, Jilin, 130015

    Study Coordinator, 0431-80596018

    Recruiting

  • The First Hospital of Jilin University ( Site 5003)

    Changchun, Jilin, 130021

    Study Coordinator, 0431-88783330

    Recruiting

  • Hunan Cancer Hospital ( Site 5002)

    Changsha, Hunan, 410013

    Study Coordinator, 0731-88651669

    Recruiting

  • Sichuan Cancer Hospital. ( Site 5018)

    Chengdu, Sichuan, 610041

    Study Coordinator, 028-85420251

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University ( Site 5039)

    Chongqing, Chongqing Municipality, 400016

    Study Coordinator, +86 023 89011606

    Recruiting

  • Chongqing University Three Gorges Hospital ( Site 5020)

    Chongqing, Chongqing Municipality, 404000

    Completed

  • Sun Yat-Sen University Cancer Center ( Site 5014)

    Guangzhou, Guangdong, 510060

    Study Coordinator, 020-87343990

    Recruiting

  • The First Affiliated Hospital Zhejiang University School of Medicine ( Site 5026)

    Hangzhou, Zhejiang, 310003

    Study Coordinator, 0571-87236855

    Recruiting

  • Zhejiang Cancer Hospital ( Site 5012)

    Hangzhou, Zhejiang, 310022

    Study Coordinator, 0571-88122222

    Recruiting

  • The Second Affiliated hospital of Zhejiang University school of medicine ( Site 5024)

    Hangzhou, Zhejiang, 310052

    Study Coordinator, 0571-89713252

    Recruiting

  • Jinan Central Hospital ( Site 5031)

    Jinan, Shandong, 250013

    Study Coordinator, 053155865197

    Recruiting

  • Taizhou Hospital of Zhejiang Province ( Site 5029)

    Linhai, Zhejiang, 317000

    Study Coordinator, 0576-85190467

    Recruiting

  • LinYi Cancer Hospital ( Site 5021)

    Linyi, Shandong, 276000

    Study Coordinator, +8605398127192

    Recruiting

  • Jiangsu Province Hospital ( Site 5009)

    Nanjing, Jiangsu, 210029

    Study Coordinator, 02568308145

    Recruiting

  • Guangxi Medical University Affiliated Tumor Hospital. ( Site 5008)

    Nanning, Guangxi, 530201

    Study Coordinator, +860771-5778582

    Recruiting

  • The Second People's Hospital of Neijiang ( Site 5016)

    Neijiang, Sichuan, 641099

    Study Coordinator, +86 0832 2380771

    Recruiting

  • Shanxi Cancer Hospital ( Site 5043)

    Taiyuan, Shanxi, 030000

    Study Coordinator, 03514881611

    Recruiting

  • Affiliated Tumor Hospital of Xinjiang Medical University ( Site 5006)

    Ürümqi, Xinjiang, 830011

    Study Coordinator, +8609917819133

    Recruiting

  • Tongji Hospital Tongji Medical Science & Technology ( Site 5007)

    Wuhan, Hubei, 430030

    Study Coordinator, 027-83663940

    Recruiting

  • The First Affiliated Hospital of Xi an Jiaotong University ( Site 5005)

    Xi'an, Shaanxi, 710061

    Study Coordinator, +8602985324094

    Recruiting

  • The First Affiliated hospital of Xiamen University ( Site 5035)

    Xiamen, Fujian, 361003

    Study Coordinator, 0592-2137232

    Recruiting

  • Xiangyang Central Hospital ( Site 5017)

    Xiangyang, Hubei, 441021

    Study Coordinator, 0710-2811523

    Recruiting

  • Xuzhou Central Hospital ( Site 5036)

    Xuzhou, Jiangsu, 221009

    Study Coordinator, 051680812397

    Recruiting

  • Henan Cancer Hospital ( Site 5001)

    Zhengzhou, Henan, 450008

    Study Coordinator, 0371-65588404

    Recruiting

Other trials in China

Mexico12 sites, 12 recruiting

  • Centro de Investigación Oncológica Galerías SC ( Site 2511)

    Aguascalientes, 20124

    Study Coordinator, +524496890593

    Recruiting

  • Grupo Médico ASSET SC ( Site 2507)

    Benito Juárez, Mexico City, 03100

    Study Coordinator, 2223813254

    Recruiting

  • Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 2510)

    Chihuahua City, 31123

    Study Coordinator, 526144253458712

    Recruiting

  • CIO - Centro de Inmuno-Oncología de Occidente ( Site 2504)

    Guadalajara, Jalisco, 44630

    Study Coordinator, 3330447001

    Recruiting

  • COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 2514)

    Mexico City, Mexico City, 04700

    Study Coordinator, +525554248970

    Recruiting

  • Centro Oncologico de Alta Especialidad, S.C. ( Site 2509)

    Mexico City, Mexico City, 06140

    Study Coordinator, +52 55 5286 5738

    Recruiting

  • Higiea Oncologia ( Site 2505)

    Mexico City, Mexico City, 11810

    Study Coordinator, +525554137773

    Recruiting

  • Filios Alta Medicina ( Site 2506)

    Monterrey, Nuevo León, 64460

    Study Coordinator, +528131813571

    Recruiting

  • Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 2501)

    Monterrey, Nuevo León, 64460

    Study Coordinator, +528125761529

    Recruiting

  • Centro de Investigacion Clinica de Oaxaca ( Site 2503)

    Oaxaca City, Oaxaca, 68020

    Study Coordinator, +529516035559

    Recruiting

  • Centro Potosino de Investigación Médica ( Site 2512)

    San Luis Potosí City, 78250

    Study Coordinator, 52 444 475 2715

    Recruiting

  • Oncare - Unidad Valle ( Site 2502)

    San Pedro Garza García, Nuevo León, 66220

    Study Coordinator, +528115337180

    Recruiting

Other trials in Mexico

Canada11 sites, 10 recruiting

  • CIUSSS- saguenay-Lac-Saint-Jean ( Site 0213)

    Chicoutimi, Quebec, G7H 5H6

    Study Coordinator, 418-541-1000

    Recruiting

  • Cross Cancer Institute ( Site 0216)

    Edmonton, Alberta, T6G 1Z2

    Study Coordinator, 7804328644

    Recruiting

  • Centre Hospitalier de l'Université de Montréal ( Site 0208)

    Montreal, Quebec, H2X 3E4

    Study Coordinator, 514-890-8444

    Recruiting

  • Jewish General Hospital ( Site 0203)

    Montreal, Quebec, H3T 1E2

    Active, not recruiting

  • St. Marys Hospital Center ( Site 0201)

    Montreal, Quebec, H3T 1M5

    Study Coordinator, 514-891-6904

    Recruiting

  • McGill University Health Centre ( Site 0204)

    Montreal, Quebec, H4A 3J1

    Study Coordinator, 514-299-6425

    Recruiting

  • Lakeridge Health ( Site 0217)

    Oshawa, Ontario, L1G 2B9

    Study Coordinator, 905-576-8711

    Recruiting

  • Hopital Du Saint-Sacrement ( Site 0210)

    Québec, Quebec, G1S 4L8

    Study Coordinator, 4186827511

    Recruiting

  • Saskatoon Cancer Centre ( Site 0215)

    Saskatoon, Saskatchewan, S7N 4H4

    Study Coordinator, 306-655-2662

    Recruiting

  • North York General Hospital ( Site 0209)

    Toronto, Ontario, M2K 1E1

    Study Coordinator, 416-756-6000

    Recruiting

  • Princess Margaret Cancer Centre ( Site 0202)

    Toronto, Ontario, M5G 2M9

    Study Coordinator, 416-946-2000

    Recruiting

Other trials in Canada

Italy10 sites, 10 recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 4605)

    Bologna, 40138

    Study Coordinator, 390512144547

    Recruiting

  • Ospedale Policlinico San Martino ( Site 4606)

    Genova, 16132

    Study Coordinator, +390105600387

    Recruiting

  • IRCCS Ospedale San Raffaele ( Site 4600)

    Milan, 20132

    Study Coordinator, 390226436530

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 4601)

    Milan, 20133

    Study Coordinator, +39 02-2390-2849

    Recruiting

  • Humanitas Istituto Clinico Catanese ( Site 4610)

    Misterbianco, Catania, 95045

    Study Coordinator, +3909573390197

    Recruiting

  • Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 4604)

    Novara, 28100

    Study Coordinator, 3903213732148

    Recruiting

  • Istituto Oncologico Veneto IRCCS ( Site 4603)

    Padova, 35128

    Study Coordinator, 0498215523

    Recruiting

  • Ospedale Santa Maria della Misericordia ( Site 4611)

    Perugia, 06129

    Study Coordinator, +390755784308

    Recruiting

  • Policlincio Gemelli ( Site 4602)

    Roma, 00168

    Study Coordinator, 0630158545

    Recruiting

  • Istituto Nazionale Tumori Regina Elena ( Site 4607)

    Rome, Roma, 00128

    Study Coordinator, +39 0652665610

    Recruiting

Other trials in Italy

France9 sites, 9 recruiting

  • Clinique Francois Chenieux ( Site 3006)

    Limoges, Haute-Vienne, 87000

    Study Coordinator, +33555058606

    Recruiting

  • CENTRE LEON BERARD ( Site 3004)

    Lyon, Auvergne-Rhône-Alpes, 69373

    Study Coordinator, +33469856440

    Recruiting

  • Institut Regional du Cancer Montpellier ( Site 3009)

    Montpellier, Herault, 34298

    Study Coordinator, +33(0)4 67 61 45 65

    Recruiting

  • Groupe Hospitalier Paris Saint Joseph ( Site 3010)

    Paris, 75014

    Study Coordinator, +33144123577

    Recruiting

  • Hôpital Européen Georges Pompidou ( Site 3011)

    Paris, 75015

    Study Coordinator, +33156093577

    Recruiting

  • Institut Jean Godinot ( Site 3002)

    Reims, Marne, 51100

    Study Coordinator, +33326504444

    Recruiting

  • Centre Henri Becquerel ( Site 3001)

    Rouen, Seine-Maritime, 76038

    Study Coordinator, +33232082575

    Recruiting

  • Institut De Cancerologie De L Ouest ( Site 3003)

    Saint-Herblain, Loire-Atlantique, 44805

    Study Coordinator, +33240679900

    Recruiting

  • HIA Sainte Anne ( Site 3007)

    Toulon, Var, 83800

    Study Coordinator, +33483162010

    Recruiting

Other trials in France

Poland9 sites, 8 recruiting

  • Bialostockie Centrum Onkologii ( Site 3810)

    Bialystok, Podlaskie Voivodeship, 15-027

    Study Coordinator, +48733100322

    Recruiting

  • Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 3802)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

    Study Coordinator, +48523743525

    Recruiting

  • Szpitale Pomorskie Sp. z o. o. ( Site 3805)

    Gdynia, Pomeranian Voivodeship, 81-519

    Study Coordinator, +48587260380

    Recruiting

  • Szpital Wojewodzki im.M.Kopernika. ( Site 3800)

    Koszalin, West Pomeranian Voivodeship, 75-581

    Study Coordinator, 48943488931

    Recruiting

  • Pratia MCM Krakow ( Site 3812)

    Krakow, Lesser Poland Voivodeship, 30-727

    Study Coordinator, +48122954100

    Recruiting

  • Wielkopolskie Centrum Onkologii-Oddział Onkologii Klinicznej i Immunoonkologii z Pododdziałem Dzien ( Site 3811)

    Poznan, Greater Poland Voivodeship, 61-866

    Study Coordinator, +48618850620

    Recruiting

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 3801)

    Siedlce, Masovian Voivodeship, 08-110

    Completed

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 3803)

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, 48225462522

    Recruiting

  • Mazowiecki Szpital Onkologiczny ( Site 3807)

    Wieliszew, Masovian Voivodeship, 05-135

    Study Coordinator, +48227661500

    Recruiting

Other trials in Poland

Ukraine9 sites, 9 recruiting

  • COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 4409)

    Cherkasy, Cherkasy Oblast, 18009

    Study Coordinator, +380472319418

    Recruiting

  • Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio ( Site 4401)

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

    Study Coordinator, +380506601626

    Recruiting

  • Ukrainian Center of Tomotherapy ( Site 4400)

    Kropyvnytskyi, Kirovohrad Oblast, 25011

    Study Coordinator, +380676239652

    Recruiting

  • Shalimov Institute of Surgery and Transplantation ( Site 4412)

    Kyiv, 03126

    Study Coordinator, +380800333911

    Recruiting

  • ME "Volyn Regional Clinical Hospital" of the VRC ( Site 4415)

    Lutsk, Volyn Oblast, 43018

    Study Coordinator, +380503782998

    Recruiting

  • Lviv Oncology Regional Treatment and Diagnostic Center ( Site 4407)

    Lviv, Lviv Oblast, 79031

    Study Coordinator, +380975814015

    Recruiting

  • ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 4411)

    Rivne, Rivne Oblast, 33010

    Study Coordinator, +380971921000

    Recruiting

  • Uzhhorod Multispecialty City Clinical Hospital ( Site 4406)

    Uzhhorod, Zakarpattia Oblast, 88017

    Study Coordinator, +380506847086

    Recruiting

  • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 4413)

    Vinnytsia, Vinnytsia Oblast, 21029

    Study Coordinator, + 380953105783

    Recruiting

Other trials in Ukraine

Turkey (Türkiye)8 sites, 8 recruiting

  • Adana Medical Park Seyhan Hastanesi ( Site 4804)

    Adana, 01140

    Study Coordinator, +90 5056166338

    Recruiting

  • Hacettepe Universite Hastaneleri ( Site 4800)

    Ankara, 06230

    Study Coordinator, 903123052929

    Recruiting

  • Gazi University Health Research and Application Center Gazi Hospital ( Site 4805)

    Ankara, 06560

    Study Coordinator, 903122158710

    Recruiting

  • Ankara Bilkent Şehir Hastanesi ( Site 4801)

    Ankara, 06800

    Study Coordinator, 0312 552 60 00

    Recruiting

  • Ege Universitesi Hastanesi ( Site 4803)

    Bornova, İzmir, 35100

    Study Coordinator, 0 232 343 4 343

    Recruiting

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 4802)

    Istanbul, 34722

    Study Coordinator, 902167770000

    Recruiting

  • Sakarya Egitim Arastirma Hsatanesi ( Site 4809)

    Sakarya, 54290

    Study Coordinator, 90 505 478 5576

    Recruiting

  • Samsun Medical Park Hastanesi ( Site 4810)

    Samsun, 55200

    Study Coordinator, 444 44 84

    Recruiting

Other trials in Turkey (Türkiye)

United Kingdom8 sites, 8 recruiting

  • Queen Elizabeth Hospital Birmingham ( Site 4017)

    Birmingham, B15 2TH

    Study Coordinator, +441213718766

    Recruiting

  • Velindre Cancer Centre Hospital ( Site 4008)

    Cardiff, CF142TL

    Study Coordinator, +442920615888

    Recruiting

  • St. James s University Hospital ( Site 4004)

    Leeds, LS9 7TF

    Study Coordinator, +441132068186

    Recruiting

  • St Bartholomew's Hospital ( Site 4001)

    London, London, City of, EC1A7BE

    Study Coordinator, 02073777000

    Recruiting

  • University College London Hospital ( Site 4007)

    London, London, City of, NW1 2PG

    Study Coordinator, +447977175703

    Recruiting

  • Nottingham University Hospital NHS Trust ( Site 4009)

    Nottingham, Nottinghamshire, NG51PB

    Study Coordinator, +441159691169

    Recruiting

  • Musgrove Park Hospital ( Site 4005)

    Taunton, Somerset, TA1 5DA

    Study Coordinator, +441823343634

    Recruiting

  • Royal Cornwall Hospital ( Site 4003)

    Truro, Cornwall, TR13LJ

    Study Coordinator, +441872258342

    Recruiting

Other trials in United Kingdom

Argentina7 sites, 7 recruiting

  • Hospital Italiano de Cordoba ( Site 2406)

    Córdoba, Córdoba Province, X5004BAL

    Study Coordinator, +543514106550

    Recruiting

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 2401)

    Mar del Plata, Buenos Aires, B7600FZN

    Study Coordinator, +54 9223 593 7663

    Recruiting

  • Instituto Alexander Fleming ( Site 2402)

    Mar del Plata, Buenos Aires, C1426ANZ

    Study Coordinator, +541132218900

    Recruiting

  • Fundacion Centro Oncologico de Integración Regional ( Site 2400)

    Mendoza, M5500AYB

    Study Coordinator, +54 9261 367 9497

    Recruiting

  • Fundacion Estudios Clinicos ( Site 2405)

    Rosario, Santa Fe Province, S2000DEJ

    Study Coordinator, +54 9346 69 9922

    Recruiting

  • Hospital Provincial del Centenario ( Site 2410)

    Rosario, Santa Fe Province, S2002KDR

    Study Coordinator, +543414307185

    Recruiting

  • Clinica Viedma ( Site 2403)

    Viedma, Río Negro Province, R8500ACE

    Study Coordinator, 54 9351 592 3598

    Recruiting

Other trials in Argentina

Netherlands7 sites, 7 recruiting

  • Meander Medisch Centrum ( Site 4500)

    Amersfoort, Utrecht, 3813 TZ

    Study Coordinator, +31338507278

    Recruiting

  • Ziekenhuis Rijnstate ( Site 4501)

    Arnhem, Gelderland, 6815 AD

    Study Coordinator, +31880056201

    Recruiting

  • Deventer Ziekenhuis ( Site 4503)

    Deventer, Overijssel, 7416 SE

    Study Coordinator, +31570596437

    Recruiting

  • Martini Ziekenhuis ( Site 4502)

    Groningen, 9728 NT

    Study Coordinator, +31505246311

    Recruiting

  • Erasmus Medisch Centrum ( Site 4505)

    Rotterdam, South Holland, 3015 GD

    Study Coordinator, +31107041733

    Recruiting

  • Zuyderland Medical Centre ( Site 4507)

    Sittard Geleen, Limburg, 6162BP

    Study Coordinator, +31884590400

    Recruiting

  • ETZ Elisabeth ( Site 4504)

    Tilburg, North Brabant, 5022 GC

    Study Coordinator, +31132210425

    Recruiting

Other trials in Netherlands

Romania7 sites, 7 recruiting

  • Spitalul Clinic Filantropia ( Site 4703)

    Bucharest, 011171

    Study Coordinator, +40213188930

    Recruiting

  • Centrul Medical Neolife- Baneasa ( Site 4706)

    Bucharest, 077190

    Study Coordinator, +40219230

    Recruiting

  • Institutul Oncologic Cluj ( Site 4701)

    Cluj-Napoca, Cluj, 400015

    Study Coordinator, +40264598362

    Recruiting

  • S.C. Radiotherapy Center Cluj S.R.L ( Site 4705)

    Comuna Floresti, Cluj, 407280

    Study Coordinator, +40219368

    Recruiting

  • Centrul de Oncologie "Sfântul Nectarie" ( Site 4702)

    Craiova, Dolj, 200542

    Study Coordinator, +40731604432

    Recruiting

  • Spitalul Municipal Schuller Ploiești ( Site 4707)

    Ploieşti, Prahova, 100337

    Study Coordinator, +40723943507

    Recruiting

  • Cabinet Medical Oncomed ( Site 4704)

    Timișoara, Timiș County, 300239

    Study Coordinator, +40356460995

    Recruiting

Other trials in Romania

Spain7 sites, 7 recruiting

  • Parc de Salut Mar - Hospital del Mar ( Site 4106)

    Barcelona, 08003

    Study Coordinator, 34932483860

    Recruiting

  • ICO L Hospitalet ( Site 4101)

    L'Hospitalet de Llobregat, Barcelona, 08908

    Study Coordinator, +34932607744

    Recruiting

  • Hospital Clinico San Carlos ( Site 4100)

    Madrid, Madrid, Comunidad de, 28040

    Study Coordinator, 34913303000/7768

    Recruiting

  • Hospital Beata María Ana ( Site 4105)

    Madrid, 28007

    Study Coordinator, 914097423/303

    Recruiting

  • Hospital Universitario Ramon y Cajal ( Site 4103)

    Madrid, 28034

    Study Coordinator, 913368263

    Recruiting

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 4104)

    Seville, Andalusia, 41013

    Study Coordinator, 34955013068

    Recruiting

  • Hospital General Universitario de Valencia ( Site 4102)

    Valencia, Valenciana, Comunitat, 46014

    Study Coordinator, 34963131800/438139

    Recruiting

Other trials in Spain

Brazil6 sites, 6 recruiting

  • Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 2307)

    Barretos, São Paulo, 14784-400

    Study Coordinator, +55 17 3321-6637

    Recruiting

  • Liga Norte Riograndense Contra o Cancer ( Site 2310)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +55 84 99817-0070

    Recruiting

  • Hospital Nossa Senhora da Conceição ( Site 2302)

    Porto Alegre, Rio Grande do Sul, 91350-200

    Study Coordinator, +55 51 35160954

    Recruiting

  • Hospital de Câncer de Recife ( Site 2300)

    Recife, Pernambuco, 50040-000

    Study Coordinator, +558132178084

    Recruiting

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 2301)

    São Jose Do Rio Preto, São Paulo, 15090-000

    Study Coordinator, +55 (17) 3201-5054

    Recruiting

  • IBCC - Núcleo de Pesquisa e Ensino ( Site 2306)

    São Paulo, 04014-002

    Study Coordinator, +55 11 4450 0300

    Recruiting

Other trials in Brazil

Chile6 sites, 6 recruiting

  • Biocenter ( Site 2009)

    Concepción, Biobio, 4070196

    Study Coordinator, +56412858421

    Recruiting

  • IC La Serena Research ( Site 2007)

    La Serena, Coquimbo Region, 1720430

    Study Coordinator, +56512386127

    Recruiting

  • Fundación Arturo López Pérez ( Site 2000)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, +56 9 6397 7440

    Recruiting

  • Clínica UC San Carlos de Apoquindo ( Site 2008)

    Santiago, Region M. de Santiago, 7620002

    Study Coordinator, +569 5504 3334

    Recruiting

  • Bradfordhill ( Site 2001)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56978878489

    Recruiting

  • ONCOCENTRO APYS ( Site 2005)

    Viña del Mar, Valparaiso, 2520598

    Study Coordinator, +56 9 92369820

    Recruiting

Other trials in Chile

Colombia6 sites, 5 recruiting

  • Centro Cancerologico del Caribe LTD ( Site 2209)

    Barranquilla, Atlántico, 080002

    Study Coordinator, +57 3132121774

    Recruiting

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2203)

    Bogotá, Bogota D.C., 110131

    Study Coordinator, +57 6017454421x90614

    Recruiting

  • Instituto Nacional de Cancerologia ( Site 2211)

    Bogotá, Bogota D.C., 111511

    Study Coordinator, +5714817000X4301

    Recruiting

  • Promotora Médica Las Américas S.A. ( Site 2206)

    Medellín, Antioquia, 050021

    Study Coordinator, +576043421010x1089

    Recruiting

  • IMAT S.A.S ( Site 2202)

    Montería, Departamento de Córdoba, 230002

    Active, not recruiting

  • Oncologos Del Occidente ( Site 2208)

    Pereira, Risaralda Department, 660001

    Study Coordinator, 573154208077

    Recruiting

Other trials in Colombia

Czechia6 sites, 6 recruiting

  • Masarykuv onkologicky ustav ( Site 3500)

    Brno, South Moravian, 656 53

    Study Coordinator, +420543134003

    Recruiting

  • Fakultni nemocnice Olomouc ( Site 3502)

    Olomouc, 77900

    Study Coordinator, +420588444295

    Recruiting

  • Fakultni nemocnice Ostrava ( Site 3505)

    Ostrava - Poruba, Moravian-Silesian Region, 708 52

    Study Coordinator, +420597372124

    Recruiting

  • Vseobecna fakultni nemocnice v Praze ( Site 3501)

    Prague, Praha 2, 128 00

    Study Coordinator, +420224966764

    Recruiting

  • Fakultni Thomayerova nemocnice ( Site 3506)

    Prague, 140 59

    Study Coordinator, +420261083733

    Recruiting

  • Fakultni nemocnice v Motole ( Site 3503)

    Prague, 150 06

    Study Coordinator, +420224434700

    Recruiting

Other trials in Czechia

Germany6 sites, 5 recruiting

  • HELIOS Klinikum Berlin-Buch ( Site 4303)

    Berlin, 13125

    Study Coordinator, +4930940153300

    Recruiting

  • Luisenkrankenhaus Düsseldorf ( Site 4305)

    Düsseldorf, North Rhine-Westphalia, 40235

    Completed

  • Universitatsklinikum Erlangen ( Site 4302)

    Erlangen, Bavaria, 91054

    Study Coordinator, +4991318544082

    Recruiting

  • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 4304)

    Essen, North Rhine-Westphalia, 45136

    Study Coordinator, +4920117433001

    Recruiting

  • Universitaetsklinikum Leipzig ( Site 4307)

    Leipzig, Saxony, 04103

    Study Coordinator, +4934197109

    Recruiting

  • Caritas Klinikum Saarbruecken St. Theresia ( Site 4301)

    Saarbrücken, Saarland, 66113

    Study Coordinator, +496814061345

    Recruiting

Other trials in Germany

Hungary6 sites, 6 recruiting

  • Budapesti Uzsoki Utcai Kórház-Onkoradiológiai Osztály ( Site 3408)

    Budapest, Pest County, 1145

    Study Coordinator, +36 1 467-3700/1245

    Recruiting

  • Semmelweis Egyetem-Belgyógyászati és Onkológiai Klinika ( Site 3404)

    Budapest, 1082

    Study Coordinator, +36 20 825 1756

    Recruiting

  • Országos Onkológiai Intézet-B-Belgyógyászati Onkológiai Osztály ( Site 3406)

    Budapest, 1122

    Study Coordinator, +36122486003352

    Recruiting

  • Debreceni Egyetem Klinikai Kozpont ( Site 3411)

    Debrecen, 4032

    Study Coordinator, +3652255840

    Recruiting

  • Békés Vármegyei Központi Kórház Pándy Kálmán Tagkórház-Megyei Onkológiai Centrum ( Site 3405)

    Gyula, Bekes County, 5700

    Study Coordinator, +36 66/526-526

    Recruiting

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 3407)

    Szeged, Csongrád megye, 6720

    Study Coordinator, +3662545404

    Recruiting

Other trials in Hungary

South Korea6 sites, 6 recruiting

  • Kyungpook National University Chilgok Hospital ( Site 5205)

    Daegu, Taegu-Kwangyokshi, 41404

    Study Coordinator, 82532002625

    Recruiting

  • National Cancer Center ( Site 5202)

    Goyang-si, Kyonggi-do, 10408

    Study Coordinator, +82319201623

    Recruiting

  • Seoul National University Bundang Hospital ( Site 5204)

    Seongnam, Kyonggi-do, 13620

    Study Coordinator, 82317877022

    Recruiting

  • Seoul National University Hospital ( Site 5200)

    Seoul, 03080

    Study Coordinator, +82220720850

    Recruiting

  • Severance Hospital Yonsei University Health System ( Site 5201)

    Seoul, 03722

    Study Coordinator, +82222288135

    Recruiting

  • Samsung Medical Center ( Site 5203)

    Seoul, 06351

    Study Coordinator, 82234106488

    Recruiting

Other trials in South Korea

Israel5 sites, 5 recruiting

  • Rambam Health Care Campus ( Site 3700)

    Haifa, 3109601

    Study Coordinator, +97247772688

    Recruiting

  • Shaare Zedek Medical Center ( Site 3704)

    Jerusalem, 9103102

    Study Coordinator, +97226555999

    Recruiting

  • Rabin Medical Center ( Site 3702)

    Petah Tikva, 4941492

    Study Coordinator, +97239377377

    Recruiting

  • Sheba Medical Center ( Site 3701)

    Ramat Gan, 5265601

    Study Coordinator, +97235303030

    Recruiting

  • Sourasky Medical Center ( Site 3703)

    Tel Aviv, 6423906

    Study Coordinator, +97236974444

    Recruiting

Other trials in Israel

Taiwan5 sites, 5 recruiting

  • Taichung Veterans General Hospital ( Site 5303)

    Taichung, 407

    Study Coordinator, +886-4-2359-2525

    Recruiting

  • National Cheng Kung University Hospital ( Site 5304)

    Tainan, 70403

    Study Coordinator, +886-6-235-3535

    Recruiting

  • National Taiwan University Hospital ( Site 5300)

    Taipei, 100225

    Study Coordinator, +886-2-23123456

    Recruiting

  • Mackay Memorial Hospital ( Site 5301)

    Taipei, 104

    Study Coordinator, +886-2-25433535

    Recruiting

  • Chang Gung Memorial Hospital ( Site 5302)

    Taoyuan, 333

    Study Coordinator, +886-3-328-1200

    Recruiting

Other trials in Taiwan

Belgium4 sites, 4 recruiting

  • ZAS Sint Augustinus ( Site 3102)

    Antwerp, Flanders, 2610

    Study Coordinator, 003234433759

    Recruiting

  • Ziekenhuis Oost Limburg ( Site 3105)

    Genk, Limburg, 3600

    Study Coordinator, 089 32 50 50

    Recruiting

  • AZ Maria Middelares ( Site 3103)

    Ghent, Oost-Vlaanderen, 9000

    Study Coordinator, +32 9 246 95 16

    Recruiting

  • UZ Gent ( Site 3101)

    Ghent, Oost-Vlaanderen, 9000

    Study Coordinator, 09 332 20 15

    Recruiting

Other trials in Belgium

Denmark4 sites, 4 recruiting

  • Aarhus Universitets hospital ( Site 3204)

    Aarhus, Central Jutland, 8200

    Study Coordinator, + 4578450000

    Recruiting

  • Rigshospitalet University Hospital ( Site 3201)

    Copenhagen, Capital Region, 2100

    Study Coordinator, +4535453545

    Recruiting

  • Herlev og Gentofte Hospital. ( Site 3205)

    Copenhagen, Capital Region, 2730

    Study Coordinator, +4538683868

    Recruiting

  • Odense Universitetshospital ( Site 3202)

    Odense, Region Syddanmark, 5000

    Study Coordinator, +4566113333

    Recruiting

Other trials in Denmark

Greece4 sites, 4 recruiting

  • Aretaieio Hospital ( Site 3900)

    Athens, Attica, 115 28

    Study Coordinator, 0030 2107286444

    Recruiting

  • University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 3903)

    Heraklion, Irakleio, 715 00

    Study Coordinator, 0030 2810392091

    Recruiting

  • General University Hospital of Larissa, Oncology Clinic ( Site 3902)

    Larissa, Thessaly, 411 10

    Study Coordinator, 0030 2413501636

    Recruiting

  • European Interbalkan Medical Center ( Site 3901)

    Thessaloniki, 570 01

    Study Coordinator, 0030 2313252011

    Recruiting

Other trials in Greece

Malaysia4 sites, 4 recruiting

  • Pantai Hospital Kuala Lumpur ( Site 5402)

    Kuala Lumpur, 59100

    Study Coordinator, +60322960888

    Recruiting

  • University Malaya Medical Centre ( Site 5403)

    Kuala Lumpur, 59100

    Study Coordinator, +60479492351

    Recruiting

  • Sarawak General Hospital ( Site 5400)

    Kuching, Sarawak, 93586

    Study Coordinator, +6082276820

    Recruiting

  • National Cancer Institute ( Site 5401)

    Putrajaya, Putrajaya, 62250

    Study Coordinator, +60388925418

    Recruiting

Other trials in Malaysia

Peru4 sites, 4 recruiting

  • Clínica Internacional - Sede San Borja ( Site 2604)

    Lima, 15036

    Study Coordinator, +51 992004083

    Recruiting

  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 2601)

    Lima, 15036

    Study Coordinator, +51 997881134

    Recruiting

  • Oncosalud ( Site 2600)

    Lima, 15036

    Study Coordinator, +5115137900

    Recruiting

  • Hospital Militar Central Coronel Luis Arias Schereiber ( Site 2603)

    Lima, 15076

    Study Coordinator, +5112443453

    Recruiting

Other trials in Peru

Finland3 sites, 3 recruiting

  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 3301)

    Helsinki, Uusimaa, 00029

    Study Coordinator, +358947174900

    Recruiting

  • Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 3304)

    Oulu, North Ostrobothnia, 90220

    Study Coordinator, +35883153038

    Recruiting

  • Tampereen yliopistollinen sairaala-Oncology ( Site 3302)

    Tampere, Pirkanmaa, 33520

    Study Coordinator, +358331166764

    Recruiting

Other trials in Finland

Philippines3 sites, 3 recruiting

  • THE MEDICAL CITY ILOILO ( Site 5704)

    Iloilo City, 5000

    Study Coordinator, +6333 3397340

    Recruiting

  • Mary Mediatrix Medical Center ( Site 5702)

    Lipa, Batangas, 4217

    Study Coordinator, (043) 773 6800

    Recruiting

  • Manila Doctors Hospital ( Site 5701)

    Manila, National Capital Region, 1000

    Study Coordinator, +639985311606

    Recruiting

Other trials in Philippines

Thailand3 sites, 3 recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 5800)

    Bangkoknoi, Bangkok, 10700

    Study Coordinator, +6624192938

    Recruiting

  • Songklanagarind hospital ( Site 5801)

    Hat Yai, Changwat Songkhla, 90110

    Study Coordinator, +6674451469

    Recruiting

  • Faculty of Medicine - Khon Kaen University ( Site 5802)

    Khon Kaen, 40002

    Study Coordinator, +6643363746

    Recruiting

Other trials in Thailand

Australia2 sites, 2 recruiting

  • Blacktown Hospital ( Site 5500)

    Blacktown, New South Wales, 2148

    Study Coordinator, +61298818000

    Recruiting

  • Peninsula Health Frankston Hospital ( Site 5501)

    Frankston, Victoria, 3199

    Study Coordinator, +61397848520

    Recruiting

Other trials in Australia

Hong Kong2 sites, 2 recruiting

  • Queen Mary Hospital ( Site 6000)

    Hong Kong, 000000

    Study Coordinator, 39103339

    Recruiting

  • Prince of Wales Hospital ( Site 6001)

    Hong Kong

    Study Coordinator, +852 3505 3555

    Recruiting

Other trials in Hong Kong

New Zealand2 sites, 2 recruiting

  • Bowen Icon Cancer Centre ( Site 5601)

    Crofton Downs, Wellington Region, 6035

    Study Coordinator, +64 9 479 2069

    Recruiting

  • Harbour Cancer & Wellness ( Site 5600)

    Newmarket, Auckland, 1023

    Study Coordinator, +64 9 220 3333

    Recruiting

Other trials in New Zealand

About this study

Official title: A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.

Being tested
Sacituzumab tirumotecan, Pembrolizumab, Rescue Medication, Paclitaxel, Nab-paclitaxel
Keywords
Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2), Antibody-drug conjugate (ADC), Trophoblast cell-surface antigen 2 (TROP2)
Medical subject headings
Triple Negative Breast Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab tirumotecanBiological

    Also called Sac-TMT, MK-2870

    IV Infusion

  • PembrolizumabBiological

    Also called MK-3475, Keytruda®

    IV Infusion

  • Rescue MedicationDrug

    Participants receive the following pre-medications before sacituzumab tirumotecan infusion: Histamine-1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion. Participants are also recommended to receive prophylactic steroid mouthwash (dexamethasone or equivalent).

  • PaclitaxelDrug

    Also called Taxol, Onxol

    IV Infusion

  • Nab-paclitaxelDrug

    Also called Abraxane

    IV Infusion

  • GemcitabineDrug

    Also called Gemzar

    IV Infusion

  • CarboplatinDrug

    Also called Paraplatin

    IV Infusion

Study groups in NCT06841354
Study groupRoleWhat they receive
Arm A: Sacituzumab TirumotecanExperimentalParticipants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) until disease progression, toxicity or discontinuation.
Receives: Biological: Sacituzumab tirumotecan; Drug: Rescue Medication
Arm B: Sacituzumab Tirumotecan + PembrolizumabExperimentalParticipants receive sacituzumab tirumotecan IV 4 mg/kg Q2W until disease progression, toxicity or discontinuation PLUS pembrolizumab IV 400 mg every 6 weeks (Q6W) for up to 18 administrations (up to ~2 years).
Receives: Biological: Sacituzumab tirumotecan; Biological: Pembrolizumab; Drug: Rescue Medication
Arm C: Treatment of Physician's Choice (TPC)Active comparatorParticipants receive physician's choice of chemotherapy agent(s): paclitaxel IV 80 mg/m^2 once every week (Q1W) OR paclitaxel IV 90 mg/m^2 on Days 1, 8, and 15, every 4 weeks (Q4W) OR nab-paclitaxel IV 100 mg/m^2 on Days 1, 8, and 15, Q4W OR gemcitabine IV 1000 mg/m^2 on Days 1 and 8, every 3 weeks (Q3W) PLUS carboplatin IV area under the curve (AUC) 2 mg/mL/min on Days 1 and 8, Q3W, until disease progression, toxicity or discontinuation.
Receives: Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.

    Measured: Up to ~39 months

  2. Overall Survival (OS) (sac-TMT versus TPC)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to ~61 months

Secondary outcomes (11)

  1. Overall Survival (OS) (sac-TMT plus pembrolizumab versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus sac-TMT)

    OS is defined as the time from randomization to death due to any cause.

    Measured: Up to ~61 months

  2. Progression-Free Survival (PFS) (sac-TMT plus pembrolizumab versus sac-TMT)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.

    Measured: Up to ~39 months

  3. Objective Response Rate (ORR) (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based on BICR.

    Measured: Up to ~39 months

  4. Duration of Response (DOR)

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 based on BICR, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.

    Measured: Up to ~39 months

  5. Change from baseline in global health status/quality of life scores, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status.

    Measured: Baseline and up to ~61 months

  6. Change from baseline in physical functioning score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of physical functioning.

    Measured: Baseline and up to ~61 months

  7. Change from baseline in emotional functioning score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their emotional functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of emotional functioning.

    Measured: Baseline and up to ~61 months

  8. Change from baseline in fatigue score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)

    The EORTC QLQ-C30 is a 30-item questionnaire 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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better level of function.

    Measured: Baseline and up to ~61 months

  9. Change from baseline in diarrhea score, on the EORTC QLQ-C30 (sac-TMT versus TPC; sac-TMT plus pembrolizumab versus TPC)

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Have you had diarrhea?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better level of function.

    Measured: Baseline and up to ~61 months

  10. Number of participants who experience one or more adverse events (AEs)

    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.

    Measured: Up to ~61 months

  11. Number of participants who discontinue study treatment due to an AE

    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.

    Measured: Up to ~61 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2025
  2. Study start16 Mar 2025
  3. Primary completion18 May 2030 (estimated)
  4. Study completion18 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06841354
Sponsor's protocol ID
2870-011
Other IDs
MK-2870-011, TroFuse-011, 2024-516834-36-00, U1111-1311-2310
Status last verified
Oct 2026
First submitted
18 Feb 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Rugo HS, Schmid P, Cortes J, Takano T, Fasching PA, Park YH, Bianchini G, Franco SX, Villarreal-Garza C, Tredan O, Yin Y, Barroso-Sousa R, Peng X, Malhotra U, Smith KL, Bardia A. TroFuse-011 study design: sacituzumab tirumotecan with or without pembrolizumab for advanced triple-negative breast cancer with PD-L1 CPS <10. Future Oncol. 2026 Aug;22(18):2121-2129. doi: 10.1080/14796694.2026.2701483. Epub 2026 Jul 31.

    PubMed 42535874

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sacituzumab tirumotecan, Pembrolizumab and Rescue Medication in people with Triple Negative Breast Neoplasms, run by Merck Sharp & Dohme LLC at 283 sites in 35 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 283 sites in United States, Japan, China, Mexico, Canada and 30 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC) (time frame: Up to ~39 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06841354, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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