AzTrials
AzTrials

Triple-Negative Breast CancerPhase 3NCT06393374

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

A Phase 3 study testing Pembrolizumab, Sacituzumab tirumotecan and Capecitabine in people with Triple-Negative Breast Cancer, run by Merck Sharp & Dohme LLC at 314 sites in 31 countries.

Recruiting

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

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple-Negative Breast Cancer
What is being tested?
Pembrolizumab, Sacituzumab tirumotecan and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,530 participants
Where
314 sitesin 31 countries
Study dates
24 Jun 2024to 14 Dec 2037
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

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

314 sites in 31 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

314 sites in 31 countries

United States93 sites, 83 recruiting

  • Hendrick Medical Center ( Site 0117)

    Abilene, Texas, 79601

    Study Coordinator, 325-670-2000

    Recruiting

  • New Mexico Oncology Hematology Consultants Ltd. ( Site 0090)

    Albuquerque, New Mexico, 87109

    Study Coordinator, 505-842-8171

    Recruiting

  • CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0109)

    Alexandria, Louisiana, 71301

    Study Coordinator, 318-528-6976

    Recruiting

  • AdventHealth Altamonte Springs ( Site 0125)

    Altamonte Springs, Florida, 32701

    Study Coordinator, 407-834-5151

    Recruiting

  • Harrington Cancer Center ( Site 0061)

    Amarillo, Texas, 79106

    Study Coordinator, 806-359-4673

    Recruiting

  • University of Michigan ( Site 0103)

    Ann Arbor, Michigan, 48109

    Study Coordinator, 800-865-1125

    Recruiting

  • Illinois Cancer Specialists (ICS) ( Site 8010)

    Arlington Heights, Illinois, 60005

    Study Coordinator, 847-259-4482

    Recruiting

  • Sanford Cancer Center Bismarck ( Site 0058)

    Bismarck, North Dakota, 58501

    Study Coordinator, 701-323-5741

    Recruiting

  • Cleveland Clinic - Mercy Hospital ( Site 0057)

    Canton, Ohio, 44708

    Study Coordinator, 330-489-1274

    Recruiting

  • Southern Illinois Hospital Services ( Site 9547)

    Carterville, Illinois, 62918

    Study Coordinator, 618-549-0721

    Recruiting

  • Ironwood Cancer & Research Centers-Research ( Site 0054)

    Chandler, Arizona, 85224

    Study Coordinator, 480-821-2838

    Recruiting

  • Levine Cancer Institute ( Site 0083)

    Charlotte, North Carolina, 28204

    Study Coordinator, 980-442-3130

    Recruiting

  • Texas Oncology - DFW ( Site 8000)

    Dallas, Texas, 75246

    Study Coordinator, 214-370-1000

    Recruiting

  • Parkland Health & Hospital System ( Site 0096)

    Dallas, Texas, 75390

    Study Coordinator, 214-645-4673

    Recruiting

  • University of Texas Southwestern Medical Center ( Site 0032)

    Dallas, Texas, 75390

    Study Coordinator, 214-645-4673

    Recruiting

  • Henry Ford Health ( Site 0010)

    Detroit, Michigan, 48202

    Study Coordinator, 313-598-2556

    Recruiting

  • Northwest Cancer Center - Dyer Clinic ( Site 0097)

    Dyer, Indiana, 46311

    Study Coordinator, 615-785-5914

    Recruiting

  • Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0044)

    Edgewood, Kentucky, 41017

    Study Coordinator, 859-301-4000

    Recruiting

  • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0056)

    Fargo, North Dakota, 58102

    Study Coordinator, 701-234-2000

    Recruiting

  • University of Connecticut Health Center ( Site 0128)

    Farmington, Connecticut, 06030

    Study Coordinator, 860-679-2100

    Recruiting

  • Cape Fear Valley Health System ( Site 0136)

    Fayetteville, North Carolina, 28304

    Study Coordinator, 472-210-8847

    Recruiting

  • SSM Health Cancer Care - Fenton ( Site 0088)

    Fenton, Missouri, 63026

    Completed

  • Texas Oncology - Northeast Texas ( Site 8005)

    Flower Mound, Texas, 75028

    Study Coordinator, 972-537-4100

    Recruiting

  • Parkview Research Center at Parkview Regional Medical Center ( Site 0011)

    Fort Wayne, Indiana, 46845

    Study Coordinator, 260-266-6313

    Recruiting

  • John Peter Smith Hospital ( Site 0106)

    Fort Worth, Texas, 76104

    Study Coordinator, 817-702-8049

    Recruiting

  • MemorialCare Orange Coast Medical Center ( Site 9501)

    Fountain Valley, California, 92708

    Study Coordinator, 714-378-7000

    Recruiting

  • Mary Washington Hospital ( Site 0129)

    Fredericksburg, Virginia, 22405

    Study Coordinator, 540-300-6182

    Recruiting

  • Hematology Oncology Associates of Fredericksburg ( Site 9550)

    Fredericksburg, Virginia, 22408

    Study Coordinator, 540-371-0079

    Recruiting

  • West Cancer Center and Research Institute ( Site 0084)

    Germantown, Tennessee, 38138

    Study Coordinator, 901-683-0055

    Recruiting

  • Altru Cancer Center ( Site 0104)

    Grand Forks, North Dakota, 58201

    Study Coordinator, 701-780-5451

    Recruiting

  • Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0046)

    Grand Junction, Colorado, 81501

    Study Coordinator, 970-298-7500

    Recruiting

  • Oncology Consultants P.A. ( Site 0107)

    Houston, Texas, 77030

    Study Coordinator, 713-600-0900

    Recruiting

  • University of Mississippi Medical Center ( Site 0043)

    Jackson, Mississippi, 39216

    Study Coordinator, 601-984-5590

    Recruiting

  • Scripps Cancer Center ( Site 0052)

    La Jolla, California, 92037

    Study Coordinator, 800-727-4777

    Recruiting

  • Laguna Clinical Research Associates LLC ( Site 0068)

    Laredo, Texas, 78041

    Study Coordinator, 956-724-8543

    Recruiting

  • Optum Care Cancer Center ( Site 9535)

    Las Vegas, Nevada, 89102

    Study Coordinator, 702-724-8787

    Recruiting

  • Comprehensive Cancer Centers of Nevada - Peak ( Site 0047)

    Las Vegas, Nevada, 89128

    Study Coordinator, 702-609-9427

    Recruiting

  • Cancer and Blood Specialty Clinic ( Site 0008)

    Los Alamitos, California, 90720

    Completed

  • SSM Health Dean Medical Group ( Site 0087)

    Madison, Wisconsin, 53715

    Study Coordinator, 516-488-2918

    Recruiting

  • Tri-County Hematology & Oncology Associates, Inc. ( Site 0076)

    Massillon, Ohio, 44646

    Study Coordinator, 330-478-0001

    Recruiting

  • Taylor Cancer Research Center ( Site 9500)

    Maumee, Ohio, 43537

    Study Coordinator, 567-402-4501

    Recruiting

  • Baptist Cancer Center ( Site 0101)

    Memphis, Tennessee, 38120

    Study Coordinator, 901-226-3077

    Recruiting

  • Bon Secours Memorial Regional Medical Center-Oncology Research Department ( Site 0020)

    Midlothian, Virginia, 23114

    Study Coordinator, 804-893-8717

    Recruiting

  • Infirmary Cancer Care ( Site 0001)

    Mobile, Alabama, 36607

    Study Coordinator, 251-435-2273

    Recruiting

  • Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0063)

    Monroe, Louisiana, 71202

    Completed

  • Intermountain Medical Center ( Site 0113)

    Murray, Utah, 84107

    Study Coordinator, 801-507-3630

    Recruiting

  • One Oncology - Tennessee Oncology ( Site 0098)

    Nashville, Tennessee, 37203

    Study Coordinator, 615-986-4350

    Recruiting

  • SCRI Oncology Partners ( Site 7000)

    Nashville, Tennessee, 37203

    Study Coordinator, 615-329-7274

    Recruiting

  • Tennessee Oncology ( Site 0111)

    Nashville, Tennessee, 37203

    Study Coordinator, 615-986-4350

    Recruiting

  • Nashville General Hospital ( Site 0072)

    Nashville, Tennessee, 37208

    Completed

  • Vanderbilt Health One Hundred Oaks ( Site 0042)

    Nashville, Tennessee, 37212

    Study Coordinator, 800-811-8480

    Recruiting

  • Yale Cancer Center ( Site 0053)

    New Haven, Connecticut, 06510

    Study Coordinator, 203-688-4242

    Recruiting

  • The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0135)

    New York, New York, 10011

    Study Coordinator, 212-604-6000

    Recruiting

  • Icahn School of Medicine at Mount Sinai ( Site 0123)

    New York, New York, 10029

    Study Coordinator, 212-241-3300

    Recruiting

  • Memorial Sloan Kettering Cancer Center ( Site 0067)

    New York, New York, 10065

    Study Coordinator, 212-639-2000

    Recruiting

  • Helen F. Graham Cancer Center & Research Institute ( Site 0018)

    Newark, Delaware, 19713

    Study Coordinator, 302-366-1200

    Recruiting

  • Virginia Oncology Associates (VOA) ( Site 8008)

    Norfolk, Virginia, 23502

    Study Coordinator, 646-694-8125

    Recruiting

  • Kaiser Permanente - Oakland ( Site 0079)

    Oakland, California, 94611

    Study Coordinator, 877-642-4691

    Recruiting

  • Profound Research LLC ( Site 0105)

    Oceanside, California, 92056

    Study Coordinator, 760-826-2020

    Recruiting

  • Hightower Clinical, LLC ( Site 0085)

    Oklahoma City, Oklahoma, 73102

    Completed

  • Orlando Health Cancer Institute ( Site 0030)

    Orlando, Florida, 32806

    Study Coordinator, 321-843-8370

    Recruiting

  • Lake Regional Hospital ( Site 0009)

    Osage Beach, Missouri, 65065

    Study Coordinator, 573-302-2772

    Recruiting

  • Sidney Kimmel Cancer Center at Jefferson ( Site 0049)

    Philadelphia, Pennsylvania, 19107

    Study Coordinator, 215-955-8874

    Recruiting

  • Providence Portland Medical Center ( Site 0116)

    Portland, Oregon, 97213

    Study Coordinator, 503-215-1979

    Recruiting

  • Providence Oncology and Hematology Care Clinic - Westside ( Site 0126)

    Portland, Oregon, 97225

    Study Coordinator, 503-215-1979

    Recruiting

  • Virginia Cancer Institute ( Site 0034)

    Richmond, Virginia, 23229

    Study Coordinator, 804-287-3000

    Recruiting

  • Kaiser Permanente - Roseville ( Site 0081)

    Roseville, California, 95661

    Study Coordinator, 877-642-4691

    Recruiting

  • Profound Research LLC ( Site 0074)

    Royal Oak, Michigan, 48073

    Completed

  • Metro-Minnesota Community Clinical Oncology ( Site 0031)

    Saint Louis Park, Minnesota, 55426

    Study Coordinator, 952-993-3252

    Recruiting

  • Mays Cancer Center ( Site 0122)

    San Antonio, Texas, 78229

    Study Coordinator, 210-450-1000

    Recruiting

  • Kaiser Permanente - San Francisco ( Site 0080)

    San Francisco, California, 94115

    Study Coordinator, 877-642-4691

    Recruiting

  • Kaiser Permanente - Santa Clara ( Site 0082)

    Santa Clara, California, 95051

    Study Coordinator, 877-642-4691

    Recruiting

  • CHRISTUS St. Vincent Regional Cancer Center ( Site 0118)

    Santa Fe, New Mexico, 87505

    Study Coordinator, 505-913-8953

    Recruiting

  • Providence Medical Foundation ( Site 9543)

    Santa Rosa, California, 95403

    Study Coordinator, 707-528-1050

    Recruiting

  • Louisiana State University Health Sciences Shreveport ( Site 0029)

    Shreveport, Louisiana, 71103

    Study Coordinator, 318-813-1429

    Recruiting

  • Holy Cross Hospital ( Site 0069)

    Silver Spring, Maryland, 20910

    Study Coordinator, 301-754-7552

    Recruiting

  • Sanford Cancer Center ( Site 0059)

    Sioux Falls, South Dakota, 57104

    Study Coordinator, 605-328-8000

    Recruiting

  • Orchard Healthcare Research Inc. ( Site 0014)

    Skokie, Illinois, 60077

    Study Coordinator, 224-534-7580

    Recruiting

  • Siteman Cancer Center ( Site 0099)

    St Louis, Missouri, 63108

    Study Coordinator, 314-362-0263

    Recruiting

  • Comprehensive Hematology Oncology ( Site 0091)

    St. Petersburg, Florida, 33709

    Completed

  • Cleveland Clinic Martin North Hospital ( Site 0114)

    Stuart, Florida, 34994

    Study Coordinator, 772-419-2146

    Recruiting

  • Northwest Medical Specialties, PLLC ( Site 0093)

    Tacoma, Washington, 98405

    Study Coordinator, 253-428-8700

    Recruiting

  • Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040)

    Thomasville, Georgia, 31792

    Completed

  • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0041)

    Tulsa, Oklahoma, 74146

    Study Coordinator, 918-505-3200

    Recruiting

  • The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0055)

    Tyler, Texas, 75701

    Study Coordinator, 903-592-6152

    Recruiting

  • Kaiser Permanente Vallejo Medical Center ( Site 0060)

    Vallejo, California, 94589

    Study Coordinator, 877-642-4691

    Recruiting

  • Kaiser Permanente - Walnut Creek ( Site 0078)

    Walnut Creek, California, 94596

    Study Coordinator, 877-642-4691

    Recruiting

  • Bass Medical Group ( Site 0089)

    Walnut Creek, California, 94598

    Completed

  • Texas Oncology - Gulf Coast ( Site 8009)

    Webster, Texas, 77598

    Study Coordinator, 281-332-7505

    Recruiting

  • Clinical Research Alliance ( Site 0086)

    Westbury, New York, 11590

    Study Coordinator, 516-734-8906

    Recruiting

  • Cancer Center of Kansas ( Site 0004)

    Wichita, Kansas, 67214

    Completed

  • Cancer Care Associates Of York ( Site 9517)

    York, Pennsylvania, 17403

    Study Coordinator, 717-741-9229

    Recruiting

  • Genesis Healthcare System ( Site 0025)

    Zanesville, Ohio, 43701

    Study Coordinator, 740-454-5271

    Recruiting

Other trials in United States

Japan26 sites, 26 recruiting

  • Juntendo University Hospital ( Site 3408)

    Bunkyo, Tokyo, 113-8431

    Study Coordinator, +81-3-3813-3111

    Recruiting

  • St.Luke's International Hospital ( Site 3427)

    Chūō, Tokyo, 104-8560

    Study Coordinator, 03-3541-5151

    Recruiting

  • Fukushima Medical University Hospital ( Site 3401)

    Fukushima, 960-1295

    Study Coordinator, +81-24-547-1111

    Recruiting

  • Gifu University Hospital ( Site 3426)

    Gifu, 501-1194

    Study Coordinator, +81-58-230-6000

    Recruiting

  • Saitama Medical University International Medical Center ( Site 3402)

    Hidaka, Saitama, 350-1298

    Study Coordinator, +81-42-984-4111

    Recruiting

  • Hiroshima City Hiroshima Citizens Hospital ( Site 3418)

    Hiroshima, 730-8518

    Study Coordinator, +81-82-221-2291

    Recruiting

  • Tokai University Hospital ( Site 3413)

    Isehara, Kanagawa, 259-1193

    Study Coordinator, +81-463-93-1121

    Recruiting

  • Social medical corporation Hakuaikai Sagara Hospital ( Site 3421)

    Kagoshima, 892-0833

    Study Coordinator, +81-99-224-1800

    Recruiting

  • National Cancer Center Hospital East ( Site 3403)

    Kashiwa, Chiba, 277-8577

    Study Coordinator, +81-4-7133-1111

    Recruiting

  • St. Marianna University Hospital ( Site 3405)

    Kawasaki, Kanagawa, 216-8511

    Study Coordinator, +81-44-977-8111

    Recruiting

  • Cancer Institute Hospital of JFCR ( Site 3404)

    Koto, Tokyo, 135-8550

    Study Coordinator, +81-3-3520-0111

    Recruiting

  • Kumamoto University Hospital ( Site 3420)

    Kumamoto, 860-8556

    Study Coordinator, +81-96-344-2111

    Recruiting

  • Kyoto University Hospital ( Site 3415)

    Kyoto, 606-8507

    Study Coordinator, +81-75-751-3111

    Recruiting

  • Nagoya City University Hospital ( Site 3414)

    Nagoya, Aichi-ken, 467-8602

    Study Coordinator, +81-52-858-7215

    Recruiting

  • Okayama University Hospital ( Site 3425)

    Okayama, 700-8558

    Study Coordinator, +81-86-223-7151

    Recruiting

  • Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3417)

    Osaka, 541-8567

    Study Coordinator, +81-6-6945-1181

    Recruiting

  • Gunma Prefectural Cancer Center ( Site 3428)

    Ōta, Gunma, 373-8550

    Study Coordinator, +81-276-38-0771

    Recruiting

  • Kitasato University Hospital ( Site 3411)

    Sagamihara, Kanagawa, 252-0375

    Study Coordinator, +81-42-778-8111

    Recruiting

  • Hokkaido University Hospital ( Site 3400)

    Sapporo, Hokkaido, 060-8648

    Study Coordinator, +81-11-716-1161

    Recruiting

  • Tohoku University Hospital ( Site 3422)

    Sendai, Miyagi, 980-8574

    Study Coordinator, +81-22-717-7000

    Recruiting

  • Showa Medical University Hospital ( Site 3406)

    Shinagawa, Tokyo, 142-8666

    Study Coordinator, +81-3-3784-8000

    Recruiting

  • Tokyo Medical University Hospital ( Site 3407)

    Shinjuku, Tokyo, 160-0023

    Study Coordinator, +81-3-3342-6111

    Recruiting

  • National Center for Global Health and Medicine ( Site 3409)

    Shinjuku, Tokyo, 162-8655

    Study Coordinator, +81-3-3202-7181

    Recruiting

  • The University of Osaka Hospital ( Site 3416)

    Suita, Osaka, 565-0871

    Study Coordinator, +81-6-6210-8290

    Recruiting

  • Mie University Hospital ( Site 3423)

    Tsu, Mie-ken, 514-8507

    Study Coordinator, +81-59-231-5246

    Recruiting

  • Kanagawa Cancer Center ( Site 3412)

    Yokohama, Kanagawa, 241-8515

    Study Coordinator, +81-45-520-2222

    Recruiting

Other trials in Japan

Canada18 sites, 17 recruiting

  • Arthur J.E. Child Comprehensive Cancer Centre ( Site 0421)

    Calgary, Alberta, T2N 5G2

    Study Coordinator, 587-231-6050

    Recruiting

  • Cross Cancer Institute ( Site 0407)

    Edmonton, Alberta, T6G 1Z2

    Study Coordinator, 7804328956

    Recruiting

  • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0417)

    Greenfield Park, Quebec, J4V 2H1

    Study Coordinator, 4504665000x3226

    Recruiting

  • QEII Health Sciences Centre - Victoria General Site ( Site 0418)

    Halifax, Nova Scotia, B3H 2Y9

    Study Coordinator, 9024732160

    Recruiting

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0424)

    Hamilton, Ontario, L8V 5C2

    Study Coordinator, 905-387-9495

    Recruiting

  • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0422)

    Kingston, Ontario, K7L 2V7

    Study Coordinator, 613-549-6666

    Recruiting

  • The Moncton Hospital ( Site 0401)

    Moncton, New Brunswick, E1C 6Z8

    Study Coordinator, 5068575756

    Recruiting

  • CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0419)

    Montreal, Quebec, H1T 2M4

    Study Coordinator, 5142523400x6244

    Recruiting

  • Centre Hospitalier de l'Université de Montréal ( Site 0403)

    Montreal, Quebec, H2X 3E4

    Study Coordinator, 5148908000

    Recruiting

  • Jewish General Hospital ( Site 0416)

    Montreal, Quebec, H3T 1E2

    Study Coordinator, 5143405222x27562

    Recruiting

  • Southlake Health ( Site 0413)

    Newmarket, Ontario, L3Y 2P9

    Completed

  • The Ottawa Hospital - General Campus ( Site 0414)

    Ottawa, Ontario, K1H 8L6

    Study Coordinator, 6137377700x70208

    Recruiting

  • Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski ( Site 0409)

    Rimouski, Quebec, G5L 5T1

    Study Coordinator, 4187243000x8029

    Recruiting

  • North York General Hospital ( Site 0415)

    Toronto, Ontario, M2K 1E1

    Study Coordinator, 4167566000

    Recruiting

  • Princess Margaret Cancer Centre ( Site 0400)

    Toronto, Ontario, M5G 2M9

    Study Coordinator, 4169464501x2245

    Recruiting

  • Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0406)

    Trois-Rivières, Quebec, G8Z 3R9

    Study Coordinator, 8196973333x63238

    Recruiting

  • BC Cancer Vancouver ( Site 0404)

    Vancouver, British Columbia, V5Z 4E6

    Study Coordinator, 6048776000

    Recruiting

  • CancerCare Manitoba ( Site 0411)

    Winnipeg, Manitoba, R2H 2A6

    Study Coordinator, 2047872127

    Recruiting

Other trials in Canada

France18 sites, 17 recruiting

  • Institut de Cancérologie de l'Ouest ( Site 1316)

    Angers, Maine-et-Loire, 49055

    Study Coordinator, 02 41 35 27 00

    Recruiting

  • Centre Hospitalier de la Cote Basque ( Site 1315)

    Bayonne, Aquitaine, 64109

    Study Coordinator, +33559443762

    Recruiting

  • CHU Besançon ( Site 1311)

    Besançon, Doubs, 25000

    Completed

  • Clinique Tivoli Ducos ( Site 1322)

    Bordeaux, Gironde, 33000

    Study Coordinator, +33556116296

    Recruiting

  • CHRU Brest - Hopital Cavale Blanche ( Site 1304)

    Brest, Finistere, 29200

    Study Coordinator, +33230338161

    Recruiting

  • Centre François Baclesse ( Site 1318)

    Caen, Calvados, 14076

    Study Coordinator, +33231455050

    Recruiting

  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 1307)

    Clermont-Ferrand, Auvergne, 63011

    Study Coordinator, 0473278005

    Recruiting

  • Centre Georges François Leclerc ( Site 1312)

    Dijon, Cote-d Or, 21079

    Study Coordinator, 03 70 63 24 03

    Recruiting

  • Hôpital Privé Drôme-Ardèche ( Site 1301)

    Guilherand-Granges, Ardeche, 07500

    Study Coordinator, +33475756604

    Recruiting

  • Hôpital Franco-Britannique - Fondation Cognacq-Jay ( Site 1321)

    Levallois-Perret, Hauts-de-Seine, 92300

    Study Coordinator, +33147591915

    Recruiting

  • CENTRE LEON BERARD ( Site 1300)

    Lyon Cedex08, Auvergne-Rhône-Alpes, 69373

    Study Coordinator, +33478782644

    Recruiting

  • Institut Paoli-Calmettes ( Site 1309)

    Marseille, Bouches-du-Rhone, 13009

    Study Coordinator, +33491223611

    Recruiting

  • Centre Antoine-Lacassagne ( Site 1308)

    Nice, Alpes-Maritimes, 06189

    Study Coordinator, +33492031000

    Recruiting

  • Hôpital Tenon ( Site 1303)

    Paris, 75020

    Study Coordinator, +33156017825

    Recruiting

  • Centre Hospitalier de Pau ( Site 1302)

    Pau, Pyrenees-Atlantiques, 64046

    Study Coordinator, +33559726996

    Recruiting

  • Centre Henri Becquerel ( Site 1319)

    Rouen, Seine-Maritime, 76038

    Study Coordinator, 02 32 08 22 22

    Recruiting

  • Institut de Cancérologie de l'Ouest ( Site 1305)

    Saint-Herblain, Loire-Atlantique, 44805

    Study Coordinator, +33240679900

    Recruiting

  • Centre de Cancerologie Les Dentellieres ( Site 1306)

    Valenciennes, Nord, 59300

    Study Coordinator, +33327091010

    Recruiting

Other trials in France

Germany17 sites, 17 recruiting

  • Helios Klinikum Berlin-Buch-Klinik für Gynäkologie und Geburtshilfe ( Site 1413)

    Berlin, 13125

    Study Coordinator, +4930940113394

    Recruiting

  • Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1409)

    Düsseldorf, North Rhine-Westphalia, 40225

    Study Coordinator, +492118117506

    Recruiting

  • Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1400)

    Erlangen, Bavaria, 91054

    Study Coordinator, +4991318533553

    Recruiting

  • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinik für Senologie/ Brustzentrum ( Site 1401)

    Essen, North Rhine-Westphalia, 45136

    Study Coordinator, +4920117433005

    Recruiting

  • Praxis fuer interdisziplinaere Onkologie und Haematologie ( Site 1423)

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

    Study Coordinator, +49761386870

    Recruiting

  • Franziskus-Hospital Harderberg ( Site 1404)

    Georgsmarienhütte, Lower Saxony, 49124

    Study Coordinator, +495415022466

    Recruiting

  • Medizinische Hochschule Hannover ( Site 1419)

    Hanover, Lower Saxony, 30625

    Study Coordinator, +495115329545

    Recruiting

  • Universitätsklinikum Schleswig-Holstein ( Site 1411)

    Lübeck, Schleswig-Holstein, 23538

    Study Coordinator, +4945150041930

    Recruiting

  • Klinikum Ludwigsburg-Klinik für Geburtshilfe und Frauenheilkunde ( Site 1405)

    Ludwigsburg, Baden-Wurttemberg, 71640

    Study Coordinator, +4971419996433

    Recruiting

  • Universitätsmedizin Johannes Gutenberg Universität Mainz-Klinik und Poliklinik für Geburtshilfe und ( Site 1418)

    Mainz, Rhineland-Palatinate, 55131

    Study Coordinator, +496131172683

    Recruiting

  • Evangelisches Krankenhaus Bethesda Mönchengladbach-Brustzentrum Niederrhein ( Site 1406)

    Mönchengladbach, North Rhine-Westphalia, 41061

    Study Coordinator, +4921618493577

    Recruiting

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Frauenklinik Brustzentrum ( Site 1402)

    Munich, Bavaria, 80336

    Study Coordinator, +4989440034645

    Recruiting

  • Klinikum Ernst von Bergmann-Frauenklinik ( Site 1408)

    Potsdam, Brandenburg, 14467

    Study Coordinator, +493312415602

    Recruiting

  • CaritasKlinikum Saarbruecken St. Theresia ( Site 1410)

    Saarbrücken, Saarland, 66113

    Study Coordinator, +496814061345

    Recruiting

  • Klinikum Mutterhaus der Borromäerinnen ( Site 1420)

    Trier, Rhineland-Palatinate, 54290

    Study Coordinator, +4906519470

    Recruiting

  • Universitaetsklinikum Tuebingen-Frauenklinik ( Site 1415)

    Tübingen, Baden-Wurttemberg, 72076

    Study Coordinator, +4970712964226

    Recruiting

  • Marien Hospital Witten ( Site 1424)

    Witten, North Rhine-Westphalia, 58452

    Study Coordinator, +49 2302 1733290

    Recruiting

Other trials in Germany

Italy14 sites, 14 recruiting

  • CRO-IRCCS ( Site 1808)

    Aviano, Friuli Venezia Giulia, 33081

    Study Coordinator, +39 0434659253

    Recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1810)

    Bologna, 40138

    Study Coordinator, +39 0512144548

    Recruiting

  • Azienda Ospedaliera Spedali Civili di Brescia ( Site 1812)

    Brescia, Lombardy, 25123

    Study Coordinator, +390303996536

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi ( Site 1805)

    Florence, Tuscany, 50134

    Study Coordinator, +390057947264

    Recruiting

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1807)

    Meldola (FC), Forli-Cesena, 47014

    Study Coordinator, +39 0543 739100

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1801)

    Milan, Lombardy, 20133

    Study Coordinator, +390223902597

    Recruiting

  • Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1809)

    Milan, Lombardy, 20141

    Study Coordinator, 02 57489970

    Recruiting

  • Ospedale San Raffaele-Oncologia Medica ( Site 1814)

    Milan, 20132

    Study Coordinator, +390226436530

    Recruiting

  • Humanitas Istituto Clinico Catanese ( Site 1811)

    Misterbianco, Catania, 95045

    Study Coordinator, +39 9573390197

    Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori ( Site 1813)

    Monza, Lombardy, 20900

    Study Coordinator, +39 0392339037

    Recruiting

  • University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 1803)

    Naples, Campania, 80100

    Study Coordinator, +390817463772

    Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Clinica Sperimentale di Senologia ( Site 1800)

    Naples, Campania, 80131

    Study Coordinator, +3908117770442

    Recruiting

  • Azienda Ospedaliero Universitaria Maggiore della Carità-SCDU ONCOLOGIA ( Site 1804)

    Novara, 28100

    Study Coordinator, +3903213733822

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 1802)

    Rome, Lazio, 00168

    Study Coordinator, +390630158545

    Recruiting

Other trials in Italy

Spain10 sites, 10 recruiting

  • CHUAC-Hospital Teresa Herrera-MEDICAL ONCOLOGY ( Site 2307)

    A Coruña, La Coruna, 15006

    Study Coordinator, +34981178000

    Recruiting

  • Hospital Universitari Vall d'Hebron-Oncology ( Site 2300)

    Barcelona, 08035

    Study Coordinator, +34932746000/ 4691

    Recruiting

  • Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2305)

    L'Hospitalet de Llobregat, Barcelona, 08908

    Study Coordinator, +34 93 260 77 44

    Recruiting

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2301)

    Madrid, Madrid, Comunidad de, 28034

    Study Coordinator, +34913368263

    Recruiting

  • Hospital Beata María Ana-oncology ( Site 2309)

    Madrid, 28007

    Study Coordinator, +34914097423

    Recruiting

  • Hospital Clinico San Carlos-Oncology Department ( Site 2306)

    Madrid, 28040

    Study Coordinator, 34 913303000x7768

    Recruiting

  • HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2308)

    Majadahonda, Madrid, Comunidad de, 28222

    Study Coordinator, +34911917358

    Recruiting

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 2304)

    Seville, Andalusia, 41013

    Study Coordinator, 34955013068

    Recruiting

  • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 2303)

    Valencia, Valenciana, Comunitat, 46009

    Study Coordinator, +93663224875

    Recruiting

  • HOSPITAL CLINICO DE VALENCIA-Oncology ( Site 2302)

    Valencia, 46010

    Study Coordinator, +34961973583

    Recruiting

Other trials in Spain

Poland9 sites, 7 recruiting

  • Bialostockie Centrum Onkologii ( Site 2105)

    Bialystok, Podlaskie Voivodeship, 15-027

    Completed

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2102)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

    Study Coordinator, +48523743029

    Recruiting

  • Szpitale Pomorskie Sp. z o. o.-Oddział Onkologii Klinicznej ( Site 2113)

    Gdynia, Pomeranian Voivodeship, 81-519

    Study Coordinator, +48587260105

    Recruiting

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 2110)

    Gliwice, Silesian Voivodeship, 44-102

    Completed

  • Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 2118)

    Kielce, Świętokrzyskie Voivodeship, 25-734

    Study Coordinator, +48885997850

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 2120)

    Krakow, Lesser Poland Voivodeship, 31-115

    Study Coordinator, +48225462758

    Recruiting

  • Zachodniopomorskie Centrum Onkologii ( Site 2108)

    Szczecin, West Pomeranian Voivodeship, 71-730

    Study Coordinator, +48914251544

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii ( Site 2100)

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, +48225462486

    Recruiting

  • Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 2101)

    Wieliszew, Masovian Voivodeship, 05-135

    Study Coordinator, +48227661501

    Recruiting

Other trials in Poland

Brazil8 sites, 8 recruiting

  • PRONUTRIR-CLINICAL RESEARCH ( Site 0609)

    Fortaleza, Ceará, 60810-180

    Study Coordinator, +558530480533

    Recruiting

  • ANIMI - Unidade de Tratamento Oncologico ( Site 0616)

    Lages, Santa Catarina, 88501-001

    Study Coordinator, +55 49 33805241

    Recruiting

  • Hospital do Câncer Mãe de Deus ( Site 0604)

    Porto Alegre, Rio Grande do Sul, 90110-270

    Study Coordinator, +555133072943

    Recruiting

  • Instituto de Oncologia Saint Gallen ( Site 0614)

    Santa Cruz do Sul, Rio Grande do Sul, 96830-180

    Study Coordinator, +55513056-8686

    Recruiting

  • IBCC - Núcleo de Pesquisa e Ensino ( Site 0601)

    São Paulo, 04014-002

    Study Coordinator, +551144500300

    Recruiting

  • Instituto do Câncer Brasil - Unidade Taubaté ( Site 0608)

    Taubaté, São Paulo, 12030-200

    Study Coordinator, +551236318559

    Recruiting

  • Oncoclínica Oncologistas Associados-Clinical Research ( Site 0607)

    Teresina, Piauí, 64049-200

    Study Coordinator, +5586999007799

    Recruiting

  • Hospital Santa Rita de Cassia ( Site 0617)

    Vitória, Espírito Santo, 29043-260

    Study Coordinator, +55 027 99846-9004

    Recruiting

Other trials in Brazil

Argentina7 sites, 7 recruiting

  • Instituto de Oncología Angel H. Roffo ( Site 0503)

    Buenos Aires, Buenos Aires F.D., C1417

    Study Coordinator, 5491152375236

    Recruiting

  • Instituto Alexander Fleming-Alexander Fleming ( Site 0509)

    Buenos Aires, Buenos Aires F.D., C1426ANZ

    Study Coordinator, +5491138850425

    Recruiting

  • Sanatorio Finochietto ( Site 0513)

    Buenos Aires, C1187AAN

    Study Coordinator, +54 113752-8000

    Recruiting

  • Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0508)

    Buenos Aires, C1431FWO

    Study Coordinator, +54 9115596-3681

    Recruiting

  • Hospital Aleman-Oncology ( Site 0501)

    Capital Federal, Buenos Aires, C1118AAT

    Study Coordinator, +541148277000

    Recruiting

  • Hospital Británico de Buenos Aires-Oncology ( Site 0502)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB

    Study Coordinator, +54911563819972

    Recruiting

  • Sanatorio Parque ( Site 0512)

    Rosario, Santa Fe Province, S2000DSV

    Study Coordinator, 543414929663

    Recruiting

Other trials in Argentina

United Kingdom7 sites, 7 recruiting

  • University Hospitals Bristol NHS Foundation Trust ( Site 2601)

    Bristol, Bristol, City of, BS2 8ED

    Study Coordinator, 441173426733

    Recruiting

  • Western General Hospital ( Site 2607)

    Edinburgh, Midlothian, EH4 2XU

    Study Coordinator, 0300 123 1600

    Recruiting

  • Addenbrooke's Hospital ( Site 2609)

    Hills Road, Cambridgeshire, CB2 0QQ

    Study Coordinator, 01223216083

    Recruiting

  • St James's University Hospital-Leeds Cancer Centre ( Site 2608)

    Leeds, LS9 7TF

    Study Coordinator, 0113 243 3144

    Recruiting

  • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2602)

    London, London, City of, EC1A 7BE

    Study Coordinator, +44 20 7377 7000

    Recruiting

  • University College London Hospital ( Site 2604)

    London, London, City of, NW1 2PG

    Study Coordinator, +44 20 3456 7890

    Recruiting

  • The Royal Cornwall Hospital ( Site 2603)

    Truro, England, TR1 3LJ

    Study Coordinator, 01872258345

    Recruiting

Other trials in United Kingdom

Czechia6 sites, 6 recruiting

  • Masarykuv onkologicky ustav ( Site 1005)

    Brno, Brno-mesto, 656 53

    Study Coordinator, +420543134000

    Recruiting

  • Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 1007)

    České Budějovice, South Bohemian Region, 37001

    Study Coordinator, +420387875001

    Recruiting

  • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1006)

    Olomouc, Olomouc Region, 779 00

    Study Coordinator, +420588444295

    Recruiting

  • Vseobecna fakultni nemocnice v Praze-Onkologická klinika VFN ( Site 1002)

    Prague, Praha 2, 128 08

    Study Coordinator, +420224966763

    Recruiting

  • Fakultni Thomayerova nemocnice - Onkologicka klinika 1. LF UK a FTN ( Site 1008)

    Prague, Praha 4, 14059

    Study Coordinator, +420261083733

    Recruiting

  • Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1000)

    Prague, Praha 5, 150 06

    Study Coordinator, +420224434701

    Recruiting

Other trials in Czechia

Denmark6 sites, 6 recruiting

  • Aalborg Universitetshospital, Syd ( Site 3206)

    Aalborg, North Denmark, 9000

    Study Coordinator, +4597661400

    Recruiting

  • Aarhus Universitets hospital ( Site 3202)

    Aarhus N, Central Jutland, 8200

    Study Coordinator, +4578450000

    Recruiting

  • Herlev og Gentofte Hospital. ( Site 3203)

    Herlev, Capital Region, 2730

    Study Coordinator, 00 45 38689193

    Recruiting

  • Odense Universitetshospital ( Site 3201)

    Odense C, Region Syddanmark, 5000

    Study Coordinator, +4566113333

    Recruiting

  • Sygehus Soenderjylland ( Site 3204)

    Sønderborg, Region Syddanmark, 6400

    Study Coordinator, +4579970000

    Recruiting

  • Vejle Sygehus. ( Site 3205)

    Vejle, Region Syddanmark, 7100

    Study Coordinator, 00 45 79406060

    Recruiting

Other trials in Denmark

Greece6 sites, 6 recruiting

  • Errikos Dunant Hospital Center-1st Medical Oncology Dept. ( Site 1508)

    Athens, Attica, 115 26

    Study Coordinator, +302106972433

    Recruiting

  • Aretaieio Hospital Oncology Unit ( Site 1505)

    Athens, Attica, 115 28

    Study Coordinator, +302107286444

    Recruiting

  • University General Hospital of Larissa ( Site 1503)

    Larissa, Thessaly, 411 10

    Study Coordinator, +302413502785

    Recruiting

  • UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 1509)

    Pátrai, Achaia, 26504

    Study Coordinator, +302610999791

    Recruiting

  • European Interbalkan Medical Center ( Site 1502)

    Thessaloniki, 570 01

    Study Coordinator, +302313252011

    Recruiting

  • European Interbalkan Medical Center ( Site 1507)

    Thessaloniki, 570 01

    Study Coordinator, +302310390671

    Recruiting

Other trials in Greece

Israel6 sites, 6 recruiting

  • Soroka Medical Center-Oncology ( Site 1704)

    Beersheba, 8410101

    Study Coordinator, 0507425629

    Recruiting

  • Shaare Zedek Medical Center ( Site 1706)

    Jerusalem, 9103102

    Study Coordinator, +97226555999

    Recruiting

  • Hadassah Medical Center ( Site 1700)

    Jerusalem, 9112001

    Study Coordinator, +972-2-6778510

    Recruiting

  • Rabin Medical Center ( Site 1702)

    Petah Tikva, 4941492

    Study Coordinator, +972-3-9378076

    Recruiting

  • Sheba Medical Center-ONCOLOGY ( Site 1701)

    Ramat Gan, 5265601

    Study Coordinator, +972-35304436

    Recruiting

  • Sourasky Medical Center ( Site 1705)

    Tel Aviv, 6423906

    Study Coordinator, +972-3-6947557

    Recruiting

Other trials in Israel

Mexico6 sites, 6 recruiting

  • Grupo Médico ASSET SC ( Site 0705)

    Benito Juárez, Mexico City, 03100

    Study Coordinator, 5516217417

    Recruiting

  • CENEIT Oncologicos ( Site 0706)

    Mexico City, Mexico City, 03100

    Study Coordinator, 5514817472

    Recruiting

  • Health Pharma Professional Research S.A. de C.V: ( Site 0709)

    Mexico City, Mexico City, 03100

    Study Coordinator, +525575864856

    Recruiting

  • COI Centro Oncologico Internacional S.A.P.I. de C.V. ( Site 0712)

    Mexico City, Mexico City, 04700

    Study Coordinator, +528008773264

    Recruiting

  • Oncare - Unidad Valle ( Site 0713)

    San Pedro Garza García, Nuevo León, 66220

    Study Coordinator, +528182188555

    Recruiting

  • CENTRO MEDICO ZAMBRANO HELLION ( Site 0711)

    San Pedro Garza García, Nuevo León, 66278

    Study Coordinator, +528188880000

    Recruiting

Other trials in Mexico

Sweden6 sites, 6 recruiting

  • Södra Älvsborg Sjukhus ( Site 3502)

    Borås, Västra Götaland County, 501 82

    Study Coordinator, +46336161000

    Recruiting

  • Gävle sjukhus ( Site 3504)

    Gävle, Gävleborg County, 801 87

    Study Coordinator, +4626154000

    Recruiting

  • Sahlgrenska Universitetssjukhuset. ( Site 3505)

    Gothenburg, Västra Götaland County, 413 45

    Study Coordinator, +46313428503

    Recruiting

  • Capio St. Gorans Sjukhus ( Site 3503)

    Stockholm, Stockholm County, 112 81

    Study Coordinator, +46858701000

    Recruiting

  • Karolinska Universitetssjukhuset Solna ( Site 3500)

    Stockholm, Stockholm County, 171 76

    Study Coordinator, +46851770000

    Recruiting

  • Akademiska Sjukhuset ( Site 3501)

    Uppsala, Uppsala County, 751 85

    Study Coordinator, +46186110000

    Recruiting

Other trials in Sweden

Austria5 sites, 5 recruiting

  • Medizinische Universitaet Innsbruck ( Site 1200)

    Innsbruck, Tyrol, 6020

    Study Coordinator, +435050423079

    Recruiting

  • Kepler Universitätsklinikum-Department for Oncology and Hematology ( Site 1206)

    Linz, Upper Austria, 4020

    Study Coordinator, +43576808373652

    Recruiting

  • Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis ( Site 1202)

    Salzburg, 5020

    Study Coordinator, +435725525826

    Recruiting

  • Medizinische Universität Wien-Universitätsklinik für Innere Medizin I, Klinische Abteilung für Onko ( Site 1201)

    Vienna, 1090

    Study Coordinator, +4314040064470

    Recruiting

  • Klinikum Wels-Grieskirchen ( Site 1205)

    Wels, Upper Austria, 4600

    Study Coordinator, +4372424150

    Recruiting

Other trials in Austria

South Korea5 sites, 5 recruiting

  • Seoul National University Hospital-Internal Medicine ( Site 3102)

    Seoul, 03080

    Study Coordinator, +82-2-2072-0850

    Recruiting

  • Severance Hospital, Yonsei University Health System-Medical oncology ( Site 3100)

    Seoul, 03722

    Study Coordinator, +82-2-2228-8135

    Recruiting

  • Asan Medical Center-Department of Oncology ( Site 3103)

    Seoul, 05505

    Study Coordinator, +8-2-3010-3216

    Recruiting

  • Gangnam Severance Hospital, Yonsei University Health System-Medical Oncology, Internal Medicine ( Site 3104)

    Seoul, 06273

    Study Coordinator, +82-2-2019-3379

    Recruiting

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 3101)

    Seoul, 06351

    Study Coordinator, +82-2-3410-6488

    Recruiting

Other trials in South Korea

Switzerland5 sites, 4 recruiting

  • Kantonsspital Graubünden-Medizin ( Site 2404)

    Chur, Kanton Graubünden, 7000

    Completed

  • HFR Fribourg - Hôpital Cantonal ( Site 2402)

    Fribourg, 1708

    Study Coordinator, +41263062260

    Recruiting

  • Clinique Générale-Beaulieu ( Site 2406)

    Geneva, Canton of Geneva, 1206

    Study Coordinator, +41228395798

    Recruiting

  • Spital Thun ( Site 2400)

    Thun, Canton of Bern, 3600

    Study Coordinator, +41 58 636 22 27

    Recruiting

  • Brust-Zentrum ( Site 2401)

    Zurich, Canton of Zurich, 8008

    Study Coordinator, +41445338141

    Recruiting

Other trials in Switzerland

Turkey (Türkiye)5 sites, 5 recruiting

  • Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2501)

    Adana, 01140

    Study Coordinator, +90 322 459 2222

    Recruiting

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi-oncology ( Site 2504)

    Ankara, 06200

    Study Coordinator, 03123360909

    Recruiting

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 2502)

    Ankara, 06520

    Study Coordinator, +90 312 253 6666

    Recruiting

  • Medipol Mega Universite Hastanesi-oncology ( Site 2503)

    Istanbul, 34214

    Study Coordinator, 444 70 44 - 17067

    Recruiting

  • Samsun Medical Park Hastanesi-medical oncology ( Site 2500)

    Samsun, 55200

    Study Coordinator, 03623114040

    Recruiting

Other trials in Turkey (Türkiye)

Australia4 sites, 4 recruiting

  • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 2701)

    Brisbane, Queensland, 4029

    Study Coordinator, +610736470209

    Recruiting

  • Frankston Hospital-Oncology and Haematology ( Site 2704)

    Frankston, Victoria, 3199

    Study Coordinator, +61397847777

    Recruiting

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 2703)

    Macquarie University, New South Wales, 2109

    Study Coordinator, +61298122979

    Recruiting

  • Westmead Hospital ( Site 2700)

    Westmead, New South Wales, 2145

    Study Coordinator, +61288906728

    Recruiting

Other trials in Australia

Colombia4 sites, 4 recruiting

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 3700)

    Bogotá, Bogota D.C., 110131

    Study Coordinator, +573183662238

    Recruiting

  • Instituto Nacional De Cancerologia ( Site 3701)

    Bogotá, Bogota D.C., 111511

    Study Coordinator, 57 3145017596

    Recruiting

  • Clinica Somer ( Site 3704)

    Rionegro, Antioquia, 054040

    Study Coordinator, 57 3125891661

    Recruiting

  • Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 3705)

    Valledupar, Cesar Department, 200001

    Study Coordinator, +5715602310

    Recruiting

Other trials in Colombia

Finland4 sites, 4 recruiting

  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1100)

    Helsinki, Uusimaa, 00029

    Study Coordinator, +358947174900

    Recruiting

  • Kuopion Yliopistollinen Sairaala-Syöpäkeskus ( Site 1101)

    Kuopio, Northern Savonia, 70210

    Study Coordinator, +35817173311

    Recruiting

  • Tampereen yliopistollinen sairaala ( Site 1102)

    Tampere, Pirkanmaa, 33520

    Study Coordinator, +358331166764

    Recruiting

  • Turku University Hospital-Department of Oncology ( Site 1103)

    Turku, Southwest Finland, 20520

    Study Coordinator, +35823130721

    Recruiting

Other trials in Finland

Portugal4 sites, 4 recruiting

  • Unidade Local de Saude Amadora/Sintra - Hospital Prof Dr Fernando Fonseca ( Site 2203)

    Amadora, Lisbon District, 2720-276

    Study Coordinator, 00351214348200

    Recruiting

  • Fundacao Champalimaud ( Site 2200)

    Lisbon, 1400-038

    Study Coordinator, 00351210480200

    Recruiting

  • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 2201)

    Lisbon, 1649-035

    Study Coordinator, 00351217805000

    Recruiting

  • Instituto Portugues de Oncologia do Porto ( Site 2202)

    Porto, 4200-072

    Study Coordinator, 00351225084000

    Recruiting

Other trials in Portugal

Belgium3 sites, 3 recruiting

  • Cliniques universitaires Saint-Luc-Medical Oncology ( Site 0901)

    Brussels, Bruxelles-Capitale, Region de, 1200

    Study Coordinator, 02 764 42 14

    Recruiting

  • AZ Maria Middelares-IKG ( Site 0903)

    Ghent, Oost-Vlaanderen, 9000

    Study Coordinator, +3292468464

    Recruiting

  • Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0902)

    Namur, 5530

    Study Coordinator, +32 (0)81 42 38 53

    Recruiting

Other trials in Belgium

Hong Kong3 sites, 3 recruiting

  • Queen Mary Hospital ( Site 3600)

    Hong Kong

    Study Coordinator, +852 2255 3838

    Recruiting

  • Hong Kong United Oncology Centre ( Site 3601)

    Kowloon

    Study Coordinator, +852 2386 8002

    Recruiting

  • Prince of Wales Hospital ( Site 3602)

    Shatin, 000000

    Study Coordinator, + 852 3505 2211

    Recruiting

Other trials in Hong Kong

Ireland3 sites, 3 recruiting

  • Bon Secours Cork Hospital ( Site 1600)

    Cork, T12 DV56

    Study Coordinator, +353214542807

    Recruiting

  • St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1601)

    Dublin, D04 T6F4

    Study Coordinator, +353 1 221 4982

    Recruiting

  • University College Hospital - Galway ( Site 1602)

    Galway, Galway

    Study Coordinator, +35391524222

    Recruiting

Other trials in Ireland

Norway3 sites, 3 recruiting

  • Drammen Sykehus, Vestre Viken HF ( Site 2001)

    Drammen, Buskerud, 3004

    Study Coordinator, +4732803000

    Recruiting

  • Oslo universitetssykehus, Radiumhospitalet ( Site 2002)

    Oslo, 0379

    Study Coordinator, +4722934000

    Recruiting

  • Stavanger Universitetssykehus ( Site 2004)

    Stavanger, Rogaland, 4011

    Study Coordinator, +4751518000

    Recruiting

Other trials in Norway

Malaysia2 sites, 2 recruiting

  • Prince Court Medical Centre ( Site 2802)

    Kuala Lumpur, 50450

    Study Coordinator, +60321600000

    Recruiting

  • Pantai Hospital Kuala Lumpur ( Site 2801)

    Kuala Lumpur, 59100

    Study Coordinator, +60327814519

    Recruiting

Other trials in Malaysia

Singapore1 site, 1 recruiting

  • National Cancer Centre Singapore-Medical Oncology ( Site 3002)

    Singapore, Central Singapore, 168583

    Study Coordinator, +6564368000

    Recruiting

Other trials in Singapore

About this study

Official title: A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery

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.

Being tested
Pembrolizumab, Sacituzumab tirumotecan, Capecitabine
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

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

  • PembrolizumabBiological

    Also called KEYTRUDA®, MK-3475, SCH 900475

    Pembrolizumab 400 mg intravenous (IV) infusion q6w

  • Sacituzumab tirumotecanBiological

    Also called MK-2870

    Sacituzumab tirumotecan 4 mg/kg IV infusion q2w

  • CapecitabineDrug

    Also called XELODA

    Capecitabine 1000 mg/m^2 to 1250 mg/m^2 by mouth BID

Study groups in NCT06393374
Study groupRoleWhat they receive
Pembrolizumab + sacituzumab tirumotecanExperimentalParticipants 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.
Receives: Biological: Pembrolizumab; Biological: Sacituzumab tirumotecan
Treatment of Physician's ChoiceActive comparatorParticipants 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.
Receives: Biological: Pembrolizumab; Drug: Capecitabine

What is being measured

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

  1. Invasive Disease-Free Survival (iDFS)

    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.

    Measured: Up to ~77 months

Secondary outcomes (8)

  1. Overall Survival (OS)

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

    Measured: Up to ~101 months

  2. Distant recurrence-free survival (DRFS)

    DRFS is the time from randomization to distant recurrence or death due to any cause, whichever occurs first.

    Measured: Up to ~101 months

  3. 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

    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.

    Measured: Baseline and up to ~60 months

  4. Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score

    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.

    Measured: Baseline and up to ~60 months

  5. Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score

    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.

    Measured: Baseline and up to ~60 months

  6. Change from baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score

    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.

    Measured: Baseline and up to ~60 months

  7. 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 ~42 weeks

  8. Number of participants who discontinue study intervention 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 24 weeks

Timeline

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

  1. First posted1 May 2024
  2. Study start24 Jun 2024
  3. Primary completion16 Dec 2030 (estimated)
  4. Study completion14 Dec 2037 (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
1,530 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06393374
Sponsor's protocol ID
2870-012
Other IDs
2023-504962-52-00, U1111-1289-8264, jRCT2031240476, 2023
Status last verified
Oct 2026
First submitted
26 Apr 2024
Last updated
5 Nov 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab, Sacituzumab tirumotecan and Capecitabine in people with Triple-Negative Breast Cancer, run by Merck Sharp & Dohme LLC at 314 sites in 31 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 15 inclusion and 21 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 314 sites in United States, Japan, Canada, France, Germany and 26 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?

Invasive Disease-Free Survival (iDFS) (time frame: Up to ~77 months). 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 NCT06393374.

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 5 Nov 2026.

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