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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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.
314 sites in 31 countries
United States93 sites, 83 recruiting
- 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
- Completed
SSM Health Cancer Care - Fenton ( Site 0088)
Fenton, Missouri, 63026
- Recruiting
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
- Completed
Cancer and Blood Specialty Clinic ( Site 0008)
Los Alamitos, California, 90720
- Recruiting
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
- Completed
Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0063)
Monroe, Louisiana, 71202
- Recruiting
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
- Completed
Nashville General Hospital ( Site 0072)
Nashville, Tennessee, 37208
- Recruiting
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
- Completed
Hightower Clinical, LLC ( Site 0085)
Oklahoma City, Oklahoma, 73102
- Recruiting
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
- Completed
Profound Research LLC ( Site 0074)
Royal Oak, Michigan, 48073
- Recruiting
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
- Completed
Comprehensive Hematology Oncology ( Site 0091)
St. Petersburg, Florida, 33709
- Recruiting
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
- Completed
Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040)
Thomasville, Georgia, 31792
- Recruiting
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
- Completed
Bass Medical Group ( Site 0089)
Walnut Creek, California, 94598
- Recruiting
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
- Completed
Cancer Center of Kansas ( Site 0004)
Wichita, Kansas, 67214
- Recruiting
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
Japan26 sites, 26 recruiting
- 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
Canada18 sites, 17 recruiting
- 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
- Completed
Southlake Health ( Site 0413)
Newmarket, Ontario, L3Y 2P9
- Recruiting
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
France18 sites, 17 recruiting
- 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
- Completed
CHU Besançon ( Site 1311)
Besançon, Doubs, 25000
- Recruiting
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
Germany17 sites, 17 recruiting
- 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
Italy14 sites, 14 recruiting
- 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
Spain10 sites, 10 recruiting
- 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
Poland9 sites, 7 recruiting
- Completed
Bialostockie Centrum Onkologii ( Site 2105)
Bialystok, Podlaskie Voivodeship, 15-027
- Recruiting
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
- Completed
Narodowy Instytut Onkologii - Oddzial w Gliwicach-Centrum Diagnostyki i Leczenia Chorob Piersi ( Site 2110)
Gliwice, Silesian Voivodeship, 44-102
- Recruiting
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
Brazil8 sites, 8 recruiting
- 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
Argentina7 sites, 7 recruiting
- 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
United Kingdom7 sites, 7 recruiting
- 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
Czechia6 sites, 6 recruiting
- 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
Denmark6 sites, 6 recruiting
- 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
Greece6 sites, 6 recruiting
- 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
Israel6 sites, 6 recruiting
- 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
Mexico6 sites, 6 recruiting
- 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
Sweden6 sites, 6 recruiting
- 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
Austria5 sites, 5 recruiting
- 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
South Korea5 sites, 5 recruiting
- 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
Switzerland5 sites, 4 recruiting
- Completed
Kantonsspital Graubünden-Medizin ( Site 2404)
Chur, Kanton Graubünden, 7000
- Recruiting
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
Turkey (Türkiye)5 sites, 5 recruiting
- 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
Australia4 sites, 4 recruiting
- 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
Colombia4 sites, 4 recruiting
- 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
Finland4 sites, 4 recruiting
- 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
Portugal4 sites, 4 recruiting
- 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
Belgium3 sites, 3 recruiting
- 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
Hong Kong3 sites, 3 recruiting
- 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
Ireland3 sites, 3 recruiting
- 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
Norway3 sites, 3 recruiting
- 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
Malaysia2 sites, 2 recruiting
- 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
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre Singapore-Medical Oncology ( Site 3002)
Singapore, Central Singapore, 168583
Study Coordinator, +6564368000
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.
- Conditions
- Triple-Negative Breast Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Pembrolizumab + sacituzumab tirumotecan | Experimental | Participants receive pembrolizumab every 6 weeks (q6w) in combination with sacituzumab tirumotecan every 2 weeks (q2w) for 24 weeks. In addition, participants receive an antihistamine, an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to sacituzumab tirumotecan infusions. Receives: Biological: Pembrolizumab; Biological: Sacituzumab tirumotecan |
| Treatment of Physician's Choice | Active comparator | Participants receive pembrolizumab q6w or pembrolizumab q6w in combination with capecitabine (twice daily [BID] on Days 1 to 14 and 22 to 35 every 42 days x 4 [2 weeks 1, 1 week off]) for 24 weeks. Receives: Biological: Pembrolizumab; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Measured: Up to ~101 months
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
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
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
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
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
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
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.
- First posted1 May 2024
- Study start24 Jun 2024
- Primary completion16 Dec 2030 (estimated)
- Study completion14 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06393374
- Acronym / sponsor ID
- 2870-012
- Conditions
- Triple-Negative Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,530 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 16 Dec 2030 (estimated)
- Study completion
- 14 Dec 2037 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab + sacituzumab tirumotecan | Experimental | Biological: Pembrolizumab, Biological: Sacituzumab tirumotecanParticipants receive pembrolizumab every 6 weeks (q6w) in combination with sacituzumab tirumotecan every 2 weeks (q2w) for 24 weeks. In addition, participants receive an antihistamine, an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to sacituzumab tirumotecan infusions. |
| Treatment of Physician's Choice | Active comparator | Biological: Pembrolizumab, Drug: CapecitabineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabAlso: KEYTRUDA®, MK-3475, SCH 900475Pembrolizumab 400 mg intravenous (IV) infusion q6w | Biological | Pembrolizumab + sacituzumab tirumotecan, Treatment of Physician's Choice |
| Sacituzumab tirumotecanAlso: MK-2870Sacituzumab tirumotecan 4 mg/kg IV infusion q2w | Biological | Pembrolizumab + sacituzumab tirumotecan |
| CapecitabineAlso: XELODACapecitabine 1000 mg/m^2 to 1250 mg/m^2 by mouth BID | Drug | Treatment of Physician's Choice |
Primary outcome
Invasive Disease-Free Survival (iDFS)
Time frame: Up to ~77 months
iDFS is the time from randomization to invasive local, regional, or distant recurrence, invasive contralateral breast cancer, or death due to any cause, whichever occurs first.
8 secondary outcomes
Overall Survival (OS)
Time frame: Up to ~101 months
Distant recurrence-free survival (DRFS)
Time frame: Up to ~101 months
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
Time frame: Baseline and up to ~60 months
Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
Time frame: Baseline and up to ~60 months
Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
Time frame: Baseline and up to ~60 months
Change from baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score
Time frame: Baseline and up to ~60 months
Number of participants who experience one or more adverse events (AEs)
Time frame: Up to ~42 weeks
Number of participants who discontinue study intervention due to an AE
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Merck Sharp & Dohme LLC
314 sites in 31 countries: see every site and its status.
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?
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.