Taking people in United StatesPhase 3

Tests a drug combination after surgery in triple-negative breast cancer

Tests sacituzumab tirumotecan plus pembrolizumab in adults with breast cancer.

Key facts

Who runs it: Merck Sharp & Dohme LLC
Where: Abilene, Albuquerque, Alexandria, Altamonte Springs, Amarillo, Ann Arbor, Arlington Heights, Bismarck, Canton, Carterville, Chandler, Charlotte, Dallas, Detroit, Dyer, Edgewood, Fargo, Farmington, Fayetteville, Fenton, Flower Mound, Fort Wayne, Fort Worth, Fountain Valley, Fredericksburg, Germantown, Grand Forks, Grand Junction, Houston, Jackson, La Jolla, Laredo, Las Vegas, Los Alamitos, Madison, Massillon, Maumee, Memphis, Midlothian, Mobile, Monroe, Murray, Nashville, New Haven, New York, Newark, Norfolk, Oakland, Oceanside, Oklahoma City, Orlando, Osage Beach, Philadelphia, Portland, Richmond, Roseville, Royal Oak, Saint Louis Park, San Antonio, San Francisco, Santa Clara, Santa Fe, Santa Rosa, Shreveport, Silver Spring, Sioux Falls, Skokie, St Louis, St. Petersburg, Stuart, Tacoma, Thomasville, Tulsa, Tyler, Vallejo, Walnut Creek, Webster, Westbury, Wichita, York, and Zanesville, United StatesSee the 93 sitesAlso in 30 other countries, 223 sites
Trial code: NCT06393374
EU 2023-504962-52-00
JRCT2031240476
U1111-1289-8264
Registry title: Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
Status: Recruiting
Phase: Phase 3
People taking part: 1,530 people, planned
Started: 24 Jun 2024
Expected to end: 14 Dec 2037
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Pembrolizumab
Sacituzumab tirumotecan
Capecitabine
Record updated: 5 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with triple-negative breast cancer who had treatment before surgery and still had cancer found at surgery. It tests a new add-on treatment after surgery.

Age: 18 years or older
Sex: All sexes
Disease stage: Triple-negative breast cancer confirmed by a central lab, with cancer still found at surgery after treatment before surgery. No signs of the cancer coming back or spreading.
Earlier treatment: Must have had the KEYNOTE-522 treatment (pembrolizumab with chemotherapy) before surgery, then surgery. Randomization within 16 weeks of surgery. Radiation after surgery, if needed, must be finished. No other cancer treatment after surgery except radiation.
Biomarker or test result: Tissue from the surgery must be given for a central lab test of TROP2 status.

Main reasons for not taking part

Known germline BRCA mutation and able to receive adjuvant olaparib
Earlier treatment with a TROP2-directed antibody drug conjugate or a topoisomerase I inhibitor-containing antibody drug conjugate
Grade >2 peripheral neuropathy
Active inflammatory bowel disease, or a history of it
History of solid organ or allogeneic tissue transplant

The registry criteria, word for word

Show all 36 criteriaShow less

Who can take part

Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
Has no evidence of locoregional or distant relapse, as assessed by the treating physician
Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC
Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery
Has non-pathologic complete response at surgery
Is able to continue on adjuvant pembrolizumab
Randomization must be conducted within 16 weeks from surgical resection
Completed adjuvant radiation therapy (if indicated) and recovered before randomization
Has provided tissue from the surgical resection for central laboratory determination of trophoblast cell surface antigen 2 (TROP2) status
If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (120 days for sacituzumab tirumotecan and 95 days for capecitabine [no restriction for pembrolizumab]): agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception
For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for sacituzumab tirumotecan, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention
Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline (except alopecia)
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B birus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization

Who cannot take part

Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention
Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC
Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy
Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting sacituzumab tirumotecan is 2 weeks
Except for 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 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 concurrent active hepatitis B and hepatitis C virus infection
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
History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
Has known additional malignancy that is progressing or has required active treatment within the past 5 years
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 history of allogeneic tissue/solid organ transplant
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)
Has Grade >2 peripheral neuropathy

Where in United States

Also in 30 other countries, 223 sites

Hendrick Medical Center (Site 0117)Abilene, United StatesContact: Study CoordinatorTaking people
New Mexico Oncology Hematology Consultants Ltd. (Site 0090)Albuquerque, United StatesContact: Study CoordinatorTaking people
CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care (Site 0109)Alexandria, United StatesContact: Study CoordinatorTaking people
AdventHealth Altamonte Springs (Site 0125)Altamonte Springs, United StatesContact: Study CoordinatorTaking people
Harrington Cancer Center (Site 0061)Amarillo, United StatesContact: Study CoordinatorTaking people
University of Michigan (Site 0103)Ann Arbor, United StatesContact: Study CoordinatorTaking people
Illinois Cancer Specialists (ICS) (Site 8010)Arlington Heights, United StatesContact: Study CoordinatorTaking people
Sanford Cancer Center Bismarck (Site 0058)Bismarck, United StatesContact: Study CoordinatorTaking people
Cleveland Clinic - Mercy Hospital (Site 0057)Canton, United StatesContact: Study CoordinatorTaking people
Southern Illinois Hospital Services (Site 9547)Carterville, United StatesContact: Study CoordinatorTaking people
Ironwood Cancer & Research Centers-Research (Site 0054)Chandler, United StatesContact: Study CoordinatorTaking people
Levine Cancer Institute (Site 0083)Charlotte, United StatesContact: Study CoordinatorTaking people
Parkland Health & Hospital System (Site 0096)Dallas, United StatesContact: Study CoordinatorTaking people
Texas Oncology - DFW (Site 8000)Dallas, United StatesContact: Study CoordinatorTaking people
University of Texas Southwestern Medical Center (Site 0032)Dallas, United StatesContact: Study CoordinatorTaking people
Henry Ford Health (Site 0010)Detroit, United StatesContact: Study CoordinatorTaking people
Northwest Cancer Center - Dyer Clinic (Site 0097)Dyer, United StatesContact: Study CoordinatorTaking people
Saint Elizabeth Medical Center Edgewood-Cancer Care Center (Site 0044)Edgewood, United StatesContact: Study CoordinatorTaking people
Sanford Fargo Medical Center-Roger Maris Cancer Center (Site 0056)Fargo, United StatesContact: Study CoordinatorTaking people
University of Connecticut Health Center (Site 0128)Farmington, United StatesContact: Study CoordinatorTaking people
Cape Fear Valley Health System (Site 0136)Fayetteville, United StatesContact: Study CoordinatorTaking people
SSM Health Cancer Care - Fenton (Site 0088)Fenton, United StatesContact: Toll Free NumberNo longer taking part
Texas Oncology - Northeast Texas (Site 8005)Flower Mound, United StatesContact: Study CoordinatorTaking people
Parkview Research Center at Parkview Regional Medical Center (Site 0011)Fort Wayne, United StatesContact: Study CoordinatorTaking people
John Peter Smith Hospital (Site 0106)Fort Worth, United StatesContact: Study CoordinatorTaking people
MemorialCare Orange Coast Medical Center (Site 9501)Fountain Valley, United StatesContact: Study CoordinatorTaking people
Hematology Oncology Associates of Fredericksburg (Site 9550)Fredericksburg, United StatesContact: Study CoordinatorTaking people
Mary Washington Hospital (Site 0129)Fredericksburg, United StatesContact: Study CoordinatorTaking people
West Cancer Center and Research Institute (Site 0084)Germantown, United StatesContact: Study CoordinatorTaking people
Altru Cancer Center (Site 0104)Grand Forks, United StatesContact: Study CoordinatorTaking people
Cancer Centers of Colorado St. Mary's Regional Hospital (Site 0046)Grand Junction, United StatesContact: Study CoordinatorTaking people
Oncology Consultants P.A. (Site 0107)Houston, United StatesContact: Study CoordinatorTaking people
University of Mississippi Medical Center (Site 0043)Jackson, United StatesContact: Study CoordinatorTaking people
Scripps Cancer Center (Site 0052)La Jolla, United StatesContact: Study CoordinatorTaking people
Laguna Clinical Research Associates LLC (Site 0068)Laredo, United StatesContact: Study CoordinatorTaking people
Comprehensive Cancer Centers of Nevada - Peak (Site 0047)Las Vegas, United StatesContact: Study CoordinatorTaking people
Optum Care Cancer Center (Site 9535)Las Vegas, United StatesContact: Study CoordinatorTaking people
Cancer and Blood Specialty Clinic (Site 0008)Los Alamitos, United StatesContact: Toll Free NumberNo longer taking part
SSM Health Dean Medical Group (Site 0087)Madison, United StatesContact: Study CoordinatorTaking people
Tri-County Hematology & Oncology Associates, Inc. (Site 0076)Massillon, United StatesContact: Study CoordinatorTaking people
Taylor Cancer Research Center (Site 9500)Maumee, United StatesContact: Study CoordinatorTaking people
Baptist Cancer Center (Site 0101)Memphis, United StatesContact: Study CoordinatorTaking people
Bon Secours Memorial Regional Medical Center-Oncology Research Department (Site 0020)Midlothian, United StatesContact: Study CoordinatorTaking people
Infirmary Cancer Care (Site 0001)Mobile, United StatesContact: Study CoordinatorTaking people
Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic (Site 0063)Monroe, United StatesContact: Toll Free NumberNo longer taking part
Intermountain Medical Center (Site 0113)Murray, United StatesContact: Study CoordinatorTaking people
One Oncology - Tennessee Oncology (Site 0098)Nashville, United StatesContact: Study CoordinatorTaking people
SCRI Oncology Partners (Site 7000)Nashville, United StatesContact: Study CoordinatorTaking people
Tennessee Oncology (Site 0111)Nashville, United StatesContact: Study CoordinatorTaking people
Vanderbilt Health One Hundred Oaks (Site 0042)Nashville, United StatesContact: Study CoordinatorTaking people
Nashville General Hospital (Site 0072)Nashville, United StatesContact: Toll Free NumberNo longer taking part
Yale Cancer Center (Site 0053)New Haven, United StatesContact: Study CoordinatorTaking people
Icahn School of Medicine at Mount Sinai (Site 0123)New York, United StatesContact: Study CoordinatorTaking people
Memorial Sloan Kettering Cancer Center (Site 0067)New York, United StatesContact: Study CoordinatorTaking people
The Blavatnik Family- Chelsea Medical Center at Mount Sinai (Site 0135)New York, United StatesContact: Study CoordinatorTaking people
Helen F. Graham Cancer Center & Research Institute (Site 0018)Newark, United StatesContact: Study CoordinatorTaking people
Virginia Oncology Associates (VOA) (Site 8008)Norfolk, United StatesContact: Study CoordinatorTaking people
Kaiser Permanente - Oakland (Site 0079)Oakland, United StatesContact: Study CoordinatorTaking people
Profound Research LLC (Site 0105)Oceanside, United StatesContact: Study CoordinatorTaking people
Hightower Clinical, LLC (Site 0085)Oklahoma City, United StatesContact: Toll Free NumberNo longer taking part
Orlando Health Cancer Institute (Site 0030)Orlando, United StatesContact: Study CoordinatorTaking people
Lake Regional Hospital (Site 0009)Osage Beach, United StatesContact: Study CoordinatorTaking people
Sidney Kimmel Cancer Center at Jefferson (Site 0049)Philadelphia, United StatesContact: Study CoordinatorTaking people
Providence Oncology and Hematology Care Clinic - Westside (Site 0126)Portland, United StatesContact: Study CoordinatorTaking people
Providence Portland Medical Center (Site 0116)Portland, United StatesContact: Study CoordinatorTaking people
Virginia Cancer Institute (Site 0034)Richmond, United StatesContact: Study CoordinatorTaking people
Kaiser Permanente - Roseville (Site 0081)Roseville, United StatesContact: Study CoordinatorTaking people
Profound Research LLC (Site 0074)Royal Oak, United StatesContact: Toll Free NumberNo longer taking part
Metro-Minnesota Community Clinical Oncology (Site 0031)Saint Louis Park, United StatesContact: Study CoordinatorTaking people
Mays Cancer Center (Site 0122)San Antonio, United StatesContact: Study CoordinatorTaking people
Kaiser Permanente - San Francisco (Site 0080)San Francisco, United StatesContact: Study CoordinatorTaking people
Kaiser Permanente - Santa Clara (Site 0082)Santa Clara, United StatesContact: Study CoordinatorTaking people
CHRISTUS St. Vincent Regional Cancer Center (Site 0118)Santa Fe, United StatesContact: Study CoordinatorTaking people
Providence Medical Foundation (Site 9543)Santa Rosa, United StatesContact: Study CoordinatorTaking people
Louisiana State University Health Sciences Shreveport (Site 0029)Shreveport, United StatesContact: Study CoordinatorTaking people
Holy Cross Hospital (Site 0069)Silver Spring, United StatesContact: Study CoordinatorTaking people
Sanford Cancer Center (Site 0059)Sioux Falls, United StatesContact: Study CoordinatorTaking people
Orchard Healthcare Research Inc. (Site 0014)Skokie, United StatesContact: Study CoordinatorTaking people
Siteman Cancer Center (Site 0099)St Louis, United StatesContact: Study CoordinatorTaking people
Comprehensive Hematology Oncology (Site 0091)St. Petersburg, United StatesContact: Toll Free NumberNo longer taking part
Cleveland Clinic Martin North Hospital (Site 0114)Stuart, United StatesContact: Study CoordinatorTaking people
Northwest Medical Specialties, PLLC (Site 0093)Tacoma, United StatesContact: Study CoordinatorTaking people
Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center (Site 0040)Thomasville, United StatesContact: Toll Free NumberNo longer taking part
Oklahoma Cancer Specialists and Research Institute, LLC (Site 0041)Tulsa, United StatesContact: Study CoordinatorTaking people
The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center (Site 0055)Tyler, United StatesContact: Study CoordinatorTaking people
Kaiser Permanente Vallejo Medical Center (Site 0060)Vallejo, United StatesContact: Study CoordinatorTaking people
Kaiser Permanente - Walnut Creek (Site 0078)Walnut Creek, United StatesContact: Study CoordinatorTaking people
Bass Medical Group (Site 0089)Walnut Creek, United StatesContact: Toll Free NumberNo longer taking part
Texas Oncology - Gulf Coast (Site 8009)Webster, United StatesContact: Study CoordinatorTaking people
Clinical Research Alliance (Site 0086)Westbury, United StatesContact: Study CoordinatorTaking people
Cancer Center of Kansas (Site 0004)Wichita, United StatesContact: Toll Free NumberNo longer taking part
Cancer Care Associates Of York (Site 9517)York, United StatesContact: Study CoordinatorTaking people
Genesis Healthcare System (Site 0025)Zanesville, United StatesContact: Study CoordinatorTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

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

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record

Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).

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

Plain-language title

Tests a drug combination after surgery in triple-negative breast cancerGenerated from the registry record. The registry title is the official one.

AI summary

From the trial's eligibility criteria. Read by machine on 12 November 2026.

Record updated

5 November 2026