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NCT06393374From ClinicalTrials.govRecruiting

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

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

  • Triple-Negative Breast Cancer

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
1,530
Started
24 June 2024
Main results due
16 December 2030
Study sites
311
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

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

Exclusion Criteria:

* Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available
* Has Grade \>2 peripheral neuropathy
* History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention
* Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC
* Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy
* Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting sacituzumab tirumotecan is 2 weeks
* Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein-4 \[CTLA-4\], OX-40 \[cluster of differentiation (CD) 134\], or CD137)
* Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
* Received prior radiotherapy within 3 weeks of start of study intervention or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has known additional malignancy that is progressing or has required active treatment within the past 5 years
* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
* Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has active infection requiring systemic therapy
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has concurrent active hepatitis B and hepatitis C virus infection
* Has history of allogeneic tissue/solid organ transplant

What this study is about

In the sponsor’s own words, from the registry.

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 sites(311)

  • Infirmary Cancer Care ( Site 0001)

    Mobile, Alabama, United States

    Recruiting

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

    Chandler, Arizona, United States

    Recruiting

  • MemorialCare Orange Coast Medical Center ( Site 9501)

    Fountain Valley, California, United States

    Recruiting

  • Scripps Cancer Center ( Site 0052)

    La Jolla, California, United States

    Recruiting

  • Cancer and Blood Specialty Clinic ( Site 0008)

    Los Alamitos, California, United States

    Completed

  • Kaiser Permanente - Oakland ( Site 0079)

    Oakland, California, United States

    Recruiting

  • Profound Research LLC ( Site 0105)

    Oceanside, California, United States

    Recruiting

  • Kaiser Permanente - Roseville ( Site 0081)

    Roseville, California, United States

    Recruiting

  • Kaiser Permanente - San Francisco ( Site 0080)

    San Francisco, California, United States

    Recruiting

  • Kaiser Permanente - Santa Clara ( Site 0082)

    Santa Clara, California, United States

    Recruiting

  • Providence Medical Foundation ( Site 9543)

    Santa Rosa, California, United States

    Recruiting

  • Kaiser Permanente Vallejo Medical Center ( Site 0060)

    Vallejo, California, United States

    Recruiting

  • Kaiser Permanente - Walnut Creek ( Site 0078)

    Walnut Creek, California, United States

    Recruiting

  • Bass Medical Group ( Site 0089)

    Walnut Creek, California, United States

    Completed

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

    Grand Junction, Colorado, United States

    Recruiting

  • University of Connecticut Health Center ( Site 0128)

    Farmington, Connecticut, United States

    Recruiting

  • Yale Cancer Center ( Site 0053)

    New Haven, Connecticut, United States

    Recruiting

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

    Newark, Delaware, United States

    Recruiting

  • AdventHealth Altamonte Springs ( Site 0125)

    Altamonte Springs, Florida, United States

    Recruiting

  • Orlando Health Cancer Institute ( Site 0030)

    Orlando, Florida, United States

    Recruiting

  • Comprehensive Hematology Oncology ( Site 0091)

    St. Petersburg, Florida, United States

    Recruiting

  • Cleveland Clinic Martin North Hospital ( Site 0114)

    Stuart, Florida, United States

    Recruiting

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

    Thomasville, Georgia, United States

    Completed

  • Illinois Cancer Specialists (ICS) ( Site 8010)

    Arlington Heights, Illinois, United States

    Recruiting

  • Southern Illinois Hospital Services ( Site 9547)

    Carterville, Illinois, United States

    Recruiting

  • Orchard Healthcare Research Inc. ( Site 0014)

    Skokie, Illinois, United States

    Recruiting

  • Northwest Cancer Center - Dyer Clinic ( Site 0097)

    Dyer, Indiana, United States

    Recruiting

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

    Fort Wayne, Indiana, United States

    Recruiting

  • Cancer Center of Kansas ( Site 0004)

    Wichita, Kansas, United States

    Completed

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

    Edgewood, Kentucky, United States

    Recruiting

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

    Alexandria, Louisiana, United States

    Recruiting

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

    Monroe, Louisiana, United States

    Completed

  • Louisiana State University Health Sciences Shreveport ( Site 0029)

    Shreveport, Louisiana, United States

    Recruiting

  • Holy Cross Hospital ( Site 0069)

    Silver Spring, Maryland, United States

    Recruiting

  • University of Michigan ( Site 0103)

    Ann Arbor, Michigan, United States

    Recruiting

  • Henry Ford Health ( Site 0010)

    Detroit, Michigan, United States

    Recruiting

  • Profound Research LLC ( Site 0074)

    Royal Oak, Michigan, United States

    Completed

  • Metro-Minnesota Community Clinical Oncology ( Site 0031)

    Saint Louis Park, Minnesota, United States

    Recruiting

  • University of Mississippi Medical Center ( Site 0043)

    Jackson, Mississippi, United States

    Recruiting

  • SSM Health Cancer Care - Fenton ( Site 0088)

    Fenton, Missouri, United States

    Completed

  • Lake Regional Hospital ( Site 0009)

    Osage Beach, Missouri, United States

    Recruiting

  • Siteman Cancer Center ( Site 0099)

    St Louis, Missouri, United States

    Recruiting

  • Optum Care Cancer Center ( Site 9535)

    Las Vegas, Nevada, United States

    Recruiting

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

    Las Vegas, Nevada, United States

    Recruiting

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

    Albuquerque, New Mexico, United States

    Recruiting

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

    Santa Fe, New Mexico, United States

    Recruiting

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

    New York, New York, United States

    Recruiting

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

    New York, New York, United States

    Recruiting

  • Memorial Sloan Kettering Cancer Center ( Site 0067)

    New York, New York, United States

    Recruiting

  • Clinical Research Alliance ( Site 0086)

    Westbury, New York, United States

    Recruiting

  • Levine Cancer Institute ( Site 0083)

    Charlotte, North Carolina, United States

    Recruiting

  • Cape Fear Valley Health System ( Site 0136)

    Fayetteville, North Carolina, United States

    Recruiting

  • Sanford Cancer Center Bismarck ( Site 0058)

    Bismarck, North Dakota, United States

    Recruiting

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

    Fargo, North Dakota, United States

    Recruiting

  • Altru Cancer Center ( Site 0104)

    Grand Forks, North Dakota, United States

    Recruiting

  • Cleveland Clinic - Mercy Hospital ( Site 0057)

    Canton, Ohio, United States

    Recruiting

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

    Massillon, Ohio, United States

    Recruiting

  • Taylor Cancer Research Center ( Site 9500)

    Maumee, Ohio, United States

    Recruiting

  • Genesis Healthcare System ( Site 0025)

    Zanesville, Ohio, United States

    Recruiting

  • Hightower Clinical, LLC ( Site 0085)

    Oklahoma City, Oklahoma, United States

    Completed

Showing 60 of 311 sites — filter to narrow it down. 297 of the 311 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06393374. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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