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RecruitingInterventionalPhase 3

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

NCT ID: NCT06393374Sponsor: Merck Sharp & Dohme LLCLast updated: 2026-06-08

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 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.

Arms & interventions

  • BiologicalPembrolizumab

    Pembrolizumab 400 mg intravenous (IV) infusion q6w

  • BiologicalSacituzumab tirumotecan

    Sacituzumab tirumotecan 4 mg/kg IV infusion q2w

  • DrugCapecitabine

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

Outcome measures

Primary

  • 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.

    Time frame: Up to ~77 months

Secondary

  • 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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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

Study locations (88)

Infirmary Cancer Care ( Site 0001)

Mobile, Alabama, 36607

Recruiting
Study Coordinator · Contact
251-435-2273

Ironwood Cancer & Research Centers-Research ( Site 0054)

Chandler, Arizona, 85224

Recruiting
Study Coordinator · Contact
480-821-2838

MemorialCare Orange Coast Medical Center ( Site 9501)

Fountain Valley, California, 92708

Recruiting
Study Coordinator · Contact
714-378-7000

Scripps Cancer Center ( Site 0052)

La Jolla, California, 92037

Recruiting
Study Coordinator · Contact
800-727-4777

Cancer and Blood Specialty Clinic ( Site 0008)

Los Alamitos, California, 90720

Completed

Kaiser Permanente - Oakland ( Site 0079)

Oakland, California, 94611

Recruiting
Study Coordinator · Contact
877-642-4691

Profound Research LLC ( Site 0105)

Oceanside, California, 92056

Recruiting
Study Coordinator · Contact
760-826-2020

Kaiser Permanente - Roseville ( Site 0081)

Roseville, California, 95661

Recruiting
Study Coordinator · Contact
877-642-4691

Kaiser Permanente - San Francisco ( Site 0080)

San Francisco, California, 94115

Recruiting
Study Coordinator · Contact
877-642-4691

Kaiser Permanente - Santa Clara ( Site 0082)

Santa Clara, California, 95051

Recruiting
Study Coordinator · Contact
877-642-4691

Providence Medical Foundation ( Site 9543)

Santa Rosa, California, 95403

Recruiting
Study Coordinator · Contact
707-528-1050

Kaiser Permanente Vallejo Medical Center ( Site 0060)

Vallejo, California, 94589

Recruiting
Study Coordinator · Contact
877-642-4691

Kaiser Permanente - Walnut Creek ( Site 0078)

Walnut Creek, California, 94596

Recruiting
Study Coordinator · Contact
877-642-4691

Bass Medical Group ( Site 0089)

Walnut Creek, California, 94598

Completed

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

Grand Junction, Colorado, 81501

Recruiting
Study Coordinator · Contact
970-298-7500

Yale Cancer Center ( Site 0053)

New Haven, Connecticut, 06510

Recruiting
Study Coordinator · Contact
203-688-4242

AdventHealth Altamonte Springs ( Site 0125)

Altamonte Springs, Florida, 32701

Recruiting
Study Coordinator · Contact
407-834-5151

Orlando Health Cancer Institute ( Site 0030)

Orlando, Florida, 32806

Recruiting
Study Coordinator · Contact
321-843-8370

Comprehensive Hematology Oncology ( Site 0091)

St. Petersburg, Florida, 33709

Recruiting
Study Coordinator · Contact
727-344-6569

Cleveland Clinic Martin North Hospital ( Site 0114)

Stuart, Florida, 34994

Recruiting
Study Coordinator · Contact
772-419-2146

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

Thomasville, Georgia, 31792

Completed

Illinois Cancer Specialists (ICS) ( Site 8010)

Arlington Heights, Illinois, 60005

Recruiting
Study Coordinator · Contact
847-259-4482

Orchard Healthcare Research Inc. ( Site 0014)

Skokie, Illinois, 60077

Recruiting
Study Coordinator · Contact
224-534-7580

Northwest Cancer Center - Dyer Clinic ( Site 0097)

Dyer, Indiana, 46311

Recruiting
Study Coordinator · Contact
615-785-5914

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

Fort Wayne, Indiana, 46845

Recruiting
Study Coordinator · Contact
260-266-6313

Cancer Center of Kansas ( Site 0004)

Wichita, Kansas, 67214

Completed

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

Edgewood, Kentucky, 41017

Recruiting
Study Coordinator · Contact
859-301-4000

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

Alexandria, Louisiana, 71301

Recruiting
Study Coordinator · Contact
318-528-6976

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

Monroe, Louisiana, 71202

Completed

Louisiana State University Health Sciences Shreveport ( Site 0029)

Shreveport, Louisiana, 71103

Recruiting
Study Coordinator · Contact
318-813-1429

Holy Cross Hospital ( Site 0069)

Silver Spring, Maryland, 20910

Recruiting
Study Coordinator · Contact
301-754-7552

University of Michigan ( Site 0103)

Ann Arbor, Michigan, 48109

Recruiting
Study Coordinator · Contact
800-865-1125

Profound Research LLC ( Site 0074)

Royal Oak, Michigan, 48073

Completed

Metro-Minnesota Community Clinical Oncology ( Site 0031)

Saint Louis Park, Minnesota, 55426

Recruiting
Study Coordinator · Contact
952-993-3252

University of Mississippi Medical Center ( Site 0043)

Jackson, Mississippi, 39216

Recruiting
Study Coordinator · Contact
601-984-5590

SSM Health Cancer Care - Fenton ( Site 0088)

Fenton, Missouri, 63026

Completed

Lake Regional Hospital ( Site 0009)

Osage Beach, Missouri, 65065

Recruiting
Study Coordinator · Contact
573-302-2772

Siteman Cancer Center ( Site 0099)

St Louis, Missouri, 63108

Recruiting
Study Coordinator · Contact
314-362-0263

Optum Care Cancer Center ( Site 9535)

Las Vegas, Nevada, 89102

Recruiting
Study Coordinator · Contact
702-724-8787

New Mexico Oncology Hematology Consultants Ltd. ( Site 0090)

Albuquerque, New Mexico, 87109

Recruiting
Study Coordinator · Contact
505-842-8171

CHRISTUS St. Vincent Regional Cancer Center ( Site 0118)

Santa Fe, New Mexico, 87505

Recruiting
Study Coordinator · Contact
505-913-8953

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

New York, New York, 10011

Recruiting
Study Coordinator · Contact
212-604-6000

Icahn School of Medicine at Mount Sinai ( Site 0123)

New York, New York, 10029

Recruiting
Study Coordinator · Contact
212-241-3300

Memorial Sloan Kettering Cancer Center ( Site 0067)

New York, New York, 10065

Recruiting
Study Coordinator · Contact
212-639-2000

Clinical Research Alliance ( Site 0086)

Westbury, New York, 11590

Recruiting
Study Coordinator · Contact
516-734-8906

Levine Cancer Institute ( Site 0083)

Charlotte, North Carolina, 28204

Recruiting
Study Coordinator · Contact
980-442-3130

Cape Fear Valley Health System ( Site 0136)

Fayetteville, North Carolina, 28304

Recruiting
Study Coordinator · Contact
472-210-8847

Sanford Cancer Center Bismarck ( Site 0058)

Bismarck, North Dakota, 58501

Recruiting
Study Coordinator · Contact
701-323-5741

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

Fargo, North Dakota, 58102

Recruiting
Study Coordinator · Contact
701-234-2000

Altru Cancer Center ( Site 0104)

Grand Forks, North Dakota, 58201

Recruiting
Study Coordinator · Contact
701-780-5451

Cleveland Clinic - Mercy Hospital ( Site 0057)

Canton, Ohio, 44708

Recruiting
Study Coordinator · Contact
330-489-1274

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

Massillon, Ohio, 44646

Recruiting
Study Coordinator · Contact
330-478-0001

Taylor Cancer Research Center ( Site 9500)

Maumee, Ohio, 43537

Recruiting
Study Coordinator · Contact
567-402-4501

Genesis Healthcare System ( Site 0025)

Zanesville, Ohio, 43701

Recruiting
Study Coordinator · Contact
740-454-5271

Hightower Clinical, LLC ( Site 0085)

Oklahoma City, Oklahoma, 73102

Recruiting
Study Coordinator · Contact
405-479-8331

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

Tulsa, Oklahoma, 74146

Recruiting
Study Coordinator · Contact
918-505-3200

Providence Portland Medical Center ( Site 0116)

Portland, Oregon, 97213

Recruiting
Study Coordinator · Contact
503-215-1979

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

Portland, Oregon, 97225

Recruiting
Study Coordinator · Contact
503-215-1979

Sidney Kimmel Cancer Center at Jefferson ( Site 0049)

Philadelphia, Pennsylvania, 19107

Recruiting
Study Coordinator · Contact
215-955-8874

Cancer Care Associates Of York ( Site 9517)

York, Pennsylvania, 17403

Recruiting
Study Coordinator · Contact
717-741-9229

Sanford Cancer Center ( Site 0059)

Sioux Falls, South Dakota, 57104

Recruiting
Study Coordinator · Contact
605-328-8000

West Cancer Center and Research Institute ( Site 0084)

Germantown, Tennessee, 38138

Recruiting
Study Coordinator · Contact
901-683-0055

Baptist Cancer Center ( Site 0101)

Memphis, Tennessee, 38120

Recruiting
Study Coordinator · Contact
901-226-3077

One Oncology - Tennessee Oncology ( Site 0098)

Nashville, Tennessee, 37203

Recruiting
Study Coordinator · Contact
615-986-4350

SCRI Oncology Partners ( Site 7000)

Nashville, Tennessee, 37203

Recruiting
Study Coordinator · Contact
615-329-7274

Tennessee Oncology ( Site 0111)

Nashville, Tennessee, 37203

Recruiting
Study Coordinator · Contact
615-986-4350

Nashville General Hospital ( Site 0072)

Nashville, Tennessee, 37208

Completed

Vanderbilt Health One Hundred Oaks ( Site 0042)

Nashville, Tennessee, 37212

Recruiting
Study Coordinator · Contact
800-811-8480

Hendrick Medical Center ( Site 0117)

Abilene, Texas, 79601

Recruiting
Study Coordinator · Contact
325-670-2000

Harrington Cancer Center ( Site 0061)

Amarillo, Texas, 79106

Recruiting
Study Coordinator · Contact
806-359-4673

Texas Oncology - DFW ( Site 8000)

Dallas, Texas, 75246

Recruiting
Study Coordinator · Contact
214-370-1000

Parkland Health & Hospital System ( Site 0096)

Dallas, Texas, 75390

Recruiting
Study Coordinator · Contact
214-645-4673

University of Texas Southwestern Medical Center ( Site 0032)

Dallas, Texas, 75390

Recruiting
Study Coordinator · Contact
214-645-4673

Texas Oncology - Northeast Texas ( Site 8005)

Flower Mound, Texas, 75028

Recruiting
Study Coordinator · Contact
972-537-4100

John Peter Smith Hospital ( Site 0106)

Fort Worth, Texas, 76104

Recruiting
Study Coordinator · Contact
817-702-8049

Oncology Consultants P.A. ( Site 0107)

Houston, Texas, 77030

Recruiting
Study Coordinator · Contact
713-600-0900

Laguna Clinical Research Associates LLC ( Site 0068)

Laredo, Texas, 78041

Recruiting
Study Coordinator · Contact
956-724-8543

Mays Cancer Center ( Site 0122)

San Antonio, Texas, 78229

Recruiting
Study Coordinator · Contact
210-450-1000

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

Tyler, Texas, 75701

Recruiting
Study Coordinator · Contact
903-592-6152

Texas Oncology - Gulf Coast ( Site 8009)

Webster, Texas, 77598

Recruiting
Study Coordinator · Contact
281-332-7505

Intermountain Medical Center ( Site 0113)

Murray, Utah, 84107

Recruiting
Study Coordinator · Contact
801-507-3630

Mary Washington Hospital ( Site 0129)

Fredericksburg, Virginia, 22405

Recruiting
Study Coordinator · Contact
540-300-6182

Hematology Oncology Associates of Fredericksburg ( Site 9550)

Fredericksburg, Virginia, 22408

Recruiting
Study Coordinator · Contact
540-371-0079

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

Midlothian, Virginia, 23114

Recruiting
Study Coordinator · Contact
804-893-8717

Virginia Oncology Associates (VOA) ( Site 8008)

Norfolk, Virginia, 23502

Recruiting
Study Coordinator · Contact
646-694-8125

Virginia Cancer Institute ( Site 0034)

Richmond, Virginia, 23229

Recruiting
Study Coordinator · Contact
804-287-3000

Northwest Medical Specialties, PLLC ( Site 0093)

Tacoma, Washington, 98405

Recruiting
Study Coordinator · Contact
253-428-8700

SSM Health Dean Medical Group ( Site 0087)

Madison, Wisconsin, 53715

Recruiting
Study Coordinator · Contact
516-488-2918