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Phase 3Recruiting

A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

Sponsored by Merck Sharp & Dohme LLC

About this study

Researchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: * Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy * Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

Where this study is enrolling (63)

  • University of Arizona Cancer Center ( Site 0035)

    Tucson, Arizona

    Call 520-694-2873

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  • Mayo Clinic Cancer Center ( Site 0034)

    Phoenix, Arizona

    Call 480-574-2802

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  • Banner MD Anderson Cancer Center ( Site 0066)

    Gilbert, Arizona

    Call 480-256-6444

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  • Providence Medical Foundation ( Site 0080)

    Fullerton, California

    Call 714-446-5900

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  • MemorialCare Health System - Long Beach Medical Center ( Site 9556)

    Long Beach, California

    Call 652-241-9755

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Show all 63 locations

  • El Camino Hospital Cancer Center ( Site 0096)

    Mountain View, California

    Call 650-988-8338

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  • Hoag Memorial Hospital Presbyterian ( Site 0010)

    Newport Beach, California

    Call 949-764-4624

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  • Helios Clinical Research ( Site 0061)

    Whittier, California

    Call 562-698-6888

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  • Community Cancer Institute ( Site 0100)

    Clovis, California

    Call 559-387-1600

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  • Roy and Patricia Disney Family Cancer Center ( Site 0055)

    Burbank, California

    Call 818-840-0921

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  • Intermountain Health Cancer Center Saint Joseph ( Site 0062)

    Denver, Colorado

    Call 303-318-3434

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  • Rocky Mountain Cancer Centers (RMCC) ( Site 8006)

    Denver, Colorado

    Call 303-430-2700

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  • Intermountain Health St. Mary's Regional Hospital ( Site 0054)

    Grand Junction, Colorado

    Call 970-298-7638

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  • AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0044)

    Altamonte Springs, Florida

    Call 407-834-5151

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  • Bioresearch Partner ( Site 0072)

    Hialeah, Florida

    Call 833-489-4968

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  • Florida Cancer Specialists - North ( Site 7002)

    St. Petersburg, Florida

    Call 727-216-1143

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  • Florida Cancer Specialists - South ( Site 7004)

    Fort Myers, Florida

    Call 239-274-9930

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  • Mayo Clinic Hospital ( Site 0013)

    Jacksonville, Florida

    Call 904-953-7290

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  • City of Hope Cancer Center - Atlanta ( Site 0102)

    Newnan, Georgia

    Call 770-400-6000

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  • Franciscan Health ( Site 0077)

    Indianapolis, Indiana

    Call 317-528-7060

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  • Fort Wayne Medical Oncology and Hematology ( Site 0084)

    Fort Wayne, Indiana

    Call 260-436-0800

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  • Ochsner Clinic Foundation ( Site 0021)

    New Orleans, Louisiana

    Call 866-624-7637

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  • Louisiana State University Health Sciences Shreveport ( Site 0053)

    Shreveport, Louisiana

    Call 318-626-0000

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  • New England Cancer Specialists ( Site 0051)

    Westbrook, Maine

    Call 207-303-3300

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  • Mercy Medical Center - Baltimore ( Site 0015)

    Baltimore, Maryland

    Call 410-951-7956

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  • Dana Farber Cancer Institute ( Site 0090)

    Boston, Massachusetts

    Call 617-632-2175

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  • Massachusetts General Hospital Cancer Center ( Site 0091)

    Boston, Massachusetts

    Call 617-726-5130

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  • Saint Luke's Cancer Institute ( Site 0059)

    Kansas City, Missouri

    Call 816-923-2677

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  • Washington University Siteman Cancer Center ( Site 0031)

    St Louis, Missouri

    Call 314-286-2341

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  • Cancer Partners of Nebraska ( Site 0068)

    Lincoln, Nebraska

    Call 402-327-7363

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  • Renown Regional Medical Center ( Site 0041)

    Reno, Nevada

    Call 775-982-4000

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  • Optum Care Cancer Center ( Site 0050)

    Las Vegas, Nevada

    Call 702-724-8787

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  • Rutgers Cancer Institute of New Jersey ( Site 0076)

    New Brunswick, New Jersey

    Call 732-253-3939

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  • Hackensack Univ Medical Center (HUMC) ( Site 0007)

    Hackensack, New Jersey

    Call 551-996-5855

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  • Altru Health System ( Site 0057)

    Grand Forks, North Dakota

    Call 701-780-5451

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  • Good Samaritan Hospital-TriHealth Cancer institute ( Site 0027)

    Cincinnati, Ohio

    Call 513-853-1300

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  • Northwest Cancer Specialists (Compass Oncology) ( Site 8010)

    Tigard, Oregon

    Call 503-280-1223

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  • St Francis Cancer Center ( Site 0093)

    Greenville, South Carolina

    Call 864-603-6200

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  • Medical University of South Carolina-Hollings Cancer Center ( Site 0016)

    Charleston, South Carolina

    Call 843-792-6434

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  • Avera Cancer Institute - Yankton ( Site 0089)

    Yankton, South Dakota

    Call 605-601-1830

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  • Avera McKennan Hospital ( Site 0002)

    Sioux Falls, South Dakota

    Call 605-322-3000

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  • Vanderbilt-Ingram Cancer Center ( Site 0038)

    Nashville, Tennessee

    Call 615-322-2064

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  • Nashville General Hospital ( Site 0017)

    Nashville, Tennessee

    Call 615-341-4383

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  • SCRI Oncology Partners ( Site 7005)

    Nashville, Tennessee

    Call 615-329-7640

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  • Tennessee Cancer Specialists ( Site 7001)

    Knoxville, Tennessee

    Call 865-934-5800

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  • Texas Oncology - San Antonio ( Site 8004)

    San Antonio, Texas

    Call 210-595-5300

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  • Texas Oncology - Northeast Texas ( Site 8002)

    Flower Mound, Texas

    Call 972-537-4100

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  • UT Southwestern ( Site 0092)

    Dallas, Texas

    Call 214-648-3111

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  • Hendrick Medical Center ( Site 0009)

    Abilene, Texas

    Call 325-670-2000

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  • Oncology Consultants P.A. ( Site 0073)

    Houston, Texas

    Call 855-827-9525

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  • Kelsey-Seybold Clinic ( Site 0088)

    Houston, Texas

    Call 713-442-0000

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  • Texas Tech University Health Sciences Center ( Site 0087)

    Lubbock, Texas

    Call 806-743-4222

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  • Kelsey-Seybold Clinic ( Site 0042)

    Houston, Texas

    Call 713-442-0000

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  • JPS Oncology and Infusion Center ( Site 0083)

    Fort Worth, Texas

    Call 817-702-8049

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  • Texas Oncology - DFW ( Site 8009)

    Dallas, Texas

    Call 214-370-1000

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  • Intermountain Medical Center ( Site 0074)

    Murray, Utah

    Call 801-507-3630

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  • Bon Secours Cancer Institute at St. Francis ( Site 0048)

    Midlothian, Virginia

    Call 804-893-8717

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  • Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8005)

    Roanoke, Virginia

    Call 540-982-0237

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  • Virginia Oncology Associates (VOA) ( Site 8008)

    Norfolk, Virginia

    Call 844-482-4812

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  • Northwest Medical Specialties, PLLC ( Site 0067)

    Tacoma, Washington

    Call 253-428-8700

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  • Cancer Care Northwest ( Site 0003)

    Spokane, Washington

    Call 509-228-1000

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  • Fred Hutchinson Cancer Center ( Site 0069)

    Seattle, Washington

    Call 855-557-0555

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  • University of Wisconsin-Madison ( Site 0024)

    Madison, Wisconsin

    Call 608-263-0796

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Who can participate

Inclusion criteria

  • ✓The main inclusion criteria include but are not limited to the following:
  • ✓Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and/or clinical assessment:
  • ✓cT1c, N1-N2
  • ✓cT2, N0-N2
  • ✓cT3, N0-N2
  • ✓cT4a-d, N0-N2
  • ✓The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
  • ✓Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.
  • ✓Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).
  • ✓Demonstrates adequate organ function.

Exclusion criteria

  • ✕The main exclusion criteria include but are not limited to the following:
  • ✕Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement
  • ✕Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer
  • ✕Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment.
  • ✕Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.
  • ✕Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).
  • ✕Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).
  • ✕Received prior treatment with a topoisomerase I inhibitor-containing ADC.
  • ✕Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
  • ✕Known additional malignancy that is progressing or has required active treatment within the past 5 years.
  • ✕Uncontrolled systemic disease.
  • ✕History of (noninfectious) pneumonitis/interstitial lung disease that required steroids, has current pneumonitis/interstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.