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

RecruitingPhase 3

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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..

About the 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

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 2,400 · Started: Jun 30, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06966700

Locations in the U.S.

ArizonaBanner MD Anderson Cancer Center ( Site 0066), Gilbert
Mayo Clinic Cancer Center ( Site 0034), Phoenix
University of Arizona Cancer Center ( Site 0035), Tucson
CaliforniaRoy and Patricia Disney Family Cancer Center ( Site 0055), Burbank
Community Cancer Institute ( Site 0100), Clovis
Providence Medical Foundation ( Site 0080), Fullerton
MemorialCare Health System - Long Beach Medical Center ( Site 9556), Long Beach
El Camino Hospital Cancer Center ( Site 0096), Mountain View
Hoag Memorial Hospital Presbyterian ( Site 0010), Newport Beach
Helios Clinical Research ( Site 0061), Whittier
ColoradoIntermountain Health Cancer Center Saint Joseph ( Site 0062), Denver
Rocky Mountain Cancer Centers (RMCC) ( Site 8006), Denver
Intermountain Health St. Mary's Regional Hospital ( Site 0054), Grand Junction
FloridaAdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0044), Altamonte Springs
Florida Cancer Specialists - South ( Site 7004), Fort Myers
Bioresearch Partner ( Site 0072), Hialeah
Mayo Clinic Hospital ( Site 0013), Jacksonville
Florida Cancer Specialists - North ( Site 7002), St. Petersburg
GeorgiaCity of Hope Cancer Center - Atlanta ( Site 0102), Newnan
IndianaFort Wayne Medical Oncology and Hematology ( Site 0084), Fort Wayne
Franciscan Health ( Site 0077), Indianapolis
LouisianaOchsner Clinic Foundation ( Site 0021), New Orleans
Louisiana State University Health Sciences Shreveport ( Site 0053), Shreveport
MaineNew England Cancer Specialists ( Site 0051), Westbrook
MarylandMercy Medical Center - Baltimore ( Site 0015), Baltimore
MassachusettsDana Farber Cancer Institute ( Site 0090), Boston
Massachusetts General Hospital Cancer Center ( Site 0091), Boston
MissouriSaint Luke's Cancer Institute ( Site 0059), Kansas City
Washington University Siteman Cancer Center ( Site 0031), St Louis
NebraskaCancer Partners of Nebraska ( Site 0068), Lincoln
NevadaOptum Care Cancer Center ( Site 0050), Las Vegas
Renown Regional Medical Center ( Site 0041), Reno
New JerseyHackensack Univ Medical Center (HUMC) ( Site 0007), Hackensack
Rutgers Cancer Institute of New Jersey ( Site 0076), New Brunswick
North DakotaAltru Health System ( Site 0057), Grand Forks
OhioGood Samaritan Hospital-TriHealth Cancer institute ( Site 0027), Cincinnati
OregonNorthwest Cancer Specialists (Compass Oncology) ( Site 8010), Tigard
South CarolinaMedical University of South Carolina-Hollings Cancer Center ( Site 0016), Charleston
St Francis Cancer Center ( Site 0093), Greenville
South DakotaAvera McKennan Hospital ( Site 0002), Sioux Falls
Avera Cancer Institute - Yankton ( Site 0089), Yankton
TennesseeTennessee Cancer Specialists ( Site 7001), Knoxville
Nashville General Hospital ( Site 0017), Nashville
SCRI Oncology Partners ( Site 7005), Nashville
Vanderbilt-Ingram Cancer Center ( Site 0038), Nashville
TexasHendrick Medical Center ( Site 0009), Abilene
Texas Oncology - DFW ( Site 8009), Dallas
UT Southwestern ( Site 0092), Dallas
Texas Oncology - Northeast Texas ( Site 8002), Flower Mound
JPS Oncology and Infusion Center ( Site 0083), Fort Worth
Kelsey-Seybold Clinic ( Site 0042), Houston
Kelsey-Seybold Clinic ( Site 0088), Houston
Oncology Consultants P.A. ( Site 0073), Houston
Texas Tech University Health Sciences Center ( Site 0087), Lubbock
Texas Oncology - San Antonio ( Site 8004), San Antonio
UtahIntermountain Medical Center ( Site 0074), Murray
VirginiaBon Secours Cancer Institute at St. Francis ( Site 0048), Midlothian
Virginia Oncology Associates (VOA) ( Site 8008), Norfolk
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8005), Roanoke
WashingtonFred Hutchinson Cancer Center ( Site 0069), Seattle
Cancer Care Northwest ( Site 0003), Spokane
Northwest Medical Specialties, PLLC ( Site 0067), Tacoma
WisconsinUniversity of Wisconsin-Madison ( Site 0024), Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.