Recruiting

Phase 3

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

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06966700

Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

HR Low-Positive/HER2-Negative Breast Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sacituzumab tirumotecan

Pembrolizumab

Rescue Medication

Carboplatin

Paclitaxel

Study Details

Brief summary:

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

Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

HR Low-Positive/HER2-Negative Breast Neoplasms

Study ID

NCT06966700

Start date

Jun 30, 2025

Status verified date

Oct, 2026

Completion date

Dec 29, 2034

Anticipated

Primary completion date

Mar 23, 2033

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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..

Study Design

Enrollment

2400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: sac-TMT

Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) + IV pembrolizumab 200 mg every 3 weeks (Q3W), for 12 weeks; then receive IV pembrolizumab 200 mg Q3W and IV carboplatin area under the curve (AUC) 1.5 + IV paclitaxel 80 mg/m\^2 once weekly, for 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant treatment of physician's choice (TPC) may be administered to participants with residual disease. TPC options are olaparib 300 mg oral twice daily (BID) for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); capecitabine 1000-1250 mg/m\^2 oral twice daily on days 1-14 and 22-35 each cycle for 4 six-week cycles; or doxorubicin 60mg/m\^2 (or epirubicin 90 mg/m\^2) IV infusion Q3W/Q2W + cyclophosphamide 600 mg/m\^2 IV infusion Q3W/Q2W for 4 doses.

active comparator: Chemotherapy

Participants receive IV carboplatin AUC 1.5 and paclitaxel 80 mg/m\^2 once weekly, alongside pembrolizumab 200 mg Q3W, for 6 weeks; then receive IV pembrolizumab 200 mg Q3W alongside IV cyclophosphamide 600 mg/m\^2 Q3W and either doxorubicin 60 mg/m\^2 Q3W or epirubicin 90 mg/m\^2 Q3W, for up to 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options are olaparib 300 mg oral BID for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); or capecitabine 1000-1250 mg/m\^2 oral BID on days 1-14 and 22-35 each cycle for 4 six-week cycles.

Interventions

Sacituzumab tirumotecan

IV infusion

Pembrolizumab

IV infusion

Rescue Medication

Participants receive rescue medication at the investigators discretion, per approved product label. Recommended rescue medications are histamine -1 (H1) receptor agonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, or steroid mouthwash (dexamethasone or equivalent).

Carboplatin

IV infusion

Paclitaxel

IV infusion

Doxorubicin

IV infusion

Epirubicin

IV infusion

Cyclophosphamide

IV infusion

Capecitabine

Oral tablet

Olaparib

Oral tablet

Primary outcome measure

Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery [ Time Frame: Up to approximately 30 weeks ]
Event-Free Survival (EFS) [ Time Frame: Up to approximately 92 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839 Trialsites@msd.com

Locations

Banner MD Anderson Cancer Center ( Site 0066)

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Study Coordinator

480-256-6444

Mayo Clinic Cancer Center ( Site 0034)

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Study Coordinator

480-574-2802

University of Arizona Cancer Center ( Site 0035)

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Study Coordinator

520-694-2873

Roy and Patricia Disney Family Cancer Center ( Site 0055)

Recruiting

Burbank, California, United States, 91505

Contacts

Study Coordinator

818-840-0921

Community Cancer Institute ( Site 0100)

Recruiting

Clovis, California, United States, 93611

Contacts

Study Coordinator

559-387-1600

Providence Medical Foundation ( Site 0080)

Recruiting

Fullerton, California, United States, 92835

Contacts

Study Coordinator

714-446-5900

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

Recruiting

Long Beach, California, United States, 90806

Contacts

Study Coordinator

652-241-9755

El Camino Hospital Cancer Center ( Site 0096)

Recruiting

Mountain View, California, United States, 94040

Contacts

Study Coordinator

650-988-8338

Hoag Memorial Hospital Presbyterian ( Site 0010)

Recruiting

Newport Beach, California, United States, 92663

Contacts

Study Coordinator

949-764-4624

Helios Clinical Research ( Site 0061)

Recruiting

Whittier, California, United States, 90602

Contacts

Study Coordinator

562-698-6888

Intermountain Health Cancer Center Saint Joseph ( Site 0062)

Recruiting

Denver, Colorado, United States, 80218

Contacts

Study Coordinator

303-318-3434

Rocky Mountain Cancer Centers (RMCC) ( Site 8006)

Recruiting

Denver, Colorado, United States, 80220

Contacts

Study Coordinator

303-430-2700

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

Recruiting

Grand Junction, Colorado, United States, 81501

Contacts

Study Coordinator

970-298-7638

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

Recruiting

Altamonte Springs, Florida, United States, 32701

Contacts

Study Coordinator

407-834-5151

Florida Cancer Specialists - South ( Site 7004)

Recruiting

Fort Myers, Florida, United States, 33901

Contacts

Study Coordinator

239-274-9930

Bioresearch Partner ( Site 0072)

Recruiting

Hialeah, Florida, United States, 33013

Contacts

Study Coordinator

833-489-4968

Mayo Clinic Hospital ( Site 0013)

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Study Coordinator

904-953-7290

Florida Cancer Specialists - North ( Site 7002)

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Study Coordinator

727-216-1143

City of Hope Cancer Center - Atlanta ( Site 0102)

Recruiting

Newnan, Georgia, United States, 30265

Contacts

Study Coordinator

770-400-6000

Fort Wayne Medical Oncology and Hematology ( Site 0084)

Recruiting

Fort Wayne, Indiana, United States, 46804

Contacts

Study Coordinator

260-436-0800

Franciscan Health ( Site 0077)

Recruiting

Indianapolis, Indiana, United States, 46237

Contacts

Study Coordinator

317-528-7060

Ochsner Clinic Foundation ( Site 0021)

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Study Coordinator

866-624-7637

Louisiana State University Health Sciences Shreveport ( Site 0053)

Recruiting

Shreveport, Louisiana, United States, 71103

Contacts

Study Coordinator

318-626-0000

New England Cancer Specialists ( Site 0051)

Recruiting

Westbrook, Maine, United States, 04092

Contacts

Study Coordinator

207-303-3300

Mercy Medical Center - Baltimore ( Site 0015)

Recruiting

Baltimore, Maryland, United States, 21202

Contacts

Study Coordinator

410-951-7956

Massachusetts General Hospital Cancer Center ( Site 0091)

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Study Coordinator

617-726-5130

Dana Farber Cancer Institute ( Site 0090)

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Study Coordinator

617-632-2175

Saint Luke's Cancer Institute ( Site 0059)

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Study Coordinator

816-923-2677

Washington University Siteman Cancer Center ( Site 0031)

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Study Coordinator

314-286-2341

Cancer Partners of Nebraska ( Site 0068)

Recruiting

Lincoln, Nebraska, United States, 68516

Contacts

Study Coordinator

402-327-7363

Optum Care Cancer Center ( Site 0050)

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Study Coordinator

702-724-8787

Renown Regional Medical Center ( Site 0041)

Recruiting

Reno, Nevada, United States, 89502

Contacts

Study Coordinator

775-982-4000

Hackensack Univ Medical Center (HUMC) ( Site 0007)

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Study Coordinator

551-996-5855

Rutgers Cancer Institute of New Jersey ( Site 0076)

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Study Coordinator

732-253-3939

Altru Health System ( Site 0057)

Recruiting

Grand Forks, North Dakota, United States, 58201

Contacts

Study Coordinator

701-780-5451

Good Samaritan Hospital-TriHealth Cancer institute ( Site 0027)

Recruiting

Cincinnati, Ohio, United States, 45220

Contacts

Study Coordinator

513-853-1300

Northwest Cancer Specialists (Compass Oncology) ( Site 8010)

Recruiting

Tigard, Oregon, United States, 97223

Contacts

Study Coordinator

503-280-1223

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

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Study Coordinator

843-792-6434

St Francis Cancer Center ( Site 0093)

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

Study Coordinator

864-603-6200

Avera McKennan Hospital ( Site 0002)

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Study Coordinator

605-322-3000

Avera Cancer Institute - Yankton ( Site 0089)

Recruiting

Yankton, South Dakota, United States, 57078

Contacts

Study Coordinator

605-601-1830

Tennessee Cancer Specialists ( Site 7001)

Recruiting

Knoxville, Tennessee, United States, 37909

Contacts

Study Coordinator

865-934-5800

SCRI Oncology Partners ( Site 7005)

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Study Coordinator

615-329-7640

Nashville General Hospital ( Site 0017)

Recruiting

Nashville, Tennessee, United States, 37208

Contacts

Study Coordinator

615-341-4383

Vanderbilt-Ingram Cancer Center ( Site 0038)

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Study Coordinator

615-322-2064

Hendrick Medical Center ( Site 0009)

Recruiting

Abilene, Texas, United States, 79601

Contacts

Study Coordinator

325-670-2000

Texas Oncology - DFW ( Site 8009)

Recruiting

Dallas, Texas, United States, 75246

Contacts

Study Coordinator

214-370-1000

UT Southwestern ( Site 0092)

Recruiting

Dallas, Texas, United States, 75390

Contacts

Study Coordinator

214-648-3111

Texas Oncology - Northeast Texas ( Site 8002)

Recruiting

Flower Mound, Texas, United States, 75028

Contacts

Study Coordinator

972-537-4100

JPS Oncology and Infusion Center ( Site 0083)

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Study Coordinator

817-702-8049

Kelsey-Seybold Clinic ( Site 0042)

Recruiting

Houston, Texas, United States, 77025

Contacts

Study Coordinator

713-239-4510

Kelsey-Seybold Clinic ( Site 0088)

Recruiting

Houston, Texas, United States, 77025

Contacts

Study Coordinator

713-239-4510

Oncology Consultants P.A. ( Site 0073)

Recruiting

Houston, Texas, United States, 77030

Contacts

Study Coordinator

713-275-3233

Texas Tech University Health Sciences Center ( Site 0087)

Recruiting

Lubbock, Texas, United States, 79430

Contacts

Study Coordinator

806-743-4222

Texas Oncology - San Antonio ( Site 8004)

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Study Coordinator

210-595-5300

Intermountain Medical Center ( Site 0074)

Recruiting

Murray, Utah, United States, 84107

Contacts

Study Coordinator

801-507-3630

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

Recruiting

Midlothian, Virginia, United States, 23114

Contacts

Study Coordinator

804-893-8717

Virginia Oncology Associates (VOA) ( Site 8008)

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Study Coordinator

844-482-4812

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

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Study Coordinator

540-982-0237

Fred Hutchinson Cancer Center ( Site 0069)

Recruiting

Seattle, Washington, United States, 98109

Contacts

Study Coordinator

855-557-0555

Cancer Care Northwest ( Site 0003)

Recruiting

Spokane, Washington, United States, 99202

Contacts

Study Coordinator

509-228-1000

Northwest Medical Specialties, PLLC ( Site 0067)

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Study Coordinator

253-428-8700

University of Wisconsin-Madison ( Site 0024)

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Study Coordinator

608-263-0796

BC Cancer - Surrey ( Site 0217)

Recruiting

Surrey, British Columbia, Canada, V3V 1Z2

Contacts

Study Coordinator

604-930-2098

BC Cancer Vancouver ( Site 0218)

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Study Coordinator

604-877-6000

NL Health Services ( Site 0232)

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

Contacts

Study Coordinator

7097772638

Royal Victoria Regional Health Centre ( Site 0233)

Recruiting

Barrie, Ontario, Canada, L4M 6M2

Contacts

Study Coordinator

705-728-9802 x43529

Health Sciences North ( Site 0234)

Recruiting

Greater Sudbury, Ontario, Canada, P3E 5J1

Contacts

Study Coordinator

7055237100

Lakeridge Health ( Site 0225)

Recruiting

Oshawa, Ontario, Canada, L1G 2B9

Contacts

Study Coordinator

9055768711

The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0209)

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Study Coordinator

6137377700

Sault Area Hospital ( Site 0226)

Recruiting

Sault Ste. Marie, Ontario, Canada, P6B 0A8

Contacts

Study Coordinator

705-759-3434

Princess Margaret Cancer Centre ( Site 0208)

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Study Coordinator

4169462000

Centre Hospitalier de l'Université de Montréal ( Site 0201)

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Contacts

Study Coordinator

5148908000

Jewish General Hospital ( Site 0200)

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Study Coordinator

514-340-8222

McGill University Health Centre ( Site 0202)

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Study Coordinator

5149341934

CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0203)

Recruiting

Québec, Quebec, Canada, G1S 4L8

Contacts

Study Coordinator

4185254444

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0206)

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Study Coordinator

8193461110

Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0204)

Recruiting

Trois-Rivières, Quebec, Canada, G8Z 3R9

Contacts

Study Coordinator

8196973333x63238

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Keywords

Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.