A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
Recruiting · NCT06966700 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
CapecitabineCarboplatinCyclophosphamideDoxorubicinEpirubicinOlaparibPaclitaxelPembrolizumabRescue MedicationSacituzumab tirumotecan
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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..
Where it is running
60 locations listed across 25 US states.
- Banner MD Anderson Cancer Center ( Site 0066) - Gilbert, Arizona, United States
- Mayo Clinic Cancer Center ( Site 0034) - Phoenix, Arizona, United States
- University of Arizona Cancer Center ( Site 0035) - Tucson, Arizona, United States
- Roy and Patricia Disney Family Cancer Center ( Site 0055) - Burbank, California, United States
- Community Cancer Institute ( Site 0100) - Clovis, California, United States
- Providence Medical Foundation ( Site 0080) - Fullerton, California, United States
- MemorialCare Health System - Long Beach Medical Center ( Site 9556) - Long Beach, California, United States
- El Camino Hospital Cancer Center ( Site 0096) - Mountain View, California, United States
- Hoag Memorial Hospital Presbyterian ( Site 0010) - Newport Beach, California, United States
- Helios Clinical Research ( Site 0061) - Whittier, California, United States
- Intermountain Health Cancer Center Saint Joseph ( Site 0062) - Denver, Colorado, United States
- Rocky Mountain Cancer Centers (RMCC) ( Site 8006) - Denver, Colorado, United States
- Intermountain Health St. Mary's Regional Hospital ( Site 0054) - Grand Junction, Colorado, United States
- AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0044) - Altamonte Springs, Florida, United States
- Florida Cancer Specialists - South ( Site 7004) - Fort Myers, Florida, United States
- Bioresearch Partner ( Site 0072) - Hialeah, Florida, United States
- Mayo Clinic Hospital ( Site 0013) - Jacksonville, Florida, United States
- Florida Cancer Specialists - North ( Site 7002) - St. Petersburg, Florida, United States
- City of Hope Cancer Center - Atlanta ( Site 0102) - Newnan, Georgia, United States
- Fort Wayne Medical Oncology and Hematology ( Site 0084) - Fort Wayne, Indiana, United States
- Franciscan Health ( Site 0077) - Indianapolis, Indiana, United States
- Ochsner Clinic Foundation ( Site 0021) - New Orleans, Louisiana, United States
- Louisiana State University Health Sciences Shreveport ( Site 0053) - Shreveport, Louisiana, United States
- New England Cancer Specialists ( Site 0051) - Westbrook, Maine, United States
- Mercy Medical Center - Baltimore ( Site 0015) - Baltimore, Maryland, United States
- Massachusetts General Hospital Cancer Center ( Site 0091) - Boston, Massachusetts, United States
- Dana Farber Cancer Institute ( Site 0090) - Boston, Massachusetts, United States
- Saint Luke's Cancer Institute ( Site 0059) - Kansas City, Missouri, United States
- Washington University Siteman Cancer Center ( Site 0031) - St Louis, Missouri, United States
- Cancer Partners of Nebraska ( Site 0068) - Lincoln, Nebraska, United States
- Optum Care Cancer Center ( Site 0050) - Las Vegas, Nevada, United States
- Renown Regional Medical Center ( Site 0041) - Reno, Nevada, United States
- Hackensack Univ Medical Center (HUMC) ( Site 0007) - Hackensack, New Jersey, United States
- Rutgers Cancer Institute of New Jersey ( Site 0076) - New Brunswick, New Jersey, United States
- Altru Health System ( Site 0057) - Grand Forks, North Dakota, United States
- Good Samaritan Hospital-TriHealth Cancer institute ( Site 0027) - Cincinnati, Ohio, United States
- Northwest Cancer Specialists (Compass Oncology) ( Site 8010) - Tigard, Oregon, United States
- Medical University of South Carolina-Hollings Cancer Center ( Site 0016) - Charleston, South Carolina, United States
- St Francis Cancer Center ( Site 0093) - Greenville, South Carolina, United States
- Avera McKennan Hospital ( Site 0002) - Sioux Falls, South Dakota, United States
- Avera Cancer Institute - Yankton ( Site 0089) - Yankton, South Dakota, United States
- Tennessee Cancer Specialists ( Site 7001) - Knoxville, Tennessee, United States
- SCRI Oncology Partners ( Site 7005) - Nashville, Tennessee, United States
- Nashville General Hospital ( Site 0017) - Nashville, Tennessee, United States
- Vanderbilt-Ingram Cancer Center ( Site 0038) - Nashville, Tennessee, United States
- Hendrick Medical Center ( Site 0009) - Abilene, Texas, United States
- Texas Oncology - DFW ( Site 8009) - Dallas, Texas, United States
- UT Southwestern ( Site 0092) - Dallas, Texas, United States
- Texas Oncology - Northeast Texas ( Site 8002) - Flower Mound, Texas, United States
- JPS Oncology and Infusion Center ( Site 0083) - Fort Worth, Texas, United States
- Kelsey-Seybold Clinic ( Site 0042) - Houston, Texas, United States
- Kelsey-Seybold Clinic ( Site 0088) - Houston, Texas, United States
- Oncology Consultants P.A. ( Site 0073) - Houston, Texas, United States
- Texas Tech University Health Sciences Center ( Site 0087) - Lubbock, Texas, United States
- Texas Oncology - San Antonio ( Site 8004) - San Antonio, Texas, United States
- Intermountain Medical Center ( Site 0074) - Murray, Utah, United States
- Bon Secours Cancer Institute at St. Francis ( Site 0048) - Midlothian, Virginia, United States
- Virginia Oncology Associates (VOA) ( Site 8008) - Norfolk, Virginia, United States
- Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8005) - Roanoke, Virginia, United States
- Fred Hutchinson Cancer Center ( Site 0069) - Seattle, Washington, United States
Showing 60 of 325 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →