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

StatusRecruiting
PhasePhase 3
Started2025-06-30
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 53 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-09
minor
Study Status, Contacts/Locations v52
Trial sites expanded: 321 → 325 locations
2026-09-01
minor
Study Status, Contacts/Locations v51
Study sites321 entries, revised
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 4616)
2026-08-27
minor
Study Status, Contacts/Locations v50
Study sitescontacts updated at 1 of 321 sites
2026-08-20
minor
Study Status, Contacts/Locations v49
Study sites319→321
2026-08-13
minor
Study Status, Contacts/Locations v48
Study sites319 entries, revised
The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 2212)
Show 4 earlier versions
2026-08-05
minor
Study Status, Contacts/Locations v47
Study sites318→319
2026-07-30
minor
Study Status, Contacts/Locations v46
Study sites317→318
2026-07-24
minor
Study Status, Contacts/Locations v45
Study sites315→317
2026-07-17
minor
Study Status, Contacts/Locations v44
Study sites314→315
2026-07-09
minor
Study Status, Contacts/Locations v43
Trial sites expanded: 310 → 314 locations
2026-06-30
minor
Study Status, Contacts/Locations v42
Trial sites expanded: 307 → 310 locations
2026-06-24
minor
Study Status, Contacts/Locations v41
Trial sites expanded: 304 → 307 locations
Trial sites expanded: 296 → 304 locations
2026-06-18
minor
Study Status, Contacts/Locations v40
Study sites296→304
2026-06-11
minor
Study Status, Contacts/Locations v39
Study sites294→296
2026-06-04
minor
Study Status, Contacts/Locations v38
Study sites292→294
2026-05-29
minor
Study Status, Contacts/Locations v37
Study sites291→292
2026-05-21
minor
Study Status, Contacts/Locations v36
Trial sites expanded: 287 → 291 locations
2026-05-13
minor
Study Status, Contacts/Locations v35
Trial sites expanded: 283 → 287 locations
2026-05-07
minor
Study Status, Eligibility, Contacts/Locations v34
Trial sites expanded: 268 → 283 locations
Eligibility criteria+131 characters
[...] N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and/or clinical assessmen [...] n receptor (ER)-low+ expression in 1% to 10% cells and HER2-), as by the most recent American Society of Clinical Oncology [...] erformance status of 0 or 1 performed within 28 days before treatmentCycle1 randomizationDay 1 (C1D1). Demonstrates adequate organ function. Exclusion Criteria: [...] rapy including investigational agents within 4 weeks before randomizationC1D1. Received prior therapy with an anti-PD-1, anti-PD-L1, or a [...] pneumonitis/interstitial lung disease that require [...]
2026-04-15
minor
Study Status, Contacts/Locations v33
Trial sites expanded: 265 → 268 locations
2026-04-09
minor
Study Status, Contacts/Locations v32
Trial sites expanded: 254 → 265 locations
2026-04-01
minor
Study Status, Contacts/Locations v31
Trial sites expanded: 249 → 254 locations
2026-03-26
minor
Study Status, Contacts/Locations v30
Trial sites expanded: 241 → 249 locations
2026-03-19
minor
Study Status, Contacts/Locations v29
Study sites234→241
2026-03-12
minor
Study Status, Contacts/Locations v28
Study sites215→234
2026-02-27
minor
Study Status, Contacts/Locations v27
Study sites206→215
2026-02-17
minor
Study Status, Contacts/Locations v26
Study sites200→206
2026-02-12
minor
Study Status, Contacts/Locations v25
Study sites193→200
2026-02-04
minor
Study Status, Contacts/Locations v24
Study sites185→193
2026-01-28
minor
Study Status, Contacts/Locations v23
Study sites180→185
2026-01-21
minor
Study Status, Contacts/Locations v22
Study sites173→180
2026-01-16
minor
Study Status, Contacts/Locations v21
Study sites169→173
2026-01-02
minor
Study Status, Contacts/Locations v20
Study sites166→169
2025-12-23
minor
Study Status, Contacts/Locations v19
Study sites158→166
2025-12-17
minor
Study Status, Contacts/Locations v18
Study sites151→158
2025-12-10
minor
Study Status, Contacts/Locations v17
Study sites144→151
2025-12-02
minor
Study Status, Contacts/Locations v16
Study sites134→144
2025-11-27
minor
Study Status, Contacts/Locations v15
Study sites120→134
2025-11-24
minor
Study Status, Contacts/Locations v14
Study sites92→120
2025-11-07
minor
Study Status, Contacts/Locations v13
Study sites84→92
2025-10-29
minor
Study Status, Contacts/Locations v12
Study sites78→84
2025-10-24
minor
Study Status, Contacts/Locations v11
Study sites58→78
2025-10-07
minor
Study Status, Contacts/Locations v10
Completion date2035-02-04→2034-12-29
Study sites41→58
2025-09-25
minor
Study Status, Contacts/Locations v9
Study sites34→41
2025-09-19
minor
Study Status, Contacts/Locations v8
Study sites24→34
2025-09-09
minor
Study Status, Contacts/Locations v7
Study sites18→24
2025-08-29
minor
Study Status, Contacts/Locations v6
Study sites12→18
2025-08-14
minor
Study Status, Contacts/Locations v5
Study sites11→12
2025-08-01
minor
Study Status, Contacts/Locations v4
Study sites9→11
2025-07-25
minor
Study Identification, Study Status, Contacts/Locations v3
Study sites6→9
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
Trial Details
NCT Number NCT06966700
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms
Enrollment 2,400 participants
Start Date 2025-06-30
Primary Completion 2033-03-23 (estimated)
Study Completion 2034-12-29 (estimated)
Updated on ClinicalTrials.gov 2026-09-25