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Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)

StatusRecruiting
PhasePhase 3
Started2024-06-24
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 77 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-09
Study Status, Contacts/Locations v76
Study sites310 entries, revised
Grupo Médico ASSET SC ( Site 0705)
2026-09-01
Study Status, Contacts/Locations v75
Study sites309→310
2026-08-27
Study Status, Contacts/Locations v74
Study sites308→309
2026-08-20
Study Status, Contacts/Locations v73
Study sitesdetails revised at 1 of 308 sites
2026-08-05
Study Status, Contacts/Locations v72
Study sites307→308
Show 4 earlier versions
2026-07-30
Study Status, Contacts/Locations v71
Study sites306→307
2026-07-24
Study Status, Contacts/Locations v70
Study sites305→306
2026-07-17
Study Status, Contacts/Locations v69
Study sites304→305
2026-06-26
Study Status, Contacts/Locations v68
Study sites303→304
2026-06-17
Study Status, Contacts/Locations v67
Trial sites expanded: 299 → 303 locations
2026-06-04
Study Status, Contacts/Locations v66
Study sites297→299
2026-05-27
Study Status, Contacts/Locations v65
Trial sites expanded: 293 → 297 locations
2026-05-21
Study Status, Contacts/Locations v64
Study sites292→293
2026-05-13
Study Status, Contacts/Locations v63
Trial sites expanded: 288 → 292 locations
2026-04-30
Study Status, Contacts/Locations v62
Study sites287→288
2026-04-22
Study Status, Contacts/Locations v61
Study sites286→287
2026-04-09
Study Status, Contacts/Locations v60
Study sites285→286
2026-04-01
Study Status, Contacts/Locations v59
Study sites284→285
2026-03-19
Study Status, Contacts/Locations v58
Study sites281→284
2026-03-12
Study Status, Contacts/Locations v57
Study sites280→281
2026-03-04
Study Status, Contacts/Locations v56
Study sites279→280
2026-02-26
Study Status, Contacts/Locations v55
Study sitesdetails revised at 2 of 279 sites
2026-02-19
Study Status, Contacts/Locations v54
Study sites276→279
2026-02-12
Study Status, Contacts/Locations v53
Study sites275→276
2026-02-04
Study Status, Contacts/Locations v52
Study sites272→275
2026-01-28
Study Status, Contacts/Locations v51
Study sites271→272
2026-01-21
Study Status, Contacts/Locations v50
Study sites270→271
2026-01-16
Study Status, Contacts/Locations v49
Study sites266→270
2026-01-02
Study Status, Contacts/Locations v48
Study sites266 entries, revised
AgiosEuropean LoukasInterbalkan ClinicMedical Center ( Site 1507)
2025-12-23
Study Status, Contacts/Locations v47
Study sites263→266
2025-12-17
Study Status, Contacts/Locations v46
Study sites262→263
2025-12-10
Study Status, Contacts/Locations v45
Study sites262 entries, revised
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 3417)
2025-12-02
Study Status, Contacts/Locations v44
Study sites258→262
2025-11-27
Study Status, Contacts/Locations v43
Study sites255→258
2025-11-24
Study Status, Contacts/Locations v42
Study sites252→255
2025-11-07
Study Status, Contacts/Locations v41
Study sites251→252
2025-10-29
Study Status, Contacts/Locations v40
Study sites248→251
2025-10-24
Study Status, Contacts/Locations v39
Study sites245→248
2025-10-17
Study Status, Contacts/Locations v38
Study sites242→245
2025-10-10
Study Status, Contacts/Locations v37
Study sitesdetails revised at 2 of 242 sites
2025-09-25
Study Status, Contacts/Locations v36
Study sites240→242
2025-09-19
Study Status, Contacts/Locations v35
Study sitescontacts updated at 2 of 240 sites
2025-09-09
Study Status, Contacts/Locations v34
Study sites236→240
2025-08-14
Study Status, Contacts/Locations v33
Study sitescontacts updated at 1 of 236 sites
2025-07-25
Study Status, Contacts/Locations v32
Study sitesdetails revised at 4 of 236 sites
2025-07-18
Study Status, Contacts/Locations v31
Study sitescontacts updated at 3 of 236 sites
2025-07-11
Study Status, Contacts/Locations v30
Study sites231→236
2025-07-04
Study Status, Contacts/Locations v29
Study sites230→231
2025-06-20
Study Status, Contacts/Locations v28
Study sites227→230
2025-06-11
Study Status, Contacts/Locations v27
Study sitescontacts updated at 1 of 227 sites
This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.
Trial Details
NCT Number NCT06393374
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Triple-Negative Breast Cancer
Enrollment 1,530 participants
Start Date 2024-06-24
Primary Completion 2030-12-16 (estimated)
Study Completion 2037-12-14 (estimated)
Updated on ClinicalTrials.gov 2026-09-25