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A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

StatusRecruiting
PhasePhase 3
Started2024-04-14
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Merck (MSD)

Amendment history

The 49 most recent of 79 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-24
Primary endpoint(s) modified1 to 2 entries
WasProgression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC)
NowPFS (Sacituzumab tirumotecan + pembrolizumab versus TPC), Progression-Free Survival (PFS) ( sacituzumab tirumotecan versus treatment of physician's choice [TPC]; pembrolizumab + sacituzumab tirumotecan versus TPC)
2026-09-01
Study Status, Contacts/Locations v78
Study sites259 entries, revised
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1582)
2026-08-27
Study Status, Contacts/Locations v77
Study sitesdetails revised at 1 of 259 sites
2026-08-13
Study Status, Contacts/Locations v76
Study sitesdetails revised at 1 of 259 sites
2026-07-24
Study Status, Contacts/Locations v75
Study sites259 entries, revised
Hospital Beata María Ana-oncology ( Site 1755)
Show 45 earlier versions
2026-07-17
Study Status, Contacts/Locations v74
Study sitesdetails revised at 2 of 259 sites
2026-07-09
Study Status, Contacts/Locations v73
Study sitesdetails revised at 2 of 259 sites
2026-06-26
Study Status, Contacts/Locations v72
Study sites259 entries, revised
St.European LUKE'SInterbalkan HOSPITALMedical S.A.Center ( Site 1347)
2026-06-04
Study Status, Contacts/Locations v71
Study sites258→259
2026-05-20
Study Status, Contacts/Locations v70
Study sites258 entries, revised
EuropeanSt. InterbalkanLUKE'S MedicalHOSPITAL CenterS.A. ( Site 1347)
2026-05-13
Study Status, Contacts/Locations v69
Study sites258 entries, revised
AgiosEuropean LoukasInterbalkan ClinicMedical Center ( Site 1347)
2026-04-01
Study Status v68
Re-verified, no change to tracked fields
2026-03-25
Study Status, Contacts/Locations v67
Study sites257→258
2026-03-12
Study Status, Contacts/Locations v66
Study sitesdetails revised at 3 of 257 sites
2026-02-26
Study Status, Contacts/Locations v65
Study sitesdetails revised at 4 of 257 sites
2026-02-19
Study Status, Contacts/Locations v64
Study sitesdetails revised at 2 of 257 sites
2026-02-12
Study Status, Contacts/Locations v63
Study sitescontacts updated at 8 of 257 sites
2026-02-03
Study Status, Contacts/Locations v62
Study sites257 entries, revised
CaritasKlinikum SaarbrückenSaarbruecken St. Theresia ( Site 1304)
2026-01-28
Study Status, Contacts/Locations v61
Study sites256→257
2026-01-21
Study Status, Contacts/Locations v60
Study sites254→256
2026-01-16
Study Status, Contacts/Locations v59
Study sitesdetails revised at 6 of 254 sites
2026-01-02
Study Status, Contacts/Locations v58
Study sitesdetails revised at 6 of 254 sites
2025-12-23
Study Status, Contacts/Locations v57
Study sitescontacts updated at 6 of 254 sites
2025-12-17
Study Status, Contacts/Locations v56
Study sites254 entries, revised
Southlake Regional Health Centre ( Site 0311)
2025-12-10
Study Status, Contacts/Locations v55
Study sites254 entries, revised
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2477)
2025-12-02
Study Status, Contacts/Locations v54
Study sitesdetails revised at 2 of 254 sites
2025-11-24
Study Status, Contacts/Locations v53
Study sitesdetails revised at 3 of 254 sites
2025-11-13
Study Status, Contacts/Locations v52
Study sitesdetails revised at 2 of 254 sites
2025-11-06
Study Status, Contacts/Locations v51
Study sitesdetails revised at 4 of 254 sites
2025-10-29
Study Status, Contacts/Locations v50
Study sitesdetails revised at 1 of 254 sites
2025-10-24
Study Status, Contacts/Locations v49
Study sites254 entries, revised
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii. ( Site 1583)
2025-10-17
Study Status, Contacts/Locations v48
Study sitescontacts updated at 1 of 254 sites
2025-10-10
Study Status, Contacts/Locations v47
Study sites253→254
2025-10-03
Study Status, Contacts/Locations v46
Study sites252→253
2025-09-25
Study Status, Contacts/Locations v45
Study sitescontacts updated at 4 of 252 sites
2025-09-19
Study Status, Contacts/Locations v44
Study sitescontacts updated at 5 of 252 sites
2025-09-10
Study Status, Contacts/Locations v43
Study sites247→252
2025-08-29
Study Status, Contacts/Locations v42
Study sites242→247
2025-08-14
Study Status, Contacts/Locations v41
Study sites239→242
2025-08-01
Study Status, Contacts/Locations v40
Study sites238→239
2025-07-25
Study Status, Contacts/Locations v39
Study sites236→238
2025-07-18
Study Status, Contacts/Locations v38
Study sites233→236
2025-07-11
Study Status, Contacts/Locations v37
Study sites232→233
2025-07-04
Study Status, Contacts/Locations v36
Study sites227→232
2025-06-26
Study Status, Contacts/Locations v35
Study sitesdetails revised at 1 of 227 sites
2025-06-20
Study Status, Contacts/Locations v34
Study sites223→227
2025-06-11
Study Status, Contacts/Locations v33
Study sites223 entries, revised
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 1136)
2025-05-28
Study Status, Contacts/Locations v32
Study sites222→223
2025-05-15
Study Identification, Study Status, Contacts/Locations v31
Study sites220→222
2025-04-30
Study Status, Contacts/Locations v30
Study sites217→220
Merck (MSD)
401 trials monitored
See 24 trials at risk
Breast Cancer
5,180 trials monitored
See 256 trials at risk
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
Trial Details
NCT Number NCT06312176
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Breast Neoplasms
Enrollment 1,200 participants
Start Date 2024-04-14
Primary Completion 2027-07-11 (estimated)
Study Completion 2031-04-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-25