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Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Study acronym: ASCENT-04
StatusActive, Not Recruiting
PhasePhase 3
Started2022-07-25
View on ClinicalTrials.gov ↗

Amendment history

2025-09-16
Study Status, Contacts/Locations v25
Study sitesdetails revised at 2 of 504 sites
2024-12-19
Study Identification, Study Status v24
Re-verified, no change to tracked fields
2024-11-22
Study Status, Contacts/Locations v23
Study sites504 entries, revised
Magee-Womens Hospital of UPMC,4300300 LondonberryHalket RoadStreet
2024-10-07
Study Status, Contacts/Locations v22
Study sites508→504
2024-09-10
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v21
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 440→confirmed 443
Study sites509→508
Show 20 earlier versions
2024-08-07
3 amendments v18-v20
3 re-verifications since 2024-05-08, no change to tracked fields
2024-03-26
Study Identification, Study Status, Arms and Interventions, Contacts/Locations v17
Study sites507→509
2024-02-20
Study Status, Contacts/Locations v16
Study sites497→507
2024-01-24
Study Status, Eligibility v15
Eligibility criteria+42 characters
[...] ividuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 [...]
2023-12-21
Study Status, Contacts/Locations v14
Study sites496→497
2023-12-06
Study Status, Contacts/Locations v13
Study sites488→496
2023-11-13
Study Status, Contacts/Locations v12
Study sites485→488
2023-10-17
Study Status, Contacts/Locations v11
Study sites477→485
2023-09-15
Study Status, Contacts/Locations v10
Study sites456→477
2023-08-10
Study Status, Contacts/Locations v9
Study sites434→456
2023-07-17
Study Status, Contacts/Locations v8
Study sites376→434
2023-05-24
Study Status, Contacts/Locations v7
Study sites337→376
2023-04-17
Study Status, Contacts/Locations v6
Study sites281→337
2023-02-09
Study Identification, Study Status, Contacts/Locations v5
Study sites246→281
2023-01-12
Study Status, Contacts/Locations v4
Study sites201→246
2022-12-09
Study Status, Contacts/Locations v3
Study sites27→201
2022-09-05
Study Status, Contacts/Locations v2
Study sites22→27
2022-08-19
Study Status, Contacts/Locations, References v1
Start dateestimated 2022-05→confirmed 2022-07-25
Study sites2→22
2022-05-16
Original filing
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).
Trial Details
NCT Number NCT05382286
Lead Sponsor Gilead Sciences
Collaborators: Merck Sharp & Dohme LLC
Conditions Triple Negative Breast Cancer, PD-L1 Positive
Enrollment 443 participants
Start Date 2022-07-25
Primary Completion 2027-02 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2025-09-18