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

Study acronym: ASCENT-03
StatusActive, Not Recruiting
PhasePhase 3
Started2022-07-20
View on ClinicalTrials.gov ↗

Amendment history

2026-04-03
Study Status v31
Re-verified, no change to tracked fields
2025-09-03
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v30
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 540→confirmed 623
Study sites516→363
2025-05-15
Study Status, Contacts/Locations v29
Study sitesdetails revised at 4 of 516 sites
2025-02-21
2 amendments v27-v28
2 re-verifications since 2025-01-17, no change to tracked fields
2024-12-20
Study Status, Contacts/Locations v26
Study sitesdetails revised at 1 of 516 sites
Show 25 earlier versions
2024-10-15
Study Status, Outcome Measures, Contacts/Locations v25
Primary completion date2027-05→2028-07
Completion date2027-05→2028-07
Study sites508→516
2024-07-09
2 amendments v23-v24
2 re-verifications since 2024-06-10, no change to tracked fields
2024-05-21
Study Status, Contacts/Locations v22
Study sites506→508
2024-05-02
Study Status v21
Re-verified, no change to tracked fields
2024-04-10
Study Status, Contacts/Locations v20
Study sites502→506
2024-03-19
Study Status, Contacts/Locations v19
Study sites495→502
2024-02-27
Study Status, Contacts/Locations v18
Study sites490→495
2024-02-05
Study Status, Contacts/Locations v17
Study sites473→490
2024-01-09
Study Identification, Study Status, Contacts/Locations v16
Study sites469→473
2023-12-19
Study Identification, Study Status, Outcome Measures, Eligibility v15
Eligibility criteria+121 characters
[...] ived an anti-PD-(L)1 inhibitor in the (neo) adjuvant setting or if they cannot be treated with a checkpoint inhibitor due to a comorbidity Centrally confirmed TNBC and PD-L1 status on fresh or archi [...] east cancer, if indicated, and ≥ 6 months must have elapsed (with the exception of endocrine therapy) between completion of treatment with curative intent and fir [...]
Secondary endpoints7 to 8 entries
[...] estionnaire, Core Questionnaire, Version 3.0 (EORTC QLQ-C30). Time to Deterioration (TTD) of Fatigue Scale of the EORTC QLQ-C30
Study title+31 characters
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer
2023-12-05
Study Status, Contacts/Locations v14
Study sites466→469
2023-11-13
Study Status, Contacts/Locations v13
Study sites458→466
2023-10-18
Study Status, Contacts/Locations v12
Study sites447→458
2023-09-27
Study Status, Contacts/Locations v11
Study sites435→447
2023-08-17
Study Status, Contacts/Locations v10
Study sites405→435
2023-07-19
Study Status, Contacts/Locations v9
Study sites365→405
2023-05-25
Study Status, Contacts/Locations v8
Study sites325→365
2023-04-17
Study Status, Contacts/Locations v7
Study sites285→325
2023-02-23
Study Identification, Study Status, Contacts/Locations v6
Study sites232→285
2023-01-17
Study Status, Contacts/Locations v5
Study sites199→232
2022-12-09
Study Status, Contacts/Locations v4
Study sites36→199
2022-09-28
Study Identification, Study Status, Contacts/Locations v3
Study sites27→36
2022-09-05
Study Status, Contacts/Locations v2
Study sites22→27
2022-08-18
Study Status, Contacts/Locations, References v1
Start dateestimated 2022-05→confirmed 2022-07-20
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) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.
Trial Details
NCT Number NCT05382299
Lead Sponsor Gilead Sciences
Conditions Triple Negative Breast Cancer, PD-L1 Negative
Enrollment 623 participants
Start Date 2022-07-20
Primary Completion 2028-07 (estimated)
Study Completion 2028-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-06