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Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

Study acronym: ASCENT-07
StatusActive, Not Recruiting
PhasePhase 3
Started2023-05-08
View on ClinicalTrials.gov ↗

Amendment history

2025-09-30
Study Status v18
Primary completion date2025-09→2028-04
Completion date2028-12→2028-04
2024-08-27
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v17
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 288 of 288 sites
2024-07-22
Study Status, Contacts/Locations v16
Study sites282→288
2024-06-20
Study Status, Contacts/Locations v15
Study sites268→282
2024-05-23
Study Status, Contacts/Locations v14
Study sites170→268
Show 13 earlier versions
2024-02-26
Study Status, Study Description, Eligibility v13
Eligibility criteria+362 characters
Key Inclusion Criteria: Able to understand and give written informed consent. Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site. Documented evide [...] BC) confirmed with the most recently available tumor biopsy preferably from a locally recurrent or metastatic site. Documented evid [...] tabine, nab-paclitaxel, or paclitaxel. Individuals must have at least one of the following: Disease progression on at least 2 or [...] th or without a cyclin-dependent kinase (CDK) 4/6 inhibitor (if ineligible or if unable to access a CDK 4/6 inhibitor) in the metastatic setting. Disease [...] [...]
2024-01-22
Study Status, Contacts/Locations v12
Study sites127→170
2023-12-21
Study Identification, Study Status, Contacts/Locations v11
Study sites118→127
2023-12-08
Study Status, Contacts/Locations v10
Study sites95→118
2023-11-16
Study Status, Contacts/Locations v9
Study sites77→95
2023-11-03
Study Status, Contacts/Locations v8
Study sites49→77
2023-10-17
Study Identification, Study Status, Contacts/Locations v7
Study sites21→49
2023-09-14
Study Identification, Study Status, Contacts/Locations v6
Study sites12→21
2023-08-15
Study Status, Contacts/Locations v5
Study sites6→12
2023-07-20
Study Status, Contacts/Locations v4
Study sites5→6
2023-06-30
Study Status, Contacts/Locations v3
Study sites4→5
2023-06-07
Study Status, Contacts/Locations v2
Study sites2→4
2023-05-17
Study Status, References v1
Start dateestimated 2023-05→confirmed 2023-05-08
2023-04-21
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
Breast Cancer
5,180 trials monitored
See 256 trials at risk
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).
Trial Details
NCT Number NCT05840211
Lead Sponsor Gilead Sciences
Conditions Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer
Enrollment 654 participants
Start Date 2023-05-08
Primary Completion 2028-04 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2025-10-03