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Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

StatusRecruiting
PhasePhase 3
Started2022-12-12
View on ClinicalTrials.gov ↗

Amendment history

2026-09-08
Study Status, Contacts/Locations v36
Trial sites expanded: 356 → 372 locations
2026-07-14
Study Status, Contacts/Locations v35
Trial sites expanded: 350 → 356 locations
2026-06-09
Study Status, Contacts/Locations v34
Trial sites expanded: 339 → 350 locations
2026-04-29
Study Status, Eligibility, Contacts/Locations v33
Trial sites expanded: 288 → 339 locations
Eligibility criteria+42 characters
[...] 0-1. Individuals must have received appropriate radiotherapy aligned with local/institutional practice and have recovered prior to starting study treatment. Adequ [...]
2026-01-16
Study Status, Contacts/Locations v32
Study sites283→288
Show 31 earlier versions
2025-11-25
Study Status, Contacts/Locations v31
Study sites276→283
2025-10-29
Study Status, Contacts/Locations v30
Study sites225→276
2025-08-13
Study Status, Contacts/Locations v29
Study sites224→225
2025-06-24
Study Status, Contacts/Locations v28
Study sites191→224
2025-04-18
Study Identification, Study Status, Sponsor/Collaborators, Conditions, Eligibility, Contacts/Locations v27
Study sites177→191
Eligibility criteria+50 characters
[...] ed as estrogen receptor (ER) and progesterone receptor (PR) <≤ 10%, human epidermal growth factor receptor 2 (HER2)-negati [...] CD137), prior treatment with any HER2-directed agent, prior endocrine therapy for > 4 weeks or planned concurrent treatment with any endocrine therapy agentwhile receiving on-study treatment. Evidence of recurrent disease following preoperative thera [...]
Collaborators2 to 3 entries
GBG Forschungs GmbH
Study title+8 characters
[...] rgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)
2025-01-29
Study Status, Contacts/Locations v26
Study sites167→177
2024-11-26
Study Status, Contacts/Locations v25
Study sites166→167
2024-10-24
Study Status, Contacts/Locations v24
Study sites161→166
2024-10-03
Study Status, Contacts/Locations v23
Study sites159→161
2024-09-06
Study Status, Contacts/Locations v22
Study sites155→159
2024-08-06
Study Status, Contacts/Locations v21
Study sites145→155
2024-06-24
Study Status, Contacts/Locations v20
Study sites132→145
2024-05-29
Study Status v19
Re-verified, no change to tracked fields
2024-04-30
Study Identification, Study Status, Sponsor/Collaborators, Conditions, Eligibility, Contacts/Locations v18
Study sites111→132
Eligibility criteria+58 characters
[...] on 137 (CD137), prior treatment with any HER2-directed agent, prior or concurrent treatment with any endocrine therapy agent. Evidence of recurrent disease following preoperative thera [...] ADCs) containing a topoisomerase inhibitor. Individuals with known germline breast cancer gene (BRCA) mutations. Myocardial in [...]
Collaborators1 to 2 entries
NSABP Foundation Inc
Study title+42 characters
[...] idual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/NSABP B-63)
2024-03-11
Study Status, Arms and Interventions, Contacts/Locations v17
Study sites96→111
2024-02-12
Study Status, Contacts/Locations v16
Study sites83→96
2024-01-12
Study Status, Contacts/Locations v15
Study sites64→83
2023-12-21
Study Status, Contacts/Locations v14
Study sites56→64
2023-12-05
Study Status, Contacts/Locations v13
Study sites47→56
2023-11-01
Study Status, Contacts/Locations v12
Study sites42→47
2023-10-10
Study Status, Contacts/Locations v11
Study sites38→42
2023-09-20
Study Status, Contacts/Locations v10
Primary completion date2027-07→2027-06
Completion date2031-01→2031-08
Study sites29→38
2023-08-02
Study Status, Contacts/Locations v9
Study sites22→29
2023-06-27
Study Status, Contacts/Locations v8
Study sites18→22
2023-06-02
Study Status, Contacts/Locations v7
Study sites17→18
2023-05-08
Study Status, Contacts/Locations v6
Study sites15→17
2023-04-20
Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v5
Study sites11→15
InterventionsCapecitabine (Drug), Pembrolizumab (Biological), Sacituzumab govitecan-hziy (SG) (Biological)→Capecitabine (Drug), Pembrolizumab (Drug), Sacituzumab govitecan-hziy (SG) (Drug)
Eligibility criteria+47 characters
[...] and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)). Adequate excision and surgical removal of all clinically [...]
Secondary endpoints5 to 6 entries
Recurrence-free Survival (RFS)
2023-02-14
Study Status, Contacts/Locations v4
Study sites8→11
2023-01-26
Study Status, Contacts/Locations v3
Study sites7→8
2023-01-12
Study Status, Contacts/Locations v2
Study sites1→7
2022-12-21
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations, References v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-03→confirmed 2022-12-12
Study sites0→1
Eligibility criteriarevised
[...] (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), XOX-40, cluster of differentiation 137 (CD137)), prior treatment with any HER2-directed agent. Evidence of [...]
2022-11-21
Original filing
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
Trial Details
NCT Number NCT05633654
Lead Sponsor Gilead Sciences
Collaborators: Alliance Foundation Trials, LLC., NSABP Foundation Inc, GBG Forschungs GmbH
Conditions Triple Negative Breast Cancer
Enrollment 1,514 participants
Start Date 2022-12-12
Primary Completion 2027-06 (estimated)
Study Completion 2031-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-09