Tests a drug combination after surgery for triple negative breast cancer
Tests sacituzumab govitecan with pembrolizumab in adults with triple negative breast cancer left after surgery.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Brasília, Curitiba, Ijuí, Itajaí, Natal, Porto Alegre, Recife, Rio de Janiero, Salvador, São Paulo, and Teresina, BrazilSee the 20 sites
- Phase
- Phase 3
Where in Brazil
- St. de Habitações Individuais Sul QI 15 - Lago Sul, Brasília - DF, BrasilBrasília, BrazilTaking people
- Rua Myltho Anselmo da Silva, 870 - Mercês, Curitiba - PR, CEP 80510-130Curitiba, BrazilTaking people
- Rua Padre Germano Mayer, 1949, Hugo Lange, Curitiba, ParanáCuritiba, BrazilTaking people
- OncositeIjuí, BrazilTaking people
- R. Aderbal Ramos da Silva, 148 - Centro, Itajaí - SC, 88300-000, BrasilItajaí, BrazilTaking people
- Av. Miguel Castro, 1355, Nossa Senhora de Nazaré, Natal/RNNatal, BrazilTaking people
- Av. Ipiranga 6690Porto Alegre, BrazilTaking people
- Av. Soledad, 569, sala 1103, Três Figueiras, CEP 90470-340Porto Alegre, BrazilTaking people
- Rua Professor Annes Dias, 295 - Centro Histórico, Porto Alegre - RS, , BrasilPorto Alegre, BrazilTaking people
- Instituto Santa Joana Recife de Ensino e PesquisaRecife, BrazilTaking people
- Hospital Esperança SARecife, BrazilNo longer taking part
- Instituto D'Or de Pesquisa e Ensino - RJRio de Janiero, BrazilTaking people
- Av. Milton Santos, 123 - Ondina, Salvador - BA, , BrasilSalvador, BrazilTaking people
- AMO Clinic - Rio VermelhoSalvador, BrazilNo longer taking part
- Av. Brigadeiro Luís Antônio 733, loja 8São Paulo, BrazilTaking people
- CIPE Centro Internacional de Pesquisa; A.C. Camargo Cancer CenterSão Paulo, BrazilTaking people
- Martiiano de Carvalho 965São Paulo, BrazilTaking people
- Hospital Sírio-Libanês SPSão Paulo, BrazilNo longer taking part
- Instituto D'Or de Pesquisa e Ensino SPSão Paulo, BrazilNo longer taking part
- Rua Gardênia, 710, Edifício Prime, 4º andar, Bairro Jóquei, Teresina - PI, CEP 60449-200Teresina, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gilead Sciences
- Trial code
- NCT05633654EU 2024-512279-10-00
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan 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
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.
Inclusion: Age > 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:; TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%, human epidermal growth factor receptor 2 (HER2)-negative per American Society of Clinical Oncology and College of American Pathologists (ASCO/CAP) guidelines (immunohistochemistry (IHC) and/or in situ hybridization (ISH)); Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery; Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue; Eastern Cooperative Oncology Group (ECOG) performance status 0-1; Individuals must have received appropriate radiotherapy aligned with local/institutional practice and have recovered prior to starting study treatment; Adequate organ function.
Exclusion: Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer; Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs) containing a topoisomerase inhibitor; Evidence of recurrent disease following preoperative therapy and surgery; Individuals with germline breast cancer gene (BRCA) mutations; Active serious infections requiring anti-microbial therapy; Note: Other protocol defined Inclusion/Exclusion criteria may apply; Prior treatment with another stimulatory or coinhibitory T-cell receptor agent (eg, cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX-40, cluster of differentiation 137 (CD137), prior treatment with any HER2-directed agent, prior endocrine therapy for > 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment; Myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or Left ventricular ejection fraction (LVEF) of < 50%.