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
- Bari, Bergamo, Bologna, Florence, Genoa, Meldola, Milan, Misterbianco, Modena, Naples, Rome, Trento, and Turin, ItalySee the 15 sites
- Phase
- Phase 3
Where in Italy
- Istituto Tumori Bari Giovanni Paolo IIBari, ItalyTaking people
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyTaking people
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- IRCCS Ospedale Policlinico San MartinoGenoa, ItalyTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
- Humanitas Istituto Clinico Catanese S.p.A.Misterbianco, ItalyTaking people
- Azienda Ospedaliero - Universitaria di ModenaModena, ItalyTaking people
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
- IRCCS Istituto Nazionale Tumori Fondazione PascaleNaples, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRome, ItalyTaking people
- Azienda Sanitaria Universitaria Integrata Del TrentinoTrento, ItalyTaking people
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurin, ItalyTaking 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%.