Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Gilead Sciences (Voir sur ClinicalTrials)
décembre 2022
août 2031
16 juillet 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Alessandro Adriano VIANSONE | 22/07/2026 07:40:06 | Contacter | ||
Critères
Tous
- 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.
Key Exclusion Criteria:
- Stage IV (metastatic) breast cancer as well as history of any prior (ipsi- or
contralateral) invasive breast cancer.
- 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.
- Evidence of recurrent disease following preoperative therapy and surgery.
- Prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (ADCs)
containing a topoisomerase inhibitor.
- Individuals with germline breast cancer gene (BRCA) mutations.
- 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%
- Active serious infections requiring anti-microbial therapy.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.