Informations générales (source: ClinicalTrials.gov)
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1
Interventional
Phase 3
Gilead Sciences (Voir sur ClinicalTrials)
juillet 2022
février 2027
02 octobre 2025
The primary objective of this study is to compare the progression-free survival (PFS)
between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's
choice (TPC) and pembrolizumab in participants with previously untreated, locally
advanced inoperable or metastatic triple-negative breast cancer, whose tumors express
programmed cell death ligand 1 (PD-L1).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Barbara PISTILLI | 19/06/2024 12:20:24 | Contacter | ||
Critères
Tous
- Individuals with locally advanced, inoperable, or metastatic triple-negative breast
cancer (TNBC) who have not received previous systemic therapy for advanced disease
and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
- Individuals must have completed treatment for Stage I to III breast cancer, if
indicated, and ≥ 6 months must have elapsed between completion of treatment
with curative intent and first documented local or distant disease recurrence.
- Individuals presenting with de novo metastatic TNBC are eligible for this
study.
- TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed
centrally on a recent or archival tumor specimen.
- Individuals must have measurable disease by computed tomography (CT) or
magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid
Tumors (RECIST) Version 1.1 criteria as evaluated locally.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Demonstrates adequate organ function
- Male and female individuals of childbearing potential who engage in heterosexual
intercourse must agree to use protocol-specified method(s) of contraception.
- Individuals with HIV must be on antiretroviral therapy (ART) and have a
well-controlled HIV infection/disease.
Key Exclusion Criteria:
- Positive serum pregnancy test or women who are lactating.
- Received prior therapy with an agent directed to another stimulatory or coinhibitory
T-cell receptor.
- Individuals may not have received systemic anticancer treatment (with the exception
of endocrine therapy) within the previous 6 months or radiation therapy within 2
weeks prior to enrollment.
- Individuals may not be participating in a study with an investigational agent or
investigational device within 4 weeks prior to randomization. Individuals
participating in observational studies are eligible.
- Have previously received topoisomerase 1 inhibitors or antibody drug conjugates
containing a topoisomerase inhibitor.
- Have an active second malignancy.
- Have active serious infection requiring antibiotics.
- Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or
Multicentric Castleman Disease.
- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Has an active autoimmune disease that has required systemic treatment in the past 2
years.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.