Trial details
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
To find out more about this trial and your cancer treatment options, please speak with your doctor.
Trial short name: ASCENT-04
Official title: 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
Principal Investigator: Dr. Katarzyna Jerzak
Cancer type: Breast
Cancer location: Breast
Disease stage: Early Cancer
Trial phase: Phase 3
Intervention: Drug: Sacituzumab Govitecan-hziy Drug: Pembrolizumab Drug: Paclitaxel Drug: nab-Paclitaxel Drug: Gemcitabine Drug: Carboplatin
Registration #:
NCT05382286 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
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).
Key Inclusion Criteria: • 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. o 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. o Individuals presenting with de novo metastatic TNBC are eligible for this study. o TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen. o 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 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.
