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Cancer trials
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Trial details

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

To find out more about this trial and your cancer treatment options, please speak with your doctor.

Trial short name: ASCENT-03

Official title: A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated With Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do 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: Paclitaxel Drug: nab-Paclitaxel Drug: Gemcitabine Drug: Carboplatin

Registration #: NCT05382299

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) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.

Key Inclusion Criteria: • Individuals, regardless of race and ethnic group, with previously untreated locally advanced, inoperable or metastatic triple-negative breast cancer (TNBC) o Individuals whose tumors are programmed cell death ligand 1 (PD-L1) negative at screening or individuals whose tumors are PD-L1 positive at screening if they have received an anti-PD-(L)1 inhibitor in the (neo)adjuvant setting o Centrally confirmed TNBC and PD-L1 status on fresh or archival tissue o Individuals must have completed treatment for Stage I-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 • Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) in accordance with per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. as evaluated locally • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 • Demonstrates adequate organ function • Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception • Individuals with human immunodeficiency virus (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 systemic anticancer treatment within the previous 6 months or radiation therapy within 2 weeks prior to enrollment • Have not recovered from adverse events (AEs) due to a previously administered agent at the time study entry • 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 • Previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor • Active second malignancy • Active serious infection requiring antibiotics • Positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection Note: Other protocol defined Inclusion/Exclusion criteria may apply.