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Trial Summary

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).

Acronym:

ASCENT 04

ACTRN/NCT /ethics:

NCT05382286

Scientific title:

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

Sponsor / Cooperative group:

Gilead Sciences

Trial & Patient Characteristics

Cancer TypeAll cancers
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexAll
Tumour Stream -
Cancer Stage-
Anticipated Start Date2022-07-25
Anticipated End Date2027-02-01

Participating Hospitals

HospitalCancer Research SA
Clinical Trial CoordinatorKelly Mead/Kate Penta
EmailMeggan.ORiley@socru.org.au
Phone08 8359 2565
Principal InvestigatorMeena Okera
Recruitment StatusRecruiting