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Protocol Summary


Protocol No.
PSCI-22-142
Prinicipal Investigator
Truica, Cristina
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
GS-US-598-6168
Title
A Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients with Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2-Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
Objective
Primary Objective: To compare the effect of SG relative to the TPC on PFS.

Key Secondary Objective: To compare the effect of SG relative to TPC on the following: OS, ORR, Change from baseline in physical functioning domain and time to deterioration (TTD) in Global Health Status/quality of life (QoL) as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQC30).
Applicable Disease Sites
Breast
Status
Open
Participating Institutions
Hershey Medical Center