A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
Start Date
4/30/2025
Completion Date
6/1/2028
Summary
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan-hziy (SG) given at an alternative dose and schedule, in participants with triple-negative breast cancer (TNBC). The primary objectives of this study are to assess the safety and tolerability of SG given at alternate dose and schedule, to assess the effect on objective response rate (ORR) and progression-free survival (PFS).
Detailed Description
Phase 1 of this study will evaluate the preliminary safety, tolerability, pharmacokinetics (PK), and efficacy of SG. Phase 2 expansion of this study will further evaluate the safety, efficacy, and PK of SG.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Sacituzumab Govitecan-hziy (SG)
Conditions
Locations
Los Angeles Cancer Network (LACN) - Good Sam
Los Angeles, California 90017
United States
Winship Cancer Institute - Emory University
Atlanta, Georgia 30322
United States
The University of Kansas Hospital
Westwood, Kansas 66205
United States
Siteman Cancer Center
St Louis, Missouri 63110
United States
West Cancer Centre
Germantown, Tennessee 38138
United States
SCRI Oncology Partners
Nashville, Tennessee 37203
United States
Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United States
Texas Oncology - DFW
Dallas, Texas 75246
United States
Virginia Oncology Associates
Norfolk, Virginia 23502
United States
St. Vincent's Hospital - Kinghorn Cancer Center
Darlinghurst, New South Wales 2010
Australia
Sunshine Coast University Private Hospital
Birtinya, Queensland 4575
Australia
John Flynn Private Hospital
Tugun, Queensland 4224
Australia
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea