Actively Recruiting
A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
Led by Gilead Sciences · Updated on 2026-01-30
100
Participants Needed
16
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study of Sacituzumab Govitecan Given at an Alternative Dose and Schedule in Participants With Advanced Triple-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent.
- Histologically or cytologically confirmed triple-negative breast cancer.
- Phase 1: Unresectable, locally advanced or metastatic TNBC refractory to or relapsed after at least one prior standard chemotherapy.
- Phase 2: Unresectable, locally advanced or metastatic TNBC with no prior systemic therapy for advanced disease.
- Phase 2: Tumors must be PD-L1 negative (CPS < 10) or if CPS ≥ 10, must have prior anti-PD-(L)1 treatment in adjuvant/neoadjuvant setting or be unable to receive anti-PD-(L)1 due to comorbidity.
- UGT1A1 genotype status required; Phase 1 safety run-in requires UGT1A1 wild-type.
- Measurable disease by CT or MRI per RECIST 1.1.
- ECOG performance status score of 0 or 1.
- Adequate hematologic counts within 2 weeks before enrollment.
- Adequate liver and kidney function.
You will not qualify if you...
- Prior treatment with a topoisomerase 1 inhibitor or antibody-drug conjugate containing a topoisomerase inhibitor.
- Prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed antibody-drug conjugate.
- Other protocol-defined exclusion criteria may apply.
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Los Angeles Cancer Network (LACN) - Good Sam
Los Angeles, California, United States, 90017
Actively Recruiting
2
Winship Cancer Institute - Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
The University of Kansas Hospital
Westwood, Kansas, United States, 66205
Actively Recruiting
4
Siteman Cancer Center
St Louis, Missouri, United States, 63110
Actively Recruiting
5
West Cancer Centre
Germantown, Tennessee, United States, 38138
Actively Recruiting
6
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
7
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Actively Recruiting
8
Texas Oncology - DFW
Dallas, Texas, United States, 75246
Actively Recruiting
9
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
10
St. Vincent's Hospital - Kinghorn Cancer Center
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
11
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia, 4575
Actively Recruiting
12
John Flynn Private Hospital
Tugun, Queensland, Australia, 4224
Actively Recruiting
13
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
14
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Not Yet Recruiting
15
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
16
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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