Receive monthly emails about the latest oncology research and technology, new patient services, resources and more!

Please select an option below to help us tailor your newsletter to best suit your content interests!

No thanks
BREAST: METASTATIC: TNBC: 1st Line: ASCENT-03

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

Title
Gilead GS-US-592-6238 Metastatic Breast Sacituzumab
Study 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

Site Link
Malignancy
Breast cancer, IBC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st or 2nd line
Investigational Agent
Sacituzumab govitecan-hziy
Drug Class
Trop-2 antibody drug conjugate
PI
Greg Vidal, MD, PhD
Sponsor
Gilead Sciences
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Previously untreated locally advanced, inoperable, or metastatic TNBC (centrally confirmed)
    • Must be PD-L1 negative (centrally confirmed) unless treated in the adjuvant or neoadjuvant setting with PD-1 inhibitors, in which case they can be PD-L1 positive
  • Must have had at least 6 months between completion of treatment for curative intent and first documented local or distant disease recurrence (if treated for curative intent in the past)
  • Measurable disease
  • ECOG PS 0-1
  • No HIV
  • No active HBV/HCV
  • No previous topoisomerase inhibitors
Objective
  • Primary
    • PFS
  • Secondary
    • OS
    • ORR
    • DOR
    • TTR
    • Safety
    • QoL
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
Triple negative; TNBC
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X