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: PD-L1+: 1st Line: ASCENT-03

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced, Inoperable, or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

Title
Gilead GS-US-592-6173 TNBC PD-L1 positive sacituzumab
Study Title

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician’s Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced, Inoperable, or Metastatic Triple-Negative Breast Cancer, Whose Tumors Express PD-L1

Site Link
Malignancy
Breast cancer, IBC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st line
Investigational Agent
Sacituzumab govitecan, pembrolizumab
Drug Class
Trop-2 antibody drug conjugate, PD-1 inhibitor
PI
Greg Vidal, MD, PhD
Sponsor
Gilead Sciences
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Locally advanced, inoperable, or metastatic TNBC (centrally confirmed) without prior therapy for advanced disease
  • PD-L1 positive (centrally confirmed)
  • If patient received treatment for early disease, must have completed treatment at least 6 months prior to development of metastatic disease
  • Measurable disease
  • ECOG PS 0-1
  • No prior topoisomerase inhibitors
  • No active autoimmune disease
  • If HIV positive may not have had Kaposi's sarcoma or Castleman's disease
  • No active HBV/HCV
Objective
  • Primary
    • PFS
  • Secondary
    • OS
    • ORR
    • DOR
    • TTR
    • Safety
    • QoL
Assessment Frequency
_
Assessment Frequency 2
_



Assessment Frequency Link
Path
TNBC, PD-L1 positive
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X