West Cancer Center

BREAST: METASTATIC: TNBC: PD-L1+: 1st Line: ASCENT-04

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

Site Link

NCT05382286

Malignancy

Breast cancer, IBC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st line

Investigational Agent

Sacituzumab govitecan, pembrolizumab

Drug Class

Trop-2 antibody drug conjugate, PD-1 inhibitor

Greg Vidal, MD, PhD

Sponsor

Gilead Sciences

Phase

Phase 3

Status

Open to Enrollment

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