Sacituzumab Govitecan Subjects PD-L1-negative Metastatic Triple-Negative Breast Cancer (ASCENT-03)
Research type
Research Study
Full 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
IRAS ID
1005207
Contact name
Joseph Park
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2021-005743-79
Clinicaltrials.gov Identifier
Research summary
The purpose of this randomised, open-label study is to see if sacituzumab govitecan can improve lifespans of patients with advanced TNBC and their tumour does not grow or spread when compared to chemotherapy (paclitaxel, or nab-paclitaxel, or the combination of gemcitabine and carboplatin), a commonly used treatment for previously untreated advanced TNBC. This study will enrol about 540 participants in about 300 locations worldwide.
Participants will receive either the experimental treatment, sacituzumab govitecan, or 1 of 3 standard chemotherapy treatment regimens. Participants total time in the study will vary depending on how their cancer responds to study treatment. Their active participation in the study, including treatment with the study medications, may continue as long as participants are safely tolerating the treatment and their cancer has not worsened (e.g. grown or metastasised) or the study is not stopped.
REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0384
Date of REC Opinion
28 Jun 2022
REC opinion
Further Information Favourable Opinion