Sacituzumab Govitecan with Pembrolizumab in PD-L1 Positive Metastatic Triple-Negative Breast Cancer
Research type
Research Study
Full 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
IRAS ID
1005204
Contact name
Sharline Madera
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2021-005742-14
Clinicaltrials.gov Identifier
Research summary
This is a randomised, open-label, international study taking place in roughly 300 sites worldwide with approx. 440 patients being enrolled. Breast cancer is the most common cancer globally, where the triple-negative breast cancer subtype has very limited treatment options and poor survival outcomes. The purpose of this study is to determine if the combination of sacituzumab govitecan + pembrolizumab (experimental treatment) can improve the lifespan of patients with advanced, PD-L1 positive triple-negative breast cancer (TNBC) and to see if their tumour does not grow or spread when compared to pembrolizumab plus a standard chemotherapy treatment (paclitaxel, nab-paclitaxel or gemcitabine with carboplatin) chosen by the study doctor.
Participants must provide written informed consent prior to undergoing study procedures. After Screening assessments are complete, eligible subjects will be randomly assigned to either 1 of 2 treatment groups; Group 1 will receive intravenous treatment of Sacituzumab govitecan + pembrolizumab and Group 2 will receive intravenous treatment of pembrolizumab + one of the standard chemotherapy treatments mentioned above. Group 1 will receive the study treatment on Days 1 and 8 of a 21-day cycle whereas Group 2 will receive study treatment on Day 1 of 21- or 28-day cycles.
After Screening, study site visits for safety and disease-related clinical assessments will occur on Days 1 and/or 8 of each treatment cycle. A safety evaluation visit will approximately 30 days after the last dose of study treatment This study includes blood sampling, brain MRI, CT scans and quality of life questionnaires.Participants’ total time in the study will vary depending on how their cancer responds to study treatment, however their active participation with the study treatment may continue until either, the blinded independent central review (BICR) verifies disease progression, consent is withdrawn, toxicity is deemed unacceptable or death.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
22/NE/0118
Date of REC Opinion
16 Aug 2022
REC opinion
Further Information Favourable Opinion