Study Summary
This trial will assess if pembrolizumab, when combined with chemotherapy, is more effective in treating hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer than chemotherapy alone. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
4 Primary · 30 Secondary · Reporting Duration: Up to approximately 75 months
Trial Safety
Phase-Based Safety
Side Effects for
Awards & Highlights
Trial Design
2 Treatment Groups
Placebo + Chemotherapy
1 of 2
Pembrolizumab + Chemotherapy
1 of 2
Active Control
Experimental Treatment
800 Total Participants · 2 Treatment Groups
Primary Treatment: pembrolizumab · No Placebo Group · Phase 3
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
What are the standard indication for pembrolizumab?
"Pembrolizumab can be used to treat three different types of cancer: unresectable melanoma, microsatellite instability high, and neuroblastoma (nb)." - Anonymous Online Contributor
Is this a new way to test treatments?
"Alfacell conducted the first pembrolizumab clinical trial in 1997 with 300 patients. After the success of that Phase 3 study, the drug received approval and today there are 2361 ongoing trials in 85 countries around the world." - Anonymous Online Contributor
Could you list other pembrolizumab studies that have been completed in the past?
"There are a total of 2361 clinical trials investigating pembrolizumab. 531 of those studies are currently in Phase 3. The vast majority of pembrolizumab trials are being conducted in Guangzhou, Guangdong. However, there are 97433 total locations running pembrolizumab trials." - Anonymous Online Contributor
Are there serious dangers associated with pembrolizumab?
"Pembrolizumab's Phase 3 status and the presence of efficacy data means that it receives a safety score of 3." - Anonymous Online Contributor
In which continent is this trial most popular?
"This clinical trial is currently underway at 42 different medical facilities. Some notable locations include Sanford Fargo Medical Center ( Site 0040) in Fargo, University of Alabama at Birmingham-Medicine ( Site 0065) in Birmingham, and University Cancer & Blood Center, LLC ( Site 0032) in Athens." - Anonymous Online Contributor