The PHASE3 study NCT04895358, investigating Pembrolizumab (Keytruda) in participants with HR+/HER2- locally recurrent inoperable or metastatic breast cancer, reached primary completion on 2026-04-24. This trial assessed the safety and efficacy of pembrolizumab plus chemotherapy compared to placebo plus chemotherapy.
Background
This study investigated Pembrolizumab in combination with chemotherapy for the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer.
Trial design
The PHASE3 study, identified as NCT04895358 (KEYNOTE-B49), enrolled 342 participants with Breast Neoplasms, specifically those with HR+/HER2- locally recurrent inoperable or metastatic breast cancer. The trial aimed to assess the safety and efficacy of Pembrolizumab plus the investigator's choice of chemotherapy compared to placebo plus the investigator's choice of chemotherapy. The primary hypotheses are that the combination of Pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) in participants with programmed cell death-ligand 1 (PD-L1) combined.
What this means
The primary completion of the PHASE3 study NCT04895358 signifies that data collection for the primary endpoints in the trial has concluded. The next steps will involve data analysis to determine the efficacy and safety profile of Pembrolizumab in combination with chemotherapy for HR+/HER2- locally recurrent inoperable or metastatic breast cancer, with results expected to be reported in due course.
Source
This information was sourced from ClinicalTrials.gov, documenting the primary completion of trial NCT04895358 on 2026-04-24. The study details are available on clinicaltrials.gov.