The Phase 3 KEYNOTE-522 study (NCT03036488) investigating pembrolizumab (Keytruda) in participants with triple-negative breast cancer (TNBC) is scheduled to reach its primary completion on 2025-10-14. This milestone marks the date when the last participant in the trial is examined or receives an intervention for the purpose of collecting primary outcome data.

Background

Pembrolizumab is an immunotherapy drug that has been investigated across various cancer types. The KEYNOTE-522 trial focuses on its use in triple-negative breast cancer (TNBC), a challenging form of breast cancer known for its aggressive nature and limited targeted treatment options. The study evaluates pembrolizumab in both neoadjuvant and adjuvant settings.

Trial design

The KEYNOTE-522 study (NCT03036488) is a Phase 3, randomized clinical trial with an enrollment of 1174 participants. The trial investigates pembrolizumab in individuals diagnosed with Triple Negative Breast Neoplasms. Participants receive either pembrolizumab plus chemotherapy or placebo plus chemotherapy as neoadjuvant therapy. Following definitive surgery, participants then receive either pembrolizumab or placebo as adjuvant therapy. The chemotherapy regimen includes carboplatin, paclitaxel, doxorubicin, and epirubicin.

What this means

The primary completion of the KEYNOTE-522 trial on 2025-10-14 signifies that all data collection for the study's primary endpoints will be finished. This is a critical step towards the eventual analysis and publication of results, which will provide important insights into the efficacy and safety of pembrolizumab in the neoadjuvant and adjuvant treatment of triple-negative breast cancer. Clinicians and researchers await these findings to potentially inform future treatment strategies for this aggressive disease.

Source

Information regarding the primary completion date for study NCT03036488, titled "Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)," was obtained from ClinicalTrials.gov. The event date of 2025-10-14 is listed on clinicaltrials.gov.