Circadian Rhythm Impact on Triple Negative Breast Cancer Response to Neoadjuvant Immunotherapy - a Feasibility Randomized Trial

What this Trial Is About

Researchers are studying the effect of the timing of pembrolizumab infusions on the treatment response in female patients with Stage II or III Triple Negative Breast Cancer (TNBC) receiving neoadjuvant therapy. This randomized clinical trial aims to compare pathological complete response rates when pembrolizumab is given either before or after noon. The study also explores treatment-related side effects and circadian rhythm factors that might influence therapy outcomes. Participants are randomly assigned to receive all three cycles of neoadjuvant pembrolizumab infusions either in the morning (before noon) or in the afternoon (after noon), each dose being 400 mg every six weeks. Patients are stratified based on their clinical stage at diagnosis. This trial includes additional evaluations such as daily body temperature, salivary cortisol levels, questionnaires on chronotype, emotional stress, exercise, substance use, and light exposure. Biomarker studies include tumor infiltrating lymphocyte analysis, cytokine measurement, RNA sequencing, and immune cell profiling from blood samples collected at baseline and before surgery. During the study, participants will be monitored for treatment response and side effects, with pathology assessed at the time of surgery to determine the primary outcome of pathological complete response. Various questionnaires and biological samples will be collected at multiple points to understand circadian rhythms and potential biomarkers. The total study duration per participant covers the neoadjuvant treatment period through surgery, with follow-up assessments as planned to gather comprehensive data on outcomes and safety.

Circadian Rhythm Impact on TNBC Response to Neoadjuvant Immunotherapy