Circadian Rhythm Impact on TNBC Response to Neoadjuvant Immunotherapy

Launched by CENTRO HOSPITALAR DE VILA NOVA DE GAIA/ESPINHO, E.P.E. · Mar 11, 2025

Keywords

ClinConnect Summary

The CIRCADIAN trial is a study looking at how the timing of a specific treatment, called pembrolizumab, affects its effectiveness in women with triple-negative breast cancer (TNBC). This is a type of breast cancer that can be harder to treat. The researchers want to see if giving this treatment at different times of the day leads to better results in shrinking tumors before surgery, which is known as achieving a pathological complete response (pCR).

To participate in this trial, women between the ages of 18 and 75 who have been diagnosed with Stage II or III TNBC and are eligible for specific pre-surgery treatments may qualify. Participants will receive pembrolizumab along with chemotherapy and will be assigned to receive their treatment either in the morning or the evening. The trial is currently recruiting participants, and it’s important to know that those who cannot fully understand the study or who may not be able to complete their treatments as planned will not be eligible. This study aims to find the best way to improve treatment outcomes for women facing this challenging diagnosis.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Female sex
• • Age 18 - 75 years old
• • Diagnosed with Stage II or III TNBC and candidates for neoadjuvant treatment with ChT+pembrolizumab after multidisciplinary group discussion.
• Exclusion Criteria:
• • Patients unable to understand or consent to the study;
• • Patients not completing ≥2 cycles of planned neoadjuvant pembrolizumab cycles or ≥50% of planned neoadjuvant ChT cycles;
• • Patients under daily ≥10 mg of prednisolone or equivalent