Circadian Rhythm Impact on TNBC Response to Neoadjuvant Immunotherapy

Recruiting now · Phase 1/Phase 2

Conditions studied: Triple Negative Breast Cancer (TNBC)

In brief

CIRCADIAN is a prospective randomized clinical trial designed to evaluate the impact of pembrolizumab infusions' time-of-day on pathological complete response (pCR) rate among TNBC patients undergoing neoadjuvant treatment.

Key facts

Study ID

NCT06880029

Run by

Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

People needed

20

Starts

2024-09-01

Expected to finish

2025-09-01

Last updated by the study team

2025-03-19

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Centro Hospitalar Vila Nova de Gaia/Espinho — Vila Nova de Gaia, Região, Portugal (enrolling)

Full record on ClinicalTrials.gov

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