RecruitingPhase 1Phase 2NCT06880029
Circadian Rhythm Impact on TNBC Response to Neoadjuvant Immunotherapy
Circadian Rhythm Impact on Triple Negative Breast Cancer Response to Neoadjuvant Immunotherapy - a Feasibility Randomized Trial
Sponsor
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Enrollment
20 participants
Start Date
Sep 1, 2024
Study Type
INTERVENTIONAL
Summary
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.
Eligibility
Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years
Inclusion Criteria3
- 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 Criteria3
- 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
Interventions
OTHERMorning pembrolizumab infusions
Patients will be randomized 1:1 to receive all three neoadjuvant pembrolizumab cycles in the morning (before noon) or in the afternoon (after noon).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06880029