Status:
RECRUITING
Circadian Rhythm Impact on TNBC Response to Neoadjuvant Immunotherapy
Lead Sponsor:
Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Conditions:
Triple Negative Breast Cancer (TNBC)
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Patients will be randomized 1:1 to receive all neoadjuvant pembrolizumab cycles (400 mg every 6 weeks) before versus after noon. Subjects will be stratified based on clinical stage at diagnosis (St. I...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06880029
Start Date
September 1 2024
End Date
September 1 2025
Last Update
March 19 2025
Active Locations (1)
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1
Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Região, Portugal, 4434-502