Circadian Rhythm Impact on TNBC Response to Neoadjuvant Immunotherapy
Recruiting · NCT06880029 · Interventional (participants receive a specific treatment) · Lead sponsor: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
View the official record on ClinicalTrials.gov →Interventions studied
Morning pembrolizumab infusions
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Centro Hospitalar Vila Nova de Gaia/Espinho - Vila Nova de Gaia, Região, Portugal