RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
OTHER
Morning 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)
Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Região, Portugal