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Circadian Rhythm Impact on TNBC Response to Neoadjuvant Immunotherapy

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsFemaleCentro Hospitalar de Vila Nova de Gaia/Espinho, E…
NCT06880029 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Morning pembrolizumab infusions
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Where

1 site
Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia, Portugal
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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