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Circadian Rhythm Impact on TNBC Response to Neoadjuvant Immunotherapy

RECRUITINGPhase 1/2Sponsored by Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Actively Recruiting
PhasePhase 1/2
SponsorCentro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Started2024-09-01
Est. completion2025-09-01
Eligibility
Age18 Years – 75 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06880029

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

Age: 18 Years – 75 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions3

Breast CancerCancerTriple Negative Breast Cancer (TNBC)

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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