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Circadian Rhythm Impact on TNBC Response to Neoadjuvant Immunotherapy

NCT06880029 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-19

No results posted yet for this study

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.

Conditions

  • Triple Negative Breast Cancer (TNBC)

Interventions

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).

Sponsors & Collaborators

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-09-01
Completion
2025-09-01

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06880029 on ClinicalTrials.gov