NCT06880029

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 11, 2025

Last Update Submit

March 15, 2025

Conditions

Triple Negative Breast Cancer (TNBC)

Keywords

TNBCImmunotherapyCircadian rhythm

Outcome Measures

Primary Outcomes (1)

  • Pathological complete response rate

    Defined as ypT0/Tis ypN0, assessed by the local pathologist.

    At the time of definitive surgery.

Study Arms (2)

Morning Group

EXPERIMENTAL

All three neoadjuvant pembrolizumab cycles in the morning (before noon)

Other: Morning pembrolizumab infusions

Afternoon Group

NO INTERVENTION

All three neoadjuvant pembrolizumab cycles in the afternoon (after noon)

Interventions

Morning pembrolizumab infusionsOTHER

Patients will be randomized 1:1 to receive all three neoadjuvant pembrolizumab cycles in the morning (before noon) or in the afternoon (after noon).

Morning Group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar Vila Nova de Gaia/Espinho

Vila Nova de Gaia, Região, 4434-502, Portugal

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Alexandra P. Guedes, Medical Oncologist M.D.

CONTACT

+351968957977alexandra95dg@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Oncologist Resident

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 17, 2025

Study Start

September 1, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations

PT(1)