Clinical trial · Interventional
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
NCT06880029CI-TRIAL-00087390CIRCADIANrecruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer (TNBC) | Triple-Negative Breast Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Morning pembrolizumab infusions | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Morning Group
- description
- All three neoadjuvant pembrolizumab cycles in the morning (before noon)
- interventionNames
- Other: Morning pembrolizumab infusions
- type
- NO_INTERVENTION
- label
- Afternoon Group
- description
- All three neoadjuvant pembrolizumab cycles in the afternoon (after noon)
Primary outcomes (1)
- measure
- Pathological complete response rate
- timeFrame
- At the time of definitive surgery.
- description
- Defined as ypT0/Tis ypN0, assessed by the local pathologist.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.