NCT06880029RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 19 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 11 Mar 2025
- Start date
- 1 Sept 2024
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06880029
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 20
- From 1 Sept 2024 to the primary completion date, 1 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Hospitalar Vila Nova de Gaia/Espinho Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.