Impact of Timing on Immunotherapy for Triple Negative Breast Cancer
Circadian Rhythm Impact on Triple Negative Breast Cancer Response to Neoadjuvant Immunotherapy - a Feasibility Randomized Trial
This study is testing whether getting immunotherapy infusions in the morning or afternoon can improve treatment results for people with triple negative breast cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E. Government |
| Drugs / interventions | pembrolizumab |
| Locations | 1 site (Vila Nova de Gaia, Região) |
| Trial ID | NCT06880029 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates how the timing of pembrolizumab infusions affects the response rate in patients with triple negative breast cancer (TNBC) undergoing neoadjuvant treatment. Patients will be randomly assigned to receive their infusions either before or after noon, with the primary goal of measuring the rate of pathological complete response (pCR). Additionally, the study will explore the relationship between circadian rhythms and treatment outcomes by assessing various biomarkers and lifestyle factors. The trial aims to provide insights into optimizing immunotherapy timing for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are females aged 18 to 75 diagnosed with Stage II or III triple negative breast cancer who are eligible for neoadjuvant treatment.
Not a fit: Patients who are unable to consent or complete the required treatment cycles may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment responses for patients with triple negative breast cancer through optimized immunotherapy scheduling.
How similar studies have performed: While the specific approach of timing immunotherapy based on circadian rhythms is novel, similar studies have shown promise in optimizing treatment schedules in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vila Nova de Gaia, Região
- Centro Hospitalar Vila Nova de Gaia/Espinho — Vila Nova de Gaia, Região, Portugal (Recruiting)
Study contacts
- Study coordinator: Alexandra P. Guedes, Medical Oncologist M.D.
- Email: alexandra95dg@gmail.com
- Phone: +351968957977
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.