Impact of Timing on Immunotherapy for Triple Negative Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.