RecruitingPhase 1Phase 2NCT06880029

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


Sponsor

Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

Enrollment

20 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether the time of day when chemotherapy and immunotherapy (pembrolizumab) is given affects how well the treatment works for triple-negative breast cancer (TNBC). Our body follows a natural 24-hour internal clock called the circadian rhythm, which influences how cells respond to drugs. Researchers believe that delivering cancer treatment at the right time of day may improve how tumors respond and reduce side effects — a growing field called chronotherapy. **You may be eligible if:** - You are female between 18 and 75 years old - You have been diagnosed with Stage II or III triple-negative breast cancer (confirmed by biopsy) - Your care team has recommended pre-surgery chemotherapy combined with pembrolizumab (immunotherapy) as part of your treatment plan - You are enrolled in a social health protection scheme **You may NOT be eligible if:** - You are pregnant or breastfeeding - You are unable to understand or consent to the study - You are not a candidate for the planned neoadjuvant (pre-surgery) treatment - You have medical contraindications to the study treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMorning pembrolizumab infusions

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


Locations(1)

Centro Hospitalar Vila Nova de Gaia/Espinho

Vila Nova de Gaia, Região, Portugal

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NCT06880029


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