WinQ : a Window of Opportunity Study With MitoQ in Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversité Catholique de Louvain
About this trial
The purpose of the study is to validate biomarkers in blood and tumor biopsy in patients with Triple Negative Breast Cancer, after a course of MitoQ treatment
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed Informed Consent Form (ICF)
Ability to comply with protocol, in the investigator's judgment
Women aged > 18 years (no limit of age)
ECOG performance status of 0 or 1
Disqualifiers
Men
Prior systemic therapy for treatment and prevention of the current breast cancer
Known allergy or hypersensitivity to MitoQ
Known active viral hepatitis
Trial design
Design model
Single group
Treatments tested in this trial
MitoQ (mitoquinol mesylate)
Dietary supplementDietary supplement course before surgery or chemo/radio-therapy
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: MitoQ supplementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Biomarkers expression
To assess the expression of biomarkers in fresh blood and tumor tissue, after a course of MitoQ, with RNAseq and RT-qPCR techniques
Time frame
Throughout the entire study, approximately during 12 months2
Lymphocyte tumor infiltration
To asses lymphocytes infiltration by immunohistochemistry
Time frame
Throughout the entire study, approximately during 12 months3
Oxidative stress
To asses the expression of biomarkers linked to oxidative stress in plasma
Time frame
Throughout the entire study, approximately during 12 monthsSponsors and contacts
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Source ClinicalTrials.gov