WinQ : a Window of Opportunity Study With MitoQ in Breast Cancer

NCT07142096 | Recruiting

• 1 other identifier: WinQ
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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

  Throughout the entire study, approximately during 12 months

• Lymphocyte tumor infiltration

  To asses lymphocytes infiltration by immunohistochemistry

  Throughout the entire study, approximately during 12 months

• Oxidative stress

  To asses the expression of biomarkers linked to oxidative stress in plasma

  Throughout the entire study, approximately during 12 months

Study Arms (1)

MitoQ supplement

EXPERIMENTAL

Dietary Supplement: MitoQ (mitoquinol mesylate)

Interventions

MitoQ (mitoquinol mesylate) DIETARY_SUPPLEMENT

Dietary supplement course before surgery or chemo/radio-therapy

MitoQ supplement

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet the following criteria for study entry:
• 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
• Histologically documented TNBC (negative ER, - PR and HER2, status); HER2 negativity will be defined using ISH or IHC assays per ASCO/CAP criteria \[1\] and ER/PR negativity will be defined with \< 10% tumor cells with ER/PgR staining using IHC. Patients with multifocal, multicentric or bilateral tumors are eligible, provided all discrete lesions are sampled and confirmed as triple- negative.
• Histologically confirmed invasive breast carcinoma
• Patient agreement to undergo appropriate systemic and surgical management after completion of window treatment
• Adequate hematologic and end-organ function, as defined by the following laboratory results obtained within 14 days prior to the first study treatment:
• ANC \> 1500 cells/µL (without granulocyte colony-stimulating factor support within
• weeks prior to Cycle 1, Day 1)
• Platelet count \> 100,000/µL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
• Hemoglobin \> 9.0 g/dL
• Patients may be transfused to meet this criterion.
• AST, ALT, and alkaline phosphatase

You may not qualify if:

• Men
• Prior systemic therapy for treatment and prevention of the current breast cancer
• Known allergy or hypersensitivity to MitoQ
• Known active viral hepatitis
• Known human immunodeficiency virus infection with detectable viral load
• Active tuberculosis
• Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
• Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of a food supplement or that may affect the interpretation of the results or render the patient at high risk from treatment complications
• Pregnant or lactating, or intending to become pregnant during the study Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
• Patients included in the study should not be under fertility preservation procedures because of the unknown effect of the treatment during human pregnancy.

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (2)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Cliniques universitaires Saint-Luc

Brussels, Belgium

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• François Duhoux, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Sonveaux, PhD

CONTACT

0032 764 52 67; pierre.sonveaux@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 26, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)