MitoQ window treatment for triple-negative breast cancer

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

We will try a short course of MitoQ in women with triple-negative breast cancer to see whether blood and tumor biomarkers change.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Université Catholique de Louvain (Academic / other)
• Locations: 2 sites (Brussels and 1 other locations)
• Trial ID: NCT07142096 on ClinicalTrials.gov

What this trial studies

This interventional window-of-opportunity protocol gives a short course of the mitochondrial agent MitoQ to women with histologically confirmed triple-negative invasive breast cancer prior to their planned surgery and systemic management. Blood samples and tumor biopsies are collected before and after MitoQ exposure to validate candidate circulating and tissue biomarkers. Eligible participants are adults with ECOG performance status 0–1 and adequate hematologic and organ function who agree to pre- and post-treatment sampling and follow-up care. The study is single-arm and non-randomized and focuses on biological marker changes rather than direct clinical endpoints.

Who should consider this trial

Good fit: Adult women with newly diagnosed, biopsy-proven triple-negative invasive breast cancer, ECOG 0–1, adequate laboratory parameters, and willingness to undergo pre- and post-treatment biopsies and follow standard care are ideal candidates.

Not a fit: Patients with hormone receptor–positive or HER2-positive tumors, metastatic disease, poor performance status, inability to delay surgery, or unwillingness to undergo repeated biopsies are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, validated blood or tissue biomarkers could show that MitoQ alters tumor biology and help guide future personalized therapies or larger clinical trials.

How similar studies have performed: Preclinical work suggests mitochondrial-targeted agents like MitoQ can affect tumor biology and small non-cancer human studies report biological effects, but using MitoQ in a pre-surgery window for TNBC is novel and not yet proven.

Eligibility criteria

Inclusion Criteria:

* 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
* 2 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
* \< 2.5 x the upper limit of normal (ULN)
* Serum bilirubin \< 1.0 x ULN
* Patients with known Gilbert disease: serum bilirubin level \< 3 x ULN
* For patients not receiving therapeutic anticoagulation: INR or aPTT \< 1.5 x ULN within 14 days prior to initiation of study treatment
* For patients receiving therapeutic anticoagulation: INR or aPTT within therapeutic limits for at least 1 week immediately prior to initiation of study treatment
* For patients receiving therapeutic anticoagulation: stable anticoagulant regimen and stable INR during the 14 days immediately preceding initiation of study treatment
* Creatinine clearance \> 30 mL/min (calculated using the Cockcroft-Gault formula)
* Serum albumin \> 2.5 g/dL
* Beta-HCG negative if applicable (cfr infra)
* Representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or at least 20 unstained slides, with an associated pathology report documenting ER, PR, and HER2 negativity. Tumor tissue should be of good quality based on total and viable tumor content.
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year, during the treatment period and for at least 1 month after the last dose of MitoQ.
* A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (\> 12 continuous months of amenorrhea with no identified cause other than menopause) and has not undergone surgical sterilization (removal of ovaries and/or uterus).
* Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, established, hormone-releasing intrauterine devices (IUDs), and copper IUDs.
* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
* Women who are not postmenopausal (\> 12 months of non-therapy-induced amenorrhea) or have undergone a sterilization procedure must have a negative serum pregnancy test result within 14 days prior to initiation of study food supplement.

Exclusion Criteria:

* 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.

Where this trial is running

Brussels and 1 other locations

• Cliniques universitaires Saint-Luc — Brussels, Belgium (Recruiting)
• Cliniques universitaires Saint-Luc — Brussels, Belgium (Not_yet_recruiting)

Study contacts

• Principal investigator: François Duhoux, MD, PhD — Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Study coordinator: Pierre Sonveaux, PhD

Conditions Breast Cancer