Phase 2 Breast Cancer Trial, Recruiting NCT06831955 Sponsor: Universitaire Ziekenhuizen KU Leuven Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT06831955
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with stage II or III triple-negative breast cancer (TNBC), confirmed by a biopsy, at a specific tumor size and spread level (confirm with trial site for exact staging details)
  • Your cancer has been tested and shows little or no estrogen receptor, progesterone receptor, or HER2 protein activity, following standard testing guidelines
  • Any type (subtype) of breast cancer tissue is acceptable for this trial
  • You are generally healthy and able to carry out daily activities with no or minimal limitations (a doctor will assess this)
  • You are able to do a supervised exercise test that measures how your heart and lungs respond to physical activity
  • Your body mass index (BMI) is 18.5 or higher (a basic measure of body weight relative to height)
  • You are pregnant or breastfeeding (confirm with trial site, as this appears listed under inclusion)
  • Your blood, kidney, and liver function are at adequate levels
  • Your long-term blood sugar level (HbA1c) is below 10%

Who may not be able to join:

  • You have received chemotherapy, immunotherapy, or other cancer-fighting drugs within the last 5 years
  • You currently use injectable medications to lower blood sugar (such as insulin)
  • You have not fully recovered from side effects or complications of a recent surgery before starting the trial
  • You have had previous treatment for breast cancer or another cancer within the last 5 years (with exceptions for certain treated skin cancers or cervical pre-cancer)
  • You have another cancer that is still active or has needed treatment in the 5 years before your breast cancer diagnosis (certain treated skin and cervical cancers may be excepted — confirm with trial site)
  • You have previously been treated with a type of chemotherapy called anthracyclines
  • You have previously received certain types of immunotherapy drugs that affect how the immune system responds to cancer (such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar treatments)
  • You have any condition that, in the doctor's opinion, could put your safety at risk or make it hard to follow the trial plan
  • You have a serious uncontrolled illness, active bleeding problems, or an active infection such as hepatitis B, hepatitis C, or HIV
  • You have an autoimmune disease (where your immune system attacks your own body) that currently requires ongoing medical treatment
  • You have type 1 diabetes
  • You have a history of alcohol use disorder (as defined by standard medical criteria)
  • You have a history of an eating disorder (as defined by standard medical criteria)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 30 June 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 February 2026
Est. completion
1 September 2028

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

Pathological Complete Response (pCR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov