Printed from Voxsanity (voxsanity.com.au) — NCT06786026 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Breast Cancer Trial, Recruiting
NCT06786026
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not 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 may be able to join
- Female patients aged 18 to 70 years old who have been diagnosed with breast cancer.
- People whose breast cancer has been confirmed by tissue testing to be estrogen receptor negative (ER-), progesterone receptor negative (PR-), and HER2 negative (sometimes called "triple negative breast cancer"), based on the most recent testing guidelines.
- People with locally advanced, returning, or spreading breast cancer who have not yet received any systemic (whole-body) treatment for this stage of disease — previous early-stage treatments (before or after surgery) are allowed, as long as the cancer came back at least 6 months after the last dose.
- People who have at least one tumour that can be measured on scans, according to standard criteria called RECIST 1.1.
- People with a general health and activity level rated as 0 or 1 on a standard scale called the ECOG score, meaning they are fully active or have only minor limitations in physical activity.
- People who have tumour tissue samples available that can be tested for biological markers.
- People whose blood counts and organ function meet specific healthy ranges, including blood cells, liver, kidneys, and thyroid, as measured by blood tests within the required timeframe (confirm with trial site for exact values).
- People who agree to join the study voluntarily and sign a consent form.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who currently have, or have a history of, an active autoimmune disease (a condition where the immune system attacks the body), such as autoimmune hepatitis, lung inflammation, eye inflammation, bowel inflammation, or certain thyroid or kidney conditions — though people with vitiligo or childhood asthma that fully resolved and needs no adult treatment may still be considered.
- People who are currently using immune-suppressing medications or steroid medicines at doses above the equivalent of 10 mg of prednisone per day, and have used these within 2 weeks before joining.
- People who have had a severe allergic reaction to other monoclonal antibody medicines (a type of targeted therapy).
- People with a known history of scarring or inflammation of the lungs (interstitial lung disease), or currently active non-infectious lung inflammation (pneumonia).
- People with known spread of cancer to the brain or spinal cord (central nervous system metastasis).
- People who have had another cancer diagnosed within the past 5 years, except for certain fully cured skin cancers or early-stage cervical cancer.
- People with uncontrolled high blood pressure (above 140/90 mmHg) or a history of hypertensive crisis — though people with a known history of high blood pressure whose levels are well controlled with medication may still be considered.
- People with serious heart or blood vessel conditions, including moderate to severe heart failure, unstable chest pain (angina), a heart attack within the past year, certain serious heart rhythm problems, or a specific abnormal heart electrical reading (QTc above 450ms for males or 470ms for females).
- People currently receiving clot-dissolving (thrombolysis) or blood-thinning (anticoagulation) treatments — low-dose aspirin or low-molecular-weight heparin used for prevention may be allowed (confirm with trial site).
- People who have had significant bleeding or a clear tendency to bleed in the 3 months before joining — further testing may be required if a stool blood test comes back positive.
- People whose tumour is growing into or very close to major blood vessels in a way that could cause dangerous bleeding.
- People with serious fluid build-up around the lungs, heart, or abdomen that requires draining may still be considered if the treating doctor assesses symptoms as stable after drainage (confirm with trial site).
- People who have had a blood clot event within the past 6 months, such as a stroke, mini-stroke, blood clot in the leg, or clot in the lung.
- People who have had a major blood vessel problem requiring surgery within the past 6 months, such as an aortic aneurysm or arterial blood clot.
- People whose urine tests show significant protein levels confirmed by a 24-hour urine collection showing more than 1.0g of protein.
- People with an active infection, an unexplained fever of 38.5°C or higher in the 7 days before starting treatment, or an abnormally high white blood cell count.
- People with a known immune deficiency condition (such as HIV), active or significant hepatitis B or C infection, or people who have received a live vaccine within 4 weeks before starting the study or who may need one during the study.
- People who, in the treating doctor's judgement, have other factors that could affect their safety or the study results, such as serious additional illnesses, mental health conditions requiring combined treatment, substance use issues, or significant social or family circumstances.
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.
Contact this trial
Phone: 021-64175590
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
9 October 2024
Est. completion
30 September 2025
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
🇨🇳 China
Primary endpoints
ORR by investigator
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 July 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.