Phase 2 Breast Cancer Trial, Not Yet Recruiting
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
- Women aged 18 or older at the time of signing the consent forms.
- People who have been confirmed through laboratory testing (from tissue or cell samples) to have breast adenocarcinoma (a type of breast cancer).
- Women with breast cancer that has either spread to other parts of the body, cannot be treated with surgery or radiation with the aim of curing it, and who have already tried standard treatments, whose cancer has come back, who have declined standard treatment, or who are otherwise not suitable for standard treatment.
- People who have at least one measurable tumour of at least 1 cm × 1 cm in size.
- People who have had a skin reaction test (similar to a tuberculin/PPD skin test) showing a result of 10 mm or less in diameter.
- For people who agree to provide tissue samples before and during treatment: an existing stored tissue sample may be used for the pre-treatment sample, but a fresh biopsy from the tumour site is preferred.
- People who are not pregnant, not breastfeeding, and not planning to become pregnant during the study, and who agree to use effective contraception (such as a double-barrier method, birth control pills, injections, or implants) if sexually active, as the trial requires this.
- People who are able to understand the study information and are willing to sign the consent forms.
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 with an ECOG performance status score of 1 or higher, meaning those whose daily functioning is somewhat or significantly affected by their illness (confirm with trial site).
- People with a life expectancy of less than 3 months.
- People with cancer that has spread to the brain, the lining around the brain or spinal cord, or who have spinal cord compression — unless the brain metastases were completely removed or treated with radiation and have shown no signs of returning within 4 weeks of that treatment.
- People who still have side effects from a previous cancer treatment that have not improved to a mild level, with the exception of hair loss.
- People who have had major surgery within 4 weeks before the first study treatment.
- People who have not waited long enough since their last cancer treatment — generally at least 3 weeks, or a specific period based on the drug used, whichever is shorter; people who received immunotherapy require at least a 4-week gap.
- People who have taken high-dose steroid medicines (such as prednisone above a certain daily amount) within 2 weeks before the first dose, or who would need to continue taking them at a similar dose during the study.
- People whose blood test results show that their white blood cell count, red blood cell level, or platelet count is too low.
- People whose liver function blood tests are above acceptable levels, based on specific thresholds that vary depending on whether liver or bone spread is present (confirm with trial site).
- People whose kidney function is below the required level, as measured by specific blood tests.
- People whose blood clotting test results are above acceptable levels, or who are taking blood-thinning medicines (low-dose aspirin under 100 mg and low-dose preventive heparin are allowed).
- People who currently have or have had another cancer, unless it was a skin cancer (basal cell or squamous cell), early-stage cervical cancer, or any other cancer that has been in full remission for more than 3 years.
- People who the trial doctor considers unsuitable for any reason, including medical conditions or concerns that the person may not be able to follow the study requirements.
- People with a known or suspected allergy or contraindication to BCG (a type of bacteria used in some treatments) or formalin.
- People with HIV requiring treatment, or active hepatitis A, B, or C infection.
- People who currently have COVID-19 or who had it within one month before joining the study.
- People who have a current or past autoimmune disease (such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or other similar conditions) that requires immune-suppressing treatment.
- People who need ongoing antibiotic treatment for an active infection.
- People who are currently pregnant or breastfeeding.
- People with a known history of severe reactions to vaccines, such as a serious allergic reaction (anaphylaxis).
- People who have had an organ transplant at any time.
- People who have received a live or weakened vaccine within 4 weeks before starting the study treatment, or during the treatment period.
- People who have had their spleen removed.
- People with a known or suspected condition affecting the immune system from birth.
- People currently taking part in another clinical trial.
- People who are in an institution due to a legal or regulatory order, or who are imprisoned.
- People with an active infection, an unexplained fever above 38.1°C, or who have taken antibiotics within 1 week before enrolment.
- People with any significant uncontrolled medical, psychiatric, or other condition, or abnormal test results, that the trial doctor believes could pose a risk or affect the study results.
- People who have previously been enrolled in this same study.
- People who are a member of the trial staff directly involved in running this study, or a close relative of such a person.
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.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Phone: +34643794364
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
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
Primary endpoints
Criteria for disease recurrence
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.