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.
- People with invasive breast cancer that has been confirmed by a tissue biopsy or pathology test.
- People who have not yet received any systemic (whole-body) treatment for breast cancer.
- People whose breast cancer tests negative for oestrogen receptors (ER), progesterone receptors (PR), and HER2 (commonly called "triple-negative"), and tests positive for a protein called PD-L1 (with a score of 1 or higher).
- People whose cancer is at an early to locally advanced stage, based on the tumour size and whether nearby lymph nodes are involved (confirm with trial site for exact staging details).
- People who have at least one tumour that can be measured on a scan, according to standard measurement guidelines.
- People who are relatively well and able to carry out daily activities, with a performance score of 0 or 1 on a standard medical scale (confirm with trial site).
- People with a life expectancy of at least 3 months.
- People whose blood counts, liver, kidney, and bone marrow are functioning well enough based on recent blood tests (within the past month, without needing corrective treatment in the 14 days before starting).
- People whose heart is functioning well, with a heart pumping strength of at least 55% on an echocardiogram (heart ultrasound).
- People whose heart electrical activity (QT interval) is within an acceptable range on an ECG.
- Women of childbearing age who have had a negative pregnancy blood test within 14 days before starting treatment, and who are not breastfeeding.
- People who are willing to use effective barrier contraception (such as condoms) during the trial and for 6 months after treatment ends.
- People who are willing to sign a consent form and follow the study procedures.
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 whose breast cancer has not been confirmed by a tissue biopsy or pathology test.
- People with bilateral breast cancer (cancer in both breasts), inflammatory breast cancer, or occult breast cancer (cancer with no detectable primary tumour in the breast).
- People whose breast cancer has spread to other parts of the body (metastatic disease).
- People who have previously received chemotherapy, radiotherapy, targeted therapy, or hormonal therapy for breast cancer.
- People who have had curative radiotherapy within the past 4 weeks, or palliative radiotherapy within the past 2 weeks before starting the trial.
- People who have previously received immunotherapy treatments such as anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint inhibitor drugs.
- People who are receiving any other anti-cancer treatments during the study.
- People who have or have had a second unrelated cancer, except for certain treated skin cancers (non-melanoma type).
- People who have previously had an organ or bone marrow transplant.
- People who have participated in another drug trial within the past 4 weeks.
- People who have been taking high-dose steroid tablets or immunosuppressant medications within the past 2 weeks (not including inhaled or topical steroids).
- People who have received a live or weakened (attenuated) vaccine within the past 4 weeks.
- People who have had a major surgery unrelated to the breast within the past 4 weeks, or who have not fully recovered from a major surgery.
- People with an active autoimmune disease, or a history of autoimmune disease that could come back and require systemic treatment (exceptions include vitiligo, psoriasis, hair loss conditions, childhood asthma that is now controlled, and type 1 diabetes managed with insulin).
- People who are HIV-positive or have a congenital or acquired immune deficiency condition.
- People who have had a heart attack, stroke (other than a minor lacunar infarct), pulmonary embolism (blood clot in the lungs), unstable chest pain (angina), or severe heart failure in the past 6 months.
- People with a clinically significant irregular heartbeat, primary heart muscle disease, atrial fibrillation (of a certain severity), uncontrolled high blood pressure, or a QT interval above the acceptable limit on an ECG.
- People with interstitial lung disease, idiopathic pulmonary fibrosis, severe chronic obstructive pulmonary disease or asthma, or autoimmune conditions affecting the lungs.
- People with active hepatitis B (with a certain level of viral activity), active hepatitis C, cirrhosis (liver scarring), or a serious infection currently requiring antibiotic or antimicrobial treatment.
- People with hereditary or acquired bleeding or clotting disorders (such as haemophilia).
- People who are allergic to or cannot receive the study drug components.
- People who are pregnant, breastfeeding, or unwilling to use contraception.
- People with other serious uncontrolled health conditions (such as poorly controlled high blood pressure, diabetes, or active infections) that would make the study treatments unsafe.
- People with epilepsy, dementia, or other neurological or psychiatric conditions that the trial doctor considers would make participation unsuitable.
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: 13603862755
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
Primary endpoints
PCR rate
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.