Printed from Voxsanity (voxsanity.com.au) — NCT06975644 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Breast Cancer Trial, Not Yet Recruiting
NCT06975644
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
- People who are willing to take part in the study and sign a consent form agreeing to participate.
- Female patients who are 18 years of age or older at the time of signing the consent form.
- Women who could potentially become pregnant must have a negative blood pregnancy test within 7 days before joining, and must agree to use a highly effective form of contraception throughout the study and for 3 months after the last dose of the study drug.
- Patients must have enough stored tumour tissue samples available for testing — specifically, at least 15 unstained tumour biopsy slides from the most recent affected site (stored samples from the original tumour are acceptable for patients who have not yet had treatment, or a new biopsy sample may be submitted).
- Patients must have a primary breast cancer that meets all of the following conditions: the cancer has been confirmed as invasive breast cancer through laboratory tissue analysis; the cancer is at a specific stage based on established medical staging guidelines (T1c–4, N0–2, M0 under AJCC 8th edition); and the cancer has been confirmed as triple-negative breast cancer (TNBC), meaning it tests negative for HER2, oestrogen receptors (ER), and progesterone receptors (PR) according to specific laboratory thresholds; unstained tumour slides must also be sent to a central laboratory as set out in the study protocol.
- Patients must be willing to have surgery if the treating team determines they are suitable for it after completing the pre-surgery treatment phase of the trial.
- Patients must have adequately functioning organs, as confirmed by blood and other laboratory tests meeting the levels specified in the study protocol.
- Patients must have a general health and activity level score of 0 or 1 on a standard medical scale (ECOG performance status), assessed within 7 days before the first dose.
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 inflammatory breast cancer, stage IV (metastatic) breast cancer, cancer in both breasts, or cancer appearing in multiple separate areas of the breast more than 5 cm apart.
- People whose scans show the tumour is growing into major blood vessels, or where the treating doctor believes there is a high risk of serious bleeding due to pressure on blood vessels.
- People with uncontrolled or symptomatic high calcium levels in the blood above specified thresholds, or who need ongoing medication (bisphosphonates) to manage calcium levels related to symptoms.
- People with other serious ongoing illnesses that would interfere with treatment, including significant lung conditions or diseases.
- People who have already received, or are currently receiving, any systemic anti-cancer treatment for their current breast cancer, such as chemotherapy, targeted therapy, biological therapy, or experimental treatments.
- People who have participated in another clinical trial within the 4 weeks before joining this study (or within 3 months if that trial involved monoclonal antibody treatments), or who plan to join another clinical trial during this study.
- People who have previously been treated with certain immune-based therapies other than PD-1/PD-L1 monoclonal antibodies — for example, CTLA-4 inhibitors — or with anti-blood vessel growth treatments (anti-angiogenic agents), including certain types of targeted drugs.
- People who have received a live or weakened (attenuated) vaccine within 28 days before the first dose, or who expect to receive one during the study.
- People who have had another cancer within the past 5 years that required treatment, unless it was a type considered fully cured — such as certain localised skin cancers, cervical pre-cancer, or thyroid cancer.
- People who have had major surgery within 28 days before the first dose (where major surgery is defined as requiring at least 3 weeks of recovery), or who have had palliative radiotherapy or tumour ablation within 2 weeks before the first dose.
- People with a known or suspected autoimmune disease, with the exception of hypothyroidism managed with hormone replacement therapy, or stable type 1 diabetes with well-controlled blood sugar levels.
- People with active hepatitis B virus (HBV) infection based on specific blood test results, unless viral levels have been reduced to a specified low level through antiviral treatment; or active hepatitis C virus (HCV) infection confirmed by blood tests; or a combined HBV and HCV infection.
- People with HIV infection, confirmed by a positive HIV antibody blood test.
- People with interstitial lung disease, non-infectious lung inflammation (pneumonitis), or uncontrolled ongoing conditions such as diabetes, lung scarring (pulmonary fibrosis), or active lung inflammation.
- People who have had a serious infection requiring hospital treatment (such as a bloodstream infection or pneumonia) within the past 4 weeks; or an active infection of moderate severity or worse requiring antibiotic treatment within the past 2 weeks; or an unexplained fever above 38.5°C during the screening period (fever thought to be caused by the tumour itself may be permitted, at the treating doctor's judgement); or active tuberculosis within the past year.
- People who have previously had a bone marrow transplant or an organ transplant from another person.
- People with nerve damage in the hands or feet rated at grade 2 or higher on a standard medical severity scale (CTCAE v5.0).
- People with a history of neurological or psychiatric conditions (such as epilepsy or dementia), or a history of drug or alcohol misuse.
- People with significant heart conditions, including heart failure with a pumping function below 50%; certain serious heart rhythm problems; unstable chest pain (angina) requiring medication; significant heart valve disease; a confirmed full-thickness heart attack on an ECG; or blood pressure that remains above 180/100 mmHg despite treatment.
- People who have received immune-stimulating medications (such as interferon or interleukin-2) within 4 weeks before the first dose.
- People who have taken immune-suppressing medications (such as steroids like prednisone, or azathioprine) within 2 weeks before the first dose, with the exception of topical or inhaled corticosteroids, or low-dose steroid replacement therapy at or below the equivalent of 10 mg per day of prednisone.
- People with a known allergy or hypersensitivity to any component of the study drugs, or who have had a severe allergic reaction to monoclonal antibody treatments in the past.
- Women who are pregnant or breastfeeding, or women who could potentially become pregnant and have a positive pregnancy test at the start of the study, or who are unwilling to use effective contraception as required.
- People whom the treating doctor or investigator believes should not participate for any reason related to safety or the ability to follow the study requirements (confirm with trial site).
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.
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.
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
Principal Investigator: Xuli Meng, Zhejiang Provincial People's Hospital
Phone: +8613282037232
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
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Zhejiang Provincial People's Hospital
Registry
ClinicalTrials.gov
Start date
1 September 2025
Est. completion
1 September 2026
Primary endpoints
Pathological complete response
Can't join this trial?
Data last synced from ClinicalTrials.gov: 31 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.