Printed from Voxsanity (voxsanity.com.au) — NCT07246317 — 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, Not Yet Recruiting
NCT07246317
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
- The person must have signed an informed consent form and be willing to follow the trial requirements.
- The person must be between 18 and 70 years old.
- The person must have a good general health status (low symptom burden) and a life expectancy of more than 6 months.
- The person must have breast cancer that has been confirmed through a tissue or cell sample analysis.
- The primary breast tumour must be larger than 2cm, or cancer must have spread to nearby lymph nodes.
- The cancer must be a specific stage (Stage II to IIIC) affecting one breast only, with no spread to distant parts of the body.
- The cancer must be confirmed as HER2-positive through laboratory testing; people whose primary tumour tests HER2-negative but whose lymph nodes test HER2-positive may also be considered.
- There must be at least one tumour that can be measured using standard imaging criteria.
- The person must be willing to have surgery after pre-surgery treatment, if the treating doctor recommends it.
- The person must be willing to provide tumour tissue samples for research testing.
- Blood counts must meet minimum levels: white blood cells, platelets, and haemoglobin must all be within acceptable ranges (confirm with trial site for exact values).
- Blood protein (albumin) levels must be adequate.
- Liver function tests, kidney function, and blood clotting measurements must all be within acceptable ranges (confirm with trial site for exact values).
- Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment, and must not be breastfeeding.
- Effective contraception must be used during treatment and for 3 months after treatment ends.
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 cancer has spread to distant parts of the body (Stage IV), or whose cancer is considered unsuitable for curative surgery after pre-surgery treatment.
- People diagnosed with inflammatory breast cancer.
- People who have had another cancer within the past 3 years, unless it was treated with surgery alone and has been in remission for 5 years, or unless it was a cured cervical carcinoma in situ, a non-melanoma skin cancer, or a superficial bladder cancer.
- People who have received chemotherapy, hormone therapy, anti-HER2 treatment, or breast surgery for breast cancer within the past 3 years (routine diagnostic biopsy is not excluded).
- People who have had major surgery or a serious injury within the 28 days before treatment begins (diagnostic biopsy is not excluded).
- People with an active autoimmune disease or a history of certain autoimmune conditions, such as autoimmune liver disease, lung inflammation, eye inflammation, bowel inflammation, or others; exceptions may apply for vitiligo or childhood asthma that fully resolved without ongoing treatment.
- People currently using immune-suppressing medications or high-dose steroid medications (above a certain daily threshold) within 2 weeks before joining the trial.
- People with a history of severe allergic reactions to monoclonal antibody medicines.
- People with known cancer spread to the brain or central nervous system.
- People with poorly controlled high blood pressure, or a history of hypertensive crisis or hypertensive brain complications.
- People with a history of heart failure or reduced heart pumping function below a certain level.
- People with a history of heart attack, significant heart rhythm problems, or moderate-to-severe heart failure.
- People with chest pain (angina) requiring ongoing medication, or a significant heart valve condition.
- People with active hepatitis C, HIV, untreated syphilis, or hepatitis B with virus levels above a certain threshold.
- People who have used certain traditional Chinese medicines with approved anti-cancer properties within 2 weeks before treatment.
- People with a significant tendency to bleed, or who have had a clinical bleeding event within the past 3 months; persistently positive stool blood tests may also require further investigation before joining.
- People whose tumour is growing into or at high risk of growing into major blood vessels in a way that could cause life-threatening bleeding.
- People with fluid build-up around the lungs, abdomen, or heart that requires ongoing drainage (people whose condition has stabilised after drainage may be considered).
- People who have had a blood clot or stroke event, such as a stroke, mini-stroke, deep vein clot, or pulmonary embolism, within the past 6 months.
- People with a known inherited or acquired tendency toward abnormal bleeding or clotting, such as haemophilia.
- People with serious wounds that are not healing, active skin ulcers, or untreated bone fractures.
- People with high levels of protein in their urine, confirmed by a 24-hour urine test showing more than 1.0g of protein.
- People with an active infection, an unexplained fever of 38.5°C or higher within the past 7 days, or a white blood cell count above a certain level at the start of the trial.
- People with a history of drug or substance abuse, or a psychiatric condition.
- People who have participated in another anti-cancer drug trial within the past 4 weeks.
- People with a known allergy to any of the medicines used in this trial or their ingredients.
- People whose overall health situation is considered by the trial doctor to pose a safety risk or to make completing the trial unlikely.
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: +8618622221173
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
Phase 2
Registry
ClinicalTrials.gov
Start date
15 December 2025
Est. completion
31 December 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
Can't join this trial?
Data last synced from ClinicalTrials.gov: 24 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.