Phase 4 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
- People aged 18 to 70 years old (any gender)
- People who have been confirmed through a needle biopsy to have invasive breast cancer at a specific stage (not spread to distant parts of the body, with tumour size and lymph node involvement within defined ranges — confirm with trial site)
- People whose breast cancer tests show high levels of a protein called HER2 (either IHC 3+, or IHC 2+ with a positive FISH test)
- People whose heart is pumping at 50% or greater efficiency, as measured by a specific heart scan
- People who are in good general physical condition, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work)
- People whose blood tests show healthy levels of blood cells, liver function, and kidney function — without having needed blood transfusions or boosting medications in the 14 days before joining
- People who are willing to participate voluntarily, sign a consent form, and attend follow-up appointments as required
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 a previous history of invasive breast cancer
- People with breast cancer affecting both breasts, inflammatory breast cancer (where the skin is red or involved), or a specific early-stage cancer classification (T1c, N0, M0 — confirm with trial site)
- People who have already had a biopsy of the main tumour or surgery on the lymph nodes or breast before joining the trial
- People who have previously received any systemic treatment for breast cancer
- People with a history of a life-threatening allergic reaction, or a known allergy to any ingredient in the study drug
- People who have taken part in another clinical drug or medical device trial within 4 weeks before joining, or who have received experimental treatment in that time
- People who had major surgery within 28 days before joining, or who have major surgery planned during the study
- People who have had another cancer (other than certain low-risk cancers such as cervical carcinoma in situ, certain skin cancers, localised prostate cancer, or ductal carcinoma in situ) within the past 5 years
- People with active hepatitis, active tuberculosis, or other serious infections currently requiring treatment
- People with a history of immune deficiency, certain autoimmune diseases (such as lupus or rheumatoid arthritis), HIV infection, or a history of organ transplantation
- People with certain heart or brain blood vessel conditions, including unstable chest pain, certain heart rhythm problems, a heart attack within the last 6 months, heart failure, significant heart conduction problems, or a stroke or brain bleed within the last 6 months
- People with poorly controlled high blood pressure (above 160/100 mmHg despite medication), or a history of hypertensive crisis or hypertensive brain injury
- People who are pregnant or breastfeeding, people of childbearing potential who test positive for pregnancy at screening, or people unwilling to use effective contraception throughout the trial and for 6 months after finishing the study medication
- People whom the trial investigators consider unsuitable for the study for other reasons
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.
Contact this trial
Phone: +8613943189777
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.
Primary endpoints
total Pathological Complete Response，tpCR
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.