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 who are first-time breast cancer patients aged 18 or older.
- People whose breast cancer has been confirmed by tissue examination (pathology) to be HER2-positive, meaning the cancer tests strongly positive on a specific protein test (IHC 3+), or moderately positive (IHC 2+) with gene amplification confirmed by a further test — regardless of hormone receptor status.
- People whose cancer is at a specific early-to-mid stage (T1c-2, N0-1, M0 according to standard staging guidelines) and who have at least one measurable area of cancer that can be tracked during the trial.
- People who are in good general health or have only mild limitations in daily activity (rated 0 or 1 on a standard health performance scale called ECOG PS).
- People whose blood test results meet specific standards without recent blood transfusions or certain medications: haemoglobin at least 100 g/L, white blood cell count (ANC) at least 1.5×10⁹/L, and platelets at least 100×10⁹/L.
- People whose liver and kidney function blood test results fall within acceptable ranges, including normal bilirubin, liver enzyme, and kidney function levels (confirm specific values with trial site).
- People whose heart is pumping effectively, with a heart function measurement (left ventricular ejection fraction) of 55% or higher on an ultrasound.
- Women who could become pregnant must have a negative pregnancy blood test taken within 7 days before joining, and must be willing to use an appropriate method of contraception during the trial and for 8 weeks after the last dose of the study drug.
- People who voluntarily agree to join the study, sign a consent form, are willing to follow the study requirements, and are able to attend follow-up appointments.
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 who have previously received any form of cancer treatment, such as chemotherapy, radiotherapy, targeted therapy, or hormone therapy.
- People who are currently receiving any other cancer treatment at the same time as this trial.
- People who have cancer in both breasts, inflammatory breast cancer, or a type of breast cancer where no obvious lump can be found (occult breast cancer).
- People whose breast cancer has not been confirmed through a tissue sample examination (histopathology).
- People who have had another type of cancer in the past 5 years, except for cervical cancer in situ that has been fully cured.
- People with serious problems affecting the heart, liver, or kidneys.
- People who are unable to swallow, have ongoing diarrhoea, or have a bowel blockage, or have other conditions that could affect how the study medication is taken or absorbed.
- People who took part in another clinical drug trial within 4 weeks before joining this trial.
- People who are known to be allergic to any ingredients in the medications used in this trial.
- People with a history of immune system problems, including a positive HIV test, hepatitis C (HCV), active hepatitis B, other immune deficiency conditions, or a history of organ transplantation.
- People who have ever had any significant heart condition, including arrhythmia requiring medication, a heart attack, heart failure, or any other heart condition that the treating doctor considers unsuitable for this trial.
- Women who are pregnant or breastfeeding, women of childbearing age with a positive pregnancy test at the start of the study, or women of childbearing age who are unwilling to use effective contraception throughout the entire trial period.
- People who have another serious illness that, in the treating doctor's judgement, poses a significant risk to their safety or could prevent them from completing the trial — such as uncontrollable high blood pressure, severe diabetes, or an active infection.
- People with a known history of neurological or psychiatric conditions, including epilepsy or dementia, or any other circumstances where the treating doctor considers participation to be 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.
Contact this trial
Phone: 86-022-23340123
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
Follow up on postoperative pathological reports for evaluation for Pathological complete response rate (tpCR: ypT0-is/ypN0)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 17 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.