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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07245797
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 must give written consent to take part in all study procedures before anything begins, as required by local rules.
- People must have untreated, one-sided (not both breasts) primary breast cancer confirmed by a core biopsy (a fine-needle aspiration alone is not enough, and an open surgical biopsy is not allowed).
- The tumour in the breast must be measurable in two directions, preferably by ultrasound.
- The cancer must be at a certain stage: classified as cT1b to cT3, regardless of whether lymph nodes are affected; in cases of multiple tumour areas, the largest one is used for measurement.
- The cancer must be HER2-positive (as defined by current ASCO/CAP guidelines), with confirmed hormone receptor status (ER and PR), HER2 status, a gene mutation called PIK3CA tested at the local site, and a cell growth marker called Ki-67 — all measured from the core biopsy.
- People must be 18 years of age or older; both female and male patients are eligible.
- People must have a good general health status, rated 0 or 1 on a standard medical scale called the ECOG scale (confirm with trial site).
- Heart function must be confirmed as normal by an ECG and a heart ultrasound within 3 months before joining, with the heart pumping function (LVEF) above 55%.
- Blood counts must meet certain minimums: enough white blood cells (neutrophils ≥ 1.5/nL), platelets (≥ 100/nL), and haemoglobin (≥ 10 g/dL).
- Liver function must be within acceptable ranges: bilirubin below the normal upper limit (with a special allowance for people with Gilbert's syndrome), liver enzymes AST and ALT no more than 1.5 times the upper normal limit, and alkaline phosphatase no more than 2.5 times the upper normal limit.
- Blood sugar levels must be within acceptable ranges: HbA1c (a measure of long-term blood sugar) below 6.5%, and fasting blood glucose below 126 mg/dL.
- Certain imaging tests (such as mammogram, breast MRI, and/or ultrasound) must be completed before joining, following the country's standard guidelines; for men where MRI is not medically appropriate, ultrasound alone is sufficient.
- People must be willing and able to attend scheduled visits, follow treatment plans, and complete required tests and procedures.
- Women who could become pregnant must agree to use non-hormonal contraception with a very low failure rate (such as copper IUDs, tubal ligation, or partner's sterilisation) or remain fully abstinent from heterosexual intercourse during treatment and for at least 60 days after the last dose (and possibly up to 2 years after the last dose of one specific drug, fulvestrant, based on local prescribing information); periodic methods such as calendar or withdrawal are not acceptable.
- Women who could become pregnant must also agree not to donate eggs during the contraception period described above.
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 is HER2-negative.
- People with inflammatory breast cancer.
- People with confirmed or clearly suspected stage IV (advanced/spread) cancer, cancer in both breasts, or invasive breast cancer (confirm with trial site).
- People who have already had a surgical biopsy that removes tissue (excisional biopsy or lumpectomy) or any lymph node surgery before joining the trial (a biopsy of a clearly affected lymph node is permitted).
- People who have already received chemotherapy, hormone therapy, or radiation therapy for their breast cancer before joining, with a limited exception: hormone replacement therapy started up to 28 days before joining, and standard fertility preservation treatments, may be allowed.
- People with a history of any previously treated cancer or who are currently receiving cancer treatment are not eligible, except for past cervical cancer in situ, or basal cell or squamous cell skin cancer; this also applies to people considered at high risk of needing cancer treatment during the study.
- People with a known allergic reaction to any of the study drugs, substances, mouse-derived proteins, or a substance called recombinant human hyaluronidase used in this trial.
- People with a confirmed diagnosis of Type 1 diabetes, or Type 2 diabetes that is not well controlled (based on the blood sugar tests described in the inclusion criteria).
- People with Type 2 diabetes currently requiring ongoing medication treatment, or any history of Type 1 diabetes.
- People known to have HIV infection if any of the following apply: their CD4+ immune cell count is below 350 cells/uL, they have had a serious infection related to their immune system in the past 12 months, they are taking immune-suppressing therapies that could interact with the study drugs.
- People with significant and active liver disease, such as sclerosing cholangitis, active hepatitis B or C infection, or autoimmune liver conditions.
- People with inflammatory bowel disease such as Crohn's disease or ulcerative colitis, or active bowel inflammation such as diverticulitis.
- People with any active eye or eye-socket condition (other than cataracts that were already present) that would need medical or surgical treatment during the study to protect vision; this also includes people with active or past uveitis (eye inflammation), vitritis, or an active eye infection.
- People with a current or previous diagnosis of lung inflammation (pneumonitis or interstitial lung disease), unless the treating doctor confirms it is inactive and does not require steroid treatment.
- People with known or suspected heart failure beyond the mildest level, coronary artery disease, chest pain (angina) requiring medication, a previous heart attack, signs of a past full-thickness heart attack on ECG, poorly controlled high blood pressure (above 160/90 mmHg despite three blood pressure medications), heart rhythm problems requiring permanent treatment, or significant heart valve disease.
- People with damaged skin at the planned injection site on the thigh.
- People who have recently had a blood clot (thromboembolism) and whose blood-thinning medication dose has not yet been stabilised or whose INR has not returned to a normal range.
- People who have used systemic (whole-body) corticosteroids within 2 weeks before starting the study, or who have not recovered from their side effects — with limited exceptions for short-term, topical, inhaled, eye-drop, or joint-injection uses of steroids, or for low-dose steroids (10 mg methylprednisolone or equivalent or less) started more than 6 months before joining.
- People currently using sex hormone treatments, which must be stopped before joining.
- People currently using other experimental drugs or any other cancer treatment.
- People who have participated in another clinical trial using an experimental or non-marketed drug within 30 days before joining.
- Women who are pregnant or breastfeeding at the time of joining.
- People with a significant history of neurological or psychiatric conditions — including psychotic disorders, dementia, or seizures — that would prevent them from understanding and giving informed consent.
- People with any other condition that the trial doctor believes would interfere with evaluating the treatment or interpreting safety and results.
- Women of childbearing potential (including those who have had a tubal ligation) must have a negative blood pregnancy test within 14 days before starting treatment; women who are pregnant, breastfeeding, or intending to become pregnant during the study or within 60 days of the last dose are not eligible.
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.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Zhimin Shao
Registry
ClinicalTrials.gov
Start date
15 December 2025
Est. completion
15 December 2026
Primary endpoints
pCR（ypT0/is ypN0）
Can't join this trial?
Data last synced from ClinicalTrials.gov: 10 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.