Printed from Voxsanity (voxsanity.com.au) — NCT06843681 — 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, By Invitation
NCT06843681
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 aged 18 to 70 who have been diagnosed with breast carcinoma in situ (a very early form of breast cancer that has not spread beyond the breast ducts or lobules).
- The breast tumour measures at least 2cm, and testing has confirmed it is HER2-positive (meaning the cancer cells have high levels of a certain protein that promotes growth).
- There is no sign that the cancer has spread to distant parts of the body.
- No previous cancer treatment of any kind has been received.
- An imaging scan taken within 2 weeks before joining the trial showed at least one measurable area of cancer.
- The heart is pumping well, with a specific heart function measurement (called LVEF) of 50% or higher, as confirmed by an ultrasound of the heart.
- Any side effects from previous treatments have mostly resolved to a mild level, and certain liver-related blood test results are within acceptable ranges (confirm with trial site).
- Liver and kidney blood test results are within acceptable ranges: total bilirubin no more than 3 times the upper limit of normal, liver enzymes (ALT/AST) no more than 2.5 times the upper limit of normal (or up to 5 times for those with liver involvement), and kidney function markers within normal limits.
- Blood counts are adequate: white blood cell count, neutrophil count (infection-fighting cells), and platelet count (clotting cells) all meet minimum levels required.
- Women who could become pregnant must agree to use contraception during the trial.
- The person is able to understand the study process, is willing to take part voluntarily, and agrees to sign a consent form.
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 stage IV (metastatic) breast cancer, meaning the cancer has spread to other parts of the body.
- People who have previously had invasive breast cancer, or who have had any systemic (whole-body) treatment to treat or prevent breast cancer.
- People who have had or currently have another type of cancer, with the exception of certain non-melanoma skin cancers or early cervical cancer.
- People with serious heart conditions that are not expected to tolerate chemotherapy, such as severe irregular heartbeat, unstable chest pain, significant heart valve disease, a certain type of heart attack visible on an ECG, or uncontrolled high blood pressure.
- People whose bone marrow, kidney, or liver function does not meet the required levels.
- People with moderate or severe nerve damage in the hands or feet (grade 2 or higher peripheral neuropathy).
- People who have low platelet counts, low white blood cell counts, anaemia, low potassium levels, or elevated liver enzyme levels beyond a mild degree.
- People who are known to be allergic to any ingredient in the study drug.
- People who have received radiotherapy, chemotherapy, hormone therapy, or who have taken part in another interventional drug trial within the 4 weeks before joining.
- Women who are pregnant or breastfeeding, or women of childbearing age who are unwilling to use effective contraception throughout the study.
- People who have any other medical condition, illness, or circumstance that the trial doctor considers would make participation unsafe or 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.
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
Print a one-page summary to share with your doctor.
Trial details
Status
By Invitation
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 March 2025
Est. completion
1 January 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Breast-conserving surgery rate after 4-6 cycles of treatment
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.