Printed from Voxsanity (voxsanity.com.au) — NCT07410559 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
Back to Breast Cancer
Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07410559
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 between 18 and 75 years of age.
- People who are generally well enough to carry out daily activities with little or no limitation (a measure of overall health used in cancer care, rated 0 or 1 on a standard scale).
- People whose main breast tumour measures more than 1 cm across.
- People with a confirmed diagnosis of invasive breast cancer that tests positive for hormone receptors (ER+) and negative for a protein called HER2, with specific laboratory results meeting set thresholds for hormone receptor level and a marker of how fast the cancer cells are growing.
- People whose cancer is at a certain stage based on tumour size and spread to nearby lymph nodes, but has not spread to other parts of the body (confirm with trial site for exact staging details).
- People who are willing to have breast cancer surgery once surgery becomes appropriate after completing pre-surgery treatment.
- People whose blood counts and organ function meet all of the following levels before starting treatment: red blood cell levels (haemoglobin) at or above a set threshold (a blood transfusion may be given beforehand if needed, but treatment cannot start until the day after any transfusion); white blood cell counts, platelet counts, liver function tests, kidney function, and blood clotting measures all within acceptable ranges as defined by the trial (confirm specific values with trial site).
- People whose heart is pumping effectively, with a heart function score of 55% or above as measured by a heart scan before starting treatment.
- Women who have not yet gone through menopause and are willing to receive hormone-suppressing injections (such as goserelin or leuprolide) before starting treatment, to bring hormone levels to a post-menopausal range; or women who are already post-menopausal due to surgery or natural menopause, confirmed by at least one of: prior removal of both ovaries; age 60 or older; or age under 60 with periods stopped for at least 12 months (without the influence of certain medications) and hormone levels confirmed in the post-menopausal range.
- Women who could potentially become pregnant must have a negative blood pregnancy test before joining, and must use an accepted form of contraception throughout the study and for at least 6 months after the last dose of study treatment.
- People who are willing to take part voluntarily, sign a consent form, follow the study requirements, and attend all 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 whose breast cancer has spread to other parts of the body (stage IV/metastatic), or who have cancer in both breasts.
- People with a previous diagnosis of invasive breast cancer.
- People with a previous diagnosis of certain non-invasive breast conditions (ductal carcinoma in situ or lobular carcinoma in situ).
- People who have previously received chemotherapy, hormone therapy, or targeted HER2 treatment for breast cancer; or who have had surgery to remove the main breast tumour or lymph nodes (other than a diagnostic biopsy or surgery for a non-cancerous breast condition); or who have had radiotherapy to the breast area.
- People who have had another cancer in the past 5 years, apart from certain fully treated skin cancers or cervical pre-cancer.
- People with moderate to severe nerve damage causing symptoms such as numbness or pain in the hands or feet (Grade 2 or higher on a standard scale).
- People who have had a serious heart or stroke-related event in the 6 months before joining the trial, such as heart failure, unstable chest pain, uncontrolled abnormal heart rhythms, significant heart valve disease, severely uncontrolled high blood pressure, a heart attack, or a stroke.
- People with serious or uncontrolled pre-existing health conditions that the trial doctor believes would make participation unsafe — examples include certain lung conditions, severe breathing difficulties, severely reduced kidney function, a history of major removal of parts of the stomach or small bowel, Crohn's disease, ulcerative colitis, or any ongoing condition causing persistent moderate or severe diarrhoea.
- People who have had major surgery within 4 weeks before joining and have not fully recovered, or who are expected to need major surgery during the trial.
- People with known active liver disease, including active hepatitis B or C at levels above set thresholds, or autoimmune liver disease.
- People with a severe uncontrolled infection or known HIV infection.
- People with an active bacterial infection requiring intravenous antibiotics, or an active fungal infection, at the time of starting study treatment.
- People who are pregnant or breastfeeding.
- People with a known allergy to the study drug or its ingredients, or who have had a severe allergic reaction to similar medicines (monoclonal antibodies) in the past.
- People with a known history of misusing alcohol, recreational drugs, or other substances.
- People with a known neurological or psychiatric condition that may affect their ability to follow the study requirements, such as epilepsy or dementia.
- People with any other serious physical or mental health condition, or abnormal test results, that the trial doctor believes would make participation unsafe or interfere with the study.
- People who have received an experimental treatment in another clinical trial within the past 30 days (or longer, depending on the treatment), or who are currently taking part in another research study that the trial organisers consider incompatible with this one.
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
Not Yet Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 July 2026
Est. completion
1 April 2029
Where this trial is recruiting
🇨🇳 China
Primary endpoints
ORR between Arm A and Arm B; pCR rate between Arm A and Arm B
Can't join this trial?
Data last synced from ClinicalTrials.gov: 7 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.