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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT07007780
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 who are female, aged 18 to 70 years old at the time of signing the consent form.
- People whose general physical health and ability to carry out daily activities is rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
- People with an estimated life expectancy of at least 3 months.
- People who have at least one tumour that can be measured using standard imaging criteria (RECIST 1.1).
- People diagnosed with invasive breast cancer at a specific stage (T1c N1-2 or T2-4 N0-2 according to standard medical staging) (confirm with trial site).
- People confirmed to have triple-negative breast cancer (TNBC) based on tissue or cell testing, meaning the cancer tests negative for HER2, oestrogen receptors, and progesterone receptors under specific laboratory criteria.
- People who have not previously received any systemic (whole-body) anti-cancer treatment.
- People who have tissue samples available for biomarker testing.
- People whose blood counts meet minimum levels — including white blood cells, platelets, and haemoglobin — without having needed blood transfusions or certain blood-boosting medications in the two weeks before starting the trial.
- People whose liver enzyme and bilirubin levels fall within acceptable ranges on blood tests.
- People whose kidneys are functioning well enough, based on a calculated measure of kidney filtration rate being at least 60 ml/min.
- People whose blood clotting tests fall within acceptable ranges.
- People whose heart pumping function (left ventricular ejection fraction) is at least 50%, as shown by a heart scan.
- People who are willing to use effective medical contraception from the time of signing the consent form until 6 months after the last dose (applies to women who could become pregnant, and to men with partners who could become pregnant).
- People who are willing to take part voluntarily, sign the consent form, follow the study requirements, and 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 whose breast cancer has spread to other parts of the body (Stage IV, also called metastatic breast cancer).
- People whose heart pumping function (left ventricular ejection fraction) is below 50% at the screening stage, or who have other significant heart conditions, or who have a history of severe heart muscle disease (Class III or IV cardiomyopathy as defined by the New York Heart Association) on the same side as the breast cancer.
- People who have already received chemotherapy, hormone therapy, targeted therapy, or radiotherapy for their currently diagnosed breast cancer before joining the trial.
- People who have previously been treated with a therapy targeting a protein called TROP2, or with a type of chemotherapy called a topoisomerase I inhibitor.
- People who have had another cancer in the past 5 years, except for certain fully treated skin cancers or cervical cancer in situ that has been cured.
- People with a known allergy to the study drug or any of its ingredients.
- People with a history of immune system deficiency or who have had an organ transplant.
- People with documented severe dry eye syndrome, severe meibomian gland disease, severe blepharitis, or a history of corneal conditions that may affect healing.
- People with a history of, current, or suspected non-infectious lung inflammation (interstitial lung disease or pneumonitis) that has required steroid treatment or cannot be ruled out by imaging; or people with significant lung problems due to conditions such as pulmonary embolism within the past 3 months, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, fluid around the lungs, certain autoimmune or inflammatory conditions affecting the lungs, or a history of surgical removal of a lung.
- People with an active autoimmune disease that has required systemic (whole-body) treatment within the past 2 years (certain hormone replacement conditions may be excluded from this — confirm with trial site).
- People with an active infection requiring systemic treatment within 2 weeks before the first dose.
- People with other health conditions that, in the investigator's judgement, may pose serious safety risks or affect the person's ability to complete the study — including but not limited to uncontrolled high blood pressure, severe diabetes, or active infections.
- People with any other condition or circumstance that, in the investigator's judgement, may interfere with evaluating the study drug, affect safety, or make participation 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.
Contact this trial
Phone: +86 13709113279
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Xijing Hospital
Registry
ClinicalTrials.gov
Start date
20 August 2025
Est. completion
31 August 2026
Primary endpoints
Pathological complete response rate (pCR)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 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.