Printed from Voxsanity (voxsanity.com.au) — NCT07581795 — 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, Not Yet Recruiting
NCT07581795
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
- Adults aged 18 or older, of any gender
- People who have had breast cancer confirmed by a laboratory test, where the cancer is advanced or has spread to other parts of the body
- People whose breast cancer has been tested and found to be HER2-positive (a specific protein found on cancer cells, confirmed by laboratory methods)
- People who have not previously received chemotherapy or HER2-targeted treatment for advanced or metastatic breast cancer, or who have only received hormone-based treatment as a first treatment — or people who did receive chemotherapy or HER2-targeted therapy before surgery or after surgery, as long as the cancer came back more than 6 months after that treatment ended
- People whose cancer has tested positive for a protein called PD-L1, with a combined positive score (CPS) of 1 or higher
- People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work) (confirm with trial site)
- People whose doctors estimate they are likely to live for at least 3 more months
- People who have at least one area of cancer that can be measured on a CT or MRI scan
- People whose heart, lungs, liver, and kidneys are working at a basically normal level
- People whose blood and organ function test results meet specific minimum levels, including healthy enough red blood cells, white blood cells, and platelets, as well as liver, kidney, and other blood chemistry results within acceptable ranges (confirm with trial site)
- People who are willing to take part voluntarily, sign a consent form, and follow the study requirements
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 are known to be allergic or sensitive to any of the study medicines or their ingredients
- People whose cancer started in the brain or spinal cord, or whose cancer has spread to the membranes around the brain; also people who have brain metastases that are causing symptoms — though people with brain metastases that are not causing symptoms and have been stable without steroid treatment for at least 4 weeks may still be considered (confirm with trial site)
- People who have had chemotherapy, targeted therapy, or major surgery within the 4 weeks before starting the trial, or hormone therapy or local radiation treatment within the 2 weeks before starting
- People who have, or are suspected to have, a lung condition called interstitial lung disease (ILD) or pneumonia that cannot be ruled out by imaging scans
- People who have had another type of cancer in the past 5 years, unless it was a type that was treated locally and fully cured — certain low-risk cancers are excluded from this restriction (confirm with trial site for specific exceptions)
- People who have received a live vaccine within 28 days before starting treatment
- People who have an active autoimmune disease (a condition where the immune system attacks the body), such as lupus, rheumatoid arthritis, multiple sclerosis, or similar conditions — though people taking stable hormone replacement therapy for an underactive thyroid are not excluded by this criterion
- People who have significant problems with blood clotting or a clear risk of serious bleeding
- People who have had certain serious heart or blood vessel problems in the 6 months before starting treatment, including heart attacks, heart failure, stroke, or severe heart rhythm problems, or whose heart is not pumping strongly enough (confirm with trial site for full details)
- People who have an active hepatitis B, hepatitis C, HIV, or active tuberculosis infection
- People who have an active infection that requires antibiotic, antiviral, or antifungal treatment
- People who have previously had an organ transplant or a bone marrow/stem cell transplant from a donor
- People with a history of substance misuse involving psychiatric medications that cannot be stopped, or people with a mental health disorder
- People who are pregnant or breastfeeding, or people of reproductive age who are not willing or able to use effective contraception
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: +8618017312991
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
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
1 February 2029
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Objective response rate （ORR）
Can't join this trial?
Data last synced from ClinicalTrials.gov: 20 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.