Phase 2 Breast Cancer Trial, Not Yet Recruiting
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 the ages of 18 and 75 years.
- People with a confirmed diagnosis of HER2-positive advanced breast cancer, verified through laboratory testing of tissue or cell samples.
- People with brain metastases (cancer that has spread to the brain) confirmed by imaging, with two separate groups in the trial: Cohort A is for people who also have cancer involvement in the lining around the brain and spinal cord (confirmed by MRI scan or fluid testing), and Cohort B is for people without that involvement who have at least one measurable brain tumour, whether previously treated or not.
- People whose doctors expect them to live for more than 12 weeks.
- People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale, meaning they are able to carry out at least some daily activities (confirm with trial site).
- People whose blood counts meet minimum levels — including white blood cells, platelets, and red blood cells — as measured by recent lab tests.
- People whose liver function test results fall within acceptable ranges, as measured by recent lab tests.
- People whose kidney function is within an acceptable range, as measured by recent lab tests.
- People whose blood clotting test results are within acceptable ranges, as measured by recent lab tests.
- People whose heart pumping function is at 50% or above, as confirmed by a heart scan.
- People who test negative for pregnancy before starting the trial, and who agree to use a reliable form of contraception from the start of the trial until at least 6 months after the last dose of the study medication.
- People who agree to participate voluntarily and provide written consent before any trial-related procedures begin.
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 applying for Cohort A who have a blockage in the flow of fluid around the brain and spinal cord that cannot be managed with treatment.
- People applying for Cohort A whose MRI scan shows a particular pattern of cancer spread around the brain lining, but whose spinal fluid test came back negative (confirm with trial site).
- People applying for Cohort A who have an active infection in the brain or spinal cord.
- People applying for Cohort A who have a significant problem with blood clotting.
- People applying for Cohort B who have evidence of cancer involving the lining around the brain or spinal cord, based on imaging, fluid testing, or clear clinical signs or symptoms.
- People who have a significant build-up of fluid in the chest or abdomen that cannot be adequately managed by draining or other treatments.
- People with a known allergy or sensitivity to any of the study drugs, their ingredients, or to similar antibody-based medicines such as trastuzumab or pertuzumab.
- People who have previously received, or are currently receiving, a type of cancer treatment called an antibody-drug conjugate (ADC) that contains a topoisomerase I inhibitor, including a drug known as fam-trastuzumab deruxtecan (DS-8201a).
- People with significant heart or blood vessel problems, including severe chest pain, heart failure with symptoms, certain heart rhythm problems requiring treatment, a heart attack within the past 6 months, or a stroke or mini-stroke.
- People known or suspected to have a condition involving scarring or inflammation of the lungs (interstitial lung disease).
- People who are currently taking part in another clinical trial involving an investigational drug.
- People who are unwilling to attend the follow-up visits required by the trial.
- People who have any other serious physical or mental health condition, or abnormal lab results, that the trial doctor believes could put them at risk, affect the trial results, 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.
Contact this trial
Principal Investigator: Bin Shao, Peking University Cancer Hospital & Institute
Phone: +86-010-88196380
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Primary endpoints
1. Number of Dose-Limiting Toxicities (DLTs) in the Sequential Dose-Escalation Cohort; CNS-PFS
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.