Printed from Voxsanity (voxsanity.com.au) — NCT07417241 — 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
NCT07417241
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.
- People who have been diagnosed with HER2-positive advanced breast cancer, confirmed through a tissue or cell sample test, with specific test results showing a high level of the HER2 protein.
- People whose general health and ability to carry out daily activities falls within an acceptable range, as measured by a standard medical scoring system (ECOG score of 0, 1, or 2).
- People with an estimated life expectancy of more than 12 weeks.
- People who have at least one tumour that can be measured using standard imaging criteria (called RECIST v1.1).
- People whose cancer stopped responding to trastuzumab (a common HER2-targeted treatment) early, defined in one of two ways: cancer that progressed during or within 12 months of receiving trastuzumab as part of early-stage treatment (for at least 9 weeks); or, for those diagnosed with advanced disease from the start, cancer that progressed during or within 3 months of receiving trastuzumab as a first treatment for advanced disease (for at least 6 weeks).
- People whose blood counts are within acceptable ranges, including white blood cells, platelets, and haemoglobin levels.
- People whose liver function test results are within acceptable ranges, including liver enzymes, bilirubin, and albumin levels (with slightly higher liver enzyme limits allowed if liver spread is present).
- People whose kidney function is within an acceptable range, based on blood tests or a standard calculation.
- People whose blood clotting test results are within acceptable ranges.
- People whose heart pumping function is at least 50%, as measured by a heart scan.
- Women who could become pregnant must have a negative pregnancy test at the screening stage, and all people of reproductive potential must agree to use effective contraception from the start of the study until 6 months after the last dose of study treatment.
- People who agree to take part voluntarily and provide written informed consent before any study-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 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 active cancer spread to the brain or the lining around the brain and spinal cord (those with inactive or symptom-free brain spread may still be considered).
- People who have been diagnosed with another cancer within the past 5 years, except for certain treated and cured cancers such as some skin cancers, early-stage cervical changes, non-invasive breast changes, or very early-stage uterine cancer.
- People who have received radiation therapy, HER2-targeted therapy, or chemotherapy within 4 weeks before joining, or hormone-based cancer therapy within 2 weeks before joining.
- People who test positive for HIV.
- People with a known allergy or sensitivity to any of the study drugs or their ingredients, or to similar types of antibody-based medicines (such as trastuzumab or pertuzumab).
- People with serious heart conditions, such as severe or unstable chest pain, heart failure with symptoms, significant irregular heart rhythms requiring treatment, a heart attack within the past 6 months, or a stroke or mini-stroke.
- People who are known or suspected to have a lung condition called interstitial lung disease.
- People who are already taking part in another clinical trial involving an investigational treatment.
- People who are unwilling to attend the required follow-up visits, or who have a serious physical or mental health condition, or abnormal test results, that the study doctor believes could put them at greater risk, affect the study 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.
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
Principal Investigator: Hanfang Jiang, 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
Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
Peking University Cancer Hospital & Institute
Registry
ClinicalTrials.gov
Start date
31 March 2026
Est. completion
31 January 2029
Primary endpoints
PFS during treatment phase 1
Can't join this trial?
Data last synced from ClinicalTrials.gov: 6 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.