Printed from Voxsanity (voxsanity.com.au) — NCT06245824 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 4 Breast Cancer Trial, Not Yet Recruiting
NCT06245824
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 have given informed consent before any study-related procedures take place.
- People aged 18 years or older.
- People with a pathology-confirmed diagnosis of advanced or metastatic breast cancer that has tested HER2-positive (IHC3+ or ISH+) on examination of either the primary or metastatic tumour at the trial site's pathology laboratory, and which may be hormone receptor-positive or hormone receptor-negative.
- People who have not received any chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer, or who have received only one previous line of hormone therapy for metastatic disease; people who received chemotherapy or HER2-targeted therapy before surgery or after surgery are eligible if more than 6 months passed between that treatment and their metastatic diagnosis.
- People with brain metastases that are either untreated but not causing symptoms requiring urgent surgery or steroid treatment, or previously treated and either stable or progressing (confirm with trial site).
- People with a performance status score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity.
- People who have at least one tumour that can be measured according to standard imaging criteria (RECIST 1.1).
- People whose heart pumping function (left ventricular ejection fraction) is 50% or greater, as measured within 28 days before screening.
- People with a life expectancy of at least 12 weeks at the time of screening.
- People with adequate blood, liver, and kidney function within 28 days before joining the trial, including: sufficient white blood cell, platelet, and haemoglobin levels without recent transfusion or growth factor support; liver function and protein levels within acceptable ranges; and kidney function showing a creatinine clearance of at least 30 mL/min; and normal blood clotting measures (for those not on blood thinners).
- People who have waited long enough since their last treatment before screening, including at least 4 weeks after major surgery or chest radiation, at least 2 weeks after brain or other palliative radiation, at least 3 weeks after hormone therapy, and at least 14 days after chloroquine or hydroxychloroquine.
- People of any gender, who agree to use contraception consistent with local regulations for clinical trial participants.
- Women who are sexually active with a non-sterilised male partner and have a negative pregnancy test (urine or blood) at screening.
- Women who are either post-menopausal for at least 1 year, surgically sterile, or using a highly effective form of contraception (less than 1% failure rate per year when used correctly) from screening through to 7 months after the last dose; women must also agree not to donate eggs or breastfeed during this period, and their non-sterilised male partners must use a condom plus spermicide (or condom alone where spermicide is not approved).
- Men who plan to be sexually active with a female partner who could become pregnant must be surgically sterile or use an accepted contraceptive method from screening through to 4 months after the last dose, and must not donate or bank sperm during this time.
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 not eligible for any of the study drugs, or who have medical reasons (contraindications) that prevent them from taking pyrotinib or T-DXd.
- People who have previously been assigned to receive pyrotinib or T-DXd in this study, or who have previously been treated with any other HER2-targeted tyrosine kinase inhibitor (TKI) drug.
- People who have previously received an antibody-drug conjugate containing a specific type of chemotherapy agent called a topoisomerase I inhibitor derived from exatecan.
- People who are currently receiving any other cancer treatment (a 3-week washout period is required for those on hormone replacement therapy or endocrine therapy for hormone receptor-positive tumours).
- People who are currently enrolled in another interventional clinical trial (participation in an observational study or the follow-up phase of a completed study is acceptable).
- People with ongoing severe nausea, vomiting, or diarrhoea, a chronic gastrointestinal disease, or a history of significant bowel surgery.
- People with substance use issues or other medical or psychological conditions that the investigator believes could interfere with participation or the interpretation of results.
- People with a history of another cancer, unless it was treated with curative intent, has shown no signs of active disease for at least 5 years, and carries a low risk of returning — with specific exceptions for certain types of treated skin cancers and in situ cancers.
- People with side effects from previous cancer treatment that have not yet resolved to mild or baseline levels (other than hair loss), except for certain stable long-term effects such as nerve damage from chemotherapy, fatigue, or specific mild hormonal or skin side effects from prior immunotherapy, provided these have been stable for at least 3 months.
- People with spinal cord compression or active, symptomatic brain metastases that require steroids or anti-seizure medication; people with treated, symptom-free brain metastases who no longer need such medications may be eligible if they have recovered from radiotherapy side effects and at least 2 weeks have passed since completing brain radiation.
- People with active primary immune deficiency, known HIV infection, or active hepatitis B or C infection; people with past hepatitis B or C infection may be eligible only if specific blood test criteria are met and local hepatitis B expertise is available (confirm with trial site).
- People with an active infection requiring intravenous antibiotics, antiviral, or antifungal treatment.
- People who have had a heart attack within the 6 months before starting the study, who have significant heart failure symptoms (NYHA Class II–IV), or who have elevated troponin levels at screening without heart-related symptoms (a heart specialist review is required before enrolment in this case).
- People with a history of non-infectious lung inflammation (interstitial lung disease or pneumonitis) that required steroid treatment, who currently have this condition, or where this condition cannot be ruled out on imaging at screening.
- People with significant ongoing lung conditions including, but not limited to, blood clots in the lungs within the past 3 months, severe asthma, severe COPD, restrictive lung disease, significant fluid around the lungs, or lung scarring following COVID-19.
- People with autoimmune, connective tissue, or inflammatory disorders (such as rheumatoid arthritis, Sjögren's syndrome, or sarcoidosis) where there is confirmed or suspected lung involvement at the time of screening.
- People who have had a lung removed (pneumonectomy).
- People who have received a live attenuated vaccine within 30 days before starting the study (mRNA and certain adenoviral vaccines are not considered live attenuated vaccines and are not subject to this restriction).
- People who, in the investigator's judgement, are unlikely to follow the study procedures and requirements.
- People who are pregnant or breastfeeding.
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.
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
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Trial details
Status
Not Yet Recruiting
Phase
Phase 4
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Registry
ClinicalTrials.gov
Start date
30 January 2024
Est. completion
1 March 2026
This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Progression free survival (PFS) based on investigator assessment
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 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.