Printed from Voxsanity (voxsanity.com.au) — NCT06561607 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 3 Breast Cancer Trial, Not Yet Recruiting
NCT06561607
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 willing to take part in the study and are likely to follow the study requirements.
- People aged between 18 and 75 years old, with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning they are fully active or have only minor limitations in physical activity).
- People who have been confirmed by lab testing to have locally advanced or metastatic breast cancer that cannot be surgically removed, with low levels of a protein called HER2.
- People whose cancer has a clearly defined hormone receptor (HR) status (confirm with trial site).
- People whose cancer has been shown by imaging scans to have gotten worse during or after their most recent treatment.
- People who have at least one area of cancer that can be measured on scans, according to standard measurement guidelines.
- People whose major organs (such as heart, liver, and kidneys) are working well enough to meet the study's 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 have had another type of cancer in the past 5 years, or who currently have another cancer at the same time.
- People who still have side effects from a previous cancer treatment that are more than mild (above grade 1 on a standard medical scale).
- People who have had major surgery, a surgical biopsy, or a serious injury within 28 days before the start of the study screening period.
- People who have wounds or broken bones that have not properly healed.
- People who have a history of a lung condition called interstitial lung disease or pneumonia that required treatment with steroid medications.
- People who have had moderate to severe lung problems or lung disease in the 3 months before joining the study.
- People who have had a blood clot in an artery or deep vein in the 6 months before joining the study.
- People who have a medical condition that makes it difficult to receive fluids through a vein, to have blood drawn, or who are unable to swallow, or who have ongoing diarrhea, bowel blockage, or other conditions that could affect how study medications are taken or absorbed.
- People who have significant heart problems, including moderate or severe coronary artery disease or a history of heart attack, certain abnormal heart rhythms (including a heart electrical reading called QTc that is 450ms or above for men, or 470ms or above for women), moderate or severe heart failure, chest pain requiring medication, or significant heart valve disease.
- People who have an active or poorly controlled infection rated grade 2 or higher on a standard medical scale within 14 days before joining the study.
- People who have liver cirrhosis or active hepatitis that is not well controlled.
- People whose kidneys have failed and who require dialysis (either haemodialysis or peritoneal dialysis).
- People who have a history of immune system deficiency, including those who are HIV-positive, have another immune deficiency condition, or have had an organ transplant.
- People whose urine tests show a significant amount of protein in the urine, confirmed by a 24-hour urine test showing more than 1.0 g of protein.
- People who have used medications that suppress the immune system, including steroid hormone therapy for immune suppression, within 2 weeks before joining the study.
- People who have a history of abusing substances that affect mental state and are unable to stop, or who have a psychiatric disorder.
- People who have received chemotherapy, high-dose radiotherapy, immunotherapy, or other cancer-fighting treatments within 4 weeks before joining the study, or who are still within 5 half-lives of such a drug (whichever period is shorter).
- People who have received hormone therapy, targeted therapy, or certain traditional Chinese medicines with an approved anti-tumour use within 2 weeks before joining the study.
- People who have cancer that has spread to the lymph vessels throughout the body, or who have moderate or large amounts of uncontrolled fluid build-up around the lungs, in the abdomen, or around the heart that needs repeated draining, or who have had therapeutic draining of such fluid within 2 weeks before joining the study.
- People who have cancer that has spread to the membranes surrounding the brain and spinal cord, or who have active cancer spread to the brain or central nervous system.
- People who have severe bone damage caused by cancer that has spread to the bones.
- People who have already received the chemotherapy drug that would be used as the comparison treatment in this trial during their current advanced or metastatic phase, or for whom that drug is not suitable due to intolerance or other medical reasons.
- People who have previously received treatment specifically targeting the HER2 protein.
- People who have had a serious allergic reaction to humanised monoclonal antibody medications (a type of targeted treatment).
- People who are allergic to any of the study drugs or any of their ingredients.
- People who have taken part in another clinical trial involving an anti-cancer drug within 4 weeks before joining this study.
- People who, in the opinion of the study doctor, have another health condition that could seriously affect their safety or their ability to complete the study, or who are considered unsuitable for other reasons.
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: 13313612989
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 3
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Registry
ClinicalTrials.gov
Start date
1 August 2024
Est. completion
1 January 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Progression-free survival (PFS) in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer as assessed by Independent Review Committee (IRC)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 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.