Phase 3 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 aged over 18.
- People with breast cancer that has been confirmed as HER2-positive through laboratory testing (either a strong positive result on one test, or a moderate result confirmed by a second test).
- People whose breast cancer has been confirmed by tissue or cell testing and has either come back in the same area or spread to other parts of the body.
- People whose HER2-positive breast cancer got worse while receiving trastuzumab (Herceptin) as a treatment after surgery.
- People whose HER2-positive breast cancer came back or spread after completing trastuzumab treatment following surgery.
- People with HER2-positive breast cancer that has come back or spread and got worse after receiving at least 4 weeks of trastuzumab as a first-line (initial) treatment.
- People with HER2-positive breast cancer that has spread and who had not previously been treated, but whose cancer got worse after receiving at least 4 weeks of trastuzumab as a first-line treatment.
- People whose genetic testing shows a mutation (change) in a specific cell-signalling pathway called PI3K/Akt/mTOR.
- People who are generally well enough to carry out basic daily activities (as measured by a standard medical scoring system), with a life expectancy of at least 6 months and who are able to attend follow-up appointments.
- People who have at least one area of cancer that can be measured on scans, according to a standard set of medical measurement guidelines.
- People whose heart and lung function is broadly normal, with the heart pumping at least 50% of its capacity on a recent test taken within 4 weeks before starting treatment.
- People with adequate liver function, meaning their bilirubin levels are within an acceptable range (up to 1.5 times the upper normal limit, with a specific allowance for people with a known condition called Gilbert's disease).
- People whose liver enzyme levels (AST and ALT) are within acceptable limits — up to 2.5 times the upper normal limit, or up to 5 times the upper normal limit if cancer has spread to the liver.
- People with adequate blood counts, including sufficient white blood cells, platelets (with some flexibility at lower levels if the treating doctor considers it acceptable), and haemoglobin levels.
- People whose blood clotting indicators (INR and aPTT) are within 1.5 times the upper normal limit, unless they are taking medications known to affect these levels.
- People with no history of serious heart, kidney, or other major organ or hormone-related diseases.
- Women of childbearing age who have a negative pregnancy test and are willing to use reliable contraception throughout the trial.
- People who have read and voluntarily signed the informed consent form for this trial.
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 taken part in another clinical trial within the past 4 weeks.
- People who have previously been treated with a type of drug called an mTOR inhibitor.
- People who have previously received a drug called Pyrotinib during first-line treatment (prior use of a related drug called lapatinib is permitted).
- People who are currently taking immunosuppressant or long-term steroid (corticosteroid) medications, or who have had radiotherapy covering more than 25% of their bone marrow within the past 4 weeks.
- People who have active brain or spinal fluid (central nervous system) metastases causing symptoms.
- People with significant problems affecting the digestive system or gut, including active stomach ulcers.
- People who carry hepatitis B or hepatitis C, or who have other known chronic liver disease, or who are HIV positive.
- People with a known allergy or sensitivity to any of the medications used in this trial.
- Women who are pregnant or breastfeeding.
- People whose heart pumping function is below 50%, or who have significant heart rhythm problems, reduced blood flow to the heart, serious heart block, heart failure, or severe heart valve disease.
- People who have had any other cancer in the 5 years before joining the trial, except for certain types that have been fully treated (such as early-stage cervical cancer, or certain types of skin cancer).
- People whose treating doctor considers them unsuitable for the trial for any other medical, social, or psychological reason.
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: Fei Ma, MD, Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College
Phone: 86-10-87788060
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
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
Primary endpoints
Progressive-free Survival (PFS)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.