Printed from Voxsanity (voxsanity.com.au) — NCT07041437 — 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
NCT07041437
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 aged 18 to 75 years old who have advanced or metastatic breast cancer.
- People with a good general health and activity level, as measured by a standard performance score of 0 or 1 (meaning mostly active and able to carry out daily activities with little or no restriction).
- People who have at least one tumour or lesion that can be measured on a scan, according to standard measurement guidelines (RECIST v1.1).
- People who are expected to live for at least 3 months.
- People whose organs (such as liver and kidneys) and bone marrow are functioning well enough, without needing corrective treatment in the 14 days before the first dose.
- Women who could become pregnant must agree to use an effective form of contraception from the start of screening until 7 months after the last dose, must not be breastfeeding during this period, and must have a negative blood pregnancy test within 7 days before the first dose; men who have not had both testicles removed and who may have sexual contact with a woman who could become pregnant must use contraception from enrolment until 7 months after the last dose.
- People who are willing and able to sign a consent form and follow all the study 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 with active (currently spreading or untreated) brain metastases; however, people with stable brain metastases may be eligible if at least 4 weeks have passed since brain-directed treatment and they meet certain conditions — such as no signs of progression on imaging, no symptoms requiring steroid or anti-seizure medication, or symptoms that do not require an increase in steroid dose (confirm with trial site).
- People who have uncontrolled fluid build-up in body cavities (such as the abdomen, around the lungs, or around the heart) that required drainage more than once in a 4-week period.
- People who have had another cancer in the past 2 years that has required treatment (other than hormone replacement therapy), except for certain cancers that were fully cured, such as cervical cancer in situ, basal cell skin cancer, squamous cell skin cancer, or papillary thyroid cancer.
- People who received cancer treatments such as surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks before the first dose, or hormone-based cancer therapy within 1 week before the first dose.
- People who still have side effects from previous cancer treatment that have not improved to a mild level (grade 1 or lower), except for hair loss or certain ongoing low-level side effects considered acceptable by the study doctor.
- People who are receiving or plan to receive other systemic cancer treatments during the study.
- People who have recently taken strong inhibitors or inducers of certain liver enzymes or drug transporters (CYP3A4, CYP2D6, P-gp, or BCRP) within a timeframe based on the specific drug's half-life (confirm with trial site).
- People who are allergic to the study drug or any of its ingredients.
- People with known significant lung conditions, including interstitial lung disease, pneumonitis (lung inflammation), or pulmonary fibrosis (lung scarring).
- People with a known history of immune system disorders, including HIV, other immune deficiency conditions, or a history of organ transplant or bone marrow/stem cell transplant from a donor.
- People with active hepatitis B (based on specific blood test results), active hepatitis C, or liver cirrhosis.
- People with an active infection currently being treated with antibiotics, antiviral, or antifungal medicines, or who have an unexplained fever above 38.5°C during the screening period before the first dose (people whose fever is related to their cancer may still be considered, at the study doctor's discretion).
- People with serious heart or blood vessel conditions, including: certain serious heart rhythm or conduction problems; a prolonged QT interval on a heart tracing (ECG) above specified thresholds; recent serious heart events such as heart attack, heart failure (NYHA Class II or higher), aortic dissection, or stroke; a heart pumping function below 50%; or high blood pressure that is not well controlled.
- People who have had a blood clot event (such as a stroke, mini-stroke, brain bleed, deep vein thrombosis, or pulmonary embolism) within the 6 months before the first dose.
- (Arm 2 of the trial only) People who have previously received or are currently receiving a type of immunotherapy called a PD-1 or PD-L1 inhibitor.
- (Arm 2 of the trial only) People who have an active autoimmune disease or a history of certain autoimmune conditions (such as autoimmune hepatitis, inflammatory bowel disease, vasculitis, or uncontrolled thyroid conditions); some autoimmune conditions may still be permitted — such as vitiligo, controlled type 1 diabetes treated with insulin, or childhood asthma that is fully resolved — but asthma that currently requires a bronchodilator is not permitted; people who have been taking steroid tablets above a certain dose (more than 10mg prednisone daily or equivalent) or other immune-suppressing medicines within 2 weeks before the first dose are also not eligible.
- (Arm 2 of the trial only) People who have received a live vaccine within 4 weeks before the first dose, or who may need a live vaccine during the treatment period.
- People who have any other condition that, in the study doctor's opinion, may affect the conduct or results of the study.
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: Hongxia Wang, Chief physician, Fudan University
Phone: +862138196379
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
Registry
ClinicalTrials.gov
Start date
30 June 2025
Est. completion
30 September 2026
Where this trial is recruiting
🇨🇳 China
Primary endpoints
ORR by investigator
Can't join this trial?
Data last synced from ClinicalTrials.gov: 9 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.