Printed from Voxsanity (voxsanity.com.au) — NCT06404463 — 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
NCT06404463
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 voluntarily and sign a consent form.
- Women aged 18 to 70 years old who have been newly diagnosed with breast cancer confirmed by tissue testing as ER-positive and HER2-negative, with a histological grade of II, a Ki-67 score of 20% or higher, and a specific stage of cancer spread (TNM stage T1c-T2 with cN1-cN2, or T3-T4 with cN0-cN2), as defined by the latest ASCO/CAP guidelines.
- People who have at least one tumour that can be measured using standard imaging criteria (RECIST 1.1).
- People with a general health score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity.
- People who can provide tumour tissue samples for biomarker testing.
- People whose major organ functions meet all of the following blood and laboratory test requirements (no blood transfusions or certain growth-factor medicines allowed in the 14 days before the first dose): (1) neutrophil count of at least 1.5×10⁹/L; (2) platelet count of at least 100×10⁹/L; (3) haemoglobin of at least 90 g/L; (4) serum albumin of at least 30 g/L; (5) thyroid-stimulating hormone (TSH) within normal limits, or if slightly outside normal, thyroid hormone levels (FT3 and FT4) must be normal; (6) total bilirubin no more than 1.5 times the upper limit of normal; (7) liver enzyme levels (ALT and AST) no more than 2.5 times the upper limit of normal, or up to 5 times if liver spread is present; (8) ALP enzyme and creatinine levels within acceptable limits; (9) a blood clotting measure (INR) of no more than 1.5, for people not on blood-thinning medication.
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 an active autoimmune disease or a history of one (such as autoimmune hepatitis, lung inflammation, eye inflammation, bowel inflammation, pituitary inflammation, blood vessel inflammation, kidney inflammation, or overactive thyroid); people with vitiligo or childhood asthma that has fully resolved and needs no treatment as an adult may still be considered, but those who need bronchodilator medicines for asthma would not be eligible.
- People who are currently using immune-suppressing medicines or steroid hormone therapy at doses above 10 mg per day of prednisone (or equivalent), and who have been doing so within the 2 weeks before enrolment.
- People who have had severe allergic reactions to other monoclonal antibody medicines.
- People with a known history of interstitial lung disease or active non-infectious lung inflammation.
- People with known cancer spread to the brain or central nervous system.
- People who have had another type of cancer in the past 5 years or at the same time as this diagnosis, except for fully treated skin basal cell carcinoma or cervical cancer in situ.
- People with high blood pressure that cannot be brought under control with medication (systolic blood pressure of 140 mmHg or higher, or diastolic blood pressure of 90 mmHg or higher); people who have previously had a hypertensive crisis or hypertensive encephalopathy (a serious brain condition caused by very high blood pressure).
- People with significant heart problems that are not well controlled, including: heart failure rated grade 2 or above on the NYHA scale; unstable angina (chest pain); a heart attack within the past year; certain serious heart rhythm problems requiring treatment; or a prolonged QTc interval on an ECG (above 450 ms for men or 470 ms for women).
- People who are currently receiving clot-dissolving (thrombolysis) or blood-thinning (anticoagulation) therapy; low-dose aspirin and low-molecular-weight heparin used for prevention are permitted.
- People who have had significant bleeding symptoms or a clear tendency to bleed in the 3 months before enrolment; if a stool blood test is positive at the start, it will be repeated, and if still positive, a gastroscopy will be required (confirm with trial site).
- People whose cancer has grown into major blood vessels, or where the treating doctor judges from imaging that the cancer is likely to grow into major blood vessels during the study, which could cause life-threatening bleeding.
- People who have fluid build-up around the lungs, in the abdomen, or around the heart that requires drainage — unless the treating doctor assesses that symptoms are stable after drainage.
- People who have had a blood clot or stroke event in the 6 months before enrolment, such as a mini-stroke (TIA), brain bleed, brain infarction, deep vein thrombosis, or pulmonary embolism.
- People with a known inherited or acquired tendency to bleed or clot abnormally (such as haemophilia or clotting disorders).
- People who have had major blood vessel disease in the 6 months before the start of treatment (for example, an aortic aneurysm needing surgery, or a recent arterial blood clot in the limbs).
- People whose urine test shows significant protein in the urine (2+ or more), confirmed by a 24-hour urine protein amount of more than 1.0 g.
- People who have an active infection, an unexplained fever of 38.5°C or higher in the 7 days before starting the medicine, or a white blood cell count above 15×10⁹/L at the start.
- People with a known immune deficiency condition such as HIV infection; people who test positive for hepatitis B surface antigen with active hepatitis B virus levels at or above 2000 IU/ml; or people who test positive for hepatitis C virus antibodies.
- People who have received a live vaccine within 4 weeks before starting the study medicine, or who may need to receive a live vaccine during the study period.
- People who, in the judgement of the treating doctor, have other factors that could affect the study results or safety, such as alcohol or drug misuse, other serious illnesses (including mental health conditions) needing additional treatment, significantly abnormal laboratory results, or family and social circumstances that may affect their wellbeing during 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: Zhimin Shao, MD,PhD, Breast cancer institute of Fudan University Cancer Hospital
Phone: +86-021-64175590
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
6 May 2024
Est. completion
6 November 2025
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.
Primary endpoints
Total Pathological complete response (tpCR) rate using the definition of ypT0/Tis ypN0
Can't join this trial?
Data last synced from ClinicalTrials.gov: 29 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.