Printed from Voxsanity (voxsanity.com.au) — NCT07716046 — 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
NCT07716046
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
- Adults aged 18 or older who have breast cancer that has spread or cannot be surgically removed, and where a cure is no longer the goal of treatment.
- People whose breast cancer has been confirmed by a laboratory test to be both hormone receptor-positive (HR+) and HER2-positive (HER2+), as defined by specific test results on tumour tissue.
- People who have not yet received any systemic treatment (such as hormone therapy, chemotherapy, HER2-targeted therapy, or CDK4/6 inhibitor drugs) for their advanced breast cancer.
- People who received treatment before or after surgery are eligible, provided that if hormone therapy was part of that earlier treatment, at least 12 months passed between finishing it and joining the trial, and if HER2-targeted therapy was part of that earlier treatment, at least 6 months passed between finishing it and joining the trial.
- People who have cancer that has spread to the brain, provided it is stable or causing no symptoms, has not progressed on recent scans after local treatment, at least 3 weeks have passed since that local brain treatment ended, and no medication is needed to manage symptoms.
- People with a general health and activity level rated 0 or 1 on the ECOG scale, meaning they are fully active or have only mild restrictions on physical activity (confirm with trial site).
- People of any menopausal status, including pre-menopausal, peri-menopausal, and post-menopausal women, where post-menopausal status is confirmed by specific criteria including age, surgical history, or hormone blood tests (confirm with trial site for specific requirements).
- People who have at least one area of cancer that can be assessed on scans according to standard measurement guidelines (RECIST 1.1).
- Women who could become pregnant must have a negative pregnancy test within 7 days before joining the trial, and must agree to use adequate contraception during the study and for 6 months after the last dose of the study drug fulvestaciclib.
- People who are willing to give informed consent, understand the study, and agree to follow all study procedures and attend follow-up visits.
- People whose blood counts and organ function meet the following minimum levels, confirmed by recent blood tests: sufficient white blood cells, red blood cells, and platelets; healthy liver and kidney function; and a heart pumping function (left ventricular ejection fraction) of at least 50%.
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 inflammatory breast cancer.
- People whose cancer has spread to the membranes lining the brain and spinal cord (leptomeningeal disease).
- People with active brain metastases that are causing symptoms or requiring steroids or other brain-directed treatment within the past 4 weeks.
- People who have been diagnosed with another type of cancer, unless it was a fully treated skin cancer (basal cell or squamous cell) or a fully treated early-stage cervical condition.
- People with a known serious allergic reaction to any ingredient in the study drugs.
- People who have had a heart attack within the past 6 months, have uncontrolled heart rhythm problems (including a specific abnormality on heart tracing), have significant heart failure (NYHA Class III or IV), have a heart pumping function below 50%, or have significant fluid build-up around the heart or lungs requiring treatment.
- People who have difficulty swallowing, active gut or digestive disease, a history of major bowel surgery, a condition that affects how the body absorbs medication, or any other condition that may interfere with the absorption of the study drugs.
- People with a known active infection, including active hepatitis B (at levels above a specified threshold), hepatitis C, syphilis, or HIV.
- People who have had major surgery, radiotherapy, immunotherapy, antibody therapy, or other cancer treatments within 30 days before the first study dose, or any recent therapy that the treating doctor believes may interfere with the study drugs.
- People who are currently taking part in another clinical trial or using another experimental treatment.
- People who have had or are planned to have an organ or bone marrow transplant.
- People with a known history of substance abuse or drug addiction.
- People who the treating doctor considers unsuitable for the trial for any other 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.
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: +86 18017312991
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 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 October 2026
Est. completion
31 August 2030
Primary endpoints
Progression-Free Survival (PFS) Assessed by Investigator
Can't join this trial?
Data last synced from ClinicalTrials.gov: 24 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.