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Phase 2 Breast Cancer Trial, Not Yet Recruiting
NCT06849947
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 at least 19 years old at the time of signing the consent form.
- People who have advanced breast cancer (either spread to nearby areas or to other parts of the body) that cannot be cured.
- People whose breast cancer is hormone receptor (HR)-positive and HER2-negative, based on the most recently tested biopsy sample.
- People whose HER2-negative status has been confirmed through specific laboratory tests according to established medical guidelines (confirm with trial site for exact test details).
- People whose hormone receptor-positive status has been confirmed through a specific laboratory test according to established medical guidelines (confirm with trial site).
- People who have previously received at least 1 year of adjuvant treatment with abemaciclib or ribociclib (medicines taken after initial treatment to reduce the chance of cancer returning).
- People whose advanced breast cancer returned at least 1 year after their last dose of adjuvant CDK4/6 inhibitor treatment (a type of targeted therapy taken after initial treatment).
- People who have received at least 2 years of adjuvant hormone therapy (either on its own or combined with CDK4/6 inhibitor treatment).
- People who are generally well enough to carry out normal daily activities, with little or no limitation (described medically as ECOG performance status 0 or 1).
- People who have at least one area of cancer that can be measured on a scan, or at least one bone lesion of a specific type (lytic bone lesion) if no measurable lesions are present.
- People whose blood counts and organ function meet the following minimum levels based on recent blood tests:
- White blood cell count (neutrophils) at or above a certain level.
- Platelet count at or above a certain level.
- Haemoglobin (a measure of red blood cells) at or above a certain level.
- Kidney function within an acceptable range.
- Liver enzyme levels within an acceptable range (with slightly higher levels permitted if cancer has spread to the liver).
- Bilirubin (a liver-related substance) within an acceptable range, with specific allowances for people with a known condition called Gilbert's Syndrome.
- People who are able to swallow the study medication.
- People who are able to communicate with the research team and follow the study procedures.
- People who are willing to stay at the clinical site as required by the study.
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 whose cancer returned one year or more after finishing adjuvant hormone therapy.
- People who have been off hormone therapy for at least 2 years.
- People whose cancer returned during, or within 1 year of, their adjuvant CDK4/6 inhibitor treatment.
- People who previously received adjuvant palbociclib (a specific CDK4/6 inhibitor), regardless of how long their cancer stayed away.
- People who did not receive any adjuvant CDK4/6 inhibitor treatment, or who received less than 1 year of it.
- People who previously received a medicine called fulvestrant as part of their adjuvant (post-surgery) treatment.
- People who have received any systemic (whole-body) treatment for advanced breast cancer.
- People who have not yet recovered from side effects of previous cancer treatments to an acceptable level, with some exceptions allowed (such as certain nerve-related side effects from taxane chemotherapy, hair loss, or other effects the treating doctor considers low risk).
- People who currently have, or have had, another cancer within the past 3 years — except for certain skin cancers or cervical cancer that has been fully removed and treated.
- People who have brain metastases (cancer that has spread to the brain) that are causing symptoms and have not yet been treated locally.
- People who have significant problems with their digestive system that could affect how the study medicines are absorbed (for example, severe nausea, vomiting, diarrhoea, or certain bowel conditions).
- People with a known history of HIV infection.
- People with any other serious, uncontrolled medical condition that the treating doctor believes would make participation unsafe (for example, chronic pancreas or liver inflammation).
- People with significant or uncontrolled heart disease or abnormal heart electrical activity, including any of the following:
- A heart attack, chest pain (angina), inflamed heart lining, or heart bypass surgery within the past 6 months.
- A diagnosed condition of weakened heart muscle (cardiomyopathy).
- A personal or family history of certain heart rhythm conditions, or risk factors for a specific dangerous heart rhythm abnormality, including abnormal levels of certain minerals in the blood, history of heart failure, or a significantly slow heart rate.
- Current use of medicines known to affect heart rhythm in a dangerous way that cannot be safely stopped or replaced.
- Inability to assess a specific heart measurement called the QTcF interval.
- Certain serious heart rhythm abnormalities or specific types of heart block (disruptions to the heart's electrical signals).
- People who are currently taking certain medicines, herbal supplements, or foods (such as grapefruit, star fruit, Seville oranges, or pomelos) that strongly affect how the body processes certain drugs, and who cannot stop these at least 7 days before starting the study.
- People who are currently taking medicines that have a very narrow safe dosing range and are processed by the same liver pathway as the study drugs.
- People who have had major surgery within 14 days before starting the study, or who have not yet recovered from major surgical side effects.
- People who have taken another investigational (experimental) drug within 14 days before the first day of treatment, or within 5 half-lives of that drug — whichever period is longer.
- People who have recently received systemic corticosteroids (steroid medicines given throughout the body) within 2 weeks before starting the study, or who have not fully recovered from their effects. Note: certain limited uses of steroids are permitted, such as single doses, skin creams, inhalers, eye drops, or local injections.
- People who are currently using other anti-cancer treatments (except for adjuvant hormone therapy alone).
- People who have received radiotherapy within 4 weeks before joining the study, or limited targeted radiation for symptom relief within 2 weeks, and who have not recovered adequately from its side effects, or where a large portion of the bone marrow was included in the radiation field.
- People who are pregnant or breastfeeding.
- People who are capable of becoming pregnant and are not using a highly effective method of contraception during treatment and for a required period afterwards (at least 3 weeks after the last dose of ribociclib, 2 years after the last dose of fulvestrant, and up to 8 weeks after the last dose of everolimus). Accepted methods include total abstinence (if this is the person's usual lifestyle), full surgical removal of the uterus, tubal ligation at least 6 weeks before starting treatment, a vasectomised sole male partner (vasectomy at least 6 months prior), or a combination of barrier methods such as condoms and an intrauterine device (IUD). Note: periodic abstinence or withdrawal methods are not accepted.
- People who are not able to understand or follow the study instructions and requirements.
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: 0234103459
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
Yeon Hee Park
Registry
ClinicalTrials.gov
Start date
1 February 2026
Est. completion
30 June 2031
Primary endpoints
Progression Free Survival
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 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.